TOGETHER 2010.
Methods | Individual-level randomised, double dummy controlled trial | |
Participants | 244 participants (122 intervention; 122 control) 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 (5/10mg) plus atorvastatin 20mg + therapeutic lifestyle changes Control: amlodipine (5/10mg) + therapeutic lifestyle changes |
|
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 | Control: 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 | Unclear risk | Double blind labeled bottles but unclear if pills were identical |
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 |