Use of Health Care Databases to Support Supplemental Indications of Approved Medications
Use of Health Care Databases to Support Supplemental Indications of Approved Medications
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DOI：
10.1001/jamainternmed.2017.3919
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发表时间：
2018-01-01
影响因子：
39
通讯作者：
Schneeweiss, Sebastian
中科院分区：
文献类型：
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作者：
Fralick, Michael;Kesselheim, Aaron S.;Schneeweiss, Sebastian
美国食品和药物管理局批准的处方药的制造商经常根据随机临床试验申请额外的适应症。真实世界的数据库分析药物的使用和结果在常规设置的护理可能有助于告知决策有关的补充indics. ObjectiveTo检查是否纵向数据从卫生保健数据库可以支持的结果，随机临床试验，导致补充适应症替米沙坦。这项队列研究使用了2003年1月1日至2009年9月30日全国卫生保健数据库中的保险索赔数据，来比较病人的治疗效果本研究复制了正在进行的替米沙坦单药治疗和与雷米普利联合治疗全球终点试验（ONTARGET）中使用的入选和排除标准，并使用倾向评分匹配来平衡74项患者特征。数据分析时间为2017年2月15日至2017年5月24日。主要结局和指标主要结局为心肌梗死、卒中或因充血性心力衰竭住院治疗的复合终点。结果在纳入研究的640 951例患者中，48 053例新处方了雷米普利。（平均[SD]年龄，68.29 [9.52]岁; 31940例男性[66.5%]）和4665例新处方替米沙坦（平均[SD]年龄，69.43 [9.60]岁; 2413例男性[51.7%]）。倾向评分匹配后，共有4665例患者新处方了替米沙坦（平均[SD]年龄，69. 43 [9. 60]岁; 2413例[51. 7%]），4665例患者新处方了雷米普利（平均[SD]年龄，69. 36 [9. 67]岁; 2343例男性[50. 2%]）。如在ONTARGET中所见，两种药物的卒中、心肌梗死和因充血性心力衰竭住院的复合风险相似（风险比，1.0; 95% CI，0.9-1.1）。此外，该研究发现，替米沙坦与血管性水肿的风险大幅降低（危害比，0.1; 95%CI，0.03-0.56）相比，ramibiant.CONCLUSIONS和相关性接受常规护理的患者的真实世界的数据分析提供了类似的随机临床试验中发现的结果，建立替米沙坦的补充适应症。在某些情况下，数据库研究可能支持已批准药物有效性的补充申请。
IMPORTANCE Manufacturers of US Food and Drug Administration-approved prescription drugs often apply for additional indications based on randomized clinical trials. Real-world database analyses on a medication's use and outcomes in routine settings of care might help to inform decision making regarding such supplemental indications.OBJECTIVE To examine whether longitudinal data from a health care database can support the results of a randomized clinical trial that led to a supplemental indication for telmisartan.DESIGN, SETTING, AND PARTICIPANTS This cohort study of patients newly prescribed telmisartan or ramipril used insurance claims data from a nationwide health care database from January 1, 2003, through September 30, 2009, to compare patient outcomes. This study replicated the inclusion and exclusion criteria used in the Ongoing Telmisartan Alone and in Combination with Ramipril Global End-point Trial (ONTARGET) and used propensity score matching to balance 74 patient characteristics. Data analysis was performed from February 15, 2017, to May 24, 2017.EXPOSURES Telmisartan use vs ramipril use.MAIN OUTCOMES AND MEASURES The primary outcome was a composite of myocardial infarction, stroke, or hospitalization for congestive heart failure.RESULTS Of the 640 951 patients included in the study, 48 053 were newly prescribed ramipril (mean [SD] age, 68.29 [9.52] years; 31 940 male [66.5%]) and 4665 were newly prescribed telmisartan (mean [SD] age, 69.43 [9.60] years; 2413 male [51.7%]). After propensity score matching, a total of 4665 patients were newly prescribed telmisartan (mean [SD] age, 69.43 [9.60] years; 2413 [51.7%]), and 4665 patients were newly prescribed ramipril (mean [SD] age, 69.36 [9.67] years; 2343 male [50.2%]). As seen in ONTARGET, the composite risk of stroke, myocardial infarction, and hospitalization for congestive heart failure was similar for the 2 medications (hazard ratio, 1.0; 95% CI, 0.9-1.1). In addition, the study found that telmisartan was associated with a substantially decreased risk of angioedema (hazard ratio, 0.1; 95% CI, 0.03-0.56) compared with ramipril.CONCLUSIONS AND RELEVANCE Real-world data analyses of patients receiving routine care provided findings similar to those found in the randomized clinical trial that established telmisartan's supplemental indication. In certain situations, database studies may support supplemental applications for effectiveness for already approved medications.