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Study to explore heart-health benefits of cocoa flavanols

BY Michael Johnsen

BOSTON — Brigham and Women’s Hospital, Seattle-based Fred Hutchinson Cancer Research Center, the National Institutes of Health and Mars, Inc. plan to partner on the largest research trial to date that will investigate the heart-health benefits of cocoa flavanols and multivitamins, the groups announced Monday. 

"Cocoa flavanols and multivitamins are two of the most promising and exciting nutritional interventions available, and this new randomized trial is the natural next step in advancing our understanding of their potential benefits," stated JoAnn Manson, chief of the division of Preventive Medicine at BWH. "In smaller studies, cocoa flavanols have been linked to improvements in intermediate risk factors for heart disease, such as reductions in blood pressure and cholesterol levels, improvements in the body’s sensitivity to insulin and improved ability of blood vessels to dilate." 

The large-scale, prospective nutritional intervention will evaluate the role of flavanols in reducing the risk of heart attack, stroke and death from cardiovascular disease. The study will also explore the effect of a daily multivitamin as compared to placebo, as a follow up to previous research conducted only in men, which suggested that multivitamins may lower the risk of cancer. 

This five-year study of 18,000 men and women nation-wide will also be the first large-scale randomized trial testing multivitamins in women.

Manson will co-lead the trial with Howard Sesso, ScD, MPH, also in the division of Preventive Medicine at BWH.

"For multivitamins, the exact mechanisms leading to lower risks of cancer remain unclear, but could be due to individual and joint effects of more than 20 vitamins and minerals," commented Sesso, who is also in the division of Preventive Medicine at BWH and co-leader of the study. "This supplement has shown favorable results in research to date, but the proposed randomized trial is needed to provide conclusive evidence." 

Recruitment of women will be done through the large nationwide Women’s Health Initiative and men will be recruited from other large population-based studies. This trial substantially increases the number of women included in randomized trials of interventions for prevention of cardiovascular disease and cancer, areas where inclusion of women has lagged. The recruitment process is slated to begin in fall 2014 and continue into 2015.

Mars, Inc. will provide financial infrastructure support, together with the Heart, Lung, and Blood Institute of NIH, as well as the cocoa flavanol-containing capsules for use in this study. 

"This collaboration represents the best of a public-private partnership in the interest of advancing science and public health. It’s exciting to be at this turning point in scientific discovery where we have the potential to achieve benefits for some of our most significant health challenges today," noted Harold Schmitz, chief science officer at Mars, Inc.

The partnership between academic hospitals, NIH and industry is expected to yield answers by 2019. 

 

 

 

 

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Kline: OTC market up 3% on returning brands and dietary supplement growth

BY Michael Johnsen

PARSIPPANY, N.J. — Sales of the U.S. OTC market in 2013 were up 3% to $23.5 billion at the manufacturer’s level, according to a blog on research firm Kline’s site posted Monday. 

"Driven by strong sales gains in analgesics, upper respiratory, nutritional and topical products, the market appears to be showing signs of recovery," wrote Laura Mahecha, Kline industry manager healthcare. "This is partly due to the long-awaited rejuvenation of several brands that have posted steep declines in the recent past as a result of supply disruptions and recalls. Brands such as Novartis’ Excedrin and Johnson & Johnson’s Tylenol and Motrin IB have experienced strong gains in 2013 thereby helping the analgesics category to post very strong gains this past year while Pfizer’s Advil, Bayer’s Aleve and private-label analgesics also posted gains in 2013."

Within nutrition, adult multivitamins, glucosamine and chondroitin and fish oils were significant market drivers, Mahecha reported. 

Looking ahead, Kline expects the OTC market to continue to expand as a result of new and innovative Rx-to-OTC switches. "With the addition of new Rx-to-OTC switch brands and, in some cases, entirely new OTC categories, the market is expected to gain considerable sales and growth in the next few years," Mahecha suggested.

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FDA approves Eliquis for DVT prophylaxis

BY Ryan Chavis

PRINCETON, N.J. and NEW YORK — Bristol-Myers Squibb Co. and Pfizer announced that the Food and Drug Administration approved a supplemental new drug application for Eliquis (apixaban). The drug is a preventive treatment for deep vein thrombosis, which can lead to pulmonary embolism for patients who have had hip or knee replacement surgery.  

“As the number of hip and knee replacement surgeries performed in the United States continues to increase, the risk of DVT following these surgeries remains a concern for physicians,” said Steven J. Romano, M.D., SVP and medicines development group head, Global Innovative Pharmaceuticals Business, Pfizer. “Eliquis provides patients and physicians with a new treatment option that offers twice daily oral dosing and no routine coagulation testing, and is broadly accessible through hospitals and managed healthcare formularies.”

An estimated 719,000 total knee replacement surgeries and 332,00 hip replacement surgeries are performed, the company said.

“DVT, which may lead to PE, is a serious medical condition,” said Richard J. Friedman, M.D., FRCSC, professor of orthopaedic surgery, Medical University of South Carolina. “The FDA approval of Eliquis gives U.S. orthopedic surgeons a new option for DVT prophylaxis in both hip and knee replacement surgery.”

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