TOGETHER 2010.
Methods | Individual‐level randomised, double dummy controlled trial | |
Participants | 244 participants (122 intervention; 122 control) from the USA with history of hypertension but no history of CVD or diabetes with ≥ 2 risk factors: age ≥ 45 years for men; ≥ 55 years for women; current smoker; family history of premature coronary heart disease in first degree relative; HDL cholesterol < 40 mg/dl; waist circumference > 102 cm in men and > 88 cm in women | |
Interventions | Intervention: single pill amlodipine (5/10 mg) plus atorvastatin 20 mg + therapeutic lifestyle changes Comparator: amlodipine (5/10 mg) + therapeutic lifestyle changes |
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Outcomes | Proportion achieving a BP goal < 140/90 mmHg and LDL‐C < 100 mg/dl at week 6; BP and LDL‐C goal at week 4; BP goal at weeks 4 and 6; change in SBP, DBP, LDL‐C, total cholesterol, HDL‐C, triglycerides at weeks 4 and 6; predicted 10‐year Framingham coronary heart disease risk score, adverse events | |
Notes | Comparator: active | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Central, computer‐based telerandomisation |
Allocation concealment (selection bias) | Low risk | Central, computer‐based telerandomisation |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Double‐blind labelled bottles and double dummy |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Reportedly double blinded |
Incomplete outcome data (attrition bias) All outcomes | High risk | Last observation carried forward used for non‐completers for final analysis |
Selective reporting (reporting bias) | Unclear risk | Primary outcomes reported |
Other bias | Low risk | No other sources of bias are identifiable |