Denver VA Medical Center, Cardiology Section 111B, 1055 Clermont St, Denver, CO 80220, USA.
JAMA. 2009 Dec 9;302(22):2458-64. doi: 10.1001/jama.2009.1800.
The US Food and Drug Administration guides clinicians through drug labeling of medications that are contraindicated or not recommended for use in specific patient groups. Little is known about the use of such medications and their effects on outcomes in clinical practice.
To investigate the use of the contraindicated/not-recommended agents enoxaparin and eptifibatide among dialysis patients undergoing percutaneous coronary intervention (PCI) and their association with outcomes.
DESIGN, SETTING, AND PARTICIPANTS: Data from 829 US hospitals on 22 778 dialysis patients who underwent PCI between January 1, 2004, and August 31, 2008.
In-hospital bleeding and death.
Five thousand eighty-four patients (22.3%) received a contraindicated antithrombotic; of these patients, 2375 (46.7%) received enoxaparin, 3261 (64.1%) received eptifibatide, and 552 (10.9%) received both. Compared with patients who did not receive a contraindicated antithrombotic, patients who did had higher rates of in-hospital bleeding (5.6% vs 2.9%; odds ratio [OR], 1.93; 95% confidence interval [CI],1.66-2.23) and death (6.5% vs 3.9%; OR, 1.68; 95% CI, 1.46-1.95). After multivariable adjustment, patients receiving contraindicated antithrombotics had significantly higher risks of in-hospital bleeding (OR, 1.66; 95% CI, 1.43-1.92) and death (OR, 1.24; 95% CI, 1.04-1.48). In 10 158 patients matched by propensity scores, receipt of contraindicated antithrombotics remained significantly associated with in-hospital bleeding (OR, 1.63; 95% CI, 1.35-1.98) but not in-hospital death (OR, 1.15; 95% CI, 0.97-1.36).
In a sample of dialysis patients undergoing PCI, 22.3% received a contraindicated antithrombotic medication. In propensity-matched analysis, receipt of these medications was significantly associated with an increased risk of in-hospital major bleeding.
美国食品和药物管理局指导临床医生对药物标签进行标注,以说明哪些药物在特定患者群体中是禁用或不推荐使用的。对于这些药物在临床实践中的使用情况及其对结果的影响,人们知之甚少。
研究接受经皮冠状动脉介入治疗(PCI)的透析患者中禁用/不推荐使用的依诺肝素和依替巴肽的使用情况及其与结局的关系。
设计、地点和参与者:这项研究的数据来自 2004 年 1 月 1 日至 2008 年 8 月 31 日期间 829 家美国医院的 22778 例透析患者,这些患者接受了 PCI。
住院期间出血和死亡。
5084 例患者(22.3%)接受了禁用的抗血栓药物治疗;其中 2375 例(46.7%)接受了依诺肝素,3261 例(64.1%)接受了依替巴肽,552 例(10.9%)同时接受了这两种药物。与未接受禁用抗血栓药物治疗的患者相比,接受禁用抗血栓药物治疗的患者住院期间出血发生率更高(5.6% vs 2.9%;比值比[OR],1.93;95%置信区间[CI],1.66-2.23)和死亡率(6.5% vs 3.9%;OR,1.68;95% CI,1.46-1.95)。经多变量调整后,接受禁用抗血栓药物治疗的患者发生住院出血的风险显著升高(OR,1.66;95% CI,1.43-1.92)和死亡(OR,1.24;95% CI,1.04-1.48)。在 10158 例经倾向评分匹配的患者中,接受禁用抗血栓药物治疗与住院出血(OR,1.63;95% CI,1.35-1.98)显著相关,但与住院死亡(OR,1.15;95% CI,0.97-1.36)无关。
在接受 PCI 的透析患者中,有 22.3%的患者接受了禁用的抗血栓药物治疗。在倾向评分匹配分析中,使用这些药物与住院大出血风险增加显著相关。