Soliman 2009.
Methods | Open label, parallel‐group RCT | |
Participants | 216 participants (105 polypill; 111 comparator); ≥ 40 years for men and ≥ 50 years for women; estimated 10‐year World Health Organization total cardiovascular risk score ≥ 20% without established cardiovascular disease | |
Interventions | Intervention: Red Heart pill 2b (75 mg aspirin, 20 mg simvastatin, 10 mg lisinopril and 12.5 mg hydrochlorothiazide) Comparator: standard practice defined by the study investigators |
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Outcomes | SBP, total cholesterol, 10‐year cardiovascular disease risk, adherence, fasting glucose, creatinine, potassium, and liver enzymes | |
Notes | Comparator: inactive/usual care | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | No method of randomisation stated |
Allocation concealment (selection bias) | Unclear risk | No method of randomisation stated |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Open label |
Blinding of outcome assessment (detection bias) All outcomes | High risk | Open label |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Unclear how missing data were handled |
Selective reporting (reporting bias) | Low risk | Primary outcomes (blood pressure, cholesterol, ten year CVD risk) all reported |
Other bias | High risk | Use of non‐study antihypertensives and statins very different between centres |