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 .
Efficacy and safety of fixed-dose combination therapy with olmesartan medoxomil and rosuvastatin in Korean patients with mild to moderate hypertension and dyslipidemia: an 8-week, multicenter, randomized, double-blind, factorial-design study (OLSTA-D RCT: OLmesartan rosuvaSTAtin from Daewoong)
The pill burden of patients with hypertension and dyslipidemia can result in poor medication compliance . This study aim ed to evaluate the efficacy and safety of fixed-dose combination ( FDC ) therapy with olmesartan medoxomil ( 40 mg ) and rosuvastatin ( 20 mg ) in Korean patients with mild to moderate hypertension and dyslipidemia . This multicenter , r and omized , double-blind , factorial- design study included patients aged ≥20 years with mild to moderate essential hypertension and dyslipidemia . Patients were r and omly assigned to receive FDC therapy ( 40 mg olmesartan medoxomil , 20 mg rosuvastatin ) , 40 mg olmesartan medoxomil , 20 mg rosuvastatin , or a placebo . The percentage change from baseline in low-density lipoprotein cholesterol levels was compared between FDC therapy and olmesartan medoxomil , and the change from baseline in diastolic blood pressure was compared between FDC therapy and rosuvastatin 8 weeks after treatment . A total of 162 patients were included . The least square mean percentage change ( st and ard error ) from baseline in low-density lipoprotein cholesterol levels 8 weeks after treatment was significantly greater in the FDC than in the olmesartan medoxomil group ( −52.3 % [ 2.8 % ] vs −0.6 % [ 3.5 % ] , P<0.0001 ) , and the difference was −51.7 % ( 4.1 % ) ( 95 % confidence interval : −59.8 % to −43.6 % ) . The least square mean change ( st and ard error ) from baseline in diastolic blood pressure 8 weeks after treatment was significantly greater in the FDC group than in the rosuvastatin group ( −10.4 [ 1.2 ] mmHg vs 0.1 [ 1.6 ] mmHg , P<0.0001 ) , and the difference was −10.5 ( 1.8 ) mmHg ( 95 % confidence interval : −14.1 to −6.9 mmHg ) . There were 50 adverse events in 41 patients ( 22.7 % ) and eight adverse drug reactions in five patients ( 2.8 % ) . The study found that FDC therapy with olmesartan medoxomil and rosuvastatin is an effective , safe treatment for patients with hypertension and dyslipidemia . This combination may improve medication compliance in patients with a large pill burden
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 .