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Trial Shows Same High/Low Dose Aspirin Outcomes

White pills

(Heung Soon, Pixabay,

17 May 2021. Results from a large-scale clinical trial show almost the same health outcomes for patients prescribed high or low doses of aspirin to prevent heart disease. Findings from the six-year study appearing in the 15 May issue of New England Journal of Medicine (registration required) and given at a virtual meeting of the American College of Cardiology, also show the feasibility of conducting lower-cost clinical trials in real-world settings.

Heart disease continues to be a major health problem in the U.S., responsible for some 655,000 deaths, making it the leading cause of death in this country, according to Centers for Disease Control and Prevention. Common aspirin is often prescribed to people with coronary heart disease, where a build-up of cholesterol narrows arteries and interrupts blood flow, yet uncertainty still remains on the optimal aspirin dosage. While aspirin is inexpensive and usually safe, it can still cause bleeding episodes in some patients, thus the dose prescribed can have safety implications.

The Adaptable clinical trial — “Adaptable” is an acronym for a 10-word title — begun in 2015, seeks to produce firm guidance on the optimal aspirin dose for heart disease patients. Given the widespread use of aspirin, the study team designed the trial with individuals already prescribed the drug, rather than recruiting new patients for a separate explanatory trial. This type of study, called a pragmatic clinical trial, aims to capture data from real-world settings instead of a carefully controlled clinical environment.

In this case, more than 15,000 participants with coronary heart disease at 40 sites in the U.S. were randomly assigned by their physicians to continue or start taking either a lower 81 milligram dose or higher 325 milligram dose of aspirin each day; the vast majority of each group (85% to 96%) were already taking aspirin. Researchers led by cardiac disease researcher W. Schuyler Jones at Duke University in Durham, North Carolina tracked participants for four years. The study team looked primarily at combined rates of death from any cause and hospitalizations for heart attack or stroke, as well as other clinical indicators, and reports of major bleeding complications requiring hospitalization.

Several cost-saving measures

The results show combined rates for death or hospitalization for heart attack or stroke are almost identical in each group, with 7.3 percent for lower-dose and 7.5 percent for higher-dose aspirin. The safety results also show nearly identical outcomes with 0.6 percent of recipients in each group hospitalized for major bleeding episodes. The findings are somewhat muddled, however, by large numbers of participants switching doses during the trial, with 42 percent in the higher-dose group switching to the lower dose and seven percent of lower-dose recipients later taking the higher dose.

The Adaptable trial is also notable for its cost-saving measures. The study uses an existing network of clinical trial sites offered by Patient-Centered Outcomes Research Institute, or PCORI, a not-for-profit group studying comparative effectiveness in medical treatments. In August 2020, Science & Enterprise reported on a study using this same network for real-world mental health outcomes from Covid-19. And the study team reduced costs further by enrolling participants online, asking them to report data through a web portal, and extracting data from participants’ electronic health records.

“We learned so many incredible things from Adaptable about how to streamline processes and alleviate the burden of participating in research for both sites and patients,” says Jones in a Duke University statement. Jones also tells Medscape Medical News the trial cost from $18 million to $19 million, while “a typical trial with this many patients conducted in the traditional way would have cost at least five or 10 times more.”

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