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 .
Estimated cardiovascular relative risk reduction from fixed-dose combination pill (polypill) treatment in a wide range of patients with a moderate risk of cardiovascular disease
Aims Recent data indicate that fixed-dose combination ( FDC ) pills , polypills , can produce sizeable risk factor reductions . There are very few published data on the consistency of the effects of a polypill in different patient population s. It is unclear for example whether the effects of the polypill are mainly driven by the individuals with high individual risk factor levels . The aim of the present study is to examine whether baseline risk factor levels modify the effect of polypill treatment on low-density lipoprotein (LDL)-cholesterol , blood pressure ( BP ) , calculated cardiovascular relative risk reduction and adverse events . Methods This paper describes a post-hoc analysis of a r and omised , placebo-controlled trial of a polypill ( containing aspirin 75 mg , simvastatin 20 mg , lisinopril 10 mg and hydrochlorothiazide 12.5 mg ) in 378 individuals without an indication for any component of the polypill , but who had an estimated five-year risk for cardiovascular disease ≥7.5 % . The outcomes considered were effect modification by baseline risk factor levels on change in LDL-cholesterol , systolic BP , calculated cardiovascular relative risk reduction and adverse events . Results The mean LDL-cholesterol in the polypill group was 0.9 mmol/l ( 95 % confidence interval ( CI ) : 0.8–1.0 ) lower compared with the placebo group during follow-up . Those with a baseline LDL-cholesterol > 3.6 mmol/l achieved a greater absolute LDL-cholesterol reduction with the polypill compared with placebo , than patients with an LDL-cholesterol ≤3.6 mmol/l ( −1.1 versus −0.6 mmol/l , respectively ) . The mean systolic BP was 10 mm Hg ( 95 % CI : 8–12 ) lower in the polypill group . In participants with a baseline systolic BP > 135 mm Hg the polypill result ed in a greater absolute systolic BP reduction with the polypill compared with placebo , than participants with a systolic BP ≤ 135 mm Hg ( −12 versus −7 mm Hg , respectively ) . Calculated from individual risk factor reductions , the mean cardiovascular relative risk reduction was 48 % ( 95 % CI : 43–52 ) in the polypill group . Both baseline LDL-cholesterol and estimated cardiovascular risk were significant modifiers of the estimated cardiovascular relative risk reduction caused by the polypill . Adverse events did not appear to be related to baseline risk factor levels or the estimated cardiovascular risk . Conclusion This study demonstrated that the effect of a cardiovascular polypill on risk factor levels is modified by the level of these risk factors . Groups defined by baseline LDL-cholesterol or systolic BP had large differences in risk factor reductions but only moderate differences in estimated cardiovascular relative risk reduction , suggesting also that patients with mildly increased risk factor levels but an overall raised cardiovascular risk benefit from being treated with a polypill
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 .