Polypill Worked in Study, FDA Evaluating Concept

Public health researchers have long believed that if patients could take one pill instead of several they would be more likely to comply with the drug regimens prescribed by their physicians.

The US Food and Drug Administration’s cardiovascular and renal drugs advisory committee is currently evaluating the “potential clinical utility” of a single pill that would contain an anti-hypertensive drug, aspirin, and a statin. The goal would be to prevent strokes and heart attacks in patients with a history of cardiovascular disease.

The committee’s discussion is being webcast at https://collaboration.fda.gov/crdac914/

The first point of debate is whether patients who resist taking such drugs separately would be more likely to them as a polypill.

Reporting at the European Society of Cardiology meeting Sept. 2 in Barcelona, Spain, cardiologist Valentin Fuster, MD, said that happened in his recent study of heart attack patients.

In the first part of a study called FOCUS, principal investigator Fuster, director of Mount Sinai Heart in New York, NY, said the global study of 2,118 patients with a history of myocardial infarction asked participants about their compliance with complex drug regimens.

The researchers found the treatment compliance rate was about 45%. The participants who did not take their medicine were more likely to smoke and have a sedentary lifestyle. They also were more likely to have certain behavioral and sociological traits—including lower literacy levels, less social support, and were more likely to be uninsured, Fuster wrote in the Journal of the American College of Cardiology. The non-adherent patients were also more likely to be under 50 years old, and to be depressed.

In the second phase of the study, the team wanted to find out whether the results would be better if the patients could take one pill with drugs shown to help prevent heart attacks, instead of three. In a randomized controlled clinical trial involving 695 patients, half of the participants got a single polypill containing aspirin, simvastatin, and Ramipril. The others were told to take all three separately. Patients were followed for 9 months.

The team found that 68% of patients getting the polypill adhered to the regimen while only 59% of the group taking the 3 drugs separately took them regularly.

“Our results suggest that the polypill has the potential to prevent more patients having a second heart attack,” Fuster wrote. He called for a randomized study to follow the patients longer to see if compliance would in fact result in fewer heart attacks.