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 .
Blood Pressure Control with a Single-Pill Combination of Indapamide Sustained-Release and Amlodipine in Patients with Hypertension: The EFFICIENT Study
Objective Despite antihypertensive treatment , most hypertensive patients still have high blood pressure ( BP ) , notably high systolic blood pressure ( SBP ) . The EFFICIENT study examines the efficacy and acceptability of a single-pill combination of sustained-release ( SR ) indapamide , a thiazide-like diuretic , and amlodipine , a calcium channel blocker ( CCB ) , in the management of hypertension . Methods Patients who were previously uncontrolled on CCB monotherapy ( BP≥140/90 mm Hg ) or were previously untreated with grade 2 or 3 essential hypertension ( BP≥160/100 mm Hg ) received a single-pill combination tablet containing indapamide SR 1.5 mg and amlodipine 5 mg daily for 45 days , in this multicenter prospect i ve phase 4 study . The primary outcome was mean change in BP from baseline ; percentage of patients achieving BP control ( BP<140/90 mm Hg ) was a secondary endpoint . SBP reduction ( ΔSBP ) versus diastolic BP reduction ( ΔDBP ) was evaluated ( ΔSBP/ΔDBP ) from baseline to day 45 . Safety and tolerability were also assessed . Results Mean baseline BP of 196 patients ( mean age 52.3 years ) was 160.2/97.9 mm Hg . After 45 days , mean SBP decreased by 28.5 mm Hg ( 95 % CI , 26.4 to 30.6 ) , while diastolic BP decreased by 15.6 mm Hg ( 95 % CI , 14.5 to 16.7 ) . BP control ( < 140/90 mm Hg ) was achieved in 85 % patients . ΔSBP/ΔDBP was 1.82 in the overall population . Few patients ( n = 3 [ 2 % ] ) reported side effects , and most ( n = 194 [ 99 % ] ) adhered to treatment . Conclusion In patients who were previously uncontrolled on CCB monotherapy or untreated with grade 2 or 3 hypertension , single-pill combination indapamide SR/amlodipine  reduced BP effectively — especially SBP— over 45 days , and was safe and well tolerated . Trial Registration Clinical Trial Registry – India
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 .