Author + information
- Ravi S. Hira, MD∗ (, )
- Kevin Kennedy, MS,
- Mahboob Alam, MD,
- Laura A. Petersen, MD, MPH,
- Christie M. Ballantyne, MD and
- Salim S. Virani, MD, PhD
- ↵∗Baylor College of Medicine, 6620 Main Street, Suite 11D, Houston, Texas 77030
We appreciate the comments of Dr. Alexopoulos and colleagues regarding our study on the frequency and practice-level variation in inappropriate and nonrecommended prasugrel prescribing from the National Cardiovascular Data Registry PINNACLE Registry (1).
We did find differences in provider and insurance characteristics, with patients who were receiving prasugrel inappropriately being less likely to have seen physicians (89.5% vs. 93.8%; p < 0.001) and to have private insurance (53.8% vs. 64.3%; p < 0.001) compared with patients receiving prasugrel appropriately. The PINNACLE Registry uses standard definitions for all practices, but data are self-reported. Some practice-level variation could be explained by reporting bias, but this could not be ascertained from the registry. Furthermore, we did want to evaluate the off-label use of prasugrel in patients without histories of acute coronary syndromes or not undergoing percutaneous coronary intervention, but this information could not be reliably extracted, as data about myocardial infarction and percutaneous coronary intervention were available for only 12 months before a patient’s visit.
The prasugrel package insert (2) does mention weight <60 kg as an additional risk factor for bleeding but does not specify that it is not recommended. The approved dose of prasugrel is 5 mg/day in patients weighing ≤60 kg, compared with the standard dose of 10 mg/day in those weighing >60 kg. We agree that despite decreased platelet reactivity, the dose of 5 mg/day in patients weighing ≤60 kg has not been studied prospectively to determine its effect on ischemic outcomes compared with clopidogrel (3) and warrants caution. Of 24,112 patients in our study who were receiving prasugrel and had weight data available, 911 (4.11%) weighed <60 kg.
We found that 4,248 of our overall cohort of 27,533 patients (15.4%) were receiving “triple therapy” with aspirin, warfarin, and prasugrel. Among them, 319 received prasugrel inappropriately (history of transient ischemic attack or stroke) and 677 for nonrecommended indications (age ≥ 75 years with no history of diabetes or myocardial infarction) likely increasing their bleeding risk. We would like to draw attention to this and are not stating that triple therapy is not recommended only in patients ≥75 years of age. Furthermore, we welcome the suggestion of the need for outcome studies in these patients, but the PINNACLE Registry at the time of the publication of this report did not collect data on ischemic and bleeding outcomes.
Please note: The views expressed in this article are those of the authors and do not necessarily represent the views of the United States Department of Veterans Affairs. Dr. Alam is a member of the advisory board for AstraZeneca. Dr. Ballantyne has received grant and research support (all paid to institution, not individual) from Abbott, Amarin, Amgen, Eli Lilly, GlaxoSmithKline, Merck & Co., Novartis, Pfizer, Regeneron, Roche, Sanofi-Synthelabo, the National Institutes of Health, and the American Heart Association. Dr. Ballantyne is a consultant for Abbott, Aegerion, Amarin, Amgen, Cerenis, Esperion, Genzyme, Kowa, Merck & Co., Novartis, Pfizer, Resverlogix, Regeneron, Roche, and Sanofi-Synthelabo. Dr. Virani has received grant and research support from the Department of Veterans Affairs Health Services Research and Development Career Development Award (09-028), the American Diabetes Association, and the American Heart Association. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
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- ↵(2013) Prasugrel [package insert] (Eli Lilly & Company, Indianapolis, IN).
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