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 .
Additive Beneficial Effects of Valsartan Combined with Rosuvastatin in the Treatment of Hypercholesterolemic Hypertensive Patients
Background and Objectives We compared the efficacy and safety of valsartan and rosuvastatin combination therapy with each treatment alone in hypercholesterolemic hypertensive patients . Subjects and Methods Patients who met inclusion criteria were r and omized to receive 1 of the following 2-month drug regimens :  valsartan 160 mg plus rosuvastatin 20 mg , valsartan 160 mg plus placebo , or rosuvastatin 20 mg plus placebo . The primary efficacy variables were change in sitting diastolic blood pressure ( sitDBP ) and sitting systolic blood pressure ( sitSBP ) , and percentage change in low-density lipoprotein-cholesterol ( LDL-C ) in the combination , valsartan , and rosuvastatin groups . Adverse events ( AEs ) during the study were analyzed . Results A total of 354 patients were screened and 123 of them were finally r and omized .  Changes of sitDBP by least squares mean ( LSM ) were -11.1 , -7.2 , and -3.6 mm Hg , respectively , and was greater in the combination , as compared to both valsartan ( p=0.02 ) and rosuvastatin ( p<0.001 ) . Changes of sitSBP by LSM were -13.2 , -10.8 , and -4.9 mm Hg , and was greater in the combination , as compared to rosuvastatin ( p=0.006 ) and not valsartan ( p=0.42 ) . Percentage changes of LDL-C by LSM were -52 , -4 , and -47 % in each group , and was greater in the combination , as compared to valsartan ( p<0.001 ) , similar to rosuvastatin ( p=0.16 ) . Most AEs were mild and resolved by the end of the study . Conclusion Combination treatment with valsartan and rosuvastatin exhibited an additive blood pressure-lowering effect with acceptable tolerability , as compared to valsartan monotherapy . Its lipid lowering effect was similar to rosuvatatin monotherapy
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 .