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 .
Reduction in cardiovascular risk using proactive multifactorial intervention versus usual care in younger (<65 years) and older (≥65 years) patients in the CRUCIAL trial
Abstract Objective : To compare the reduction in calculated Framingham 10 year coronary heart disease ( CHD ) risk after 52 weeks ’ intervention with a proactive multifactorial intervention ( PMI ) strategy ( based on single-pill amlodipine/atorvastatin [ SPAA ] ) versus continuing usual care ( UC ) ( based on investigators ' best clinical judgment ) among younger ( < 65 years ) and older ( ≥65 years ) patients . Research design and methods : Sub- analysis of the Cluster R and omized Usual Care versus Caduet Investigation Assessing Long-term risk ( CRUCIAL ) trial . Eligible patients had hypertension and ≥3 cardiovascular risk factors . Main outcome measure : Treatment-related reduction in calculated Framingham 10 year CHD risk between baseline and Week 52 in younger and older patients . Results : Nine hundred patients ( 63.5 % ) were < 65 years ( mean age 54.2 years , 57.4 % men ) and 517 patients ( 36.5 % ) were ≥65 years ( mean age 70.5 years , 42.7 % men ) . Younger patients had  lower mean baseline CHD risk  versus older patients ( 17.1 % vs. 22.6 % ) . A greater reduction in calculated CHD risk at Week 52 was observed in the PMI versus the UC arm in both younger ( −33.2 % vs. −2.9 % , p < 0.001 ) and older ( −32.7 % vs. −5.7 % , p < 0.001 ) patients . Least-squares mean treatment differences ( PMI vs. UC ) in percentage change from baseline in calculated CHD risk were similar in younger and older patients ( −26.3 % vs. −25.7 % , age interaction p = 0.887 ) . CHD risk reduction was slightly greater among younger men than younger women ( −29.3 vs. −23.9 , gender interaction p = 0.062 ) . A low proportion of patients discontinued the PMI strategy due to adverse events in both age groups ( 5.8 % vs. 6.1 % , respectively ) . Study limitations included ad-hoc ( not pre-specified ) sub-group analysis and short duration of follow-up . Conclusions : The PMI strategy based on the inclusion of SPAA in the treatment regimen is more effective than UC in reducing calculated CHD risk . This strategy may be considered as the treatment of choice in younger and older hypertensive patients with additional cardiovascular risk factors
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 .