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Polypill pushes on
It has been calculated that a polypill containing aspirin, a β blocker, a statin and an angiotensin-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.
A total of 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, hydrochlorothiazide 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 7.4 mm Hg and diastolic blood pressure by 5.6 mm Hg. Although the Polycap reduced low-density lipoprotein cholesterol by 0.70 mmol/l, this was less than the effect of simvastatin alone (0.83 mmol/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 with those projected by another study …