A Polypill for primary prevention of XXXX : a feasibility study of the World Health Organization.

@entity1 @entity3413 @entity918 @entity117 @entity3595 @entity3593 @entity551 @entity65 @entity165
BACKGROUND: The feasibility of conducting a large-scale Polypill clinical trial in developing countries remains unclear. More information is needed regarding the efficacy in reducing the risk factors of @entity65 ( @entity65 ), side effects, improvement in adherence and physician/ @entity1 "acceptability" of the Polypill. METHODS: We conducted an open-label, parallel-group, randomized clinical trial involving three sites in @entity3595 Lanka that enrolled a total of 216 @entity1 without established @entity65 . The trial compared a Polypill (75 mg @entity117 , 20 mg @entity3413 , 10 mg @entity3593 and 12.5 mg @entity918 ) to Standard Practice. After randomization, @entity1 were followed monthly for three months. Pre-specified primary outcomes included @entity551 , total @entity165 and estimated 10-year @entity65 risk. We also evaluated the recruitment process and acceptability of the Polypill by both physicians and @entity1 . RESULTS: @entity1 were recruited in a six-month period as planned. Two hundred three @entity1 (94.0%) completed the treatment program and returned for their three-month follow-up visits. No safety concerns were reported. These findings suggest a high rate of @entity1 acceptability, a finding that is bolstered by the majority of @entity1 completing the trial (90%) indicating that they would take the Polypill "for life" if proven to be effective in reducing @entity65 risk. Approximately 86% of the physicians surveyed agreed with and supported use of the Polypill for primary prevention and 93% for secondary prevention of @entity65 . Both the Polypill and Standard Practice resulted in marked reductions in systolic blood pressure, total @entity165 and 10-year risk of @entity65 . However, the differences between the treatment groups were not statistically significant. CONCLUSIONS: We successfully completed a Polypill feasibility trial in @entity3595 Lanka. We were able to document high acceptability of the Polypill to @entity1 and physicians. We were unable to estimate the risk factor reductions on the Polypill because the control group received similar treatment with individual drugs. The Polypill was however simpler and achieved comparable risk factor reductions, highlighting its potential usefulness in the prevention of @entity65 . TRIAL REGISTRATION NUMBER: NCT00567307.
