An international randomised placebo-controlled trial of a four-component combination pill ("polypill") in people with raised cardiovascular risk.
<h4>Background</h4>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 ar...
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Public Library of Science (PLoS)
2011
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oai:doaj.org-article:16dd80222e3b4ed69eabb956c7b80aed2021-11-18T06:53:17ZAn international randomised placebo-controlled trial of a four-component combination pill ("polypill") in people with raised cardiovascular risk.1932-620310.1371/journal.pone.0019857https://doaj.org/article/16dd80222e3b4ed69eabb956c7b80aed2011-01-01T00:00:00Zhttps://www.ncbi.nlm.nih.gov/pmc/articles/pmid/21647425/?tool=EBIhttps://doaj.org/toc/1932-6203<h4>Background</h4>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.<h4>Methods</h4>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.<h4>Findings</h4>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.<h4>Conclusions</h4>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.<h4>Trial registration</h4>Australian New Zealand Clinical Trials Registry ACTRN12607000099426.PILL Collaborative GroupAnthony RodgersAnushka PatelOtavio BerwangerMichiel BotsRichard GrimmDiederick E GrobbeeRod JacksonBruce NealJim NeatonNeil PoulterNatasha RafterP Krishnam RajuSrinath ReddySimon ThomStephen Vander HoornRuth WebsterPublic Library of Science (PLoS)articleMedicineRScienceQENPLoS ONE, Vol 6, Iss 5, p e19857 (2011) |
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DOAJ |
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Medicine R Science Q |
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Medicine R Science Q PILL Collaborative Group 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 Ruth Webster An international randomised placebo-controlled trial of a four-component combination pill ("polypill") in people with raised cardiovascular risk. |
| description |
<h4>Background</h4>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.<h4>Methods</h4>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.<h4>Findings</h4>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.<h4>Conclusions</h4>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.<h4>Trial registration</h4>Australian New Zealand Clinical Trials Registry ACTRN12607000099426. |
| format |
article |
| author |
PILL Collaborative Group 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 Ruth Webster |
| author_facet |
PILL Collaborative Group 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 Ruth Webster |
| author_sort |
PILL Collaborative Group |
| title |
An international randomised placebo-controlled trial of a four-component combination pill ("polypill") in people with raised cardiovascular risk. |
| title_short |
An international randomised placebo-controlled trial of a four-component combination pill ("polypill") in people with raised cardiovascular risk. |
| title_full |
An international randomised placebo-controlled trial of a four-component combination pill ("polypill") in people with raised cardiovascular risk. |
| title_fullStr |
An international randomised placebo-controlled trial of a four-component combination pill ("polypill") in people with raised cardiovascular risk. |
| title_full_unstemmed |
An international randomised placebo-controlled trial of a four-component combination pill ("polypill") in people with raised cardiovascular risk. |
| title_sort |
international randomised placebo-controlled trial of a four-component combination pill ("polypill") in people with raised cardiovascular risk. |
| publisher |
Public Library of Science (PLoS) |
| publishDate |
2011 |
| url |
https://doaj.org/article/16dd80222e3b4ed69eabb956c7b80aed |
| work_keys_str_mv |
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