UMPIRE 2013.
Methods | Randomised, open label, blinded endpoint clinical trial of an FDC‐based treatment strategy compared with usual care | |
Participants | ≥18 years old and established CVD or an estimated 5‐year CVD risk of 15% or greater in India and 3 European countries (England, Ireland, and the Netherlands) | |
Interventions | Intervention: one of two versions of the fixed‐dose combination ((1) aspirin 75 mg, simvastatin 40 mg, lisinopril 10 mg, atenolol 50 mg or (2) aspirin 75 mg, simvastatin 40 mg, lisinopril 10 mg, hydrochlorothiazide 12.5 mg) Comparator: usual care |
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Outcomes | Primary: adherence to indicated medications (self‐reported current use of antiplatelet, statin, and ≥ 2 BP‐lowering therapies, defined as taking the medication for at least 4 days during the week preceding the visit) at baseline and at the end of the trial and changes in SBP and LDL‐C from baseline to the end of the trial. Secondary: adherence at 12 months, reasons for stopping cardiovascular medications, quality of life, serious adverse events, and changes in total cholesterol, HDL‐C, triglycerides, and creatinine from baseline to 12 months and end of study and cardiovascular events (including coronary heart disease, heart failure leading to death or hospital admission, and cerebrovascular or peripheral arterial disease events) |
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Notes | Comparator: inactive/usual care | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Randomisation occurred through web‐based clinical data management system |
Allocation concealment (selection bias) | Low risk | Randomisation occurred through web‐based clinical data management system |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Participants and personnel were unblinded |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Outcome assessors were blinded |
Incomplete outcome data (attrition bias) All outcomes | Low risk | At the end of the study, data on self‐reported adherence, systolic BP, and LDL‐C were available for 1921 (96%), 1849 (92%), and 1807 (90%) randomized participants, respectively |
Selective reporting (reporting bias) | Low risk | All primary and secondary outcomes reported |
Other bias | Unclear risk | Participants randomized to the intervention arm received fixed‐dose combination therapy at no cost compared with participants randomized to usual care who were responsible for their drug costs |