The use of a fixed-dose combination (FDC) strategy for blood pressure, cholesterol and platelet control in patients with or at high risk of cardiovascular disease significantly improves medication adherence, according to results of the UMPIRE Trial published Sept. 3 in the Journal of the American Medical Association 

The study – a randomized, open-label, blinded-end-point trial among 2,004 participants in India and Europe – found that after a 15-month median follow up period, participants assigned to an FDC-based strategy had improved adherence when compared to those who were given "usual care" (86 percent versus 65 percent adherence; p < .001) with concurrent reductions in systolic blood pressure (-2.6 mm Hg) and low-density lipoprotein cholesterol (LDL-C) (-4.2 mg/dL). Prior to the study, the baseline adherence to antiplatelet, statin and two or more blood-pressure lowering medications was 61.5 percent, mean blood pressure was 137/78 mm Hg and LDL-C was 91.5 mg/dL.

The authors note the potential their study proves as it is the "first randomized trial to assess the long-term use of an FDC containing anti-platelet, statin, and blood pressure-lowering drugs compared with usual care in patients with cardiovascular disease." They add that their results "suggest that FDCs could play a role in increasing uptake of statins, aspirin, and combination blood-pressure lowering drugs in patients with cardiovascular disease not currently receiving such treatment." Further, this "scaled up access to core cardiovascular medicines" is in line with "national cardiovascular disease prevention goals" and the World Health Organization's non-communicable disease control plans, they explain.

In a related editorial comment, J. Michael Gaziano, MD, MPH, FACC, from the Division of Aging at Brigham and Women's in Boston, MA, discusses the challenges to widespread study and use of the polypill, including criticism of the UMPIRE study design. "Until additional rigorous data are available that demonstrate that the polypill improves clinical cardiovascular disease outcomes, it may be more important to carefully assess the multiple medications many patients currently are prescribed, often by several physicians." He adds that "although the potential remains for use of various cardiovascular disease polypills in certain settings, the precise advantage of this strategy remains largely unproven."

Keywords: Lipoproteins, LDL, Cholesterol, Follow-Up Studies, Hydroxymethylglutaryl-CoA Reductase Inhibitors, India, Cardiovascular Diseases, Blood Pressure, Blood Platelets, Europe