普拉格雷使用增加 但常为超适应证使用

洛杉矶——密歇根大学的Amneet Sandhu博士在美国心脏协会(AHA)年会上报告，自FDA在2009年7月批准抗血小板药物普拉格雷上市以来，这种药物在美国的应用增长之迅速令人惊讶，但并非总是用于适当的患者。

根据从密歇根州44家医院的55,821例患者中收集的数据，自2010年第一季度至2011年第四季度，对于接受经皮冠脉介入操作的患者，普拉格雷处方量增加了1倍以上，自2010年前3个月PCI后出院患者的8%增加到2011年最后3个月PCI后出院患者的22%。

但一些普拉格雷 (Effient)处方从两个重要方面脱离了核准适应证。首先，在2年期间，28%的接受PCI+普拉格雷治疗的患者在操作前短时间内无急性冠脉综合征事件，而普拉格雷的美国说明书中指出，该药仅用于近期有不稳定心绞痛或心肌梗死患者接受PCI之后。

普拉格雷的第二种过度应用是对于有禁忌证的患者，即既往有脑血管疾病、体重≤60 kg或年龄≥75岁的患者。根据回顾记录，在密歇根州被处方普拉格雷的PCI后患者中，有5%~10%存在至少1种上述禁忌证。在接受普拉格雷治疗的患者中，最常见的禁忌证为有卒中或短暂脑缺血病史，占有禁忌证患者的一半以上。第二个常见的禁忌证为年龄≥75岁，有禁忌证的普拉格雷治疗患者中的35%属于这种情况。

研究者使用的是密歇根心血管联盟的蓝十字蓝盾公司收集的数据。Sandhu医生披露无相关利益冲突。他的两名合作者接受了密西根蓝十字蓝盾公司提供的研究支持，并有一名合作者为该公司的雇员。

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By: MITCHEL L. ZOLER, Cardiology News Digital Network

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.