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 .
Changes in calculated coronary heart disease risk using proactive multifactorial intervention versus continued usual care in Latin-American and non-Latin-American patients enrolled in the CRUCIAL trial
Abstract Objective : To compare the change in calculated coronary heart disease ( CHD ) risk using a proactive multifactorial intervention ( PMI ) versus usual care ( UC ) , among Latin-American ( LA ) and non-LA patients enrolled in the CRUCIAL trial . Research design and methods : This is a sub- analysis of the Cluster R and omized Usual Care versus Caduet Investigation Assessing Long-term-risk ( CRUCIAL ) trial . CRUCIAL was a prospect i ve , multinational , open-label , cluster-r and omized trial . Eligible patients had hypertension and ≥3 additional cardiovascular risk factors , but no history of CHD and baseline total cholesterol ≤6.5 mmol/l ( 250 mg/dl ) .  The PMI strategy was implemented by the inclusion of single-pill amlodipine/atorvastatin ( SPAA ) in the patients ’ treatment regimen . Overall , 20 % of patients resided in the LA region . Main outcome measure : Treatment-related change in calculated Framingham 10-year CHD risk between baseline and Week 52 in the LA and non-LA regions . Results : A greater relative reduction in calculated CHD risk after 52 weeks ’ follow-up was observed for patients in the PMI arm compared with UC arm in both LA ( −32.8 % vs. −7.5 % , p = 0.003 ) and non-LA regions ( −33.1 % vs. −3.3 % , p < 0.001 ) , region interaction p = 0.316 . The proportion of patients discontinuing treatment in the PMI arm due to adverse events ( AEs ) was low in both regions ( both 5.9 % ) . Conclusions : The PMI approach based on the inclusion of SPAA in the patients ’ treatment regimen may improve the management of CHD risk among patients residing in LA and non-LA regions . Clinicians may be reassured by the low rate of AEs leading to discontinuation of SPAA in both regions
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 .