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]

C. Carnovale
Primo
;
M. Gringeri;V. Battini;G. Mosini
Secondo
;
E. Invernizzi;F. Mazhar;F. Bergamaschi;M. Fumagalli;G.V. Zuccotti;E.G.I. Clementi;S. Radice
Penultimo
;
V. Fabiano
Ultimo
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
2021
28-gen-2021
Article (author)
File in questo prodotto:
File Dimensione Formato  
BJCP2021.pdf

accesso riservato

Tipologia: Publisher's version/PDF
Dimensione 828.33 kB
Formato Adobe PDF
828.33 kB Adobe PDF   Visualizza/Apri   Richiedi una copia
Pubblicazioni consigliate

I documenti in IRIS sono protetti da copyright e tutti i diritti sono riservati, salvo diversa indicazione.

Utilizza questo identificativo per citare o creare un link a questo documento: https://hdl.handle.net/2434/812508
Citazioni
  • ???jsp.display-item.citation.pmc??? 4
  • Scopus 9
  • ???jsp.display-item.citation.isi??? 8
social impact