Use of ‘Polypill' Combination Drugs Improves Medication Adherence in Patients with Heart Disease

Results from the UMPIRE study show that use of fixed-dose combination cardiovascular drugs improve medication adherence and improve blood pressure and cholesterol levels in patients.

Patients with cardiovascular disease are more likely to take blood-pressure, cholesterol-reducing, and antiplatelet drugs when these medications are combined in a polypill, according to late-breaking clinical trial results presented at the American Heart Association 2012 Scientific Sessions, in Los Angeles, California.

“There has been uncertainty about a fixed-dose combination strategy for cardiovascular disease prevention. While many physicians have anticipated that adherence might be improved, the reduced number of drugs and doses could offset the benefits of simplicity”, said Simon Thom, MD, FRCP, lead author of the “Use of a Multidrug Pill in Reducing Cardiovascular Events (UMPIRE)” study.

Thom also said that the majority of patients that have experienced cardiovascular events, or who are at higher risk for them, often do not receive physician-recommended medications over the long term.

In high-income countries, up to one-third of the population does not take all recommended medications after cardiovascular events. In low-income countries, where most cardiovascular deaths now occur, treatment gaps frequently exceed 90%.

The UMPIRE trial was designed to test a strategy that may encourage long-term preventive medication use. “This is the first time that the impact of a fixed-dose, combination strategy has been tested in people with cardiovascular disease,” said Thom.

In the randomized study, researchers conducted a Prospective, Randomized, Open-label, Blinded-Endpoint (PROBE) clinical trial involving more than 2,000 participants (with an average age of 62 years) with established cardiovascular disease, or an estimated 5-year CVD risk of 15% or greater. Participants were randomized to receive either a fixed-dose combination-based medication or usual care. The study was conducted over the span of 15 months in Europe and India.

In the study, half of the patients were given a combination pill that contained aspirin, a cholesterol-lowering agent (statin), and two blood pressure-lowing drugs. The other half took their medication as usual (multiple pill usage).

The fixed-dose combination version 1 of the study contained aspirin (75mg), simvastatin (40mg), lisinopril (10mg), and atenolo (50mg). Version 2 of this study contained hydrochlorothiazide (12.5mg) instead of atenolol.

The group that took the fixed-dose combination pill improved adherence by a third and experienced lower blood pressure and cholesterol levels as compared to those that were taking multiple pills.