TIPS 2009.
Methods | Individual‐level RCT | |
Participants | 2053 participants (205 aspirin; 205 thiazide; 209 thiazide + ramipril; 207 thiazide + atenolol; 205 ramipril + atenolol; 204 thiazde + ramipril + atenolol; 204 thiazide + ramipril + atenolol + aspirin; 202 simvastatin; 412 Polycap [thiazide + ramipril + atenolol + simvastatin + aspirin); 45‐80 years old without prior cardiovascular disease but with at least one risk factor: type 2 diabetes; blood pressure > 140/90 mmHg but < 160/100 mmHg; smoker within the past five years; waist‐to‐hip ratio > 0.85 for women and 0.90 for men; LDL cholesterol > 3.1 mmol/L but less 4.5 mmol/L or HDL cholesterol < 1.04 mmol/L | |
Interventions | Intervention: Polycap (thiazide 12.5 mg, atenolol 50 mg, ramipril 5 mg, simvastatin 20 mg, aspirin 100 mg) Comparator: 8 other drug/drug combination groups listed above |
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Outcomes | LDL for the effect of lipid‐lowering drugs, BP for antihypertensive drugs, heart rate for the effects of atenolol, urinary 11‐dehydrothromboxane B2 for the antiplatelet effects of aspirin, rates of discontinuation of drugs for safety | |
Notes | Comparator: active | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Central computer randomisation |
Allocation concealment (selection bias) | Low risk | Central computer randomisation |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Placebo control using identical capsule |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Double‐blinding reported; probably occurred given research team's prior studies |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Unclear how missing SBP and LDL‐C data at week 12 follow‐up were handled |
Selective reporting (reporting bias) | Low risk | Primary outcomes reported |
Other bias | Low risk | No other sources of bias are identifiable |