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UMPIRE: Polypill strategy improved adherence, systolic BP, LDL
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LOS ANGELES — Patients with CVD who were assigned a fixed-dose combination therapy of statin, antiplatelet and BP-lowering drugs experienced improved adherence, BP and cholesterol according to researcher Simon A. Thom, MD, FRCP.
“The use of preventive medications post-CVD is disappointingly low worldwide. In high-income countries, patients have about a 50% chance of being on aspirin, statin and BP-lowering therapy after a heart attack ... In low-income countrires, you’re pretty likely to be on nothing at all by way of preventive medication,” Thom, lead author of the UMPIRE trial and a professor of CV medicine and pharmacology at Imperial College in London, said during a presentation at the American Heart Association Scientific Sessions.
“We have conducted a pro-design trial to test the hypothesis that a fixed-dose combination-based strategy — a polypill — for delivery of preventive medications, compared with usual care, might improve adherence to indicated therapy.”
UMPIRE is an ongoing randomized, controlled clinical trial that examined the impact of a combination therapy, also known as a “polypill-based strategy,” according to Thom.
The trial included 2,004 patients (mean age, 62 years) with established CVD or a 5-year risk of ≥15% in India and Europe who were randomly assigned to one of two fixed-dose combination-based strategies (n=1,002) or usual care (n=1,002). Patients in the fixed-dose combination 1 group were administered aspirin 75 mg, simvastatin 40 mg (Zocor, Merck), lisinopril 10 mg and atenolol 50 mg while patients in fixed-dose combination 2 group were given hydrochlorothiazide 12.5 mg instead of atenolol.
Primary endpoints included adherence to the medication administered and changes to systolic BP and LDL from baseline.
According to data, the fixed-dose combination improved patient adherence by 33%, as indicated by improvements in systolic BP (–2.6 mm Hg; 95% CI, –4 to –1.1) and LDL (–0.11 mmol/L; 95% CI, –0.17 to –0.05). These findings continued through 15 months.
“The fixed-dose combination strategy including aspirin, statin and two BP-lowering drugs improves adherence, BP and cholesterol in patients with established CVD and in those at high risk,” Thom said.
For more information:
Thom S. Late-breaking clinical trials: Treatments for prevention of cardiovascular events: A population perspective. Presented at: the American Heart Association Scientific Sessions 2012; Nov. 3-7, 2012; Los Angeles.
Disclosure: Thom reports no relevant financial disclosures.