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 .
Pharmacokinetics of a telmisartan/rosuvastatin fixed-dose combination: a single-dose, randomized, open-label, 2-period crossover study in healthy Korean subjects.
OBJECTIVE As hypertension and dyslipidemia are frequent comorbidities , antihypertensive drugs and lipid-lowering agents are often prescribed together for their treatment . Telmisartan and rosuvastatin are widely used together to treat hypertension and dyslipidemia . A combination formulation of these two drugs would improve patient compliance due to ease of dosing . The purpose of this study was to assess bioequivalence of single-dose administration of a newly-developed fixed-dose combination ( FDC ) tablet containing telmisartan/rosuvastatin 80/20 mg ( test treatment ) and coadministration of a telmisartan 80-mg tablet and a rosuvastatin 20-mg tablet ( reference treatment ) in healthy Korean male volunteers . METHODS This was a single-dose , r and omized , open-label , 2-period crossover study enrolling healthy males aged 20 - 50 years with BMI between 18.5 and 25 kg/m2 . Each subject received a single dose of the reference and test treatments with a 14-day washout period . Blood sampling was performed at prespecified intervals for up to 72 hours after dosing . Primary pharmacokinetic parameters were Cmax , AUClast , and AUC0-∞ of telmisartan , rosuvastatin , and N-desmethyl rosuvastatin . Bioequivalence was assessed by determining whether the 90 % confidence intervals ( CIs ) of the geometric mean ratios ( test treatment/reference treatment ) of these parameters were within the st and ard range of 80 % to 125 % . Adverse events were monitored via regular interviews with the subjects and by physical examinations . RESULTS 60 subjects were enrolled and 55 completed the study . The 90 % CIs of the geometric mean ratios of Cmax , AUClast , and AUC00-∞ were 0.9262 - 1.1498 , 0.9294 - 1.0313 , and 0.9312 - 1.0320 for telmisartan , 0.9041 - 1.0428 , 0.9262 - 1.0085 , and 0.9307 - 1.0094 for rosuvastatin , and 0.8718 - 1.0022 , 0.8901 - 0.9904 , and 0.8872 - 0.9767 for N-desmethyl rosuvastatin , respectively . There was no statistical difference in the incidence of adverse events ( AEs ) ( all of which were mild or moderate ) between the reference and test treatments . CONCLUSIONS Our findings suggest that the telmisartan/rosuvastatin FDC is bioequivalent to coadministration of separate tablets , and both treatments were safe and well tolerated . Administration of this FDC tablet is expected to improve patient compliance
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 .