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Comparison of Risk Factor Reduction and Tolerability of a Full-Dose Polypill (With Potassium) Versus Low-Dose Polypill (Polycap) in Individuals at High Risk of Cardiovascular Diseases
Circulation: Cardiovascular Quality and Outcomes, 08/02/2012
Clinical Article
Yusuf S et al. – The full–dose polycap reduces blood pressure (BP) and low–density lipoprotein cholesterol to a greater extent compared with the low dose, with similar tolerability. Therefore, the full–dose polycap should potentially lead to larger benefits.
Methods- After a run–in period, 518 individuals with previous vascular disease or diabetes mellitus from 27 centers in India were randomly assigned to a single–dose polycap or to 2 capsules of the polycap plus K+supplementation for 8 weeks.
- The effects on BP, heart rate (HR), serum lipids, serum and urinary K+, and tolerability were assessed using an intention–to–treat analysis.
- The full–dose polycap (plus K+ supplementation) reduced BP by a further 2.8 mm Hg systolic and 1.7 mm Hg diastolic, compared with that observed with the low–dose polycap (P=0.003; P=0.001), but there were no differences in HR (0.1 bpm).
- The differences in total and low–density lipoprotein cholesterol between the full–dose and low–dose polycap was 7.2 mg/dL (P=0.014) and 6.6 mg/dL (P=0.006), respectively, but there were no differences in high–density lipoprotein cholesterol or triglycerides.
- The rates of discontinuation of the study drug after randomization were similar in the 2 groups (6.9% low dose versus 7.8% full dose).