Aims: To investigate the statistical association between hypoglycaemia and β-blocker use and to define what patient and drug characteristics could potentially increase the risk for its occurrence. Methods: We investigated the relationship between pharmacological parameters of β-blockers and the occurrence of hypoglycaemia by conducting a case/non case analysis using the Food and Drug Administration Adverse Event Reporting System database. Pharmacological properties that could represent a predictive factor for hypoglycaemia were analysed through a multilinear binary logistic regression (null hypothesis rejected for values of P <.05). We also performed a systematic review of clinical studies on this association. Results: Of 83 954 selected reports, 1465 cases (1.75%) of hypoglycaemia were identified. The association was found statistically significant for nadolol (reporting odds ratio [95% confidence interval]: 6.98 [5.40–9.03]), celiprolol (2.35 [1.35–4.10]), propranolol (2.14 [1.87–2.46]) and bisoprolol (1.42 [1.25–1.61]). Paediatric cases (n = 310) showed a positive association with hypoglycaemia for long half-life drugs (odds ratio [95% confidence interval]: 2.232 [1.398–3.563]) and a negative association for β1-selectivity (0.644 [0.414–0.999]). Seven papers were included in the systematic review. Because of great heterogeneity in study design and demographics, hypoglycaemia incidence rates varied greatly among studies, occurring in 1.73% of the cases for propranolol treatment (n total participants = 575), 6.6% for atenolol (n = 30) and 10% for carvedilol (n = 20). Conclusion: Nadolol appears to be the β-blocker significantly most associated with hypoglycaemia and children represent the most susceptible sample. Furthermore, long half-life and nonselective β-blockers seem to increase the risk for its occurrence.

β-blockers associated hypoglycaemia: new insights from a real-world pharmacovigilance study [Beta-blocker-associated hypoglycaemia: New insights from a real-world pharmacovigilance study] / C. Carnovale, M. Gringeri, V. Battini, G. Mosini, E. Invernizzi, F. Mazhar, F. Bergamaschi, M. Fumagalli, G.V. Zuccotti, E.G.I. Clementi, S. Radice, V. Fabiano. - In: BJCP. BRITISH JOURNAL OF CLINICAL PHARMACOLOGY. - ISSN 1365-2125. - (2021). [Epub ahead of print] [10.1111/bcp.14754]

β-blockers associated hypoglycaemia: new insights from a real-world pharmacovigilance study [Beta-blocker-associated hypoglycaemia: New insights from a real-world pharmacovigilance study]

Carla Carnovale;Michele Gringeri;Vera Battini;Giulia Mosini;Elena Invernizzi;Faizan Mazhar;Francesco Bergamaschi;Mara Fumagalli;Gian Vincenzo Zuccotti;Emilio Clementi;Sonia Radice;Valentina Fabiano
2021

Abstract

Aims: To investigate the statistical association between hypoglycaemia and β-blocker use and to define what patient and drug characteristics could potentially increase the risk for its occurrence. Methods: We investigated the relationship between pharmacological parameters of β-blockers and the occurrence of hypoglycaemia by conducting a case/non case analysis using the Food and Drug Administration Adverse Event Reporting System database. Pharmacological properties that could represent a predictive factor for hypoglycaemia were analysed through a multilinear binary logistic regression (null hypothesis rejected for values of P <.05). We also performed a systematic review of clinical studies on this association. Results: Of 83 954 selected reports, 1465 cases (1.75%) of hypoglycaemia were identified. The association was found statistically significant for nadolol (reporting odds ratio [95% confidence interval]: 6.98 [5.40–9.03]), celiprolol (2.35 [1.35–4.10]), propranolol (2.14 [1.87–2.46]) and bisoprolol (1.42 [1.25–1.61]). Paediatric cases (n = 310) showed a positive association with hypoglycaemia for long half-life drugs (odds ratio [95% confidence interval]: 2.232 [1.398–3.563]) and a negative association for β1-selectivity (0.644 [0.414–0.999]). Seven papers were included in the systematic review. Because of great heterogeneity in study design and demographics, hypoglycaemia incidence rates varied greatly among studies, occurring in 1.73% of the cases for propranolol treatment (n total participants = 575), 6.6% for atenolol (n = 30) and 10% for carvedilol (n = 20). Conclusion: Nadolol appears to be the β-blocker significantly most associated with hypoglycaemia and children represent the most susceptible sample. Furthermore, long half-life and nonselective β-blockers seem to increase the risk for its occurrence.
hypoglycaemia; pharmacovigilance; real-world data; β-blockers;
Settore BIO/14 - Farmacologia
Settore MED/38 - Pediatria Generale e Specialistica
28-gen-2021
BJCP. BRITISH JOURNAL OF CLINICAL PHARMACOLOGY
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Utilizza questo identificativo per citare o creare un link a questo documento: http://hdl.handle.net/2434/812508
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