| Methods |
Open label, parallel group randomised clinical trial |
| Participants |
216 (105 Polypill; 111 control); ≥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) Control: Standard practice defined by the study investigators |
| Outcomes |
SBP, total cholesterol, 10-year cardiovascular disease risk, adherence, fasting glucose, creatinine, potassium, and liver enzymes |
| Notes |
Control: 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) |
High risk |
Open label |
| 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 |
