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The cardiovascular safety of antiobesity drugs-analysis of signals in the FDA Adverse Event Report System Database.
Int J Obes (Lond). 2020 May; 44(5):1021-1027.IJ

Abstract

AIMS

Over the past several decades, many antiobesity drugs have been withdrawn from the market due to unanticipated adverse events, often involving cardiotoxicity. This study aimed to evaluate the presence of cardiovascular safety signals with currently marketed antiobesity drugs.

METHODS

We used the US Food and Drug Administration Adverse Event Reporting System (FAERS) database and retrieved data from January 2013 through December 2018. We performed disproportionality analyses to detect cardiovascular safety signals with three antiobesity drugs recently approved for marketing: lorcaserin, naltrexone-bupropion, phentermine, and phentermine-topiramate. Three main cardiovascular outcomes were evaluated: valvular disorders, and pulmonary hypertension (PH) and other cardiovascular events (myocardial infarction, stroke, cardiovascular death, cardiac failure, and arrhythmia).

RESULTS

During the evaluated period, a total of 6,787,840 adverse event reports were submitted to FAERS. Of these, 2687 involved lorcaserin, 3960 involved phentermine/phentermine-topiramate, and 2873 involved naltrexone-bupropion. Lorcaserin was associated with a significantly greater proportion of reports of valvular disorders (ROR = 4.39; 95% CI 2.72-5.07). None of the antiobesity drugs were associated with a safety signal for valvulopathy, PH, or other cardiovascular events.

CONCLUSIONS

Our analyses revealed a signal for valvular disorders with lorcaserin and did not detect a safety signal for other cardiovascular events with recently approved antiobesity drugs. Further research is needed to explore and validate this signal.

Authors+Show Affiliations

Division of Clinical Pharmacy, Faculty of Medicine, School of Pharmacy, The Institute for Drug Research, The Hebrew University of Jerusalem, Jerusalem, Israel.No affiliation info availableDivision of Clinical Pharmacy, Faculty of Medicine, School of Pharmacy, The Institute for Drug Research, The Hebrew University of Jerusalem, Jerusalem, Israel.Division of Clinical Pharmacy, Faculty of Medicine, School of Pharmacy, The Institute for Drug Research, The Hebrew University of Jerusalem, Jerusalem, Israel.Division of Clinical Pharmacy, Faculty of Medicine, School of Pharmacy, The Institute for Drug Research, The Hebrew University of Jerusalem, Jerusalem, Israel.Division of Clinical Pharmacy, Faculty of Medicine, School of Pharmacy, The Institute for Drug Research, The Hebrew University of Jerusalem, Jerusalem, Israel. ilan.matok@ekmd.huji.ac.il.

Pub Type(s)

Journal Article

Language

eng

PubMed ID

32152496

Citation

Gorelik, Einat, et al. "The Cardiovascular Safety of Antiobesity Drugs-analysis of Signals in the FDA Adverse Event Report System Database." International Journal of Obesity (2005), vol. 44, no. 5, 2020, pp. 1021-1027.
Gorelik E, Gorelik B, Masarwa R, et al. The cardiovascular safety of antiobesity drugs-analysis of signals in the FDA Adverse Event Report System Database. Int J Obes (Lond). 2020;44(5):1021-1027.
Gorelik, E., Gorelik, B., Masarwa, R., Perlman, A., Hirsh-Raccah, B., & Matok, I. (2020). The cardiovascular safety of antiobesity drugs-analysis of signals in the FDA Adverse Event Report System Database. International Journal of Obesity (2005), 44(5), 1021-1027. https://doi.org/10.1038/s41366-020-0544-4
Gorelik E, et al. The Cardiovascular Safety of Antiobesity Drugs-analysis of Signals in the FDA Adverse Event Report System Database. Int J Obes (Lond). 2020;44(5):1021-1027. PubMed PMID: 32152496.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - The cardiovascular safety of antiobesity drugs-analysis of signals in the FDA Adverse Event Report System Database. AU - Gorelik,Einat, AU - Gorelik,Boris, AU - Masarwa,Reem, AU - Perlman,Amichai, AU - Hirsh-Raccah,Bruria, AU - Matok,Ilan, Y1 - 2020/03/09/ PY - 2019/04/05/received PY - 2020/02/06/accepted PY - 2020/01/15/revised PY - 2020/3/11/pubmed PY - 2020/3/11/medline PY - 2020/3/11/entrez SP - 1021 EP - 1027 JF - International journal of obesity (2005) JO - Int J Obes (Lond) VL - 44 IS - 5 N2 - AIMS: Over the past several decades, many antiobesity drugs have been withdrawn from the market due to unanticipated adverse events, often involving cardiotoxicity. This study aimed to evaluate the presence of cardiovascular safety signals with currently marketed antiobesity drugs. METHODS: We used the US Food and Drug Administration Adverse Event Reporting System (FAERS) database and retrieved data from January 2013 through December 2018. We performed disproportionality analyses to detect cardiovascular safety signals with three antiobesity drugs recently approved for marketing: lorcaserin, naltrexone-bupropion, phentermine, and phentermine-topiramate. Three main cardiovascular outcomes were evaluated: valvular disorders, and pulmonary hypertension (PH) and other cardiovascular events (myocardial infarction, stroke, cardiovascular death, cardiac failure, and arrhythmia). RESULTS: During the evaluated period, a total of 6,787,840 adverse event reports were submitted to FAERS. Of these, 2687 involved lorcaserin, 3960 involved phentermine/phentermine-topiramate, and 2873 involved naltrexone-bupropion. Lorcaserin was associated with a significantly greater proportion of reports of valvular disorders (ROR = 4.39; 95% CI 2.72-5.07). None of the antiobesity drugs were associated with a safety signal for valvulopathy, PH, or other cardiovascular events. CONCLUSIONS: Our analyses revealed a signal for valvular disorders with lorcaserin and did not detect a safety signal for other cardiovascular events with recently approved antiobesity drugs. Further research is needed to explore and validate this signal. SN - 1476-5497 UR - https://www.unboundmedicine.com/medline/citation/32152496/The_cardiovascular_safety_of_antiobesity_drugs-analysis_of_signals_in_the_FDA_Adverse_Event_Report_System_Database L2 - http://dx.doi.org/10.1038/s41366-020-0544-4 DB - PRIME DP - Unbound Medicine ER -
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