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FDA Favors Polypill Combination Therapy for Cardiovascular Patients

  • December 17, 2014
  • RPh on the Go

polypill-cardiovascular-diseaseThe combination therapy in a polypill approach for patients with cardiovascular disease received favor from various FDA officials and agency advisors. The polypill combination therapy concept has been around for a decade, but is not in use at this point.

Stanford University School of Medicine cardiologist Philip Sager says it should be widely used for secondary prevention. He also maintains it could provide major benefits for public health, especially in underserved areas.

Sager serves on the FDA’s Cardiovascular and Renal Drugs Advisory Committee. In September, he and fellow members of the committee met to discuss whether the idea of fixed dose polypill products was feasible to help prevent cardiovascular events. The community also worked to identify patients who could benefit from these products.

FDA officials say they did not seek advice on whether or not the polypill approach could be used as a first defense against cardiovascular disease, only whether or not it would be a viable secondary treatment option.

The FDA has already approved many fixed-dose combination products to treat high blood pressure, as well as products that contain both a statin with either aspirin or amlodipine. These approvals were based on pharmacodynamic and pharmacokinetic data. The data demonstrated that component drugs do not interfere with each other when they are formulated together.

The FDA drug division’s deputy director of clinical science, Robert Temple, says the FDA must know the effects of the combinations are – and they must know this for any and all polypill products. They sought the advice of the committee experts because they wanted to know about additional information necessary to approve a cardiovascular polypill.

The FDA says the polypill concept was first raised in 2002 by Salim Yusuf of McMaster University in Hamilton, Ontario. He estimated the risk of cardiovascular events among heart disease patients could be reduced by 75% with a polypill that contains aspirin, a beta blocker, a statin, and an angiotensin-converting enzyme inhibitor.

In the presentation Yusuf presented to the committee, he said polypills have been approved in 11 countries – and at least five of those countries are developing products for use in the United States.

Though initially skeptical about the benefits of a polypill, agency officials have changed their mind – suggesting that it will not create any bigger risk than what is already present when using the medications outside of a polypill format. According to a report published in September, half of the patients given a three-drug polypill were still taking the medication nine months later, whereas only 41% of patients given the three separate drugs were still taking them at the nine month point. Therefore, the polypill approach could ensure patients are receiving better quality care, simply by making their medication regimens easier.


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