Polypill linked with improved BP, LDL levels

PILL Collaborative Group. PLoS One. 2011;doi:10.1371/journal.pone.0019857.

A pill containing aspirin plus BP- and cholesterol-lowering agents was linked to reductions in systolic BP and LDL, according to recent results.

The pill contains 75 mg of aspirin, 10 mg of lisinopril, 12.5 mg of hydrochlorothiazide and 20 mg of simvastatin. There were 378 eligible participants who had no indication for any component of the pill but who had an estimated 5-year CVD risk of more than 7.5%.

Baseline data indicated that the mean BP was 134 mm Hg/81 mm Hg and the mean LDL cholesterol was 3.7 mmol/L.

A 9.9 mm Hg reduction in systolic BP (95% CI, 7.7-12.1) was linked to polypill treatment at 12 weeks’ follow-up. The pill also was associated with a reduction in LDL cholesterol of 0.8 mmol/L (95% CI, 0.6-0.9).

Patients in the treatment group discontinued at a rate of 23% vs. an 18% discontinuation rate in the placebo group (RR=1.33; 95% CI, 0.89-2.00).

Adverse events were reported in 58% of recipients and 42% of placebo recipients (P=.001). These events were evident early on in the trial but generally did not warrant cessation of treatment, according to the researchers.

The primary outcomes of the randomized, double blind, placebo-controlled trial were systolic BP, LDL cholesterol and tolerability (proportion discontinued randomized therapy) by 12 weeks.

“This polypill achieved sizeable reductions in [systolic] BP and LDL cholesterol but caused side effects in about one in six people,” the researchers wrote. “The halving in predicted cardiovascular risk is moderately lower than previous estimates and the side effect rate is moderately higher. Nonetheless, substantial net benefits would be expected among patients at high risk.”

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