TY - JOUR
T1 - Cardiovascular Safety during and after Use of Phentermine and Topiramate
AU - Ritchey, Mary E.
AU - Harding, Abenah
AU - Hunter, Shannon
AU - Peterson, Craig
AU - Sager, Philip T.
AU - Kowey, Peter R.
AU - Nguyen, Lan
AU - Thomas, Steven
AU - Cainzos-Achirica, Miguel
AU - Rothman, Kenneth J.
AU - Andrews, Elizabeth B.
AU - Anthony, Mary S.
N1 - Publisher Copyright:
© Copyright 2019 Endocrine Society.
PY - 2018/11/9
Y1 - 2018/11/9
N2 - 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. 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. Design Retrospective cohort study. Setting MarketScan, US insurance billing data. 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. Interventions PHEN and TPM, taken separately and together (including fixed dose). Main Outcome Measures MACE, a composite of hospitalization for acute myocardial infarction and stroke and in-hospital CV death. 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). 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.
AB - 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. 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. Design Retrospective cohort study. Setting MarketScan, US insurance billing data. 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. Interventions PHEN and TPM, taken separately and together (including fixed dose). Main Outcome Measures MACE, a composite of hospitalization for acute myocardial infarction and stroke and in-hospital CV death. 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). 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.
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U2 - 10.1210/jc.2018-01010
DO - 10.1210/jc.2018-01010
M3 - Article
C2 - 30247575
AN - SCOPUS:85059497698
SN - 0021-972X
VL - 104
SP - 513
EP - 522
JO - Journal of Clinical Endocrinology and Metabolism
JF - Journal of Clinical Endocrinology and Metabolism
IS - 2
ER -