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 .
Reliability Analysis of a Newly Developed Questionnaire for Quality Control of Follow-up Visits in PolyIran Study.
BACKGROUND The PolyIran study is a large-scale pragmatic cluster r and omized controlled trial of fixed-dose combination therapy ( Polypill ) for prevention of cardiovascular diseases ( CVD ) in Iran . The PolyIran Quality Control Program ( PIQCP ) including a new question naire was developed to assess the quality of data collection during follow-up visits . The aim of this study was to assess the inter-rater reliability of PIQCP question naire . METHODS The study was conducted in 26 ( 11 % ) r and omly selected clusters ( from a total of 236 PolyIran clusters ) . All participants within these 26 clusters were enrolled .  The quality scores were measured according to the PIQCP guidelines by two independent raters . The intraclass correlation coefficients ( ICC ) were measured . In addition , the quality scores were categorized into good ( 70 % ) and poor ( < 70 % ) . The kappa coefficient was used to assess inter-rater agreement for this categorical quality scores . RESULTS A total number of 945 PolyIran participants were enrolled of which , 501 ( 53 % ) were from intervention arm . In 934 participants ( 98.8 % ) , the quality score could be successfully identified by both raters . The ICC ( 95%CI ) of the overall quality scores was 0.985 ( 0.983 - 0.987 ) . It was 0.976 ( 0.972 - 0.980 ) and 0.988 ( 0.986 - 0.990 ) in intervention and control arms , respectively . We found excellent agreement between the two raters in identifying participants with good and poor quality scores ( kappa = 0.988 , P < 0.001 ) . The kappa values were 0.972 ( P < 0.001 ) and 1.000 ( P < 0.001 ) in intervention and control arms , respectively . DISCUSSION Our results suggested that the PIQCP question naire is a reliable tool for assessing quality of data collection in PolyIran follow-up visits . Using this measure will help us in efficient monitoring of the PolyIran follow-ups and may ensure high quality data
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 .