Abstract:
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.
journal_name
JAMA Intern Medjournal_title
JAMA internal medicineauthors
Fralick M,Kesselheim AS,Avorn J,Schneeweiss Sdoi
10.1001/jamainternmed.2017.3919subject
Has Abstractpub_date
2018-01-01 00:00:00pages
55-63issue
1eissn
2168-6106issn
2168-6114pii
2663852journal_volume
178pub_type
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journal_title:JAMA internal medicine
pub_type: 杂志文章
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abstract:IMPORTANCE:Feasibility, effectiveness, and sustainability of large-scale readmission reduction efforts are uncertain. The Greater New Haven Coalition for Safe Transitions and Readmission Reductions was funded by the Center for Medicare & Medicaid Services (CMS) to reduce readmissions among all discharged Medicare fee-f...
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abstract:Importance:Among patients who had acute kidney injury (AKI) during hospitalization, there is a need to improve risk prediction such that those at highest risk for subsequent loss of kidney function are identified for appropriate follow-up. Objective:To evaluate the association of post-AKI proteinuria with increased ri...
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pub_type: 杂志文章,多中心研究,随机对照试验
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更新日期:2013-02-25 00:00:00
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pub_type: 杂志文章,多中心研究
doi:10.1001/jamainternmed.2020.0950
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doi:10.1001/jamainternmed.2013.10081
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abstract:Importance:Lung cancer has become a leading cause of death among people living with human immunodeficiency virus (HIV) (PLWH). Over 40% of PLWH in the United States smoke cigarettes; HIV independently increases the risk of lung cancer. Objective:To project cumulative lung cancer mortality by smoking exposure among PLW...
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更新日期:2019-04-01 00:00:00
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doi:10.1001/jamainternmed.2016.9616
更新日期:2017-05-01 00:00:00
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doi:10.1001/jamainternmed.2019.6398
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更新日期:2018-09-01 00:00:00
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pub_type: 杂志文章,评审
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更新日期:2019-06-03 00:00:00
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pub_type: 杂志文章,多中心研究
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更新日期:2018-07-01 00:00:00
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更新日期:2020-10-01 00:00:00
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更新日期:2013-11-25 00:00:00
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更新日期:2017-01-01 00:00:00
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更新日期:2015-01-01 00:00:00