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 .
PolyPill for Prevention of Cardiovascular Disease in an Urban Iranian Population with Special Focus on Nonalcoholic Steatohepatitis: A Pragmatic Randomized Controlled Trial within a Cohort (PolyIran - Liver) - Study Protocol.
BACKGROUND Cardiovascular disease ( CVD ) is among the most common causes of mortality in all population s. Nonalcoholic steatohepatitis is a common finding in patients with CVD . Prevention of CVD in individual patients typically requires periodic clinical evaluation , as well as diagnosis and management of risk factors such as hypertension and hyperlipidemia . However , this is re source consuming and hard to implement , especially in developing countries . We design ed a study to investigate the effects of a simpler strategy : a fixed-dose combination pill consisting of aspirin , valsartan , atorvastatin and hydrochlorthiazide ( PolyPill ) in an unselected group of persons aged over 50 years . DESIGN The PolyIran-Liver study was performed in Gonbad city as an open label pragmatic r and omized controlled trial nested within the Golestan Cohort Study . We r and omly selected 2,400 cohort study participants aged above 50 years , r and omly assigned them to intervention or usual care and invited them to participate in an additional measurement study ( if they met the eligibility criteria ) to measure liver related outcomes . Those agreeing and r and omized to the intervention arm were offered a daily single dose of PolyPill . We will follow participants for 5 years . The primary outcome is major cardiovascular events , secondary outcomes include all-cause mortality and liver related outcomes : liver stiffness and liver enzyme levels . Cardiovascular outcomes and mortality will be determined from the cohort study and liver-related outcomes in those consenting to follow up . Analysis will be by allocated group . TRIAL STATUS Between October and December 2011 , 1,320 intervention and 1,080 control participants were invited to participate in the additional measurement study . For all these participants , the major cardiovascular events will be determined using blind assessment of outcomes through the cohort study . In the intervention and control arms , 875 ( 66 % ) and 721 ( 67 % ) respectively , met the eligibility criteria and agreed to participate in the additional measurement study . Liver related outcomes will be measured in these participants . Of the 1,320 participants r and omized to the intervention , 787 ( 60 % ) accepted the PolyPill . CONCLUSION The PolyIran-liver urban study will provide us with important information on the effectiveness of PolyPill on major cardiovascular events , all-cause mortality and liver related outcomes . ( Clinical Trials.gov ID : NCT01245608 )
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 .