Yu Zhou1, Wenhuo Xie1, Linyao Wang1, Xinyan Zhu1, Jianbin Li1, Libin Liu2, Shuaijun Zhu3, Lijing Wang4. 1. Department of Clinical Pharmacy and Pharmacy Administration, School of Pharmacy, Fujian Medical University, Fuzhou, China. 2. Department of Endocrinology, Fujian Medical University Union Hospital, Fuzhou, China. 3. Department of Critical Care Medicine, Fujian Medical University Union Hospital, Fuzhou, China. zhushuaijun@fjmu.edu.cn. 4. Department of Endocrinology, Fujian Medical University Union Hospital, Fuzhou, China. wanglijing@fjmu.edu.cn.
Abstract
INTRODUCTION: An association between tumor necrosis factor (TNF)-α inhibitors and hypoglycemia has been detected in a few case reports and small case series; however, no relevant pharmacovigilance data have been published yet. OBJECTIVE: The objective of this study was to detect and characterize relevant safety signals between hypoglycemia and TNF-α inhibitor use. METHODS: Indication-focused disproportionality analysis was conducted to detect increased reporting of TNF-α-associated hypoglycemia compared with all other reports with the same indication during the same time period. Reporting odds ratios (RORs) with 95% confidence intervals (CIs) were calculated to determine disproportionality. To reduce potential confounding factors, adjusted RORs were further calculated by logistic regression to control for age, sex, diabetes status, and concomitant drugs that potentially affect blood glucose levels. RESULTS: In all, 1086 adverse drug reactions related to TNF-α inhibitors were reported as 'hypoglycemia'. There were no disproportionality signals of hypoglycemia in TNF-α inhibitor users with indication of inflammatory bowel disease. When TNF-α inhibitors were considered as a class, disproportion for hypoglycemia only emerged in indication of psoriasis (n = 267, ROR 1.20, 95% CI 1.02-1.41). In further analyses of specific TNF-α inhibitor type, significant RORs for hypoglycemia were found in indication of rheumatic disease, including adalimumab in ankylosing spondylitis (n = 37, ROR 1.97, 95% CI 1.28-3.04), psoriasis (n = 160, ROR 1.64, 95% CI 1.37-1.97), and rheumatoid arthritis (n = 230, ROR 1.35, 95% CI 1.16-1.56) and infliximab in psoriasis (n = 18, ROR 2.14, 95% CI 1.33-3.42). After adjusting for confounding factors, only the signals of adalimumab were stable. CONCLUSIONS: Our study identified some potential pharmacovigilance signals between hypoglycemia and TNF-α inhibitors, which warrants further validation.
INTRODUCTION: An association between tumor necrosis factor (TNF)-α inhibitors and hypoglycemia has been detected in a few case reports and small case series; however, no relevant pharmacovigilance data have been published yet. OBJECTIVE: The objective of this study was to detect and characterize relevant safety signals between hypoglycemia and TNF-α inhibitor use. METHODS: Indication-focused disproportionality analysis was conducted to detect increased reporting of TNF-α-associated hypoglycemia compared with all other reports with the same indication during the same time period. Reporting odds ratios (RORs) with 95% confidence intervals (CIs) were calculated to determine disproportionality. To reduce potential confounding factors, adjusted RORs were further calculated by logistic regression to control for age, sex, diabetes status, and concomitant drugs that potentially affect blood glucose levels. RESULTS: In all, 1086 adverse drug reactions related to TNF-α inhibitors were reported as 'hypoglycemia'. There were no disproportionality signals of hypoglycemia in TNF-α inhibitor users with indication of inflammatory bowel disease. When TNF-α inhibitors were considered as a class, disproportion for hypoglycemia only emerged in indication of psoriasis (n = 267, ROR 1.20, 95% CI 1.02-1.41). In further analyses of specific TNF-α inhibitor type, significant RORs for hypoglycemia were found in indication of rheumatic disease, including adalimumab in ankylosing spondylitis (n = 37, ROR 1.97, 95% CI 1.28-3.04), psoriasis (n = 160, ROR 1.64, 95% CI 1.37-1.97), and rheumatoid arthritis (n = 230, ROR 1.35, 95% CI 1.16-1.56) and infliximab in psoriasis (n = 18, ROR 2.14, 95% CI 1.33-3.42). After adjusting for confounding factors, only the signals of adalimumab were stable. CONCLUSIONS: Our study identified some potential pharmacovigilance signals between hypoglycemia and TNF-α inhibitors, which warrants further validation.
Authors: Uday N Shivaji; Caroline L Sharratt; Tom Thomas; Samuel C L Smith; Marietta Iacucci; Gordon W Moran; Subrata Ghosh; Neeraj Bhala Journal: Aliment Pharmacol Ther Date: 2019-02-08 Impact factor: 8.171
Authors: T Pina; S Armesto; R Lopez-Mejias; F Genre; B Ubilla; M A Gonzalez-Lopez; M C Gonzalez-Vela; A Corrales; R Blanco; M T Garcia-Unzueta; J L Hernandez; J Llorca; M A Gonzalez-Gay Journal: J Eur Acad Dermatol Venereol Date: 2014-10-29 Impact factor: 6.166
Authors: I A M van den Oever; M Baniaamam; S Simsek; H G Raterman; J C van Denderen; I C van Eijk; M J L Peters; I E van der Horst-Bruinsma; Y M Smulders; M T Nurmohamed Journal: Rheumatol Int Date: 2020-08-10 Impact factor: 2.631