Abstract
BackgroundThere 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.MethodsWe 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.FindingsAt 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.ConclusionsThis 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.Trial RegistrationAustralian New Zealand Clinical Trials Registry ACTRN12607000099426
Highlights
In 2001, the World Health Organisation and The Wellcome Trust convened a meeting of experts to discuss evidence-based and affordable interventions for non-communicable diseases.[1]
A major impetus for the meeting was the potential of fixed-dose combination pills containing aspirin, statin and blood pressure lowering agents, noting ‘‘the use of a single pill could well encourage patients to adhere to treatment as well as seriously reduce the cost of the drugs.’’ A programme of research was outlined, including stability and bio-availability testing followed by assessment of short-term effects on blood pressure, cholesterol, platelet aggregation, safety and side effects, ideally including developing country participants
As noted by the European Medicines Agency (EMA)[12] ‘‘the terms primary/secondary prevention have yielded their place for a more comprehensive strategy aimed at treating patients at high risk of cardiovascular disease...current therapeutic strategies are aimed at identifying global cardiovascular disease risk in an individual and treating all risk factors
Summary
In 2001, the World Health Organisation and The Wellcome Trust convened a meeting of experts to discuss evidence-based and affordable interventions for non-communicable diseases.[1] A major impetus for the meeting was the potential of fixed-dose combination pills containing aspirin, statin and blood pressure lowering agents, noting ‘‘the use of a single pill could well encourage patients to adhere to treatment as well as seriously reduce the cost of the drugs.’’ A programme of research was outlined, including stability and bio-availability testing followed by assessment of short-term effects on blood pressure, cholesterol, platelet aggregation, safety and side effects, ideally including developing country participants. No reliable placebo-controlled data are available on both efficacy and tolerability
Sign-in/Register to view highlights & summary Sign-in/Register to access full text options 
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a callDisclaimer: All third-party content on this website/platform is and will remain the property of their respective owners and is provided on "as is" basis without any warranties, express or implied. Use of third-party content does not indicate any affiliation, sponsorship with or endorsement by them. Any references to third-party content is to identify the corresponding services and shall be considered fair use under The CopyrightLaw.
