Polypill pushes on

It has been calculated that a polypill containing asprin, a beta-blocker, a statin and an angotensin-converting enzyme inhibitor could reduce cardiovascular events in people with cardiovascular disease by about 75%. It has further been suggested that the addition of folic acid, and the use of three separate agents to lower blood pressure (each in low doses), could enable a polypill preparation to reduce cardiovascular disease by more than 80%. The Indian Polycap Study (TIPS) was designed to examine the efficacy of just such a formulation, named the Polycap pill.

2053 patients without cardiovascular disease, all aged 45-80 years but with one cardiovascular risk factor, were randomised to the Polycap (n=412) or to one of eight other groups – each with about 200 patients – of aspirin alone, simvastatin alone, hydrochlorthiazide alone, three different combinations of two blood-pressure lowering drugs, three blood-pressure lowering drugs alone, or three blood-pressure-lowering drugs with aspirin.

Compared with groups not receiving blood pressure drugs, the Polycap reduced systolic blood pressure by 7.4mmHg and diastolic blood pressure by 5.6mmHg. Although the Polycap reduced LDL cholesterol by 0.70mmol/L, this was less than the effect of simvastatin alone (0.83mmol/L; p=0.04). Tolerability of the Polycap was similar to that of other treatments, with no evidence of higher intolerability as the number of active components increased.

This phase II study confirms that a polypill formulation can be tolerated and used to reduced multiple risk factors. Importantly, the study also demonstrates that the effects of a polypill may not necessarily be totally predicted by its components – the weakness of the cholesterol effect demonstrates this. Of course, the trial does not tell us about morbidity and mortality effects, although the authors predict these values and compare them to those projected by another study by Wald and Law (see table). Nonetheless, this study marks an important step in the ongoing development of the polypill.

Study

Agent

Reductions in Risk Factors

Reduction in CHD risk (%)

LDL Cholesterol

Wald & Law

Simvastatin 40mg/day

1.74 mmol/L

61%

Polycap

Simvastatin 20mg/day

0.80mmol/L

27%

Diastolic Blood Pressure

Wald & Law

3 classes of drugs at half standard doses

-11 mmHg

46%

Polycap

3 classes of drugs at half standard doses

-5.7 mmHg

24%

Serum Homocysteine

Wald & Law

Folic acid

3 μmol/L

16%

Polycap

Not assessed

Platelet function

Wald & Law

Aspirin 75mg/day

Not quantified

32%

Polycap

Aspiring 100mg/day

Assumed to be similar

32%

All above

Wald & Law

88%

Polycap

62%

·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, randomized trial. Lancet 2009; DOI:10.1016/S0140-6736(09)60611-5.

· Cannon CP. Can the polypill save the world from heart disease? Lancet 2009; DOI:10.1016/S0140-6736(09)60652-8.

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