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. Author manuscript; available in PMC: 2015 Apr 16.
Published in final edited form as: Cochrane Database Syst Rev. 2014 Apr 16;4:CD009868. doi: 10.1002/14651858.CD009868.pub2

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