PMID- 36789109
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20230308
IS  - 2472-1972 (Electronic)
IS  - 2472-1972 (Linking)
VI  - 7
IP  - 4
DP  - 2023 Feb 9
TI  - Adverse Events Related to Tirzepatide.
PG  - bvad016
LID - 10.1210/jendso/bvad016 [doi]
LID - bvad016
AB  - CONTEXT: Tirzepatide is a dual glucose-dependent insulinotropic peptide (GIP) and 
      glucagon-like peptide-1 receptor agonist (GLP-1 RA) approved by the US Food and 
      Drug Administration in May 2022 for patients with type 2 diabetes mellitus 
      (T2DM). OBJECTIVE: We aimed to determine the rates of individual adverse events 
      (AEs) related to 3 studied doses of tirzepatide. METHODS: We performed a 
      systematic review with meta-analysis including 5 databases (PubMed, Embase, 
      CINAHL, Scopus, and Web of Science) for all clinical trials reporting AEs related 
      to tirzepatide. The safety data from individual studies were extracted and 
      analyzed through meta-regression to assess rates of individual AEs. Study quality 
      assessment was performed using the National Heart, Lung, and Blood Institute 
      Quality Assessment Tool for Observational Cohort and Cross-Sectional Studies. 
      RESULTS: Ten trials (6836 participants) were included. Gastrointestinal (GI) AEs 
      were the most commonly reported AEs and were dose dependent 39% (95% CI, 
      35%-43%), 46% (95% CI, 42%-49%), and 49% (95% CI, 38%-60%) for the 5, 10, and 
      15 mg dose, respectively. Among all GI AEs, nausea and diarrhea were most 
      frequent at any dose of tirzepatide. Drug discontinuation due to AEs was highest 
      with the 15 mg dose of tirzepatide (10%). Incidence of mild hypoglycemia (blood 
      glucose < 70 mg/dL) was highest with tirzepatide 10 mg dose 22.6% (9.2%-39.8%). 
      Rates of fatal AEs, severe hypoglycemia, acute pancreatitis, cholelithiasis, and 
      cholecystitis were extremely low (</= 1%) across all doses of tirzepatide. 
      CONCLUSION: Tirzepatide is associated with a dose-dependent increase in incidence 
      of GI AEs and AEs leading to drug discontinuation. Severe hypoglycemia, fatal 
      AEs, acute pancreatitis, cholelithiasis, and cholecystitis are rare with this 
      medication.
CI  - (c) The Author(s) 2023. Published by Oxford University Press on behalf of the 
      Endocrine Society.
FAU - Mishra, Rahul
AU  - Mishra R
AUID- ORCID: 0000-0001-5631-1164
AD  - Department Hematology and Oncology, Cleveland Clinic Foundation, Cleveland, Ohio 
      44195, USA.
FAU - Raj, Rishi
AU  - Raj R
AUID- ORCID: 0000-0002-4151-3246
AD  - Department of Endocrinology, Diabetes, and Metabolism, Pikeville Medical Center, 
      Pikeville, Kentucky 41501, USA.
FAU - Elshimy, Ghada
AU  - Elshimy G
AUID- ORCID: 0000-0002-6372-9099
AD  - Department of Endocrinology, Diabetes, and Metabolism, Medical College of 
      Georgia, Augusta University, Augusta, Georgia 30912, USA.
FAU - Zapata, Isain
AU  - Zapata I
AUID- ORCID: 0000-0001-9009-8475
AD  - Department of Biomedical Sciences, Rocky Vista University, Parker, Colorado 
      80112, USA.
FAU - Kannan, Lakshmi
AU  - Kannan L
AUID- ORCID: 0000-0001-8306-6723
AD  - Department of Nephrology, Pikeville Medical Center, Pikeville, Kentucky 41501, 
      USA.
FAU - Majety, Priyanka
AU  - Majety P
AUID- ORCID: 0000-0001-6657-4726
AD  - Division of Endocrinology, Diabetes and Metabolism, Virginia Commonwealth 
      University, Richmond, Virginia 23298, USA.
FAU - Edem, Dinesh
AU  - Edem D
AUID- ORCID: 0000-0002-6115-7189
AD  - Department of Endocrinology and Diabetes, University of Arkansas for Medical 
      Sciences, Little Rock, Arkansas 72205, USA.
FAU - Correa, Ricardo
AU  - Correa R
AUID- ORCID: 0000-0003-2761-2907
AD  - Department of Endocrinology, Diabetes and Metabolism, Institute of Endocrinology 
      and Metabolism, Cleveland Clinic, Cleveland, Ohio 44195, USA.
LA  - eng
PT  - Journal Article
PT  - Review
DEP - 20230126
PL  - United States
TA  - J Endocr Soc
JT  - Journal of the Endocrine Society
JID - 101697997
PMC - PMC9915969
OTO - NOTNLM
OT  - LY3298176
OT  - adverse events
OT  - diabetes
OT  - dual GIP/GLP-1 receptor agonist
OT  - glucose
OT  - meta-analysis
OT  - safety
OT  - systematic review
OT  - tirzepatide
EDAT- 2023/02/16 06:00
MHDA- 2023/02/16 06:01
PMCR- 2023/01/26
CRDT- 2023/02/15 02:08
PHST- 2022/10/09 00:00 [received]
PHST- 2023/02/15 02:08 [entrez]
PHST- 2023/02/16 06:00 [pubmed]
PHST- 2023/02/16 06:01 [medline]
PHST- 2023/01/26 00:00 [pmc-release]
AID - bvad016 [pii]
AID - 10.1210/jendso/bvad016 [doi]
PST - epublish
SO  - J Endocr Soc. 2023 Jan 26;7(4):bvad016. doi: 10.1210/jendso/bvad016. eCollection 
      2023 Feb 9.