An International Randomised Placebo-Controlled Trial of a Four-Component Combination Pill (“Polypill”) in People with Raised Cardiovascular Risk
by PILL Collaborative Group
There has been widespread interest in the potential of combination
cardiovascular medications containing aspirin and agents to lower blood
pressure and cholesterol (‘polypills’) to reduce cardiovascular
disease. However, no reliable placebo-controlled data are available on both
efficacy and tolerability.
We conducted a randomised, double-blind placebo-controlled trial of a
polypill (containing aspirin 75 mg, lisinopril 10 mg, hydrochlorothiazide
12.5 mg and simvastatin 20 mg) in 378 individuals without an indication for
any component of the polypill, but who had an estimated 5-year
cardiovascular disease risk over 7.5%. The primary outcomes were
systolic blood pressure (SBP), LDL-cholesterol and tolerability (proportion
discontinued randomised therapy) at 12 weeks follow-up.
At baseline, mean BP was 134/81 mmHg and mean LDL-cholesterol was 3.7 mmol/L.
Over 12 weeks, polypill treatment reduced SBP by 9.9 (95% CI: 7.7 to
12.1) mmHg and LDL-cholesterol by 0.8 (95% CI 0.6 to 0.9) mmol/L. The
discontinuation rates in the polypill group compared to placebo were
23% vs 18% (RR 1.33, 95% CI 0.89 to 2.00,
p = 0.2). There was an excess of side effects known to
the component medicines (58% vs 42%,
p = 0.001), which was mostly apparent within a few
weeks, and usually did not warrant cessation of trial treatment.
This polypill achieved sizeable reductions in SBP and LDL-cholesterol but
caused side effects in about 1 in 6 people. 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.
Australian New Zealand Clinical Trials Registry ACTRN12607000099426
For the full article visit: An International Randomised Placebo-Controlled Trial of a
Four-Component Combination Pill (“Polypill”) in People with Raised
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