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Cardiovascular Safety During and After Use of Phentermine and Topiramate.
- Source :
-
The Journal of clinical endocrinology and metabolism [J Clin Endocrinol Metab] 2019 Feb 01; Vol. 104 (2), pp. 513-522. - Publication Year :
- 2019
-
Abstract
- Context: Increases in heart rate were seen during the clinical program for fixed-dose combination phentermine (PHEN) and topiramate (TPM), an oral medication indicated for weight management; however, the effect on cardiovascular (CV) outcomes is uncertain.<br />Objective: The aim of the present study was to determine the extent to which the rates of major adverse CV events (MACE) in patients using PHEN and TPM (including fixed dose) differed from the MACE rates during unexposed periods.<br />Design: Retrospective cohort study.<br />Setting: MarketScan, US insurance billing data.<br />Patients or Other Participants: Patients aged >18 years with ≥6 months of continuous enrollment in the database before taking PHEN and/or TPM or after stopping these medications.<br />Interventions: PHEN and TPM, taken separately and together (including fixed dose).<br />Main Outcome Measures: MACE, a composite of hospitalization for acute myocardial infarction and stroke and in-hospital CV death.<br />Results: Because the outcomes are rare and the duration of medication use was brief, few events occurred. The MACE rates among current users of PHEN/TPM, fixed-dose PHEN/TPM, and PHEN were lower than those among unexposed former users. In contrast, the rate of MACE among current users of TPM was greater than among unexposed former users [incidence rate ratio: PHEN/TPM, 0.57; 95% CI, 0.19 to 1.78; fixed-PHEN/TPM, 0.24; 95% CI, 0.03 to 1.70; PHEN, 0.56; 95% CI, 0.34 to 0.91; TPM, 1.58; 95% CI, 1.33 to 1.87).<br />Conclusions: Overall, the data indicated no increased risk of MACE for current PHEN/TPM users; however, the 95% CIs for the PHEN/TPM groups were broad, indicating that the data were compatible with a wide range of possible values.
- Subjects :
- Adolescent
Adult
Drug Combinations
Female
Heart Rate drug effects
Hospitalization statistics & numerical data
Humans
Incidence
Male
Middle Aged
Myocardial Infarction chemically induced
Myocardial Infarction therapy
Obesity drug therapy
Retrospective Studies
Stroke chemically induced
Stroke therapy
Weight Loss drug effects
Young Adult
Anti-Obesity Agents adverse effects
Myocardial Infarction epidemiology
Phentermine adverse effects
Stroke epidemiology
Topiramate adverse effects
Subjects
Details
- Language :
- English
- ISSN :
- 1945-7197
- Volume :
- 104
- Issue :
- 2
- Database :
- MEDLINE
- Journal :
- The Journal of clinical endocrinology and metabolism
- Publication Type :
- Academic Journal
- Accession number :
- 30247575
- Full Text :
- https://doi.org/10.1210/jc.2018-01010