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 .
Slovak Trial on Cardiovascular Risk Reduction Following National Guidelines with CaDUET® (The STRONG DUET Study)
Introduction The efficacy and safety of single-pill amlodipine/atorvastatin for reducing blood pressure ( BP ) , low-density lipoprotein cholesterol ( LDLC ) , and predicted 10-year cardiovascular ( CV ) risk have been demonstrated in low CV risk countries . The Slovak Trial on Cardiovascular Risk Reduction Following National Guidelines with CaDUET ® ( amlodipine besylate/atorvastatin calcium ; Pfizer , Morrisville , PA , USA ; STRONG DUET ) study evaluated its clinical utility in Slovakia , one of the highest CV risk regions in Europe . Methods This was a two-phase study involving 100 outpatient cardiologist and internist departments in Slovakia . Phase 1 assessed BP control and CV risk profiles in adults with treated hypertension , and phase 2 was an open-label , multicenter , observational study . In the phase 2 study , patients with treated but uncontrolled hypertension and three or more coronary heart disease risk factors received single-pill amlodipine/atorvastatin ( 5/10 or 10/10 mg ) for 12 weeks . Major outcomes were the percentage of patients achieving target BP ( ≤140/90 mmHg ) and /or LDL-C ( ≤3 mmol/L ) and reductions in predicted 10-year CV risk . Results Of the 4,672 phase 1 patients , 80.8 % had uncontrolled hypertension and 61.4 % had dyslipidemia . Of the 1,406 phase 2 patients , 90.3 % of patients achieved target BP at week 12 , 66.3 % achieved target LDL-C , and 60.7 % achieved both . The mean 10-year CV risk was reduced by 49 % ( P < 0.0001 ) ; treatment was well-tolerated and safe . ConclusionS ingle-pill amlodipine/atorvastatin was associated with significant improvements in BP , LDL-C target attainment , and 10-year CV risk in patients with uncontrolled hypertension in Slovakia . The treatment was well-tolerated and safe . Use of single-pill amlodipine/atorvastatin in high CV-risk countries could lead to significant improvements in CV risk management
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 .