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The FDA has accepted a supplemental new drug application (sNDA) for empagliflozin tablets (Jardiance) from Boehringer Ingelheim Pharmaceuticals Inc and Eli Lilly and Company, which is being investigated as a potential treatment to reduce the risk of disease progression and cardiovascular death in individuals with 

“There is a significant need for additional therapies that reduce the risk of kidney disease progression and hospitalizations in adults with CKD,” Mohamed Eid, MD, MPH, MHA, vice president of clinical development and medical affairs in cardio-renal-metabolism and respiratory medicine at Boehringer Ingelheim, said in a statement. “This application acceptance is an important step forward for the approximately 37 million [individuals] in the [United States] living with CKD.”

The sNDA is based on results from EMPA-KIDNEY (

), a phase 3 trial, which showed that empagliflozin significantly reduced the risk of disease progression or cardiovascular death in individuals with CKD by 28% compared with the placebo. Both arms were used, in addition to the standard of care.

The study was the first (sodium-glucose co-transporter 2) SGLT2 inhibitor CKD trial to show a significant reduction in the risk of hospitalization of any cause, at a 14% relative risk reduction with empagliflozin compared with the placebo and the top of standard of care.

Investigators also saw that the reductions in key secondary endpoints, including hospitalization for heart failure, cardiovascular death, or all-cause death were not statistically significant.

“This marks another exciting milestone for [empagliflozin], potentially extending its ability to positively impact the approximately 1 billion [individuals] diagnosed with a cardio, renal, or metabolic condition,” Jeff Emmick, MD, PhD, vice president of product development at Lilly, said in the statement. “We look forward to working with the FDA during the review process and eagerly await a decision later this year on the indication for CKD, which doubles a person’s risk for hospitalization.”

EMPA-KIDNEY was the largest and broadest SGLT2 inhibitor trial for CKD to date and provided additional data for individuals who are commonly seen in clinical practice. Investigators enrolled 6609 individuals, including individuals without diabetes, those with underlying causes of CKD, and those across the spectrum of estimated glomerular filtration rate (eGFR) and urine albumin-creatine ratio.

The safety profile from the trial was consistent with the previously known safety profile for empagliflozin.

Empagliflozin is a once-daily tablet that is prescribed alongside diet and exercise to lower blood sugar for individuals with type 2 diabetes (T2D). It also is indicated to reduce the risk of cardiovascular death with T2D and known cardiovascular diseases.

Empagliflozin can also be used to reduce the risk of cardiovascular death and hospitalization for heart failure (HF) in individuals with HF.

It is not used for individuals with type 1 diabetes or to improve glycemic control in individuals with T2D with an eGFR <30 mL/min/1.73 m2.

The results were presented during the American Society of Nephrology’s Kidney Week 2022 and published in 

US FDA accepts supplemental new drug application for Jardiance for adults with chronic kidney disease. Lilly. News release. January 20, 2023. Accessed January 23, 2023. https://investor.lilly.com/news-releases/news-release-details/us-fda-accepts-supplemental-new-drug-application-jardiancer-0

Articles

The supplemental new drug application is based on results from a landmark phase 3 trial showing that empagliflozin tablets provided meaningful results.

FDA Accepts sNDA for Jardiance as Potential Treatment for Chronic Kidney Disease

The FDA has approved Adacel (tetanus toxoid, reduced diptheria toxoid, and acellular pertussis vaccine; Tdap) during the third trimester of pregnancy to help protect against pertussis in infants younger than 2 months of age.

The Adacel vaccine is FDA-approved for active booster immunization against tetanus, diphtheria, and pertussis in individuals ages 10 through 64 years. It was the first vaccine globally to have a licensed indication for use in pregnancy to help prevent pertussis in young infants.

Pertussis is a highly contagious respiratory infection. Very young infants are at the highest risk of complications due to pertussis because of their still developing immune systems, and nearly half of babies ages 6 months and younger who get pertussis may need care in the hospital. Additionally, 1 out of 100 infants hospitalized for pertussis dies.

Although it can be prevented with vaccination, pertussis often goes undiagnosed. It can lead to severe and sometimes life-threatening health problems, such as exacerbation of chronic medical conditions such as asthma. For children and adults, initial symptoms typically develop between 7 and 10 days after exposure and are the same as a common cold. The next stage of illness is characterized by frequent bouts of paroxysmal cough and inspiratory whooping.

The CDC recommends Tdap vaccination during every pregnancy. When given during the third trimester, Adacel can help pregnant individuals create antibodies against the bacteria that cause pertussis, which are passed to the infant before birth. These antibodies help protect the infant against whooping cough during the first few months of life.

The efficacy of Adacel when administered during the third trimester to prevent pertussis among infants younger than 2 months of age was established in a clinical study using innovative real-world data, according to a press release. In that study, the efficacy of the vaccine at preventing pertussis was found to be 88%.

Available safety data in the retrospective passive surveillance study and ongoing pregnancy registry during the third trimester of pregnancy did not reveal any vaccine-related adverse effects on pregnancy or on the fetus or infant.

“We are pleased to receive the FDA’s approval for use of Adacel vaccine specifically during pregnancy to help protect young infants against pertussis, a potentially life-threatening disease,” said Michael Greenberg, MD, MPH, North America Medical Head of Vaccines at Sanofi, in the press release. “We pursued the label expansion to align fully with the long-standing health agency recommendations to provide Tdap vaccination to every woman in every pregnancy. We hope for higher and higher rates of Tdap vaccination in pregnancy so that fewer and fewer infants are likely to get pertussis.”

FDA approves Adacel for immunization during pregnancy to help protect young infants against pertussis. News release. Sanofi; January 17, 2023. Accessed January 17, 2023. 

https://www.news.sanofi.us/2023-01-17-FDA-approves-Adacel-R-for-immunization-during-pregnancy-to-help-protect-young-infants-against-pertussis

The vaccine was 88% effective at preventing pertussis among infants younger than 2 months when administered during the third trimester of pregnancy.

FDA Approves Adacel Vaccine During Pregnancy to Protect Infants Against Pertussis

The FDA has granted emergency use authorization (EUA) to a molecular polymerase chain reaction (PCR) assay test manufactured by Becton, Dickinson and Company (BD) and CerTest Biotec for detection of monkeypox (Mpox) virus. The VIASURE Monkeypox Virus Real Time PCR Reagents for BD MAX System may help to inhibit the global spread of the infectious virus.

"The Mpox outbreak continues to be designated as a global health emergency—the World Health Organization's highest level of alert," said Nikos Pavlidis, vice president of Molecular Diagnostics at BD, in a press release. "The large installed base of the BD MAX System in hospital labs provides broad access to testing for a wide range of infectious diseases, now including the mpox virus. EUA for the assay enables it to be used for timely diagnosis and may help avert further global spread of the disease."

 is a double-stranded DNA viral infection that was initially discovered when 2 outbreaks occurred in 1958 in a research laboratory with monkeys in Africa. Signs and symptoms of the virus typically present within 3 weeks of exposure with a painful, blister-like rash frequently occurring around the genitals; however, the rash may also develop around the face, chest, hands, or feet.

Other symptoms of Mpox include swollen lymph nodes, fever, fatigue, muscle ache, or respiratory symptoms that present as a cough or sore throat. The virus is self-limiting with a recovery period typically lasting 2 to 4 weeks; however, until the rash resolves and new skin forms, the virus can still spread. Individuals with an active infection should isolate, avoid intimate activity, avoid sharing personal household items, and sanitize hands and any objects or surfaces they come in contact with.

According to the CDC, there have been more than 80,000 Mpox cases reported worldwide. There have been more than 29,000 cases and 14 deaths reported in the United States. The number of Mpox cases is expected to rise, which requires ongoing testing, vaccinations, and medication services by health care providers, including pharmacists.

The fully integrated, automated BD MAX System allows nucleic acid extraction and real-time PCR to produce results for up to 24 samples across multiple syndromes in under 3 hours, according to BD. The system provides an extensive variety of tests for health care-associated infections, respiratory infections, sexually transmitted infections, gastrointestinal infections, and women's health, according to BD.

The VIASURE Monkeypox Virus PCR Detection assay for the BD MAX System is available in a lyophilized format. The assay is available in a tube that snaps into a test-specific position on the BD MAX ExK TNA extraction strip supplied by BD.

"We were able to quickly develop the VIASURE mpox molecular test by leveraging the BD MAX System's open system reagent suite," said Nelson Fernandes, managing director of CerTest Biotec, in a press release. "The EUA for the assay enables use for clinical diagnosis of the disease, in addition to surveillance and the research and development of vaccines and treatments."

BD, CerTest Biotec Announce Emergency Use Authorization for Mpox Diagnostic Test. BD. News release. 

https://news.bd.com/2023-01-09-BD,-CerTest-Biotec-Announce-Emergency-Use-Authorization-for-Mpox-Diagnostic-Test

The number of Mpox cases is expected to rise, which requires ongoing testing, vaccinations, and medication services by health care providers.

FDA Grants Emergency Use Authorization to PCR Assay Test for Monkeypox Virus

The FDA has approved tocilizumab (Actemra; Genentech) for the intravenous (IV) treatment of COVID-19 in individuals who are hospitalized and are receiving systemic corticosteroids and require supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation. Tocilizumab is the first FDA-approved monoclonal antibody treatment of COVID-19, recommended for use as a single 60-minute IV infusion.

“With new variants emerging, FDA-approved treatments including [tocilizumab] remain essential to the continued fight against COVID-19,” said Levi Garraway, MD, PhD, chief medical officer and head of Global Product Development at Genentech, in a statement. “[Tocilizumab] is the first FDA-approved monoclonal antibody for treating patients with severe COVID-19, providing an important option for hospitalized patients and their healthcare providers who continue to be on the frontlines treating COVID-19.”

Investigators evaluated tocilizumab for the treatment of COVID-19 in 4 randomized, controlled studies (

) in more than 5500 individuals who were hospitalized. The results of the 4 studies showed that tocilizumab may improve outcomes in individuals who were receiving corticosteroids and required supplemental oxygen or breathing support.

The FDA approval is based on the results from the RECOVERY (

) trials in particular. The EMPACTA trial was the first global, phase 3 study investigating COVID-19 that focused on individuals from underrepresented racial and ethnic groups. There were no new warnings or precautions related to tocilizumab noted in the trials, with the most common adverse events being anxiety, constipation, diarrhea, hypertension, insomnia, nausea, and urinary tract infection.

Tocilizumab is the first humanized interleukin-6 receptor antagonist and has also been approved for the treatment of individuals with moderately active rheumatoid arthritis who have used 1 or more disease-modifying antirheumatic drugs, including methotrexate, that did not offer enough relief.

The approval follows the FDA’s emergency use authorization (EUA) issued in June 2021 for the drug in hospitalized adults and children aged 2 years and older with COVID-19. However, the FDA approval does not include individuals aged 2 years to less than 18 years. The EUA for this age range currently remains in place after the FDA approval of tocilizumab for adults.

Tocilizumab is approved for use for COVID-19 in the United States, European Union, Japan, the United Kingdom, New Zealand, Russia, and Brazil. It is also provisionally approved in Australia and authorized for emergency use in Ghana, Mexico, and Korea for individuals who are hospitalized with severe or critical COVID-19. WHO has also recommended and prequalified the drug.

Genentech and Roche said that the worldwide manufacturing capacity of tocilizumab has significantly increased in 2022, which resulted in tocilizumab IV and tocilizumab subcutaneous (SC) being available to meet patient demands. However, tocilizumab SC has not been authorized for the treatment of COVID-19 in the United States.

FDA approves Genentech’s Actemra for the treatment of COVID-19 in hospitalized adults. Business Wire. News release. December 21, 2022. Accessed December 22, 2022. https://www.businesswire.com/news/home/20221221005002/en

Intravenous tocilizumab (Actemra; Genentech) has been approved for the treatment of COVID-19 in individuals who are hospitalized and receiving systemic corticosteroids and supplemental oxygen.

FDA Approves Tocilizumab as First Monoclonal Antibody Treatment of COVID-19

Booster vaccination was associated with lower rates of SARS-CoV-2 infection, hospitalization, and death among nursing home residents in a 

Morbidity and mortality related to COVID-19 has been high in nursing homes throughout the pandemic. In response to surges in infections with the Delta variant of SARS-CoV-2 during summer and autumn of 2021, the CDC recommended that high-risk individuals who received a 2-dose mRNA vaccine series should receive a booster dose. However, there are limited data on the efficacy of boosters for preventing infection and death in nursing home residents, who are particularly vulnerable to SARS-CoV-2–associated morbidity and mortality.

The study used electronic health record data from 2 large, multi-state long-term care systems to estimate vaccine effectiveness (VE) in individuals who received both an initial series of mRNA vaccines and a booster dose versus those who received a primary vaccine series but did not receive a booster dose.

“Nursing homes are an optimal environment for measurement of VE because of residential stability, systematic documentation of immunizations (including boosters), and frequent testing for SARS-CoV-2,” the authors wrote.

The study followed long-term nursing home residents, defined as living in a facility for at least 100 days, for up to 12 weeks after booster vaccination to track incidences of confirmed SARS-CoV-2 infection, hospitalization, or death. The VE estimation considered the ratio of cumulative incidences in the boosted cohort compared with the unboosted cohort.

A total of 10,949 residents from 202 community nursing homes within the Genesis HealthCare system and 4321 residents from 128 Veterans Health Administration community living centers (VHA CLCs) were included in the study. All residents had completed an initial 2-dose series of an mRNA vaccine. A total of 8332 residents in the Genesis HealthCare system (system 1) and 3289 in the VHA CLCs (system 2) were boosted. Results for each health system were reported separately, primarily due to data use agreements that prevented data exportation from their respective secure servers.

Residents who were boosted showed reduced incidences of SARS-CoV-2 infection in both health systems. In system 1, boosted individuals were 37.7% less likely to be infected, and in system 2, boosted residents were 57.7% less likely to get infected. The incidence of hospitalization was 74.4% lower in in boosted patients within system 1, and 64.1% lower in boosted patients in system 2.

The estimated VE for SARS-CoV-2–death was 87.9% in system 1, but boosted individuals in system 2 were not at a significantly lower risk of death compared with unboosted residents. There was a slight reduction in death among boosted patients, however. Boosted residents in system 1 showed an 80.3% reduction in the combined end point of SARS-CoV-2–associated hospitalization or death, while boosted patients in system 2 showed a 63.8% reduction in the combined end point.

The 2 nursing home populations were significantly different in size and population demographics, but each demonstrated the efficacy of mRNA SARS-CoV-2 vaccine boosters for the overall high-risk nursing home population. While data in this population are sparse, the cohort study found much lower risks of SARS-CoV-2 infection, hospitalization, and death among the included nursing home populations. These findings emphasize the importance of SARS-CoV-2 booster vaccinations in this population.

McConeghy KW, Bardenheier B, Huang AW, et al. Infections, hospitalizations, and deaths among US nursing home residents with vs without a SARS-CoV-2 vaccine booster. 

. 2022;5(12):e2245417. Published 2022 Dec 1. doi:10.1001/jamanetworkopen.2022.45417

There are limited data on the efficacy of boosters for preventing infection and death in nursing home residents, but the findings suggest that boosters may have significantly reduced COVID-19–associated morbidity and mortality in this population.

Study Finds SARS-CoV-2 Booster Vaccination Lowers Infections, Hospitalizations, and Deaths in Nursing Homes

The FDA has authorized expanded eligibility for the updated bivalent COVID-19 boosters for children between 6 months and 4 years of age, the agency announced today. Omicron variant-targeted booster shots made by Pfizer-BioNTech and Moderna were already available to individuals 5 years of age and older.

“More children now have the opportunity to update their protection against COVID-19 with a bivalent COVID-19 vaccine, and we encourage parents and caregivers of those eligible to consider doing so—especially as we head into the holidays and winter months where more time will be spent indoors,” FDA Commissioner Robert M. Califf, MD, said in a press release “As this virus has changed, and immunity from previous COVID-19 vaccination wanes, the more people who keep up to date on COVID-19 vaccinations, the more benefit there will be for individuals, families and public health by helping prevent severe illnesses, hospitalizations, and deaths.”

The FDA action authorizes children 6 months through 5 years of age who were administered the original monovalent Moderna COVID-19 vaccine to receive a single booster of the updated bivalent Moderna COVID-19 vaccine 2 months following completion of a primary series with the monovalent vaccine.

For children 6 months through 4 years of age who have yet to begin the 3-dose primary series of the Pfizer-BioNTech COVID-19 vaccine or who have not yet received the third dose of the primary series, the updated bivalent Pfizer-BioNTech COVID-19 vaccine can now be administered as the third dose in the primary series after 2 doses of the original monovalent vaccine.

Notably, children 6 months through 4 years of age who completed the 3-dose Pfizer-BioNTech COVID-19 primary vaccine series with the original monovalent vaccine are not eligible for the updated bivalent booster dose at this time.

“Children in this age group who already completed their primary series would still be expected to have protection against the most serious outcomes from the currently circulating omicron variant,” the FDA said in a press release. “The data to support giving an updated bivalent booster dose for these children are expected in January. The agency is committed to evaluating those data as quickly as possible.”

Both the Moderna and Pfizer-BioNTech bivalent COVID-19 vaccines include an mRNA component that corresponds to the original COVID-19 strain to induce a broadly protective immune response against COVID-19. The updated bivalent vaccines also contain an mRNA component that corresponds to the Omicron variant BA.4 and BA.5 lineages to confer superior protection against Omicron, according to the FDA.

In terms of adverse events (AEs), those administered the updated bivalent vaccines may experience similar AEs to individuals who were previously administered the original monovalent mRNA COVID-19 vaccines, according to the FDA.

“Vaccines remain the best defense against the most devastating consequences of disease caused by the currently circulating omicron variant, such as hospitalization and death. Based on available data, the updated, bivalent vaccines are expected to provide increased protection against COVID-19,” Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research, said in a press release. “Parents and caregivers can be assured that the FDA has taken a great deal of care in our review, and we encourage parents of children of any age who are eligible for primary vaccination or a bivalent COVID-19 vaccine booster dose to consider seeking vaccination now as it can potentially help protect them from COVID-19 during a time when cases are increasing.”

Coronavirus (COVID-19) Update: FDA Authorizes Updated (Bivalent) COVID-19 Vaccines for Children Down to 6 Months of Age. FDA. News release. December 8, 2022. 

https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-updated-bivalent-covid-19-vaccines-children-down-6-months

Booster shots updated for the Omicron variant BA.4 and BA.5 lineages cleared for children 6 months through 4 years of age.

FDA Authorizes Bivalent COVID-19 Vaccine Booster for Children 6 Months to 4 Years of Age

, AllerVie Health allergist Maxcie Sikora, MD, discussed steps that parents and clinicians can take to minimize the risk of food-induced allergic reactions during the holiday season. Parties and get-togethers often present challenges for patients with allergies, particularly with home-cooked food that may have unclear ingredients. To avoid allergic reactions, Sikora suggested some steps families can take, including hosting events themselves and teaching children to ask before eating food from others.

Perfect. So, just to get started, what potential allergens do you see at kind of the Thanksgiving and holiday type of gatherings?

Well, you know, just like we talked about before, the incidence of food allergy is so incredible. As we mentioned in our Halloween discussion, 1 in 4 children in a classroom basically have a food allergy. One in 13 people in general have a food allergy or a food intolerance. So, you know, the likelihood, especially at large family gatherings, that you're going to have somebody there that actually has a food allergy or food intolerance is quite high. So, you know, for young children, especially children under the age of 2, you still have the most common food allergies as problems, which are milk and wheat, soy, peanuts, seafood—those are all major allergens. So, you know, knowing that is of utmost importance if you're hosting a big gathering, that you ask people if they have any food allergies or food intolerances that you need to be aware of. I think that's just classy as a host, and responsible as a host to just know that.

I know in our last conversation we discussed that it was really important to really look at how to deal with those situations. As a parent, I think, you know, unfortunately, kind of the best way to deal with a group setting situation as a parent when you're dealing with a big holiday such as Thanksgiving or Christmas is to host it yourself. I wish that I could say there was a better way to do it. But I think from a from a control standpoint—and if you read any of and I'm sure parents who are listening this know this, if you read any of the major food allergy blogs, etc., they're really discussing like how to deal with holidays. Their biggest recommendation is that you host whatever the event is, so that you have control of the food that's there. Because unfortunately, you know, so many people that haven't dealt with a child or a family member with food allergy, they don't really understand the implications of even trace quantities of that food allergen being in some of those products. And they might not even recognize that traces of certain food allergens are actually in those products. So, it kind of takes that responsibility off of those people, and basically allows you to have control of the situation.

One of the things that I read somewhere, and also I had thought about, is the way to kind of make that happen to where you're still having a family gathering and still having people participate is potentially inviting family members and friends over to help you prepare the meal. You know, it doesn't have to be you doing all of this yourself. But maybe having it be a fun thing where you provide the ingredients, they come over and help you cook for the holiday, and then you have the meal there and you have control. And it's also a great way to educate people who aren't fully aware of what you deal with on a regular basis. How to educate them on reading labels and knowing hidden sources of food allergens. As we age, the adult population, the biggest food allergens for them are nuts and seafood. Seafood is not such a big deal during the holidays, unless you live in a coastal area, like where I grew up, because you know, definitely around New Orleans and like in Charleston, the bigger cities that are coastal, you know, there are seafood dishes that we prepare for holidays. But in general, all over our country, it's more nut products that people use and holiday dishes that we don't even think about potentially as being very harmful to people who are allergic. But in a lot of cases, those are the major food allergens where people can have anaphylaxis and sometimes even die from trace amounts. So, it is it is definitely a time of year where those things are prolific. And you definitely can harm people at your family meals or your friend meals. Now granted, most of those people that have food allergies, they're very aware of this and they're going to alert you before they even come to your home regarding this, but I think it is important to be mindful of that when hosting a big gathering.

Yeah, absolutely. We talked about packaged candy before, which a lot of them have the ingredients listed, but homemade food can present different challenges. I know for myself, I don't even know the ingredients half the time in something. How can parents make sure they’re safe?

They basically, unfortunately, can't. They shouldn't allow their children to eat things made by other people. I mean, I hate to say that, but it's one of those things where it's very difficult to know what is in homemade candies. And as we know, that's such a lovely gift to give people because it's so thoughtful, and it's something that you've given and made from the heart for other people. So, I guess one of the things I would say is don't be offended if people say that they can't take that home, because it's probably not because they don't want to eat it. It's just because they're trying to protect other family members that potentially have a food allergy. But really, truly, even like processed foods, you know. There was an article on foodallergy.org, which I talked about in the Halloween discussion we had, just recently talking about candy canes, like some candy canes actually are processed with other food allergens. So, even though you think candy canes are basically just sugar and food coloring, in certain places where those candy canes are produced, they're actually produced on lines of things that have milk and have nuts. And so, you know, even our best thought processes, we were thinking, “Oh, a candy cane should not be a problem, or peppermint shouldn't be a problem.” To somebody who's food allergic, you really have to be mindful of reading those labels. And just like with our Halloween discussion, snack size things sometimes contain different ingredients, even in pre-packaging, than their full-size sisters and brothers do when it comes to candy.

So, you really do have to read those labels very, very mindfully and know that truly, in our country, the standard food allergens—milk, egg, wheat, soy, peanut, and all the tree nuts—those should be in bold print on the label. But sometimes that doesn't happen, especially with specialty foods and specialty candies. And so, in general, I would just say if you know this ahead of time, and you know you're providing things for a household with food allergy, you may want to give them gifts of non-food items. And I would also say that for parents who are trying to deal with the holidays with their children, like stocking stuffers and things, just like with Halloween with the Teal Pumpkin Project, it may be better to do stocking stuffers that aren't candy derived, you know, non-food items for fun, versus food items for fun. And then with the knowledge that if you do have a family gathering, that you kind of see, well, you definitely need to be the person supervising and overseeing the food preparation. And you know, if people ask what they can bring, just ask them to bring themselves to enjoy the holiday, that this is your gift to them to provide a meal without any stressors, or they can bring ice, or they can bring, you know, bottled beverages, you know, nothing really homemade, because you just never know. But that's what I would say.

Yeah, that makes sense. How can parents have these conversations with family? We talked before about kind of meeting some resistance or people just not understanding, so how can they do that?

I think, you know, it's mainly just education. And maybe it also is, like we talked about, like helping them prep the meal. I mean, I don't think that people understand how hard it is for parents and people with food allergy to plan a meal and to prepare a meal. I mean, it's a whole different level, it's not just opening like your favorite cookbook and going through and finding these fabulous recipes. You really have to be mindful of all the ingredients you're using, reading labels for everything, really knowing where they're sourced. And the general public I don't feel understands the gravity that goes into prepping a meal for somebody with a life-threatening food allergy. So, potentially, it is more allowing them to be part of the process, knowing, kind of sharing in that, and sympathizing with everything that goes into that, because that's a huge deal.

I also think it is good to have like other resources to allow them to realize kind of the gravity of it. Just like some of the parent-run websites, as I've mentioned before, foodallergy.org. There's a lot of good data to allow family members to just kind of look at, and even posting. I think families do really well, families with food allergy do a lot. You know, whether or not we agree with all the social media platforms or not, you know, there is a lot of good from the standpoint of posting informative articles and videos through your social media to potentially allow some of your friends and family to see what you deal with on a regular basis, through an educational and informative post, not negative post.

Yeah, that's wonderful. How can parents start educating the really young children who just want to grab everything?

So, I think the biggest thing is that, you know, you kind of unfortunately have to instill a tiny bit of fear and respect, just to start allowing them to understand that they can't have certain foods or things in certain foods that it could harm them. And that if they are uncertain about what is in the food—or, actually, don't even give them that choice, especially, you know, under the age of 2- to 3-year-old range, you know. Unfortunately for them, they don't always have that discernment, they just want to eat the candy, or eat the goodie that somebody has given them. So, anything that's not given to them by their parents, they really should be taught to ask before they eat whatever that item is. And, you know, at Halloween, we discussed don’t eat your candy before you get home, and your parents can look at it. It’s kind of the same thing with this. If you guys go to a social gathering at church or at a friend's house, or at a party or at a community center where they're giving out candy, you know, if you haven't been part of the organizational aspect of it and had something provided for your child that was allergen free, you really want to tell your children before you guys even get there. Like, “Okay, we need to see all the candy that you've been given before you eat it, so we can check it and make sure that it won't hurt you.” And it is one of those things that’s very difficult from the aspect of you want them to enjoy the holiday. You don't want them to be frightened about the holidays, you want them to enjoy this and feel the love and laughter and brightness of the holiday season. But they also have to be a tiny bit fearful that something that they are given by others might cause a reaction. And so that's the fine line that you have to deal with. And it really is probably more of an issue to make it less about food, and more about festivities and non-food items. And that's hard, because we eat all the time during the holidays. But it's probably more just changing the social group that you're in, it’s mindset, where it's probably really better in your case to do more activity-driven things versus food-driven socialization.

What medications should parents have on hand? What should they know in case something goes wrong.

Absolutely. So, you know, obviously, the epinephrine device is key. Any person—child or adult—who has a food allergy should have an epinephrine device that can be provided. The prescription can be provided by your provider, whether it be your primary care provider, your specialist, whomever, and then that epinephrine device is then filled by the pharmacists of the world. And so, and if you have a question about how to use that device, you then can ask your primary care office, you can ask your pharmacist, you can ask anybody how to use it. And there's also videos online for that as well. So definitely that, and then for other minor type reactions that you can discern, probably have some generic Benadryl, which would be diphenhydramine, with you. But the mainstay of treatment for any sort of severe allergic reaction is going to be your epinephrine device and administering that and going to your local emergency room following the administration or the reaction, not because you gave epinephrine, but because those symptoms can sometimes come back after an allergic reaction, and you need to be monitored by medical professionals for a few hours after the reaction to make sure that no symptoms return.

Is there anything you want to add anything that I didn't ask about?

Just like with our Halloween discussion, I just think that we all could do, meaning the world could do with some patience and love and empathy and sympathy for others. And so, in this situation, this is a large group of people that sometimes is not truly identified or sometimes marginalized, that we really need to reach out and try to understand and know that this is very difficult for parents and for adults with food allergy during holiday seasons, because they are fearful of ingesting something or coming in contact with something, even if it's a cross contamination, you know, like preparing a meal. And their allergen just happens to have the same utensil used and there's a small amount of it, that small amount could trigger a life-threatening allergic reaction. We just need to be mindful of that and if a parent or a friend says, “Look, you know, I appreciate you inviting me to this dinner. But do you mind if I just hosted at my house? It would make me feel more comfortable,” that you're not offended by that. It's just an understanding that it's their safety measure to try to provide safe a safe environment for their children, their spouse, their partner, or them themselves, you know that they want to spend time with you, but they need that security measure as part of the process.

Yeah, absolutely. Thank you so much for talking with me about all of this.

No problem. Thanks. Again, this is a good platform to do this.

Videos

Parties and get-togethers often present challenges for patients with allergies, particularly with home-cooked food that may have unclear ingredients. 

Parents, Clinicians Can Take Steps to Manage Food Allergies During the Holidays

Study authors of a recent study published in 

 explained that they observed significant new onset morbidity in children, adolescents, and adults across 13 prespecified diagnosis/symptom complexes following COVID-19 infection. Although long-term health issues from COVID-19 are a major public health concern, evidence on post-acute COVID-19 syndrome, or post-COVID-19, is still limited, specifically among children and adolescents.

During the study, the researchers used comprehensive health care data on approximately 46% of the German population and analyzed post-COVID-19-associated morbidity among 2 groups—children/adolescents and adults. The study authors noted that routine data from German statutory health insurance organizations covering the period between January 1, 2019 and December 31, 2020 were used for their analysis, with the base population including all individuals insured for at least 1 day in 2020. The team then identified individuals with polymerase chain reaction (PCR)-confirmed COVID-19 through June 30, 2020.

The researchers then assigned a control cohort using 1:5 exact matching on age and sex, and propensity score matching on preexisting medical conditions. Further, the date of COVID-19 diagnosis was used as index date for both cohorts, which were followed for incident morbidity outcomes documented in the second quarter after index date or later.

In all, 96 prespecified outcomes were aggregated into 13 diagnosis/symptom complexes and 3 domains (physical, mental, and physical/mental overlap). The researchers then used Poisson regression to estimate incidence rate ratios with 95% confidence intervals.

The population of participants included 11,950 children/adolescents between age 0 and 11 years and 145,184 adults between age 18 and 49 years. The mean follow-up time was 236 days in children/adolescents and 254 days in adults, and the COVID-19 and control cohorts were well balanced regarding covariates.

In at least 1/100 person-years in the COVID-19 cohort in children and adolescents, the specific outcomes with the highest incidence rate ratios (IRR) and an incidence rate (IRs) were malaise/fatigue/exhaustion, cough, and throat/chest pain.

In adults, this included disturbances of smell and taste, fever, and dyspnea. For health outcomes combined, IRs per 1000 person-years in the COVID-19 cohort were significantly higher than those in the control in both children/adolescents and adults. The magnitude of increased documented morbidity was similar for the physical, mental, and physical/mental overlap domain.

In the COVID-19 cohort, IRs were higher in all 13 diagnosis/symptom complexes in adults and in 10 diagnosis/symptom complexes in children/adolescents. The IRR estimates were similar for age groups 0 to 11 and 12 to 17, and IRs in children/adolescents were consistently lower than those in adults.

Additionally, the study authors noted that there were study limitations, such as potentially unmeasured confounding and detection bias. However, the study authors also explained that these findings expand the existing available evidence on post-COVID-19 conditions in younger age groups and confirm previous findings in adults.

Roessler M, Tesch F, Batram M, et al. Post-COVID-19-associated morbidity in children, adolescents, and adults: A matched cohort study including more than 157,000 individuals with COVID-19 in Germany. PLOS Medicine. November 10, 2022. Accessed November 18, 2022. 

https://doi.org/10.1371/journal.pmed.1004122

Although long-term health issues from COVID-19 are a major public health concern, evidence on post-COVID-19 symptoms are still limited, specifically among children and adolescents. 

Data Analysis Shows Significant New Onset Morbidity Post-COVID-19 in Children, Adolescents, Adults

A guided mindfulness-based stress reduction program may be as effective as escitalopram for patients with anxiety disorders, according to the authors of a study published in 

. The data were released shortly after the United States Preventive Services Task Force recommended screening for anxiety disorders due to their high prevalence.

“Our study provides evidence for clinicians, insurers and health care systems to recommend, include and provide reimbursement for mindfulness-based stress reduction as an effective treatment for anxiety disorders because mindfulness meditation currently is reimbursed by very few providers,” said first study author Elizabeth Hoge, MD, director of the Anxiety Disorders Research Program and associate professor of psychiatry at Georgetown, in a press release. “A big advantage of mindfulness meditation is that it doesn’t require a clinical degree to train someone to become a mindfulness facilitator. Additionally, sessions can be done outside of a medical setting, such as at a school or community center.”

Anxiety disorders include generalized anxiety, social anxiety, panic disorder, and fear of certain places or situations, including crowds and public transportation. These disorders contribute to an increased risk of suicide, disability, and distress, and are commonly treated in psychiatric clinics.

Currently prescribed medications for anxiety disorders can be very effective; however, many patients have difficulty gaining access to these drugs, do not respond to them, or find adverse effects to be a barrier to adherence. Standardized mindfulness-based interventions, such as mindfulness-based stress reduction (MBSR), can lower feelings of anxiety; however, previous studies have not compared these interventions with effective anti-anxiety drugs.

The clinicians recruited 276 patients between June 2018 and February 2020 from 3 hospitals in Boston, New York City, and Washington, DC, and randomly assigned them to either MBSR or escitalopram. MBSR was offered weekly for 8 weeks via 2 and a half-hour in-person classes, a daylong retreat weekend class during the fifth or sixth week, and 45-minute daily home practice exercises.

Symptoms of anxiety were assessed at enrollment and at completion of the intervention at 8 weeks, along with post-treatment assessments at 12 and 24 weeks after enrollment. For the blinded assessments, trained clinical evaluators did not know whether the patients they were measuring received the drug or MBSR.

By the end of the study, 102 patients had completed MBSR and 106 had completed their medication course. The patients were relatively young, with a mean of 33 years, and included 156 women, who represented 75% of the enrollees.

Using validated assessments, the researchers measured the severity of symptoms of anxiety across all the disorders using a scale of 1 to 7, with 7 being severe anxiety. Both groups experienced decreased anxiety symptoms, dropping from a mean of about 4.5 for both, which translates to an approximately 30% reduction in the severity of peoples’ anxiety.

After participating in a previous study and again in the current study, enrollee Olga Cannistraro said she learned 2 key MBSR techniques.

“It gave me the tools to spy on myself. Once you have awareness of an anxious reaction, then you can make a choice for how to deal with it. It’s not like a magic cure, but it was a lifelong kind of training. Instead of my anxiety progressing, it went in the other direction, and I’m very grateful for that,” Cannistraro said in a press release.

Hoge said it is important to highlight that although mindfulness meditation works, not everyone is willing to invest the time and effort to successfully complete all of the necessary sessions and do regular home practice, which enhances the effect.

“Also, virtual delivery via videoconference is likely to be effective, so long as the ‘live’ components are retained, such as question-and-answer periods and group discussion,” Hoge said in a press release.

Hoge added that there are phone apps available that offer guided meditation, but the researchers do not know how the apps compared with the full in-person, weekly group class experience.

Most enrollees completed their 8-week course of treatment before the COVID-19 pandemic started. Further, the research team conducted a second phase of the study during the pandemic that involved reorganizing the treatments to an online video conference, which will continue to be analyzed in future analyses. The effects of MBSR on sleep and depression will also be analyzed in future studies.

Mindfulness-Based Stress Reduction is as Effective as an Antidepressant Drug for Treating Anxiety Disorders. Georgetown University Medical Center. November 9, 2022. Accessed November 10, 2022. 

https://gumc.georgetown.edu/news-release/mindfulness-based-stress-reduction-is-as-effective-as-an-antidepressant-drug-for-treating-anxiety-disorders/

Patients with anxiety disorders were found to be able to use mindfulness techniques to manage generalized anxiety, social anxiety, panic disorder, and fear of certain places or situations, including crowds and public transportation.

Study: Mindfulness Can Effectively Reduce Stress for Patients With Anxiety Disorders

A recent study discovered the first evidence in humans that short-term lifestyle changes can disrupt the response to insulin of blood vessels and the first analysis showing men and women reacting differently to these changes, according to the authors of a study conducted at the University of Missouri School of Medicine.

Previous studies had analyzed the topic of sugary diets, with researchers suggesting that the consumption of sugary drinks is associated with higher cancer risk and the risk of obesity.

 A feature of obesity and type 2 diabetes is vascular insulin, which contributes to vascular disease.

During this trial, the researchers examined vascular insulin resistance in 36 young and healthy men and women by exposing them to 10 days of reduced physical activity and cutting their step count from 10,000 to 5,000 steps per day. The participants also increased their sugary beverage intake to 6 cans of soda per day.

“We know that incidence of insulin resistance and cardiovascular disease is lower in premenopausal women compared to men, but we wanted to see how men and women reacted to reduced physical activity and increased sugar in their diet over a short period of time,” said Camila Manrique-Acevedo, MD, associate professor of medicine, in a press release.

The results highlighted that only in men did the sedentary lifestyle and high sugar intake cause decreased insulin-stimulated leg blood flow and a drop in a protein, called adropin, which regulates insulin sensitivity and is an important biomarker for cardiovascular disease.

“These findings underscore a sex-related difference in the development of vascular insulin resistance induced by adopting a lifestyle high in sugar and low on exercise,” Manrique-Acevedo said in a press release. “To our knowledge, this is the first evidence in humans that vascular insulin resistance can be provoked by short-term adverse lifestyle changes, and it’s the first documentation of sex-related differences in the development of vascular insulin resistance in association with changes in adropin levels.”

Manrique-Acevedo added that she would like to analyze how long it takes to reverse these vascular and metabolic changes and more fully assess the impact of the role of sex in the development of vascular insulin resistance.

Sedentary Lifestyle and Sugary Diet More Detrimental to Men. University of Missouri School of Medicine. October 27, 2022. Accessed November 2, 2022. 

https://medicine.missouri.edu/news/sedentary-lifestyle-and-sugary-diet-more-detrimental-men

Antrim A. Sugary Drinks Consumption Associated with Higher Cancer Risk. 

. July 17, 2019. Accessed November 2, 2022. 

https://www.contemporaryclinic.com/view/sugary-drinks-consumption-associated-with-higher-cancer-risk

A feature of obesity and type 2 diabetes is vascular insulin, which contributes to vascular disease.

Study: Sedentary Lifestyle, Sugary Diet More Detrimental to Men

In an interview, allergist with AllerVie Health, Maxcie Sikora, MD, discussed some risks associated with Halloween for children with food allergies. She also discussed precautions that parents can take as well as alternatives to candy.

Q: What risks are associated with Halloween for children with allergies?

I would just say from a food allergy perspective, Halloween is very daunting for families of patients with food allergy. In general, you know, as you mentioned, it really does depend on the age. In the younger age group, they're much more likely to have the common kind of food allergy triggers like milk, egg, wheat, soy, and those allergens are typically outgrown as they become older. So, in the older child population, you know, meaning like elementary school and above, that's when the majority of those children should start outgrowing their food allergens, but they still have food allergies. As we all know, nut allergy, whether it's peanut or tree nut, is a major allergen. But then there are also still children who have milk and egg and wheat and soy. And then you also have children who have sesame allergy, you have some other rare allergies. And you also have children who have food intolerances that don't fall under that allergy spectrum, that may not have anaphylaxis to the foods, but will have other complaints such as gastrointestinal complaints when they ingest these foods.

Q: What are some precautions parents can take for particularly young children, who might not completely understand their allergy or which foods could be dangerous?

Absolutely. So, just in case parents and watchers of this video want to look at that the Food Allergy Research and Education (FARE) Organization, they have a website called FoodAllergy.org. And so, they have some great tips on there and I gleaned a lot of this from them just to have kind of a standard protocol. But mainly, you know, the biggest thing for children, both young and old, is to not eat the candy while they're trick-or-treating. That's a huge deal. No eating of candy while you're out trick-or-treating. Like right when you get the candy, don't eat it, because that candy needs to be evaluated to make sure that it does not contain the allergens to which they're allergic. And as we all remember from childhood, as soon as we received our favorite candy, we wanted to eat it immediately. So, I'd say that's the number one rule.

In the past, I've had parents tell me that what they've done in neighborhoods in which they live for young children is distribute safe candy to their neighbors, like a goodie bag just for their child. And especially in a community where you know your neighbors, then when your child goes to the door for trick-or-treating and does their trick-or-treat and, you know, is excited about receiving their candy, they are given candy that is specifically for them, that is safe for them, provided by the parents ahead of time. So, that's another option.

The other thing that I highly recommend is that you don't eat candy that doesn't have the ingredients on the label because the snack-size candies that are that are given out at Halloween sometimes contain different ingredients than the full-size candies. So even if you've, you know, eaten this particular candy before and not had any problems with it, the snack sized candy still may contain some of those allergens that you're trying to avoid. So that for sure is a big deal. And then also just not ingesting candy that you can't see the label because the labeling on candies or foods in general are also going to tell you if it's processed with other major food allergens, and so some children and adults can have food reactions from cross contact with allergens to which they're allergic and they wouldn't even think about it by eating this particular candy that obviously doesn't have their food allergens in that particular candy.

Q: How do precautions change as children get older?

Obviously, as children get older, we're not always out there with them, observing them and trick-or-treating. I think definitely the not eating the candy while trick-or-treating goes for any age, just so they're aware that they need to wait until they get to a space where they can sit down and look at everything and look at the labels. Definitely, as children age, if they've had food allergy from a very early age, they're even better than their parents usually at being able to read a label and identify what they can and cannot have, to the point where some of them will even pick the candy that they want from the actual house in which they're visiting that doesn't contain a food allergy. Then, I think the biggest thing that parents and people, neighbors who are providing candy and other things to trick-or-treaters, is to have a teal pumpkin like what's behind me, that allows you to have other things to give out for Halloween that are not allergenic. Meaning like non-food items, you know, like little trinkets, stickers, or you know, glow in the dark bracelets, you know, things like that, that are easily obtained that you can keep in that bucket. And it actually can be, if you don't use them all, you can reuse them. So, it's nice that you can offer something that isn't candy to somebody with a food allergy. And I think to people who have the teal pumpkin, most food-allergic parents recognize that and appreciate that. And, you know, they kind of also try to steer their children towards the teal pumpkin items versus like the food items, if that makes sense.

So, I think there's definitely ways to keep children safe and, like we all know, it definitely takes a village to have a healthy child. And in this case with, you know, one in 13 children having a food allergy, that's 2 in every classroom. So, it's a huge deal. And especially if you live in a neighborhood where many trick-or-treaters come by your home, it is super-duper important to have something available that is safe for a child with food allergy to enjoy and to not feel left out in a in a wonderful holiday such as Halloween.

Q: Are there any medications or anything parents should have on hand in case of an allergic reaction?

So, in general, many of us who are pediatric allergists, probably all of us actually, recommend that the parent always carry an EpiPen, no matter what the situation is. And in this case, this is a situation that could potentially lead to some sort of accidental exposure, even with them being as cautious as possible. So, for sure, they should have their EpiPen. And, you know, for severe allergic reaction that is your first line of defense. And so, I would definitely recommend that it varies on what everybody else chooses to carry. But most parents carry their EpiPen and also carry like Benadryl as well. But in the case of any suspected severe allergic reaction, your EpiPen is your first line of treatment and then seek care at an emergency center.

Q: What is the role of pharmacists in educating parent and children about the risks and precautionary steps to take?

So, I think there's a huge role in pharmacy for this, the first being the importance of their EpiPen. Because you guys in the pharmacy world are the gatekeepers for their epinephrine. So, the epinephrine devices are majorly important. And also, I know that you guys also are wonderful at reminding them about when their epinephrine device expires, which is also super important because, you know, they may have their epinephrine device, but it may actually be already expired. And I would prefer that in a situation with high risk such as trick-or-treating that they have their current and in-date epinephrine device. So that, for sure, is an important thing that pharmacists can do.

The other thing is just reminding them about the precautions, you know, just things that we talked about—not eating the candy while they're out trick-or-treating, reading labels. Things that you guys already tell people because you're giving them the information on side effects of medications all the time and cross reactivity of medications, and it's a very similar thing, except in this case, you're protecting them from their food allergy and you're providing them with extra care which is part of our need in health care as to help care for our all of our patients.

Q: Do you have any tips for approaching these conversations?

I think that it's really important when somebody addresses or ask about an allergy, especially to food, that people are very open minded about it. I find that a lot of parents and people with food allergy are not respected or believed when they tell somebody that they're allergic to a food. You know, people generally kind of blow that off or make it less important than it actually is. And I think just a little bit of compassion and sympathy for the day-to-day life where they're really living in fear of encountering something that could cause major health problems and sometimes, in certain situations, the possibility of death if they ingest it. It's just so important that we really respect others and show compassion every day, whether or not you know anybody that has a food allergy—which I find very hard to believe now that the ratio is 1 in 13—that we just try to help others and really see the need in the community and step up and try to protect those children and adults that have this food allergy. And one of those things we can do is help enjoy a holiday, you know, that a lot of us participate in and fully enjoy and allow these people to not feel ostracized because of their food allergy, they you know. They’re able to trick or treat, dress up, visit other houses, and feel safe in those communities doing so. The FARE Organization also has a teal pumpkin map on their website. So, if you are a person who has a teal pumpkin at your house, you can add your address to the list. And parents with children with food allergies actually utilize that list in order to know where to go to be safely trigger-free. So that's another thing that we all can do to help out.

Q: Is there anything you’d like to add?

I think, you know, my whole spiel about compassion with food allergy, I just find that that is something that I really feel like puts a lot of stress and strain and anxiety on both parents and people suffering with food allergy, the lack of understanding and the lack of compassion of the general public, to where they don't feel safe, in their community. Sometimes they don't feel safe going to grab a cup of coffee or going to a local restaurant or a cafe. And so, it's really important to understand that this is a serious issue. It's definitely a health problem that is growing throughout the world. And unfortunately, it doesn't seem to be going away. So, we need to understand that and help try to facilitate a safer lifestyle for these people who have this problem.

Pharmacists can remind parents to have an EpiPen on hand and to carefully review candy after trick-or-treating.

Counsel Patients About Pediatric Allergy Risks, Precautions On Halloween

Children and young adults with Down syndrome are 4 times more likely to be diagnosed with diabetes, according to the findings of a study published in 

The study, by Queen Mary University of London and King’s College London, examined just under 10,000 individuals with Down syndrome and almost 40,000 individuals without. Data from the UK Clinical Practice Research Datalink, from 1990 to 2020, were used.

This is the first time that investigators examined the incidence of diabetes and obesity in Down syndrome across one of the disorder’s biggest cohorts.

“This is the largest study ever conducted in Down syndrome patients to show that they have unique needs with regards to diabetes and obesity, and that screening and intervention, including a healthy diet and physical activity, at younger ages is required compared to the general population,” Andre Strydom, MRCPsych, MSc, PhD, professor in intellectual disabilities at King’s College London, said in a statement. “The results will help to inform the work of NHSE's LeDeR program to reduce inequalities and premature mortality in people with Down syndrome and learning disabilities.”

Investigators found that children aged 5 to 14 years with Down dyndrome have about a 10 times greater chance of having type 2 diabetes (T2D) than children without. They think, based on the results, that children with Down syndrome must be more closely monitored for early signs of diabetes, excess weight, and obesity.

Investigators emphasize that identifying diabetes as early as possible helps individuals with the complications that diabetes can bring later in life.

Despite the findings, investigators found that individuals with Down syndrome were typically diagnosed with diabetes much earlier. The average age of diagnosis of diabetes for an individual with Down syndrome was aged 38 years compared to with aged 53 years for those without the genetic disorder.

Excess body weight and genetics could be the reason behind the increased risk, investigators said.

Individuals with Down syndrome were found to have a higher body mass index and reach its peak at an earlier age, which increases the risk of T2D at a younger age.

Additionally, investigators found that there was also an increased risk of T1D, because of extra chromosomes and issues with the immune system for those with Down syndrome.

“This study highlights the importance of early screening for diabetes and weight issues in [individuals] with Down syndrome, especially children and young adults,” Li Chan, PhD, reader in Molecular Endocrinology and Metabolism and Consultant Pediatric Endocrinologist at Queen Mary University of London, said in the statement.

“Currently there is a sizeable gap in research into the condition, which affects around 40,000 people in the [United Kingdom],” Chan said. “To help plug this gap in knowledge, we are conducting further research into how genetics affects a[n individual] with Down syndrome’s predisposition to diabetes and obesity and hope to shed further light on this important medical issue."

Children and young adults with Down syndrome four times more likely to have diabetes. News release. Science Daily. October 4, 2022. Accessed October 17, 2022. https://www.sciencedaily.com/releases/2022/10/221004104957.htm

Investigators find that individuals aged 5 to 14 years with the genetic disorder are also at greater risk for TD2.

Study: Children, Young Adults With Down Syndrome Have 4 Times Greater Chance of Diabetes

New research from Baycrest Foundation suggests that the gut microbiome plays a role in how diet and exercise affect brain health and dementia risk. The findings could help experts optimize strategies to prevent dementia, according to the study authors.

Lifestyle interventions to reduce risk of dementia often include diet and exercise, which in turn affect the gut microbiome.

“We know that imbalances in the microbiome are associated with impaired cognition,” said lead author Noah Koblinsky, an exercise physiologist and project coordinator at Baycrest’s Rotman Research Institute (RRI), in a press release. “However, we don’t know much about the role of the microbiome when we use lifestyle interventions, such as diet and exercise, to support brain health. Can we tailor lifestyle interventions to specifically target the gut microbiome, and will this help to optimize their effects on cognition? In this review study, we aimed to address this gap in knowledge.”

The team reviewed any existing research on diet and exercise interventions that looked at both the microbiome and brain health and published their findings in 

According to the study, the gut microbiome does appear to play a role in how diet and exercise affect brain health, although more research is needed to understand exactly how.

Studies have shown that diets have a significant impact on the microbiome, with a Mediterranean-style diet appearing to have the greatest benefit to a healthy gut microbiome and brain, according to the study. For example, one study with 1200 older adults asked half the participants to follow a Mediterranean-style diet for 12 months, while the other half did not follow this diet. Those in the Mediterranean diet group showed significant improvements in cognition and had healthier microbiomes associated with better brain health.

In another study, investigators used antibiotics to “kill off” the gut microbiome in a sample of rats. They then gave the rats microbiome transplants from rats that had either been fed an unhealthy diet or a healthy diet. According to the study, the researchers found that the rats in the unhealthy diet group showed worse memory performance, as well as inflammation in the intestines and brain.

These findings support the idea that the microbiome plays a role in the way diet impacts brain health. The team found fewer studies examining exercise, but the studies that did suggest that starting exercise, specifically aerobic exercise, can lead to changes in the gut microbiome and brain health at the same time.

After this review of existing research, the team is now launching a randomized controlled trial focused on diet and exercise and are looking to secure funding to include analysis of microbiome changes.

“By better understanding how changes to the gut microbiome affect the relationship between lifestyle and brain health, we can strengthen existing lifestyle interventions and create new strategies to reduce dementia risk, helping older adults everywhere age fearlessly,” said senior author Nicole Anderson, PhD, senior scientist at the RRI, in the press release.

Research suggests gut microbiome plays a role in lifestyle’s effects on dementia risk. News release. Baycrest; October 11, 2022. Accessed October 26, 2022. 

https://www.baycrest.org/Baycrest-Pages/News-Media/News/Research/Research-suggests-gut-microbiome-plays-a-role

A Mediterranean-style diet appears to provide the greatest benefit to a healthy gut microbiome and brain.

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