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A phase 3 trial investigating the PD-1 inhibitor cemiplimab (Libtayo, Regeneron) in patients with recurrent or metastatic cervical cancer who had previously progressed on chemotherapy showed a significant improvement in overall survival (OS), with a reduction in the risk of death by 31% compared to chemotherapy in the overall population, according to a presentation at the European Society for Medical Oncology Virtual Plenary.

These positive results add to the previously reported data showing an improvement in OS with cemiplimab compared to chemotherapy. In light of these positive findings, the data from this trial will be used as the basis for regulatory submissions in 2021.

"Improvements in progression-free survival [PFS] and objective response rate [ORR] were also demonstrated in the overall population compared to chemotherapy. Taken together, this landmark trial—which enrolled patients regardless of PD-L1 expression status—helps support the use of [cemiplimab] as a potential new second-line treatment for women with advanced cervical cancer who face a poor prognosis and limited treatment options," said trial investigator Krishnansu S. Tewari, MD, professor and director of the Division of Gynecologic Oncology at the University of California, Irvine, in a press release.

Currently, cervical cancer is the fourth leading cause of cancer mortality in women globally, with the most frequently diagnosed age group being women aged 35 to 44 years. Every year, approximately 570,000 women are diagnosed with cervical cancer, with deaths among those diagnosed totaling more than 250,000 annually. In the United States alone, there are approximately 14,500 patients diagnosed annually, with approximately 4000 women dying from the disease each year.

Although human papillomavirus infection is the cause of a majority of cases, approximately 80% are also classified as squamous cell carcinoma (SCC), which occurs from within cells in the lining at the bottom of the cervix. The remaining 20% of cases are classified as adenocarcinomas, which arises from glandular cells in the upper cervix. When detected early, cervical cancer is generally curable and can be managed; however, in advanced stages, the treatment options available become limited.

In the overall patient population, the investigators found that OS, PFS, and ORR significantly improved for those treated with cemiplimab (n=304), compared to chemotherapy (n=304). Specifically, the investigators observed a 31% reduction in mortality risk (hazard ratio [HR]: 0.69; 95% confidence interval [CI]: 0.56-0.84; one-sided p=0.00011), a 25% reduction in disease progression risk (HR: 0.75; 95% CI: 0.63-0.89; one-sided p=0.00048), and 16% ORR (50 patients; 95% CI: 13-21%; one-sided p=0.00004), compared to 6% with chemotherapy (19 patients).

Among this population, the median duration of response was 16 months with cemiplimab (95% CI: 12 months to not yet evaluable) and 7 months with chemotherapy (95% CI: 5-8 months), per Kaplan-Meier estimates.

Seventy-eight percent of trial participants were found to have advanced cervical cancer classified as SCC and also went on to experience significant improvements following treatment with cemiplimab (n=239) versus chemotherapy (n=238).

Specifically, patients in this population experienced a 27% reduction in mortality risk (HR: 0.73; 95% CI: 0.58-0.91; one-sided p=0.00306), a 29% reduction in disease progression risk (HR: 0.71; 95% CI: 0.58-0.86; one-sided p=0.00026), and 18% ORR (42 patients; 95% CI: 13-23%) compared to 7% with chemotherapy (16 patients; 95% CI: 4-11%).

Although the investigators did not set the assessment of adenocarcinoma as a pre-specified endpoint, a post-hoc analysis demonstrated that patients treated with cemiplimab (n=65) compared to chemotherapy (n=66) experienced a 44% reduction in mortality risk (HR: 0.56; 95% CI: 0.36-0.85; nominal one-sided p<0.005), a 9% reduction in disease progression risk (HR: 0.91; 95% CI: 0.62-1.34), and 12% ORR (8 patients; 95% CI: 6-23%), compared to 5% with chemotherapy (3 patients; 95% CI: 1-13%).

Additionally, the phase 3 trial demonstrated that patients treated with cemiplimab experienced an improvement or maintenance of their baseline Global Health Status/Quality of Life (GHS/QOL) over time. However, patients treated with chemotherapy experienced a deterioration that was clinically significant by cycle 8, per the European Organisation for Research and Treatment of Cancer QLQ-C30 (overall estimated mean change [95% CI]: improvement of 1.01 [-2.033, 4.047] for Libtayo, worsening of -6.81 [-10.977, -2.637] for chemotherapy; difference: 7.81; one-sided nominal p=0.00040).

The investigators observed no safety signals for patients treated with cemiplimab. The investigators had assessed safety in patients who received at least 1 dose of study treatment, which included 300 patients in the cemiplimab group (median duration of exposure: 15 weeks; range: 1-101 weeks) and 290 patients in the chemotherapy group (median duration of exposure: 10 weeks; range: 1-82 weeks).

In terms of adverse events (AEs) observed during the trial, investigators found 88% of cemiplimab patients and 91% of chemotherapy patients experienced AEs. In 15% or more of cemiplimab patients, AEs included anemia (25% cemiplimab, 45% chemotherapy), nausea (18% cemiplimab, 33% chemotherapy), fatigue (17% cemiplimab, 16% chemotherapy), vomiting (16% cemiplimab, 23% chemotherapy), decreased appetite (15% cemiplimab, 16% chemotherapy), and constipation (15% cemiplimab, 20% chemotherapy).

Additionally, grade 3 or higher AEs were observed in 45% of cemiplimab patients and 53% of chemotherapy patients, whereas in 15% or more of patients, certain grade 3 or higher AEs were observed more frequently in the cemiplimab group. These AEs included asthenia (2% cemiplimab, 1% chemotherapy) and pyrexia (less than 1% cemiplimab, 0% chemotherapy).

The investigators also observed immune-related AEs in 16% of cemiplimab patients and fewer than 1% of chemotherapy patients. The AEs at grade 3 or higher occurred in 6% of cemiplimab patients and fewer than 1% of chemotherapy patients. However, patients discontinuing treatment due to AEs only occurred among 8% of cemiplimab patients and 5% of chemotherapy patients.

Positive Phase 3 Libtayo® (cemiplimab) Results in Advanced Cervical Cancer Presented at ESMO Virtual Plenary. Tarrytown, NY: Regeneron Pharmaceuticals; May 12, 2021. 

https://investor.regeneron.com/news-releases/news-release-details/positive-phase-3-libtayor-cemiplimab-results-advanced-cervical

Articles

A phase 3 trial investigating the PD-1 inhibitor cemiplimab in patients with recurrent or metastatic cervical cancer who had previously progressed on chemotherapy showed a significant improvement in overall survival.

Positive Results for the Treatment of Advanced Cervical Cancer 

interviewed Lea Davis, PhD, an associate professor of medicine in the Department of Medicine at Vanderbilt University Medical Center and an investigator in the Vanderbilt Genetics Institute, on a recent study she co-authored that was published in 

 on the epidemiology of functional seizures among adults treated at a university hospital.

During the interview, Davis discussed the findings of her research in relation to the epidemiology of functional seizures.

Videos

Lea Davis, PhD, an associate professor of medicine in the Department of Medicine at Vanderbilt University Medical Center and an investigator in the Vanderbilt Genetics Institute, discussed the epidemiology of functional seizures.

Understanding the Epidemiology of Functional Seizures

Individuals who are fully vaccinated against COVID-19 can resume activities they were doing prior to the pandemic, according to updated guidance from the CDC. The agency also advised that fully vaccinated individuals can resume many activities without wearing a mask or social distancing.

The CDC considers individuals in the United States to be fully vaccinated 2 weeks after receiving their second of a 2-dose Moderna or Pfizer-BioNTech vaccine series, or 2 weeks after receiving a single-dose Johnson & Johnson vaccine.

According to the CDC, outdoor activities deemed safest for fully vaccinated people, but less safe for unvaccinated individuals, include:

dining with friends from multiple households

attending crowded events, such as a live performance, parade, or sporting event

Some examples of indoor activities considered safest by the CDC for fully vaccinated individuals that are less safe for unvaccinated peers include:

going to an uncrowded shopping center or museum

attending a small gathering of people from multiple households, whether fully vaccinated or not

attending a full-capacity worship service or singing with a chorus

participating in a high-intensity exercise activity

In the updated guidance released today, the CDC cautioned that masks and social distancing may still be required of fully vaccinated individuals in adherence to federal, state, local, tribal, and territorial laws, rules, and regulations, as well as policies put into place by businesses and workplaces.

The agency is advising that all travelers, regardless of vaccination status, will still need to wear a mask when using public forms of transportation, including planes, buses, and trains. They should also continue to practice social distancing and frequent hand washing or use of hand sanitizer while traveling.3 However, fully vaccinated individuals do not need COVID-19 testing before or after traveling, nor do they need to quarantine upon arrival at a destination in the United States.

Individuals who are fully vaccinated should continue paying close attention to policies and COVID-19 situations at international destinations prior to making the trip. International travelers still need to provide a negative test result for COVID-19 or documentation of recovery from the virus prior to boarding international flights, regardless of vaccination status. The CDC also advises international travelers to obtain testing for COVID-19 within 3 days upon return to the United States, but these fully vaccinated individuals do not need to self-quarantine.

CDC guidance advises individuals who are not fully vaccinated to delay taking trips, if possible, until they are fully vaccinated. Those who do travel are advised to take a viral COVID-19 test 1 to 3 days prior to taking the trip and get tested again 3 to 5 days after returning home, as well as self-quarantining for a full 7 days.

When you’ve been fully vaccinated. CDC. Updated May 13, 2021. Accessed May 13, 2021. 

https://www.cdc.gov/coronavirus/2019-ncov/vaccines/fully-vaccinated.html

Choosing safer activities. CDC. Updated May 13, 2021. Accessed May 13, 2021. 

https://www.cdc.gov/coronavirus/2019-ncov/daily-life-coping/participate-in-activities.html

Domestic travel during COVID-19. CDC. Updated April 27, 2021. Accessed May 13, 2021. 

https://www.cdc.gov/coronavirus/2019-ncov/travelers/travel-during-covid19.html

The CDC considers individuals in the United States to be fully vaccinated 2 weeks after receiving a complete series of COVID-19 vaccine doses.

CDC Says Fully Vaccinated Individuals can Resume Activities Without a Mask

During National Women’s Health Week, which takes place from May 9 to May 15, CVS Health announced new initiatives to further support women’s health and wellness during the month of May.

“Through our new initiatives to support women’s health and wellness in May, we aim to use our unmatched community presence and our diversified model to meet women where they are to help make preventative care more convenient and accessible for women,” said Eileen Howard Boone, senior vice president, corporate social responsibility & philanthropy and chief sustainability officer for CVS Health, in an interview with 

An example of an initiative CVS Health is doing is the 1100 MinuteClinic locations that are promoting a no-cost heart health screening program called “Know Your Numbers.” Patients will learn 5 key personal health numbers that can help them determine their risk for heart disease, including cholesterol, high-density lipoprotein (good) cholesterol, blood pressure, blood sugar, and body mass index.

“We know that nearly 80% of cardiac events can be prevented, yet many women don't have the awareness about this disease to understand and prevent their risk. That's why offering these free heart health screenings is so important, especially this year when so many people have put off preventative care,” Boone said.

In addition, CVS Pharmacy locations nationwide will raise funds to support the Go Red for Women movement. From now until May 29, customers can support the movement by making a donation at check-out or online at 

Mental and physical health has become more crucial than ever before since the start of the COVID-19 pandemic. Through the ExtraCare Rewards program, members will receive deals on women’s wellness items in-store, including weekly promotions on products such as vitamins and skin care, as well as feminine care and beauty products, until May 22.

“Given all of the responsibilities women have taken on, it can be difficult to find time to prioritize health and wellness. During National Women’s Health Week, we hope that women learn that although it’s been hard to prioritize preventative care during the pandemic, it’s essential for women to find the time to take care of themselves,” Boone told 

CVS Health announces new initiatives to support women’s health and wellness in May. CVS Health. Published May 3, 2021. Accessed May 13, 2021. 

https://cvshealth.com/news-and-insights/press-releases/cvs-health-announces-new-initiatives-to-support-womens-health-and

CVS Health Announces New Initiatives to Support Women's Health and Wellness in May

Contemporary Clinic spoke with Patricia Ryan Krause, MS, RN, MSN, PNP-BC, from the National Association of Pediatric Nurse Practitioners (NAPNAP) about Global Health Awareness Month 2021, which takes place in May.

This second part of the interview covers how to work with refugees with chronic conditions, any special considerations while working with those who experienced trauma while/before/after immigrating, and what she hopes to see for the future of patients who are impacted by health inequalities.

Special Considerations and Helping Patients with Health Inequalities

Because several pharmaceutical companies pulled back from the federal 340B program last fall, many patients with diabetes are now seeing skyrocketing insulin prices, according to Anne Webster, NP, with UnityPoint Health.

Webster said she has been forced to prescribe less effective insulin options in recent months and has seen patients beginning to ration their medications. In addition to impacting their physical health, Webster said she has seen patients struggling with their mental and financial wellbeing over the last few months, and she sees no end in sight. The only solution, she said, is for Health and Human Services Director Xavier Becerra, JD, to enforce federal policies to ensure affordable medication access.

Because several pharmaceutical companies pulled back from the federal 340B program last fall, many patients with diabetes are now seeing skyrocketing insulin prices.

Rising Insulin Prices Impact Patients’ Diabetes Management, Holistic Wellness

Moderate alcohol intake, defined as no more than 1 alcoholic drink for women and 2 for men per day, has been associated with a lower risk of dying from cardiovascular disease when compared with individuals who abstain from drinking or partake in excessive drinking, according to a new study being presented at the American College of Cardiology's 70th Annual Scientific Session. According to the authors of the study, the finding suggests that reducing stress-related brain signals can be heart protective, and other therapies with the same effects but fewer adverse effects than alcohol should be pursued.

“We found that stress-related activity in the brain was higher in nondrinkers when compared with people who drank moderately, while people who drank excessively—more than 14 drinks per week—had the highest level of stress-related brain activity,” said Kenechukwu Mezue, MD, a fellow in nuclear cardiology at Massachusetts General Hospital, in a press release. “The thought is that moderate amounts of alcohol may have effects on the brain that can help you relax, reduce stress levels and, perhaps through these mechanisms, lower the incidence of cardiovascular disease.”

While a connection between stress and heart disease is widely accepted, there has been limited research on how modifying stress levels may improve and protect heart health, according to the authors of the study. A related study by the same team found that exercise had a similar effect on brain activity as well as on the incidence of cardiovascular disease and events.

“The current study suggests that moderate alcohol intake beneficially impacts the brain-heart connection. However, alcohol has several important side effects, including an increased risk of cancer, liver damage and dependence, so other interventions with better side effect profiles that beneficially impact brain-heart pathways are needed,” Mezue said in the release.

The researchers gathered data from the Mass General Brigham Biobank health care survey of 53,064 participants, of which 59.9% were women and the average age was 57.2 years. Alcohol intake was self-reported and was classified as low (<1 drink/week), moderate (1-14 drinks/week), or high (>14 drinks/week). Major adverse cardiovascular events, including heart attack, stroke, or related hospitalizations, were determined using diagnostic codes. Of these patients, 752 underwent 18F-fluorodeoxyglucose positron emission tomography, which can show areas in the brain that have increased activity, allowing the researchers to objectively measure activity in regions of the brain known to be associated with stress.

Fifteen percent of the participants experienced a major adverse cardiovascular event, occurring in 17% in the low alcohol intake group, and 13% in the moderate alcohol intake group. In adjusted analysis, individuals reporting moderate alcohol intake were found to have a 20% lower chance of having a major event compared to the low alcohol intake cohort and had lower stress-related brain activity. This association remained significant after controlling for demographic variables, cardiovascular risk factors, socioeconomic variables, and psychological factors.

“Previous studies by our group and others have shown a robust association between heightened amygdalar activity and a higher risk of major adverse cardiovascular outcomes, such as heart attack, stroke, or death. In the current study, path analyses showed that the link between moderate alcohol intake and lowered cardiovascular event risk is significantly mediated though reductions in amygdalar activity,” Mezue said in the release.

The current study is limited due to the self-reporting of alcohol intake based on the average consumption of drinks per week, according to its authors. Further, the data is from a single center, and each participant in the imaging sub-study only received a single brain scan. Further study would be needed to show that the observed reductions in brain activity are the direct result of moderate alcohol intake through repeated brain scans and more detailed alcohol intake assessments over time.

Alcohol in moderation may help the heart by calming stress signals in the brain [news release]. EurekAlert; May 6, 2021. Accessed May 6, 2021. 

https://www.eurekalert.org/pub_releases/2021-05/acoc-aim050421.php

According to the authors of the study, the finding suggests that reducing stress-related brain signals can be heart protective, and other therapies with the same effects but fewer adverse effects than alcohol should be pursued.

Moderated Alcohol Intake May Reduce Stress Signals in the Brain, Improve Cardiovascular Health

Today is National Nurses Day, so Bernadette Melnyk, PhD, the chief wellness officer and dean of the College of Nursing at Ohio State University, joined Contemporary Clinic to discuss the results of a recent study she was the lead author on which shone some light on the extent to which alarmingly high levels of stress, depressive symptoms, and anxiety have been affecting critical care nurses nationwide, even before the COVID-19 pandemic began.

So, Dr. Melnyk, what were some of the findings from the study you recently published, and why might critical care nurses be experiencing such high levels of stress, depressive symptoms, and anxiety?

 Our study findings showed very high rates of depressive symptoms affecting 40% of the sample, and this was a random sample of critical care nurses throughout the United States. So, we can generalize those findings to all critical care nurses in the American Association of Critical Care Nurses.

We also found a little over 50% of these nurses met the cutoff for clinical anxiety on the valid and reliable screen that we used. But very importantly, we found that the poorer the physical and mental health of these nurses, the more medical errors they made over the last 5 years, and that's very sad.

I don't want that to put a poor light on critical care nurses because they're fabulous, but it gets back to the issue of: If we don't support our clinicians’ health and well-being, it is going to affect health care quality and safety. 

Absolutely, yeah. How are these mental health concerns affecting nurses ability to also provide patient care, as well as other medical services?

 Well, I think any time any person experiences stress, depression, or anxiety to the point that it's going to interfere with concentration, judgment, or functioning, it will affect the quality and safety of care.

These are wonderful, caring, well-meaning nurses, but the level of burnout, depression, even suicide, in nurses is higher than the general population. So, health care systems really need to invest in fixing system problems that we know are the root cause of burnout, depression, and anxiety, as well as offer great screening programs and wellness evidence-based programs to protect oneself against these mental health issues.

It's just so critical. We know what works, we just got to translate it much quicker into the real world.

Right, right. How have these mental health concerns specifically impacted critical care nurses during the COVID-19 pandemic?

 They definitely have skyrocketed even further. Think about being a critical care nurse taking care of very, very sick people whose family members could not come in and be with them.

So those nurses had to be the primary support for dying people. That adds to the already stressed-out situation that they're functioning in. I think we're going to see an aftermath of skyrocketing rates of post-traumatic stress disorder and chronic grief reactions as we pull out of this.

Yeah. What are some ways nurses can approach an awareness of their experience of these mental health concerns?

 I think for one we've got to just become self-aware and honest with ourselves, and if any clinician is experiencing burnout, depression, or anxiety to the point where it's interfering with their concentration or functioning, they've got to get help.

It is not selfish to take good self-care. It's truly necessary to be able to take great care of others.

Yeah, and what has been the impact of programs like the Stress, Trauma and Resilience (STAR) Program or the Buckeye Paws program for critical care nurses?

 At Ohio State, we have such a fabulous menu of options to help all of our clinicians, faculty, staff, and students. Buckeye Paws is our pet therapy program, and honestly you should see the faces and the stress melt off of clinicians when those trained dogs step up on the unit.

We also have this other STAR programming for both patients as well as our own clinicians who are experiencing issues with stress and trauma. We offer evidence-based mindfulness programs and cognitive behavior skills building programs that we now work to decrease depression, anxiety, and stress.

Yeah, that is excellent, that is excellent. Why is it important for all medical health professionals or medical professionals to focus on continuing to care for themselves while caring for their patients?

 As clinicians, we cannot pour from empty cups. When we get on an airplane and the oxygen mass drop, we're told to put them on ourselves first before we can be effective in helping others.

Again, oftentimes clinicians want to help everybody else, but they often don't focus on their self-care. Self-care is not a nicety, it's a necessity. We have got to take a little bit of time—I call them micro-recovery breaks—during the day to focus on effective strategies that'll decrease our stress and improve our mood.

Yeah absolutely. What is the value of nurses in health care today?

 Nurses are at the bedside of patients 24/7. They are there to make observations, to pick up early complications, and to nurture the emotions and spirit of patients who are often seriously ill. They are such a valuable piece of our workforce.

Absolutely, absolutely. Is there anything you would like nurses to know on this National Nurses Day?

 I'm going to give all of our nurses a dose of vitamin G for gratitude. People honestly underestimate the power of practicing daily gratitude. If we get up every morning and just think about a few things and people we're grateful for and then do it again when we go to bed at night, it will so decrease our stress, decrease blood pressure, improve our mood.

So, I’m going to give all nurses out there a dose of vitamin G today, and just thank you, thank you so much for everything you do every day to transform health and improve lives. You are greatly appreciated.

Thank you so much for taking the time to speak with me today, Dr. Melnyk, and for sharing these important words on this National Nurses Day.

Today is National Nurses Day, so Bernadette Melnyk, PhD, the chief wellness officer and dean of the College of Nursing at Ohio State University, joined Contemporary Clinic to discuss the high levels of stress, depression, and anxiety affecting critical care nurses nationwide. 

Expert: This National Nurses Day, ‘Self-care Is Not a Nicety, It's a Necessity’ for Nurses

Krause discussed what Global Health Awareness month is, its importance for health care providers, and how to overcome the barriers of treating migrant or refugees properly.

The Importance of Global Health Awareness Month 2021 

interviewed Bethany Hall, MSN, owner of Healing Connection, on the role nurse practitioners have in understanding and approaching care for children with complex developmental trauma (CDT).

In this discussion, Hall explains ways nurse practitioners can learn how to identify signs and symptoms of CDT in pediatric populations.

What kind of services are available for nurse practitioners who are interested in understanding CDT further?

So, along with everybody else, we've kind of switched to a more virtual platform during the pandemic. So, I recently launched our website, and we're working on getting a lot more of our trainings in an on-demand and virtual format because it's difficult to travel and to do speaking engagements.

So, I do currently offer any virtual trainings via Zoom. So, on our website, we have a list of different topics for medical professionals, such as understanding [adverse childhood experiences] scores and their long-term effect on health outcomes or increasing felt safety in your family practice. So, there's a variety of topics that we've already spoken to.

We also love to tailor our education to specific interest areas. So, if your family practice group really wants to learn more about a specific topic in this area, we love to get that feedback and can develop specific training programs for your practice or your group of colleagues, and we can offer all of that via Zoom.

Once it's safe to do so, I also travel and speak as part of panels and provide in-person training. So, some of our trainings are even up to 3 days long, where we go through a really in-depth understanding of the effects of trauma on the brain, body, and belief system, and how we can coach parents, how we can be medical advocates in that area. 

So, like I said, we are really trying to work towards that platform to get more of our trainings online, but currently we do offer all of our talks and education via Zoom conferencing.

Bethany Hall, MSN, owner of Healing Connection, discusses ways nurse practitioners can learn how to identify signs and symptoms complex developmental trauma in pediatric populations.

Ways to Identify, Understand Complex Developmental Trauma in Children

Officials with the FDA have approved an 8 mg dose naloxone hydrochloride nasal spray (Kloxxado; Hikma Pharmaceuticals) for the emergency treatment of known or suspected opioid overdose in adult and pediatric patients.

 This product is a higher dosage of naloxone hydrochloride than the 2 mg and 4 mg dosage products previously approved by the FDA.

Naloxone hydrochloride is an opioid antagonist that reverses the effects of opioids, including respiratory depression, sedation, and hypotension. According to Hikma, the drug has a long history of safe use as the standard of care for reversing opioid overdoses.

Naloxone hydrochloride can be administered by individuals with or without medical training to help reduce opioid overdose deaths. If administered quickly, the drug can counter the opioid overdose effects, usually within minutes. According to the FDA, a higher dose of naloxone provides an additional option in the treatment of opioid overdoses.

According to Hikma, widely prescribing and distributing naloxone may play a vital role in the fight against opioid overdose. With the increasing prevalence of illicitly manufactured synthetic opioids, a higher dose of naloxone may be required to revive a patient

The use of naloxone in patients who are opioid-dependent may result in opioid withdrawal characterized by body aches, diarrhea, increased heart rate, fever, runny nose, sneezing, goose bumps, sweating, yawning, nausea or vomiting, nervousness, restlessness, or irritability, shivering or trembling, abdominal cramps, weakness, and increased blood pressure.

According to Hikma, the company expects its naloxone hydrochloride nasal spray 8 mg to be available in the second half of 2021.

Hikma announces US FDA approval of KLOXXADO TM (naloxone hydrochloride) nasal spray 8mg [news release]. April 30, 2021; Hikma Pharmaceuticals. Accessed May 3, 2021. 

https://www.hikma.com/newsroom/article-i5120-hikma-announces-us-fda-approval-of-kloxxado-tm-naloxone-hydrochloride-nasal-spray-8mg/

FDA Approves Higher Dosage of Naloxone Nasal Spray to Treat Opioid Overdose [news release]. April 30, 2021; FDA. Accessed May 3, 2021. 

https://www.fda.gov/news-events/press-announcements/fda-approves-higher-dosage-naloxone-nasal-spray-treat-opioid-overdose

This product is a higher dosage of naloxone hydrochloride than the 2 mg and 4 mg dosage products previously approved by the FDA.

Higher Dosage of Naloxone Nasal Spray Approved by FDA for Treating Opioid Overdose 

An analysis of blood samples from patients infected with SARS-CoV-2 revealed that immune cells circulating in the blood triggered by the gut's response to infection were limited in number when compared to immune cells that had been triggered elsewhere in the body, according to a study published in 

. According to the investigators, the finding suggests the gut may not provide long-lasting systemic immunity from the coronavirus disease 2019 (COVID-19).

“Although the gut is considered an important portal of entry for the virus, the immune response in the blood of COVID-19 patients is dominated by lymphocytes—cells that protect the body from infection—that have been triggered by other areas of the body,” said Dr Sebastian Zundler, the study’s author and research group leader, Department of Medicine 1, University Hospital Erlangen, Germany, in a press release. “Further work is needed, but these findings may have implications for oral COVID-19 vaccines.”

The researchers used flow cytometry to detect and measure the different types of immune cells that were found in the blood samples of patients currently positive for COVID-19, patients who had recovered from COVID-19, and individuals who had never been infected.

“There is a special mechanism in the lymphoid tissue of the gut that triggers the production of an imprint marker called ‘a4b7 integrin.’ This marker causes T cells to head towards the gut to fight infection. We can use this marker to identify whether there are lymphocytes circulating in the blood that were triggered by the gut's immune response,” said Dr Tanja Müller, lead author of the study, in the press release. 

“We found relatively few immune cells with this marker in the blood of patients with COVID-19. This could be because of the ‘dilution’ by cells generated at other sites of infection—most probably the lung—or alternatively by the selective attraction of these gut-imprinted immune cells to organs other than the gut since there was no difference between patients with and without symptoms that suggested an intestinal element to their infection," added Müller.

There is a possibility that, if the gut-imprinted immune cells are diluted in comparison to immune cells triggered by other parts of the body, there could be implications for the oral-based COVID-19 vaccines currently under development, according to the study’s authors. However, further research is required to establish the significance of the findings.

“Our study adds to our understanding of the human immune response to SARS-CoV-2 infection, but we cannot yet finally answer the question about the fate of the gut-imprinted immune cells—whether they are ‘diluted’ or ‘attracted’ elsewhere,” Zundler said, in the press release. “Assessing biopsy samples from the gut and autopsy samples from the lungs will help us to answer this important question.”

Gut's immune response in COVID-19 may not provide efficient protection of other organs [news release]. EurekAlert; April 20, 2021. Accessed April 23, 2021. 

https://www.eurekalert.org/pub_releases/2021-04/f-gir041521.php

A Study of immune cells circulating in the blood found that the gut's immune response to COVID-19 infection may not provide sufficient whole-body immunity from the virus.

Study: Immune Response From the Gut May Not Provide Systemic Immunity to COVID-19

Medication should be considered for patients with slightly elevated blood pressure who do not respond to 6 months of healthy lifestyle changes, according to a new statement from the American Heart Association (AHA) published in 

. This statement serves to fill a gap in guideline recommendations by addressing how to manage untreated, stage 1 high blood pressure not fully addressed in the 2017 treatment guidelines.

The 2017 American College of Cardiology/American Heart Association Blood Pressure Management Guidelines' recommendation for patients with stage 1 hypertension—defined as blood pressure levels of 130-139/80-89 mm Hg—and a low risk of heart attack or stroke within 10 years is to first treat with healthy lifestyle changes, and then repeat the blood pressure check in 6 months. For patients with stage 1 hypertension and a high 10-year risk of heart attack or stroke, the guidelines recommend antihypertensive medication in addition to healthy lifestyle.

The newly issued statement suggests clinicians should consider medication for patients with a low 10-year risk if the blood pressure goals (<130/80 mm Hg) are not met after 6 months of sustained healthy lifestyle changes. This would apply to around 10% of American adults with high blood pressure.

Many patients with stage 1 hypertension are adults under age 40 years. Randomized controlled trials following these patients for cardiovascular disease risk are lacking, leading the statement writing committee to base their conclusion on other forms of evidence, including observational studies focused on the relationship between blood pressure and cardiovascular disease.

“We know that people with blood pressure lower than 130/80 mm Hg have fewer markers of cardiovascular risk like elevated coronary calcium, enlargement of the heart, or buildup of fatty deposits called atherosclerosis in arteries of the neck,” said Daniel W. Jones, MD, FAHA, chair of the statement writing group, in a press release. “There is strong evidence that treating high blood pressure saves lives by reducing the risks for heart attack and stroke.”

The healthy lifestyle changes recommended include achieving ideal body weight, exercising, limiting dietary sodium, enhancing potassium intake and following the Dietary Approaches to Stop Hypertension (DASH) diet. The DASH diet consists of a combination diet with fruits and vegetables, low-fat dairy products, and reduced saturated and total fats. It is recommended that these patients limit alcohol and forego smoking.

“It is very hard in America and most industrialized countries to limit sodium sufficiently to lower blood pressure, and it is difficult for all of us to maintain a healthy weight in what I refer to as a toxic food environment,” Jones said in the release. “We want clinicians to advise patients to take healthy lifestyle changes seriously and do their best. We certainly prefer to achieve blood pressure goals without adding medication; however, successfully treating high blood pressure does extend both years and quality of life.”

If slightly high blood pressure doesn't respond to lifestyle change, medication can help [news release]. EurekAlert; April 29, 2021. Accessed April 29, 2021. 

https://www.eurekalert.org/pub_releases/2021-04/aha-ish042621.php

Medication should be considered for patients with slightly elevated blood pressure who do not respond to 6 months of healthy lifestyle changes, according to a new statement from the American Heart Association (AHA) published in Hypertension. 

American Heart Association Advises Considering Medication for Certain Patients With Stage 1 Hypertension

Contemporary Clinic spoke with Dr. Kelly Clark, president of Addiction Crisis Solutions and DisposeRx board member, about the impact of the pandemic on opioid use and the importance of proper disposal.

Clark also highlighted how health care providers can counsel their patients on safely dispose of their unused medications, National Clean Out Your Medicine Cabinet Day, and the future of opioid use with the ongoing COVID-19 pandemic.

The Impact of the COVID-19 Pandemic on Opioid Use and Proper Disposal Tips

Americans who are fully vaccinated against the coronavirus disease 2019 (COVID-19) no longer need to wear masks when outside alone, with members of their household, or when attending small outdoor gatherings, according to new CDC guidelines released Tuesday.

When choosing activities and debating whether to wear a mask, the guidelines said Americans should consider how COVID-19 is spreading in their community, the number of people they will be around, and whether the activity will be outside. Outdoor visits and activities are still safer than indoor options, for both vaccinated and unvaccinated people, although the guidelines said fully vaccinated individuals can safely participate in some indoor events.

The CDC maintained its earlier recommendations for some safety measures, however, such as advising vaccinated adults to continue wearing masks and staying socially distanced when at outdoor performances or sporting events, when visiting indoor shopping malls or movie theaters, and anywhere where the vaccination and health status of nearby people is unknown. Regardless of vaccination status, the guidelines said people should still avoid large gatherings, crowds, and spaces that are not well ventilated.

The guidelines listed a wide range of activities and where vaccinated and unvaccinated people would be safest, less safe, and least safe. Although all activities were deemed “safest” for fully vaccinated people with masks, unvaccinated people with masks were only considered “less safe” or “least safe.”

Some indoor, less safe activities for unvaccinated people with a mask included visiting a barber or hair salon; going to an uncrowded, indoor shopping center or museum; riding public transport with limited occupancy; and attending a small, indoor gathering of people from multiple households. Some activities deemed “least safe” for unvaccinated people—even with mask-wearing—include going to an indoor movie theater; attending a full-capacity worship service; singing in an indoor chorus; eating at an indoor restaurant or bar; and participating in an indoor, high intensity exercise class.

Both vaccinated and unvaccinated people can walk, run, or bike outdoors with members of their household or attend small, outdoor gatherings with fully vaccinated family and friends without a mask, according to the guidelines. Fully vaccinated people do not need to wear masks to attend a small, outdoor gathering with fully vaccinated or unvaccinated people, although unvaccinated people should still wear masks at these events. Vaccinated people also do not need to wear a mask when dining at an outdoor restaurant with friends from multiple households, although the guidelines said they should wear a mask when attending a crowded, outdoor event.

CDC; Choosing Safer Activities. April 27, 2021. Accessed April 27, 2021. 

Americans who are fully vaccinated against COVID-19 no longer need to wear masks when outside alone, with members of their household, or when attending small outdoor gatherings.

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