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 .
Recruiting equal numbers of indigenous and non-indigenous participants to a ‘polypill’ randomized trial
Introduction Māori are disproportionately affected by cardiovascular disease ( CVD ) , which is the main reason for the eight year difference in life expectancy between Māori and non-Māori . The primary care-based IMPACT ( IMProving Adherence using Combination Therapy ) trial evaluates whether fixed dose combination therapy ( a “ polypill ” ) improves adherence to guideline -based therapy compared with current care among people at high risk of CVD . Interventions shown in trials to be effective do not necessarily reduce ethnic disparities , and may in fact widen them . Indigenous population s with poorer health outcomes are often under-represented in trials so the effect of interventions can not be assessed for them , specifically . Therefore , the IMPACT trial aim ed to recruit as many Māori as non-Māori to assess the consistency of the effect of the polypill . This paper describes the methods and results of the recruitment strategy used to achieve this . Methods Experienced Māori research ers were involved in trial governance throughout trial development and conduct . The trial Steering Committee included leading Māori research ers and was committed to equal recruitment of Māori and non-Māori . Additional funding and Māori research nurses were sought to allow home-based assessment , establishment of the relationship between research nurse and participant , more family involvement prior to enrollment , continuity of the research nurse-participant relationship , and acknowledgement of other Māori culturally important procedures , interactions , language and manners . Primary care practice s with high enrollment of Māori were targeted , with over-sampling of potentially eligible Māori patients , lower thresholds for screening of Māori and 6 months continued Māori recruitment after non-Māori recruitment had finished . Results A total of 257 Māori and 256 non-Māori participants were r and omized . Four Māori and eight non-Māori participants were r and omized per research nurse per month . Potentially eligible Māori were more likely than non-Māori to proceed to subsequent stages of recruitment . Differences between r and omized Māori and non-Māori were evident ( e.g. Maori were less likely to have established coronary artery disease ) . Conclusions Recruitment of equal numbers of indigenous and non-indigenous participants is possible if it is prioritised , adequately re source d and self-determination is supported . Trial registration The trial is registered with the Australian New Zeal and Clinical Trial Registry
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 .