Prasugrel's use grows, but often off label

LOS ANGELES – Use of the antiplatelet drug prasugrel has jumped impressively in the United States since the Food and Drug Administration approved the drug in July 2009 – but not always for the right patients.

From the first quarter of 2010 to the last quarter of 2011, prasugrel prescriptions more than doubled for patients who underwent a percutaneous coronary intervention, from 8% of patients discharged following a PCI during the first 3 months of 2010 to 22% of discharged post-PCI patients during the final 3 months of 2011, according to data collected on 55,821 patients from 44 Michigan hospitals.

But several prasugrel (Effient) prescriptions fell outside of labeled indications in two important ways. First, throughout the 2-year period, 28% of the patients who underwent PCI and received prasugrel did not have an acute coronary syndrome event immediately before their procedure, Dr. Amneet Sandhu and his associates said in a poster at the annual scientific sessions of the American Heart Association. Prasugrel’s U.S. labeling specifies that it should be used following PCI only in patients who have recently had unstable angina or a myocardial infarction.

The second egregious prasugrel use was in patients with labeled contraindications for the drug: a prior history of cerebrovascular disease, weight of 60 kg or less, and age of 75 years or older. According to the reviewed records, 5%-10% of post-PCI patients who were prescribed prasugrel in Michigan had one or more of these contraindications, reported Dr. Sandhu, an internal medicine physician at the University of Michigan, Ann Arbor, and his associates. The most common contraindication in prasugrel recipients was a history of stroke or transient ischemic attack, in just over half of the patients with a contraindication. The next most common was age of 75 or older, which applied to 35% of the prasugrel recipients with a contraindication.

"Prasugrel use in patients with known contraindications is not uncommon, and may be a suitable target for focused quality-improvements efforts," noted the researchers, who used data collected by the Blue Cross Blue Shield of Michigan Cardiovascular Consortium.

Dr. Sandhu said he had no disclosures. Two of his associates received research support from Blue Cross Blue Shield of Michigan, and one associate was an employee of the company.

LOS ANGELES – Use of the antiplatelet drug prasugrel has jumped impressively in the United States since the Food and Drug Administration approved the drug in July 2009 – but not always for the right patients.

From the first quarter of 2010 to the last quarter of 2011, prasugrel prescriptions more than doubled for patients who underwent a percutaneous coronary intervention, from 8% of patients discharged following a PCI during the first 3 months of 2010 to 22% of discharged post-PCI patients during the final 3 months of 2011, according to data collected on 55,821 patients from 44 Michigan hospitals.

But several prasugrel (Effient) prescriptions fell outside of labeled indications in two important ways. First, throughout the 2-year period, 28% of the patients who underwent PCI and received prasugrel did not have an acute coronary syndrome event immediately before their procedure, Dr. Amneet Sandhu and his associates said in a poster at the annual scientific sessions of the American Heart Association. Prasugrel’s U.S. labeling specifies that it should be used following PCI only in patients who have recently had unstable angina or a myocardial infarction.

The second egregious prasugrel use was in patients with labeled contraindications for the drug: a prior history of cerebrovascular disease, weight of 60 kg or less, and age of 75 years or older. According to the reviewed records, 5%-10% of post-PCI patients who were prescribed prasugrel in Michigan had one or more of these contraindications, reported Dr. Sandhu, an internal medicine physician at the University of Michigan, Ann Arbor, and his associates. The most common contraindication in prasugrel recipients was a history of stroke or transient ischemic attack, in just over half of the patients with a contraindication. The next most common was age of 75 or older, which applied to 35% of the prasugrel recipients with a contraindication.

"Prasugrel use in patients with known contraindications is not uncommon, and may be a suitable target for focused quality-improvements efforts," noted the researchers, who used data collected by the Blue Cross Blue Shield of Michigan Cardiovascular Consortium.

Dr. Sandhu said he had no disclosures. Two of his associates received research support from Blue Cross Blue Shield of Michigan, and one associate was an employee of the company.

LOS ANGELES – Use of the antiplatelet drug prasugrel has jumped impressively in the United States since the Food and Drug Administration approved the drug in July 2009 – but not always for the right patients.

From the first quarter of 2010 to the last quarter of 2011, prasugrel prescriptions more than doubled for patients who underwent a percutaneous coronary intervention, from 8% of patients discharged following a PCI during the first 3 months of 2010 to 22% of discharged post-PCI patients during the final 3 months of 2011, according to data collected on 55,821 patients from 44 Michigan hospitals.

But several prasugrel (Effient) prescriptions fell outside of labeled indications in two important ways. First, throughout the 2-year period, 28% of the patients who underwent PCI and received prasugrel did not have an acute coronary syndrome event immediately before their procedure, Dr. Amneet Sandhu and his associates said in a poster at the annual scientific sessions of the American Heart Association. Prasugrel’s U.S. labeling specifies that it should be used following PCI only in patients who have recently had unstable angina or a myocardial infarction.

The second egregious prasugrel use was in patients with labeled contraindications for the drug: a prior history of cerebrovascular disease, weight of 60 kg or less, and age of 75 years or older. According to the reviewed records, 5%-10% of post-PCI patients who were prescribed prasugrel in Michigan had one or more of these contraindications, reported Dr. Sandhu, an internal medicine physician at the University of Michigan, Ann Arbor, and his associates. The most common contraindication in prasugrel recipients was a history of stroke or transient ischemic attack, in just over half of the patients with a contraindication. The next most common was age of 75 or older, which applied to 35% of the prasugrel recipients with a contraindication.

"Prasugrel use in patients with known contraindications is not uncommon, and may be a suitable target for focused quality-improvements efforts," noted the researchers, who used data collected by the Blue Cross Blue Shield of Michigan Cardiovascular Consortium.

Dr. Sandhu said he had no disclosures. Two of his associates received research support from Blue Cross Blue Shield of Michigan, and one associate was an employee of the company.