By Professor Juan Tamargo, Madrid, Spain
The effects of a polypill containing three BP-lowering medications (amlodipine 2.5 mg, losartan 25 mg and hydrochlorothiazide 12.5 mg) along with the lipid-lowering simvastatin 40 mg was evaluated for the primary prevention of cardiovascular diseases. In total, 86 patients aged >50 years experienced a 12% reduction in BP (SBP/DBP 17.9/9.8 mm Hg) and 39% fall in LDL cholesterol (1.4 mmol/L) during the 12-week study. They concluded that if people took the polypill long term from age 50, an estimated 28% would avoid or delay a heart attack or stroke during their lifetime and gain, on average, 11 years of life free of cardiovascular events.
To explain why aspirin was not included in their formulation, the authors mentioned that once you have achieved the large BP and cholesterol reductions observed in their study, the residual benefit you get from aspirin does not justify its risk in CVD prevention.
Despite these interesting results, this study presents two main limitations: a) is included only 86 patients and b) the follow-up was very short (12 weeks) so that the authors can not provide evidence of the long-term efficacy and safety of their polypill. Indeed, in this short-term study side effects were more frequent with the polypill than placebo (29% vs 13%, p=0.01) and myalgia was more common with the polypill compared with placebo (11% vs 1.2%, respectively). Furthermore, the high adherence rate observed (98%) has never been reached in the daily clinical practice. Thus, it would be of great interest to confirm these preliminary results in a large scale, long-term trial.
1. Wald DS, Morris JK, Wald NJ. Randomized polypill crossover trial in people aged 50 and over. PLoS ONE 2012; 7:e41297.