An International Randomised Placebo-Controlled Trial of a Four-Component Combination Pill (“Polypill”) in People with Raised Cardiovascular Risk
2011

Polypill Reduces Cardiovascular Risk

Sample size: 378 publication 10 minutes Evidence: moderate

Author Information

Author(s): Anthony Rodgers, Anushka Patel, Otavio Berwanger, Michiel Bots, Richard Grimm, Diederick E. Grobbee, Rod Jackson, Bruce Neal, Jim Neaton, Neil Poulter, Natasha Rafter, P Krishnam Raju, Srinath Reddy, Simon Thom, Stephen Vander Hoorn

Primary Institution: The George Institute for Global Health

Hypothesis

Can a Polypill Safely Halve Cardiovascular Risk?

Conclusion

The polypill achieved significant reductions in blood pressure and cholesterol but caused side effects in about 1 in 6 people.

Supporting Evidence

  • The polypill reduced systolic blood pressure by 9.9 mmHg.
  • LDL-cholesterol was reduced by 0.8 mmol/L.
  • Discontinuation rates were 23% for the polypill group compared to 18% for placebo.
  • 58% of the polypill group reported side effects compared to 42% in the placebo group.
  • Most side effects were known issues related to the individual components of the polypill.

Takeaway

A special pill can help people with heart risks feel better by lowering their blood pressure and cholesterol, but some might feel sick from it.

Methodology

Randomised, double-blind placebo-controlled trial comparing a polypill to placebo over 12 weeks.

Potential Biases

Potential bias due to the relatively narrow participant demographics and the short duration of the study.

Limitations

Short follow-up period and the inability to definitively attribute side effects to specific components of the polypill.

Participant Demographics

Participants were adults aged 18 and older with a 5-year cardiovascular disease risk over 7.5%.

Statistical Information

P-Value

p=0.2

Confidence Interval

95% CI: 7.7 to 12.1 mmHg for SBP reduction; 95% CI: 0.6 to 0.9 mmol/L for LDL-cholesterol reduction.

Statistical Significance

p<0.05

Digital Object Identifier (DOI)

10.1371/journal.pone.0019857

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