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 .
Comparison of a morning polypill, evening polypill and individual pills on LDL-cholesterol, ambulatory blood pressure and adherence in high-risk patients; a randomized crossover trial.
AIMS Cardiovascular polypills are a novel strategy in the prevention of cardiovascular disease . Based on considerations about the effectiveness , the individual pills of a polypill are taken at different times of the day . This study aim ed therefore to compare the use of a polypill in the morning , in the evening or the individual components taken at their usual times on cardiovascular risk factors and patient acceptability . METHODS The study was a r and omized three-period crossover trial . Seventy-eight patients with established cardiovascular disease were r and omly allocated to the use of polypill ( aspirin 75 mg , simvastatin 40 mg , lisinopril 10 mg and hydrochlorothiazide 12.5 mg ) in the morning , in the evening or use of the individual agents taken at different time points ( Trial : NCT01506505 ) . RESULTS Using the polypill in the evening result ed in a 0.2 mmol/L ( 95%-confidence interval ( CI ) : 0.1 to 0.3 ) lower fasting LDL-cholesterol compared to the use in the morning , and not statistically significantly different mean 24-hour systolic BP ( mean difference : 0.7 mmHg ; 95%-CI ; -2.1 to 3.4 ) . Compared to the use of the individual agents , the mean LDL-cholesterol was 0.2 mmol/L ( 95%-CI : 0.1 to 0.3 ) higher when using the polypill in the morning , but not statistically significantly different when used in the evening ( mean difference : -0.1 mmol/L ; 95%-CI : -0.1 to 0.0 ) . Furthermore , there were no differences in mean 24-hour systolic BP with morning use ( mean difference : 0.4 mmHg ; 95%-CI ; -1.5 to 2.3 ) or evening use ( mean difference : 1.0mmHg ; 95%-CI ; -0.8 to 2.8 ) of the polypill compared to the individual agents . The adherence was 5.2 % ( 95%-CI : 1.4 to 9.1 ) higher with morning use of the polypill and 5.0 % ( 95%-CI : 1.5 to 8.5 ) higher with evening use compared to the individual agents . Treatment with the polypill was preferred by 92 % of the participants . CONCLUSION The use of a polypill in the evening was more effective in lowering LDL-cholesterol , and result ed in not statistically significantly different ambulatory BP levels compared to the use of a polypill in the morning . Therapy with a polypill was associated with an increased adherence . The polypill is highly preferred by patients , demonstrating a potential role for the polypill in the prevention of cardiovascular disease
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 .