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 .
An economic case for a cardiovascular polypill? A cost analysis of the Kanyini GAP trial.
OBJECTIVE To measure the costs of a polypill strategy and compare them with those of usual care in people with established cardiovascular disease ( CVD ) or at similarly high cardiovascular risk . DESIGN A within-trial cost analysis of polypill-based care versus usual care with separate medications , using data from the Kanyini Guidelines Adherence with the Polypill ( GAP ) trial and linked health service and medication administrative cl aims data . PARTICIPANTS Kanyini GAP participants who consented to Australian Medicare record access . MAIN OUTCOME MEASURES Mean health service and pharmaceutical expenditure per patient per year , estimated with generalised linear models . Costs during the trial ( r and omisation January 2010 - May 2012 , median follow-up 19 months , maximum follow-up 36 months ) were inflated to 2012 costs . RESULTS Our analysis showed a statistically significantly lower mean pharmaceutical expenditure of $ 989 ( 95 % CI , $ 648-$1331 ) per patient per year in the polypill arm compared with usual care ( P < 0.001 ; adjusted , excluding polypill cost ) . No significant difference was shown in health service expenditure . CONCLUSIONS This study provides evidence of significant cost savings to the taxpayer and Australian Government through the introduction of a CVD polypill strategy . The savings will be less now than during the trial due to subsequent reductions in the costs of usual care . Nonetheless , given the prevalence of CVD in Australia , the introduction of this polypill could increase considerably the efficiency of health care expenditure in Australia . TRIAL REGISTRATION Australian New Zeal and Clinical Trials Registry ACTRN126080005833347
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 .