June 05, 2014
By David Douglas
NEW YORK - The platelet inhibitor prasugrel is being widely prescribed for off-label indications and to patients who shouldn't be receiving it, according to a study of US data.
As Dr. Ravi Hira told Reuters Health by email, "In this national registry of cardiovascular disease patients, we found that almost one in five patients (18.3%) were receiving prasugrel inappropriately or for a non-recommended indication. This potentially places these patients at higher risk of major bleeding and poor outcomes."
Dr. Hira added, "We also found significant regional and practice-level variation in this inappropriate use. These results indicate a need to reduce inappropriate or non-recommended prasugrel prescribing."
Dr. Hira of Baylor College of Medicine in Houston and colleagues evaluated data on patients receiving prasugrel from FDA approval in 2009 until 2013. In all, more than 27,000 patients from 123 practices were identified.
Prasugrel use in patients with a documented history of prior stroke or transient ischemic attack was deemed to be inappropriate. Non-recommended treatment was defined as use in patients aged 75 years and older without diabetes or a prior MI.
Using these criteria, 13.9% of patients had inappropriate prescriptions and 4.4% were receiving the drug for a non-recommended indication, the authors report in a May 7 online paper in the Journal of the American College of Cardiology.
Patients in the appropriate prescribing group had higher rates of private insurance and treatment by a physician provider. Those in the inappropriate group had a higher prevalence of comorbidities such as diabetes, hypertension, dyslipidemia, and atrial fibrillation.
By practice, inappropriate prescribing ranged from zero to 90%, with a median of 4.4%. Thus, the researchers say, given two "identical" patients treated at two randomly chosen practices, one would be 189% more likely to receive prasugrel inappropriately. Non-recommended prasugrel prescribing ranged from zero to 19.8%, with a median of 2.6%.
In addition, of the 4248 (15.4%) patients who received "triple therapy" with aspirin, warfarin, and prasugrel, 319 received prasugrel inappropriately and 677 did so for a non-recommended indication.
"It is possible," say the investigators, "that triple therapy with prasugrel in this group, even when appropriate, may lead to increased rates of major bleeding and offset any anti-ischemic benefit of prasugrel."
Summing up, Dr. Hira said, "Some of the implications of our study are the need for potential interventions such as decision support algorithms or the use of audit and feedback to prevent this inappropriate or non-recommended use of prasugrel."
"The adoption of new medications," he concluded, "must be closely monitored to ensure safety and appropriate use in patients."
J Am Coll Cardiol 2014.
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