Immune checkpoints inhibitors and hyperglycemia: A Meta-analysis of randomized controlled trials.


Journal

Diabetes research and clinical practice
ISSN: 1872-8227
Titre abrégé: Diabetes Res Clin Pract
Pays: Ireland
ID NLM: 8508335

Informations de publication

Date de publication:
Apr 2020
Historique:
received: 29 07 2019
revised: 17 01 2020
accepted: 05 03 2020
pubmed: 18 3 2020
medline: 28 7 2020
entrez: 18 3 2020
Statut: ppublish

Résumé

Immune checkpoint inhibitors (ICI) exert their therapeutic effect by modulating the immune system and potentiating antitumor immunity. ICI have been associated with several immune-related adverse events, such as diabetes. However, no formal metaanalysis with this respect has been conducted so far. Aim of the present metaanalysis of randomized trials is to assess the effects of ICI on incident diabetes and hyperglycemia. A MEDLINE, Scopus, ISI-WOS, and Cochrane database search was performed to identify trials, enrolling patients with any form of cancer, up to April 23rd, 2019 in which ICI have been compared either with placebo or active comparators. Data were extracted from published reports or, if not available, from clinicaltrials.gov. The principal endpoints were the incidence of diabetes and cases of hyperglycemia, reported as adverse events. Mantel-Haenszel Odds Ratio with 95% Confidence Interval (MH-OR) was calculated for all outcomes. The study has been registered on PROSPERO website (CDR133927). Out of 42 trials retrieved, 40 reported information on incident diabetes or hyperglycemia. No association of ICI with incident diabetes (MH-OR 1.27 [0.66, 2.43], p = 0.47) was observed; whereas there was a trend toward an increased risk of hyperglycemia (MH-OR 1.45 [0.99, 2.13], p = 0.060), which reached statistical significance in sensitivity analyses and when analyzing separately placebo-controlled trials (MH-OR 1.95 [1.10, 3.49], p = 0.020). I ICI treatment is associated with an increased risk of hyperglycemia, and an increase in the risk of diabetes cannot be excluded.

Sections du résumé

BACKGROUND BACKGROUND
Immune checkpoint inhibitors (ICI) exert their therapeutic effect by modulating the immune system and potentiating antitumor immunity. ICI have been associated with several immune-related adverse events, such as diabetes. However, no formal metaanalysis with this respect has been conducted so far. Aim of the present metaanalysis of randomized trials is to assess the effects of ICI on incident diabetes and hyperglycemia.
METHODS METHODS
A MEDLINE, Scopus, ISI-WOS, and Cochrane database search was performed to identify trials, enrolling patients with any form of cancer, up to April 23rd, 2019 in which ICI have been compared either with placebo or active comparators. Data were extracted from published reports or, if not available, from clinicaltrials.gov. The principal endpoints were the incidence of diabetes and cases of hyperglycemia, reported as adverse events. Mantel-Haenszel Odds Ratio with 95% Confidence Interval (MH-OR) was calculated for all outcomes. The study has been registered on PROSPERO website (CDR133927).
FINDINGS RESULTS
Out of 42 trials retrieved, 40 reported information on incident diabetes or hyperglycemia. No association of ICI with incident diabetes (MH-OR 1.27 [0.66, 2.43], p = 0.47) was observed; whereas there was a trend toward an increased risk of hyperglycemia (MH-OR 1.45 [0.99, 2.13], p = 0.060), which reached statistical significance in sensitivity analyses and when analyzing separately placebo-controlled trials (MH-OR 1.95 [1.10, 3.49], p = 0.020). I
INTERPRETATION CONCLUSIONS
ICI treatment is associated with an increased risk of hyperglycemia, and an increase in the risk of diabetes cannot be excluded.

Identifiants

pubmed: 32179128
pii: S0168-8227(20)30365-X
doi: 10.1016/j.diabres.2020.108115
pii:
doi:

Substances chimiques

Antibodies, Monoclonal 0

Types de publication

Journal Article Meta-Analysis Review

Langues

eng

Sous-ensembles de citation

IM

Pagination

108115

Informations de copyright

Copyright © 2020. Published by Elsevier B.V.

Déclaration de conflit d'intérêts

Declaration of Competing Interest MM has received speaking fees from Astra Zeneca, Bristol Myers Squibb, Boehringer-Ingelheim, Eli-Lilly, Merck, Novo Nordisk, Sanofi, and Novartis and research grants from Bristol Myers Squibb; LN has no conflicts of interest; ID has received speaking fees from Novonordisk; BN is presently employee of Novo Nordisk; GS has received speaking fees from Novo Nordisk, Merck Sharp & Dohme, Sanofi, Boehringer Ingelheim, Eli Lilly, Astra Zeneca, L-Nutra, Theras, Sanofi, Mundipharma, Omikron, and Novartis, and consultancy fees from Servier, Novo Nordisk, Boehringer Ingelheim, Eli Lilly, Astra Zeneca, Merck Sharp & Dohme, Sanofi, Amgem and GlaxoSmithKline; EM has received consultancy fees from Merck and Novartis speaking fees from Astra Zeneca, Bristol Myers Squibb, Boehringer-Ingelheim, Eli-Lilly, Merck, Novo Nordisk, Sanofi, and Novartis and research grants from Merck, Novartis, and Takeda.

Auteurs

Matteo Monami (M)

Diabetology, Careggi Hospital and University of Florence, Italy. Electronic address: matteo.monami@unifi.it.

Lara Naletto (L)

Diabetology, Careggi Hospital and University of Florence, Italy.

Besmir Nreu (B)

Diabetology, Careggi Hospital and University of Florence, Italy.

Ilaria Dicembrini (I)

Diabetology, Careggi Hospital and University of Florence, Italy.

Giorgio Sesti (G)

Department of Medical and Surgical Sciences, University Magna Græcia of Catanzaro, Catanzaro, Italy.

Edoardo Mannucci (E)

Diabetology, Careggi Hospital and University of Florence, Italy.

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Classifications MeSH