An International Randomised Placebo-Controlled Trial of a Four-Component Combination Pill (“Polypill”) in People with Raised Cardiovascular Risk 英文参考文献.docVIP

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An International Randomised Placebo-Controlled Trial of a Four-Component Combination Pill (“Polypill”) in People with Raised Cardiovascular Risk 英文参考文献.doc

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

AnInternationalRandomisedPlacebo-ControlledTrialof aFour-ComponentCombinationPill(‘‘Polypill’’)in PeoplewithRaisedCardiovascularRisk PILLCollaborativeGroup* Abstract Background: There hasbeenwidespread interestin thepotential ofcombinationcardiovascular medicationscontaining aspirin and agents to lower blood pressure and cholesterol (‘polypills’) to reduce cardiovascular disease. However, no reliableplacebo-controlleddataareavailableonbothefficacyandtolerability. Methods: We conducted a randomised, double-blind placebo-controlled trial of a polypill (containing aspirin 75mg, lisinopril 10mg, hydrochlorothiazide 12.5mg and simvastatin 20mg) in 378 individuals without an indication for any componentofthepolypill,butwhohadanestimated5-yearcardiovasculardiseaseriskover7.5%.Theprimaryoutcomes were systolic blood pressure (SBP), LDL-cholesterol and tolerability (proportion discontinued randomised therapy) at 12 weeksfollow-up. Findings: At baseline, mean BP was 134/81mmHg and mean LDL-cholesterol was 3.7mmol/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 discontinuationratesinthepolypillgroupcomparedtoplacebowere23%vs18%(RR1.33,95%CI0.89to2.00,p=0.2). Therewasanexcessofsideeffectsknowntothecomponentmedicines(58%vs42%,p=0.001),whichwasmostlyapparent withinafewweeks,andusuallydidnotwarrantcessationoftrialtreatment. Conclusions:ThispolypillachievedsizeablereductionsinSBPandLDL-cholesterolbutcausedsideeffectsinabout1in6 people.Thehalvinginpredictedcardiovascularriskismoderatelylowerthanpreviousestimatesandthesideeffectrateis moderatelyhigher.Nonetheless,substantialnetbenefitswouldbeexpectedamongpatientsathighrisk. TrialRegistration:AustralianNewZealandClinicalTrialsRegistryACTRN12607000099426 Citation:PILLCollaborativeGroup(2011)AnInternationalRandomisedPlacebo-ControlledTrialofaFour-ComponentCombinationPill(‘‘Polypill’’)inPeoplewith RaisedCardiovascularRisk.PLoSONE6(5):e19857.do