Latest polypill trial yields largest improvements yet

Jul 24 2012

By Piriya Mahendra

The results of the first trial to administer the polypill on the basis of age alone has shown the largest reductions in blood pressure (BP) and cholesterol level of any polypill trial to date, researchers report.

The results of the current study are more likely to be accurate than other polypill trials because of its crossover, rather than parallel group, design, which has greater statistical power and avoids the dilution of the estimation of effect due to participants who did not take their allocated treatment, claim David Wald (Queen Mary University of London, UK) and team.

In their study, the polypill, which consisted of amlodipine 2.5 mg, losartan 25 mg, hydrochlorothiazide 12.5 mg, and simvastatin 40 mg and was administered to 84 participants aged a mean of 59 years, reduced mean systolic BP by 17.9 mmHg and diastolic BP by 9.8 mmHg compared with placebo.

In addition, low-density lipoprotein (LDL) cholesterol was reduced by 1.4 mmol/L, as reported in PLoS One.

Of note, aspirin was not included in the pill. The authors say this was because "the risk of bleeding in people without existing cardiovascular disease (CVD) might be unacceptable in relation to the expected benefit."

Further analysis revealed that the BP and LDL cholesterol reductions observed in the current study were close to those expected from meta-analyses of randomized trials of the individual classes of polypill components, at 12%, 11%, and 39% observed for systolic BP, diastolic BP, and LDL cholesterol, respectively.

At the end of the trial, 24 of the participants reported one or more side-effects while on the polypill, including cough, muscle ache/pain, ankle swelling, flushing, rash, or tongue or lip swelling. However, none of these participants considered their symptoms troublesome enough to stop treatment.

The authors say that based on the quantitative relationship of LDL cholesterol and BP with ischemic heart disease and stroke risk, and given the composition of the polypill they used, the predicted effect in reducing ischemic heart disease events is 72% and in reducing stroke is 64%.

"This polypill, designed principally for primary prevention, therefore has considerable potential for the prevention of cardiovascular disease," they conclude.

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