The effects of fixed-dose combination therapy on all-cause mortality or ASCVD events are uncertain .
A limited number of trials reported these outcomes , and the included trials were primarily design ed to observe changes in ASCVD risk factor levels rather than clinical events , which may partially explain the observed differences in risk factors that were not translated into differences in clinical outcomes among the included trials .
Fixed-dose combination therapy is associated with modest increases in adverse events compared with placebo , active comparator , or usual care but may be associated with improved adherence to a multidrug regimen .
Ongoing , longer-term trials of fixed-dose combination therapy will help demonstrate whether short-term changes in risk factors might be maintained and lead to expected differences in clinical events based on these changes
BACKGROUND Atherosclerotic cardiovascular disease ( ASCVD ) is the leading cause of death and disability worldwide , yet ASCVD risk factor control and secondary prevention rates remain low .
A fixed-dose combination of blood pressure- and cholesterol-lowering and antiplatelet treatments into a single pill , or polypill , has been proposed as one strategy to reduce the global burden of ASCVD .
OBJECTIVES To determine the effect of fixed-dose combination therapy on all-cause mortality , fatal and non-fatal ASCVD events , and adverse events .
We also sought to determine the effect of fixed-dose combination therapy on blood pressure , lipids , adherence , discontinuation rates , health-related quality of life , and costs .
Polypill for the prevention of cardiovascular disease (PolyIran): study design and rationale for a pragmatic cluster randomized controlled trial
Background The complexity of treatment regimens , costs and pill burden decrease the medication adherence and contribute to shortfall in cardiovascular preventive drug coverage . The polypill , a fixed dose combination pill of established drugs , is expected to increase adherence and reduce the costs whilst preventing major cardiovascular events ( MCVE ) . Design and methods The PolyIran trial is a pragmatic cluster r and omized trial nested within the Golestan Cohort Study ( GCS ) . Subjects were r and omized to either non-pharmacological preventive interventions alone ( minimal care arm ) or together with a polypill ( polypill arm ) comprising hydrochlorothiazide , aspirin , atorvastatin and either enalapril or valsartan . This study benefits from the infrastructure of the primary health care system in Iran and the interventions are delivered by the local auxiliary health workers ( Behvarz ) to the participants . The primary outcome of the study is the occurrence of first MCVE within five years defined as non-fatal and fatal myocardial infa rct ion , unstable angina , sudden death , heart failure , coronary artery revascularization procedures , and non-fatal and fatal stroke . Trial status From February 2011 to April 2013 , 8410 individuals ( 236 clusters ) attended the eligibility assessment . Of those , 3421 in the polypill arm and 3417 in the minimal care arm were eligible . The study is ongoing . Conclusion The infrastructure of GCS and the primary health care system in Iran enabled the conduct of this pragmatic large-scale trial . If the polypill strategy proves effective , it may be implemented to prevent cardiovascular disease in developing countries
The effects of fixed-dose combination therapy on all-cause mortality or ASCVD events are uncertain .
A limited number of trials reported these outcomes , and the included trials were primarily design ed to observe changes in ASCVD risk factor levels rather than clinical events , which may partially explain the observed differences in risk factors that were not translated into differences in clinical outcomes among the included trials .
Fixed-dose combination therapy is associated with modest increases in adverse events compared with placebo , active comparator , or usual care but may be associated with improved adherence to a multidrug regimen .
Ongoing , longer-term trials of fixed-dose combination therapy will help demonstrate whether short-term changes in risk factors might be maintained and lead to expected differences in clinical events based on these changes
BACKGROUND Atherosclerotic cardiovascular disease ( ASCVD ) is the leading cause of death and disability worldwide , yet ASCVD risk factor control and secondary prevention rates remain low .
A fixed-dose combination of blood pressure- and cholesterol-lowering and antiplatelet treatments into a single pill , or polypill , has been proposed as one strategy to reduce the global burden of ASCVD .
OBJECTIVES To determine the effect of fixed-dose combination therapy on all-cause mortality , fatal and non-fatal ASCVD events , and adverse events .
We also sought to determine the effect of fixed-dose combination therapy on blood pressure , lipids , adherence , discontinuation rates , health-related quality of life , and costs .