PILL 2011.
Methods | Individual‐level RCT | |
Participants | 378 participants (189 intervention; 189 comparator) from 7 countries (Australia, Brazil, India, Netherlands, New Zealand, UK, USA) with 5‐year Framingham coronary heart disease risk ≥ 7.5% or if Framingham risk was between 5% and 7.5%, two or more additional untreated risk factors were needed (body mass index > 30 kg/m2, waist circumference > 102 cm in men or > 88 cm in women; heart rate > 80 bpm; fasting glucose 5.6 mmol/L‐7 mmol/L, triglycerides > 1.7 mmol/L; family history of first degree relative with premature ischaemic heart disease or stroke (men < 55 years; women: < 65 years), or glomerular filtration rate < 60mL/min | |
Interventions | Intervention: Red heart pill (aspirin 75 mg, lisinopril 10 mg, hydrochlorothiazide 12.5 mg and simvastatin 20 mg) Comparator: placebo |
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Outcomes | Change in SBP; change in LDL‐C; tolerability; secondary outcomes included discontinuation, DBP, total cholesterol, HDL‐C, total cholesterol:HDL cholesterol ratio, non‐HDL cholesterol, triglycerides, frequency of switching/adding open‐label treatment, estimated effects on CVD risk | |
Notes | Comparator: inactive/placebo | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Central computer‐based randomisation |
Allocation concealment (selection bias) | Low risk | Central computer‐based randomisation |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Specifically reported and use of placebo control |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Outcome assessors and study staff all blinded |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Low rates of loss to follow‐up (experimental 2%; control 1%); however, last observation carried forward method used for missing continuous data at week 12 |
Selective reporting (reporting bias) | Low risk | Outcomes outlined in methods paper were reported in the primary manuscript |
Other bias | Low risk | No other sources of bias are identifiable |