Castellano 2014.
| Study characteristics | ||
| Methods | Parallel randomised controlled clinical trial Randomisation ratio: 1:1 Equivalence design: 2‐sided confidence interval Open‐label |
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| Participants | N recruited = 695 N randomized = 695 (345 control, 350 intervention) N reported outcomes = 695 included for intention‐to‐treat analysis, but only 458 completed all visits for per protocol analysis Mean age for Phase 1 is 64 ± 11 years (not reported for Phase 2) INCLUSION CRITERIA Participants previously included in Phase 1 (cross‐sectional study of FOCUS) but not in Phase 2 (randomised controlled trial of FOCUS) EXCLUSION CRITERIA Secondary dyslipidaemia, contraindication to any of the components of the polypill, participation in another trial, previous percutaneous transluminal coronary angioplasty with a drug eluting stent within the previous year, severe congestive heart failure (New York Heart Association functional class III to IV), serum creatinine > 2 mg/dl, any condition limiting life expectancy < 2 years, and pregnancy or premenopause COUNTRY/SETTING: Argentina, Brazil, Italy, Paraguay, and Spain STUDY PERIOD: January 2011 to January 2014 |
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| Interventions | Number of study centres: 63 outpatient clinics in Argentina, Paraguay, Italy and Spain INTERVENTION GROUP FDC polypill containing aspirin 100 mg, simvastatin 40 mg, and rampiril at 3 different doses: 2.5,5, or 10 mg given once daily CONTROL GROUP Received aspirin, simvastatin, and ramipril as 3 separate drugs given once daily |
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| Outcomes | TIME OF OUTCOME MEASUREMENTS Participants were followed at 1, 4, and 9 months PRIMARY OUTCOME: percentage of participants taking medication adequately at 9 months in each arm assessed by attendance at the final 9‐month visit and the Morisky‐Green questionnaire (MAQ) and pill count methods, simultaneously. SECONDARY OUTCOMES: risk factor control in each study arm (BP and lipid LDL‐cholesterol levels at months 1 and 9), incidence of adverse events (including death, reinfarction, and rehospitalisation for any CV cause), rate of treatment withdrawal, tolerability, and quality of life, economic end points (medical and nonmedical costs data not shown) |
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| Notes | Commercial funding/non‐commercial funding/other funding: Not reported; however, it is stated in the text that the FOCUS trial "provided both the polypill group and the control group with free medications." Stated aim for study: "This randomized trial aims to analyze the impact of a polypill strategy on adherence in post‐MI patients." |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | "a central electronic randomization service assigned participants to 1 of 2 arms" |
| Allocation concealment (selection bias) | Low risk | See above |
| Blinding (performance bias and detection bias) All outcomes | Unclear risk | Unblinded but "pill count enabled a more objective assessment of adherence during the trial" |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | 78 participants (43 intervention, 35 control) were lost to follow‐up, 27 participants (14 intervention, 13 control) discontinued the medications due to an adverse effect |
| Selective reporting (reporting bias) | Low risk | All outcomes reported |