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. Author manuscript; available in PMC: 2015 Apr 16.
Published in final edited form as: Cochrane Database Syst Rev. 2014 Apr 16;4:CD009868. doi: 10.1002/14651858.CD009868.pub2

Malekzadeh 2010.

Methods Block randomisation
Participants 475 participants (241 polypill; 234 control) without cardiovascular disease, hypertension, or hyperlipidaemia aged 50 to 79 years (men) and 55 to 79 years (women)
Interventions Intervention: Polypill (aspirin 81 mg, enalapril 2.5 mg, atorvastatin 20 mg and hydrochlorothiazide 12.5 mg)
Control: placebo
Outcomes Hospital admissions / major cardiovascular events / seated and standing BP, LDL-C, total cholesterol, triglycerides, HDL-C and fasting glucose
Notes Control: inactive/placebo
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Computer generated block randomisation
Allocation concealment (selection bias) Low risk Computer generation allocation to numbered list of blister packs manufactured by Alborz Darou
Blinding of participants and personnel (performance bias) All outcomes Low risk Identical blister packs used for participant blinding
Blinding of outcome assessment (detection bias) All outcomes Low risk Outcome assessors (clinicians) blinded to allocation
Incomplete outcome data (attrition bias) All outcomes High risk High rate of loss to follow-up at 12 months (experimental 32%; control 22%)
Selective reporting (reporting bias) Low risk Primary outcome reported (changes in blood pressure and LDL cholesterol)
Other bias High risk Run-in period excluded participants with low (<70%) adherence; large differences in baseline characteristics between intervention and control groups