Fixed-Dose Combination Therapy for Cardiovascular Risk Improves Adherence

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Fixed-Dose Combination Therapy for Cardiovascular Risk Improves Adherence

But associated reductions in systolic blood pressure and LDL cholesterol were modest.

Does fixed-dose combination (FDC) therapy (or polypill) improve adherence to multiple pharmacologic therapies known to reduce the risk for cardiovascular disease (CVD)? Investigators examined this question in a randomized trial of 2000 adults in India and Europe (mean age, 62; mostly men) with or at high risk for CVD. Patients received either one of two forms of FDC therapy (physician’s choice) or continued usual care.

About 60% of FDC patients received a polypill containing aspirin (75 mg), simvastatin (40 mg), lisinopril (10 mg), and atenolol (50 mg); the remainder received a similar polypill containing hydrochlorothiazide (12.5 mg) instead of atenolol. Treating physicians could stop, add, or switch medications as needed. Patients received FDC medication without cost, whereas control patients paid for medications as usual. At a median follow-up of 15 months, self-reported adherence to prescribed medication was significantly better in the intervention group than in the control group (86% vs. 65%), with corresponding reductions in systolic blood pressure (mean difference, 2.6 mm Hg) and LDL cholesterol (4.2 mg/dL). Benefits were greater among patients with low adherence at baseline. No significant differences were noted in adverse events or major cardiovascular events.


Did the polypill group show improved adherence because participants only had to take one pill instead of several? We can’t tell from this study, because the polypill was free of charge, whereas control patients had to pay for medications. Moreover, reductions in systolic blood pressure and LDL cholesterol were modest at best. Cardiovascular events were too few to assess the clinical value of this approach.

Thomas L. Schwenk, MD reviewing Thom S et al. JAMA 2013 Sep 4.


Thom S et al. Effects of a fixed-dose combination strategy on adherence and risk factors in patients with or at high risk of CVD: The UMPIRE randomized clinical trial. JAMA 2013 Sep 4; 310:918. [PubMed ® abstract]

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