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 .
Facilitators and barriers to implementation of a pragmatic clinical trial in Aboriginal health services.
OBJECTIVE To identify facilitators and barriers to clinical trial implementation in Aboriginal health services . DESIGN Indepth interview study with thematic analysis . SETTING Six Aboriginal community-controlled health services and one government-run service involved in the Kanyini Guidelines Adherence with the Polypill ( KGAP ) study , a pragmatic r and omised controlled trial that aim ed to improve adherence to indicated drug treatments for people at high risk of cardiovascular disease . PARTICIPANTS 32 health care providers and 21 Aboriginal and Torres Strait Isl and er patients . RESULTS A fundamental enabler was that participants considered the research to be governed and endorsed by the local health service . That the research was perceived to address a health priority for communities was also highly motivating for both providers and patients . Enlisting the support of Aboriginal and Torres Strait Isl and er staff champions who were visible to the community as the main source of information about the trial was particularly important . The major implementation barrier for staff was balancing their service delivery roles with adherence to often highly dem and ing trial-related procedures . This was partially alleviated by the research team 's provision of onsite support and attempts to make trial processes more streamlined . Although more intensive support was highly desired , there were usually insufficient re sources to provide this . CONCLUSION Despite strong community and health service support , major investments in time and re sources are needed to ensure successful implementation and minimal disruption to already overstretched , routine services . Trial budgets will necessarily be inflated as a result . Funding agencies need to consider these additional re source dem and s when supporting trials of a similar nature
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 .