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 |