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 .
Greater cardiovascular risk reduction with once-daily fixed combination of three antihypertensive agents and statin versus free-drug combination: The ALL-IN-ONE trial.
BACKGROUND The ultimate goal of antihypertensive therapy is cardiovascular risk ( CVR ) reduction . The aim of this study was to compare the efficacy and safety of once-daily fixed combination ( ODFC ) versus free-drug combination ( FDC ) of 3antihypertensive agents and statin . METHODS The ALL-IN-ONE trial was a 12-week r and omized , prospect i ve , multicenter trial . A total of 305 hypertensive patients were r and omized 1:1 . The " fixed group " was given an ODFC of perindropil 10 mg plus indapamide 2.5 mg plus amlodipine 5 or 10 mg plus atorvastatin 20 mg . The " free group " was given a FDC of the 3antihypertensive agents plus atorvastatin 20 mg . Primary end-points were the differences in clinic BP , cholesterol levels and CVR risk between the 2 groups after treatments . Secondary end-points included intragroup differences in clinic BP . Safety and compliance were also assessed . RESULTS At 12-weeks , the fixed group had lower systolic BP and similar diastolic BP compared to the free group . BP targets at week 12 were more commonly reached with fixed than free combination ( 89 % and 80 % respectively , p=0.048 ) . For cholesterol serum in both groups there was a significant reduction of values . Also CVR reduction was greater in those taking ODF . Safety was not significantly different between the 2 groups . Conversely , compliance was significantly greater in the fixed-group vs. the free-group . CONCLUSION This r and omized trial shows that ODF combination of perindropil , indapamide and amlodipine is as safe as free combination of the 3 drugs , but is associated with a greater efficacy in BP control , compliance and , associated with statin , in cholesterol reduction . A better cardiovascular risk control is achieved with ODF combination than with a free administration . Clinical Trials.gov ID : NCT02710539
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 .