Laurie Toich, Associate Editor

This article was originally published by Specialty Pharmacy Times.

Many studies suggest that certain dietary interventions may reduce the risk of multiple sclerosis (MS) or improve symptoms. The Mediterranean diet, in particular, has garnered significant attention for MS. The diet, which is rich in fish and vegetables, has been shown to reduce inflammation in patients with MS.

Novel study findings suggest that eating fish 1 to 3 times per month, plus daily fish oil supplements, may reduce MS risk. These results suggest that omega-3 fatty acids could lower the risk of developing MS, according to a press release.

The preliminary study will be presented at the American Academy of Neurology’s 70th Annual Meeting in April.

“Consuming fish that contain omega-3 fatty acids has been shown to have a variety of health benefits, so we wanted to see if this simple lifestyle modification, regularly eating fish and taking fish oil supplements, could reduce the risk of MS,” said study author Annette Langer-Gould, MD, PhD.

For more information about the study and its results, visit

Articles

Many studies suggest that certain dietary interventions may reduce the risk of multiple sclerosis (MS) or improve symptoms. The Mediterranean diet, in particular, has garnered significant attention for MS.

Fish Consumption May Help Lower Multiple Sclerosis Risk

Consuming nuts may help reduce the risk of colon cancer recurrence, according to a new study published in the

Many studies have explored the link between food consumption and the risk of cancer. Certain types of foods—especially those with antioxidants&mdash;have been found to protect against cancer, while others have been shown to increase the risk of developing cancer.

The study's findings showed that patients with stage 3 colon cancer who regularly consumed nuts had a lower risk of disease recurrence and mortality compared with patients who do not consume nuts.

Included in the study were 826 patients with colon cancer who were followed for a median of 6.5 years after treatment with surgery and chemotherapy.

The authors discovered that patients who regularly consumed two 1-ounce servings of nuts had a 42% improvement in disease-free survival and a 57% increase in overall survival, according to the study.

“Further analysis of this cohort revealed that disease-free survival increased by 46% among the subgroup of nut consumers who ate tree nuts rather than peanuts,” said senior author Charles S. Fuchs, MD.

The authors characterized tree nuts as almonds, walnuts, hazelnuts, cashews, and pecans, while peanuts are considered legumes.

“These findings are in keeping with several other observational studies that indicate that a slew of healthy behaviors—including increased physical activity, keeping a healthy weight, and lower intake of sugar and sweetened beverages&mdash;improve colon cancer outcomes,” said lead author Temidayo Fadelu, MD. “The results highlight the importance of emphasizing dietary and lifestyle factors in colon cancer survivorship.”

The researchers said this finding was significant because it uncovers a relationship between biological processes and worsened disease outcomes for colon cancer and chronic conditions, such as type 2 diabetes (T2D).

Previous studies suggest that nuts may help reduce insulin resistance, which is often a precursor to T2D.

The authors also noted that other studies indicate that patients with colon cancer whose lifestyle factors increase insulin resistance have poor outcomes.

“These studies support the hypothesis that behaviors that make you less insulin-resistant, including eating nuts, seem to improve outcomes in colon cancer,” Dr Fuchs said. “However, we don’t know yet what exactly about nuts is beneficial.”

The authors hypothesized that nuts may reduce hunger without consumption of carbohydrate-rich food or types that are linked to poor outcomes; however, patients may not be eating nuts due to concerns over fat content, according to the study.

“People ask me if increasing nut consumption will lead to obesity, which leads to worse outcomes,” Dr Fuchs said. “But what’s really interesting is that in our studies, and across the scientific literature in general, regular consumers of nuts tend to be leaner.”

These results suggest that diet can make a difference in colon cancer outcomes, according to the study. The authors previously found that coffee consumption also reduced recurrence and mortality among this patient population, highlighting an additional way to potentially improve outcomes for these patients.

“First and foremost, I talk about avoiding obesity, exercising regularly, and staying away from a high-carbohydrate diet. Then we talk about things like coffee and nuts. If you like coffee or nuts, enjoy them, and if you don’t, there are many other helpful steps you can take,” Dr Fuchs said. “Overall, we are working to apply the same rigorous science to the understanding of diet and lifestyles in the colon cancer patient population that we apply to defining new drugs.”

Certain types of foodsâ€”especially those with antioxidantsâ€”have been found to protect against cancer, while others have been shown to increase the risk of developing cancer.

Could Nut Consumption Lower Risk of Colon Cancer Recurrence?

Officials with the FDA are urging consumer to be wary of unapproved products that claim to prevent, treat, or cure influenza, according to a press release.

This year’s flu season not only resulted in a significant number of flu infections, but also an uptick in concerns regarding the potential of individuals purchasing unapproved products.

The FDA is especially concerned that patients may be lured into purchasing counterfeit antivirals online from websites posing as pharmacies, according to the release. They are advising patients to be cautious when purchasing influenza drugs online.

“This year the flu has been widespread, impacting millions of patients across the country, and leading to a new record number of flu-related hospitalizations,” FDA Commissioner Scott Gottlieb, MD, said in the release. “We understand the toll this year’s flu season has taken on peoples’ lives. As the flu continues to make people sick—and even cause deaths&mdash;unscrupulous actors may also be taking advantage of unsuspecting consumers by promoting their fraudulent products that have not been reviewed by the FDA to be safe and effective.”

The FDA advises Americans that there are no legal OTC products that can prevent or cure the flu itself; however, there are legally marketed OTC drugs that can address the symptoms of the flu, including fever, muscle aches, and congestion.

In the release, the agency noted that several claims may indicate that a product is fraudulent:

·      reduces severity and length of the flu

·      boosts immunity without vaccination

·      boosts your immune response against the flu

Health scams—such as fraudulent flu drugs&mdash;can result in wasted money, delays in diagnosis and treatment, and may lead to serious injury or death, according to the release.

To combat fraud, the FDA issues warnings to the public and regularly takes actions against the companies that promote these products. Due to some companies moving their operations to new websites, there are still a number of unapproved and potentially harmful products being sold to Americans, according to the release.

Officials with the FDA are urging consumer to be wary of unapproved products that claim to prevent, treat, or cure influenza. 

FDA: Be Wary of Fraudulent, Unproven Flu Products

The US Preventive Services Task Force (USPSTF) issued a final recommendation that addresses screening for ovarian cancer.

Due to the available evidence, the task force does not recommend screening for ovarian cancer among women without any signs of the condition, according to an agency news bulletin.

This is a D recommendation, the task force noted.

Ovarian cancer is troublesome to diagnose and most patients do not exhibit symptoms until the later stages of the disease. Additionally, symptoms are similar to those of other conditions and can be present in healthy women, which further complicates diagnosis, according to the task force.

These factors make it more likely that ovarian cancer is diagnosed at a later stage when treatments are less effective. Ovarian cancer is the fifth most common cancer death among women, causing more than 14,000 per year.

Currently, screening tests are unable to correctly determine whether or not a patient has ovarian cancer. There is also a lack of FDA-approved screening tests for the disease.

The task force concluded that screening may result in a patient undergoing unnecessary surgery when she does not have cancer.

“The task force recommends against screening for ovarian cancer in women who have no signs or symptoms,” said task force member Michael J. Barry, MD. “Evidence shows that current screening methods do not prevent women from dying of ovarian cancer and that screening can lead to unnecessary surgery in women without cancer.”

The US Preventive Services Task Force (USPSTF) issued a final recommendation that addresses screening for ovarian cancer. 

USPSTF Does Not Recommend Ovarian Cancer Screening

Today, the FDA approved ZTlido (lidocaine topical system) 1.8% for the treatment of pain associated with post-herpetic neuralgia (PHA), which is caused by shingles, according to a press release from Sorrento Therapeutics.

Sorrento said its newly-approved product marks significant progress for analgesics because it can deliver pain relief for up to 12 hours, including during exercise.

“ZTlido was designed to solve a problem that is commonly reported with transdermal/topical patches: they don’t stay on. Based on the adhesion study results with ZTlido, we believe that ZTlido product will be welcomed by health care providers, patients, and payers who are looking for an effective and efficient, local pain treatment,” Henry Ji, PhD, chairman and CEO of Sorrento and Scilex, said in a press release. “We also intend to explore the expansion of ZTlido into additional indications and the underlining platform technology of ZTlido for other active pharmaceutical ingredients (APIs) and combinations of APIs.”

ZTildo is based on new technology that allows for superior adhesion and drug delivery, according to the release.

Notably, ZTlido requires a 36-mg/topical system compared with a 700-mg/patch of Lidoderm (lidocaine patch 5%) to achieve the same dose, Sorrento reported.

The safety and efficacy profile of the topical system was explored in comparative pharmacokinetic studies. The study results demonstrated bioequivalence between the products, according to the release.

The FDA previously reported that adhesion was a significant hurdle for effective transdermal drug delivery. To address this, the manufacturer developed a patch with a goal of maintaining skin contact for 12 hours.

Adhesion performance was investigated in a clinical trial of 54 healthy patients. The results showed that there was no patch lift off the skin among 87% of patients over a 12-hour period, according to Sorrento.

Another 13% of patients experienced some edges lifting off the skin and no patients had significant patch lift off the skin, according to the release.

Another phase 1 clinical trial showed that ZTlido was superior to Lidoderm at 3 hours and over 12 hours in terms of adhesion, Sorrento reported.

“Topical lidocaine is an important option for healthcare providers to have in their armamentarium for treating PHN, a difficult-to-treat neuropathic pain,” Jeff Gudin, MD, director, Pain Management and Palliative Care, Englewood Hospital and Medical Center, said in the release. “The Centers for Disease Control and Prevention’s guideline of non-opioid treatments for chronic pain recognizes topical lidocaine as an alternative first-line therapy. ZTlido now offers providers and patients this option.”

ZTlido (lidocaine topical system) shows superior adhesion compared with other topical non-opioid pain patches.



Non-Opioid Pain Patch Approved by FDA for Post-Herpetic Neuralgia

Patients undergoing cancer treatment may benefit from engaging in physical activity, according to a recent study.

Results from a clinical trial presented at the 2018 Cancer Survivorship Symposium showed that exercising during adjuvant chemotherapy could lead to increased engagement in physical activity in the future.

The authors found that patients with breast or colon cancer who participated in an 18-week exercise

program during chemotherapy engaged in 142 more minutes of physical activity per week after 4 years than those who did not exercise, according to the study.

“It is well known that exercise during chemotherapy can lessen treatment-related side effects, such as fatigue, pain, and nausea,” said lead study author Anne M. May, PhD. “Our study is the first to show that people who are physically active during treatment maintain higher levels of physical activity in the long run, and this is really important for their health and well-being.”

The PACT study examined whether engaging in exercise during chemotherapy may be able to mitigate adverse events. After surgery for breast or colon cancer, patients were randomized to participate in an 18-week exercise program or to receive usual care during chemotherapy.

The exercise program included 60 minutes of moderate-to-high intensity aerobic and strength training twice per week supervised by a physical therapist. Patients were also instructed to participate in 30 minutes of home-based exercise 3 days per week.

The authors previously reported that the program reduced treatment-related fatigue in the short-term.

After 4 years, the authors surveyed 128 participants to quantify the potential long-term benefits of the intervention. Of these patients, 70 participated in the exercise program and 58 received standard care.

Patients in the exercise group reported participating in moderate-to-vigorous physical activity for an average of 90 minutes per day compared with an average of 70 minutes per day for the usual care group, according to the study.

“The exercise program was designed to keep patients physically active long-term, so we’re really pleased to see that even 4 years later people who received the intervention were still more active,” Dr May said.

The authors noted that the exercise program incorporated cognitive changes that aimed to increase confidence during physical activity and the physical therapist discussed the maintenance of the program after completion.

Additionally, patients in the exercise cohort had lower levels of fatigue compared with the usual care cohort after 4 years; however, the difference was not statistically significant, according to the study.

The authors said that further studies are needed to confirm that exercising would also be effective in reducing both short- and long-term adverse events among patients treated for other cancers and current studies suggest the intervention may be successful.

Patients undergoing cancer treatment may benefit from engaging in physical activity. 