It had been suggested that low-dose aspirin might protect against cancer, but we saw no reduction in any cancers we are continuing to follow the participants to see whether any benefits appear later." Professor Jane Armitage, principal investigator, Nuffield Department of Population Health, University of Oxford, UK, said: "Even though we showed clearly that aspirin reduces the risk of vascular events, including heart attacks, strokes, and mini-strokes, it also increased the risk of major bleeds, mainly from the gastrointestinal tract, so overall there was no clear benefit. Researchers noted it was not possible to identify a group of patients in whom the benefits of aspirin use clearly outweighed the risks. These findings were consistent even among participants at the highest cardiovascular risks. However, a first major bleed occurred in 314 of those in the aspirin group (4.1 percent) compared with 245 of those in the placebo group (3.2 percent) meaning nine of every 1,000 participants suffered a first major bleed during the trial due to aspirin. According to researchers, this translated to 11 of every 1,000 participants avoiding a serious vascular event during the trial as a result of aspirin, as well as a 12 percent proportional reduction in the risk of serious vascular events. Overall findings showed a first serious vascular event occurred in 685 participants (8.5 percent) in the aspirin group compared with 743 in the placebo group (9.6 percent). During an average 7.4 years of follow up, they assessed the primary efficacy endpoint of first serious vascular event (non-fatal heart attack, non-fatal stroke, or death from cardiovascular cause) as well as the primary safety endpoint of first major bleed serious enough to require hospitalization or be fatal. In the ASCEND aspirin study, simultaneously published in the New England Journal of Medicine (NEJM), researchers randomly assigned 15,480 patients with diabetes but no history of cardiovascular disease to aspirin (100 mg daily) or placebo. 26 found fish oil supplements did not reduce the risk of cardiovascular events or stroke in this patient group. Additionally, a separate ASCEND study also presented Aug. 26 from the ASCEND trial as part of ESC Congress 2018. Read the plain language summary of results and learn more about the ADAPTABLE study.The benefits of aspirin use in preventing serious vascular events in diabetic patients were largely counterbalanced by major bleeding events, said investigators presenting findings on Aug. This should allow many more clinical questions to be answered, with obvious benefits to health care consumers.” -Baigent 2021, New England Journal of Medicine. “ADAPTABLE is a major achievement because it has shown a method of conducting trials efficiently and at low cost in the United States, and the method can now be adapted and used more widely. The study and used electronic health record data to identify patients low-touch recruitment strategies and a patient portal for consent, collection of patient-reported outcomes, and follow-up. 2021, New England Journal of MedicineĪn accompanying editorial states that this trial represents a step forward for pragmatic clinical trials, demonstrating proof-of-concept for PCORnet. “As interest grows for real-world evidence, the trial provides a demonstration that randomized clinical trials can leverage electronic health record data, direct-to-patient methods, and patient-reported outcomes to address important, patient-centered questions.” -Jones, et al. It enrolled 15,076 patients with cardiovascular disease at 40 health centers across the United States. The study, funded by PCORI, is the first randomized controlled trial conducted using PCORnet®, the National Patient-Centered Clinical Research Network, which involves patient representatives during all phases of the trial. Trial participants frequently switched their dose, which may have biased the results toward the null: 41.6% of patients who were assigned to take the 325 mg dose switched to 81 mg daily dose. Recently published results of the ADAPTABLE study demonstrate no difference in rates of death, hospitalization for heart attack or stroke, or bleeding in those who were assigned to high- versus low-dose aspirin (325 mg versus 81 mg).
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