However, low doses were better adherent, so starting with “baby aspirin” may be the best choice for most patients, said Schuyler Jones, MD, an assistant professor of medicine at the Duke Clinical Institute (DCRI). It was. Lead author of a study called ADAPTABLE.Results at the same time New England Journal of Medicine..1
Many praised the practical design of this test, but it had one major drawback. Doctors couldn’t stop changing the patient’s dose, and many did. resulting in, journal We asked about the reliability of the findings and whether investigators need to run a pilot to clarify this issue.2
However, Jones welcomed the arrival of a direct comparison. “There wasn’t really a clear answer as to the most effective and safe dose of aspirin for these patients. Instead, there were contradictory findings that 81 mg may reduce the risk of bleeding. There are some studies that suggest, but higher doses may provide more effective prevention of heart attacks and strokes, “he said in a statement. “In these early studies, we primarily investigated aspirin (81 or 325 mg daily) compared to placebo.”
The study design combined classic clinical trial elements with electronic health records and billing data, including both commercial payer and CMS data. A secure website where patients can participate by mail, email, or phone and follow up every 3-6 months for a little over 2 years (26.2 months) from April 2016 to June 2019. I registered from. Established atherosclerotic cardiovascular disease and one other risk factor. The median age was 67 years. Most patients were white, 9% black, 3% Hispanic, and 1% Asian. The patient group was balanced at the beginning of the study, with 7540 taking 81 mg and 7536 taking a daily dose of 325 mg.
However, of the 96% who were taking aspirin before the study, 85% were taking baby aspirin. Also, during the study, dose switching was randomized to a daily dose of 325 mg compared to a dose of 81 mg (only 7.1% switching) (41.6% of this group had at least one dose). Was much more common among).
“We made every effort to maintain the study dose, but nevertheless people felt very strongly about it, so dose switching happened so often, especially in the 325 mg group. The different effects of the two doses on the two doses are less clear, “Jones said, noting that many patients in each group stayed at the doses assigned for more than a year. The investigator will perform additional analysis to learn why patients switch doses.
If the patient is taking 325 mg of aspirin and is well tolerated, it may be okay to continue, but if aspirin is restarted or started for the first time, it will probably start at a lower dose. need to do it.
Colin Baigent of Oxford University wasn’t very convinced. “Because switching is unlikely to be random, the bias resulting from this degree of crossover can mask the true difference in efficacy and / or safety, and is not significantly different. We can’t even conclude that, which means that the effects of the doses are comparable between the two dose groups, “he writes. journal.
The results are as follows.
- Hazard ratio (HR) 1.02 (0.91- 1.14), P = 0.75.
- The primary safety endpoint for this study was hospitalization for bleeding requiring blood transfusions. This is a rare event, with 53 participants taking a dose of 81 mg (0.63%) and a dose of 325 mg (0.60%) for HR (95% CI) = 1.18 (0.79 -1.77). It occurred only in 44 participants who took it.
- Results were consistent regardless of age, race / ethnicity, gender, previous use of double antiplatelet therapy, or whether the patient had diabetes or chronic kidney disease.
- During the study, 11% of the 325 mg group stopped taking aspirin, compared to 7% of the 81 mg group.
ADAPTABLE is the first clinical trial using PCORnet, the National Patient-Centered Clinical Research Network, a partnership of clinical research networks funded by the Patient-Centered Outcomes Institute (PCORI) that funded the study.
1. Jones WS, Mulder H, Wruck LM, etc. of the ADAPTABLE team. Comparison of the effectiveness of desired medications in cardiovascular disease. N Engl M Med.. Published May 15, 2021.
2. Baigent C. Practical testing-requires an adaptable design. N Engl J Med.. Published May 15, 2021. DOI: 10.1056 / NEJMe2106430
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