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TIPS for Reducing Cardiovascular Risk

In a large feasibility trial, one small pill had favorable effects on many important risk markers.

In 2003, Wald and Law proposed that combining low-dose antihypertensives, a statin, aspirin, and folic acid could substantially reduce cardiovascular events (JW Cardiol Aug 22 2003). But would combining multiple agents into one pill diminish their pharmacologic effects? To find out, investigators for The Indian Polycap Study (TIPS) compared the effects of Polycap — a combination of thiazide (12.5 mg), atenolol (50 mg), ramipril (5 mg), simvastatin (20 mg), and aspirin (100 mg) — with those of 8 individual and variously combined formulations of its components on LDL levels, blood pressure, pulse rates, urinary 11-dehydrothromboxane B2 levels, and rate of treatment discontinuation. This manufacturer-sponsored, factorial, randomized trial included 2053 healthy adults in India, aged 45 to 80, each of whom had one cardiovascular risk factor.

After 8 to 12 weeks of treatment, reductions in blood pressure, heart rate, and 11-dehydrothromboxane B2 were similar in the Polycap group and the individual- or combined-therapy groups. LDL reduction was slightly less in the Polycap group than in the simvastatin-alone group, but was greater than that in groups without simvastatin. Tolerability and discontinuation rates were similar in the Polycap group and the other-formulation groups. Based on extrapolation from individual risk reductions, the investigators estimate that Polycap could potentially reduce cardiovascular risk by 50% to 60%.

Comment: In this short-term study, one pill containing multiple agents proved noninferior to the same agents given separately or in various combinations. These findings demonstrate that a polypill approach could be an effective, convenient, feasible way to reduce cardiovascular risk factors. Polycap seems ripe for the large, long-term studies of cost and outcomes that must be completed before such a pill can assume a role in clinical practice.

— JoAnne M. Foody, MD

Published in Journal Watch Cardiology March 30, 2009

Citation(s):

Yusuf S et al for The Indian Polycap Study (TIPS). Effects of a polypill (Polycap) on risk factors in middle-aged individuals without cardiovascular disease (TIPS): A phase II, double-blind, randomised trial. Lancet 2009 Mar 30; [e-pub ahead of print]. (http://dx.doi.org/10.1016/S0140-6736(09)60611-5)

Cannon CP. Can the polypill save the world from heart disease? Lancet 2009 Mar 30; [e-pub ahead of print]. (http://dx.doi.org/10.1016/S0140-6736(09)60652-8)

Reader Remarks:

Review and add to remarks on this article

• polypill
  JEROME NADLER, 22 Feb 2010 12:31 PM EST
  I would prefer to use separate meds to acheive the desired effect of each Rx. ei.,Total LDL in the 60-70... [more]

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