Wald 2012.
Methods | Individual‐level randomised double‐blind placebo‐controlled cross‐over trial | |
Participants | 86 individuals (43 Polypill then placebo; 43 placebo then Polypill) aged 50 years or over without history of cardiovascular disease who were previously taking simvastatin and blood pressure‐lowering drugs; limited to participants living in London or could travel easily to London | |
Interventions | Intervention: fixed‐dose combination (amlodipine 2.5mg, losartan 25mg, hydrochlorothiazide 12.5mg, simvastatin 40mg) daily for 12 weeks Comparator: placebo |
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Outcomes | SBP, DBP, total cholesterol, LDL‐C, HDL‐C, triglycerides, apoB, adherence (pill counts of fixed‐dose combination compared with placebo), adverse events | |
Notes | Comparator: 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‐generated block randomisation with sequential identical blister packs |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Placebo controlled |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Outcome assessors reported as being blinded |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Primary outcomes reported |
Selective reporting (reporting bias) | Unclear risk | Adverse event data not clearly described; only proportion of individuals with "symptom", which was assumed to be an adverse event |
Other bias | Low risk | No need for intention‐to‐treat analysis as cross‐over design. Any losses to follow‐up clear |
apoB: apolipoprotein B CHD: coronary heart disease CVD: cardiovascular disease DBP: diastolic blood pressure ECG: electrocardiogram HDL‐C: high‐density lipoprotein cholesterol LDL‐C: low‐density lipoprotein cholesterol PVD: peripheral vascular disease RCT: randomised controlled trial SBP: systolic blood pressure