Characteristic analysis of adverse reactions to natural and synthetic alpha-glucosidase inhibitors: a descriptive analysis using World Health Organisation-VigiAccess.

OBJECTIVE: To systematically characterise adverse drug reactions (ADRs) of four alpha (α)-glucosidase inhibitors - acarbose, voglibose, miglitol and mulberry twig alkaloids - using real-world data from the World Health Organisation VigiAccess® database.

METHODS: A retrospective descriptive analysis was conducted on 9410 ADR reports (1983-2024). Disproportionality analyses (reporting odds ratio [ROR]/empirical Bayesian geometric mean [EBGM]) identified drug-adverse-event associations.

RESULTS: Gastrointestinal disorders were the most frequently reported system organ class for all drugs (acarbose: 43.10 %; voglibose: 39.02 %; miglitol: 40.81 %; mulberry twig alkaloids: 23.68 %). For acarbose, diarrhoea (report rate 7.51 %, ROR = 6.53, 95 %CI 6.07-7.02; EBGM = 6.11, 95 %CI 5.68-6.57) and abdominal distension (report rate 7.45 %, ROR = 56.69, 95 %CI 52.68-61.00; EBGM = 52.30, 95 %CI 48.60-56.27) showed the highest reporting rates. Notably, mulberry twig alkaloids exhibited unique cardiac signals, including chest pain (report rate: 7.89 %, ROR = 14.80, 95 % CI: 4.55-48.13; EBGM = 13.71, 95 % CI: 4.22-44.59) and supraventricular tachycardia (report rate: 2.63 %, ROR = 198.83, 95 % CI: 27.28-1449.26; EBGM = 193.61, 95 % CI: 26.56-1411.23).

CONCLUSION: This study provides the first large-scale comparison of natural versus synthetic α-glucosidase inhibitors, highlighting gastrointestinal toxicity as a shared risk and cardiotoxicity as a novel concern for mulberry twig alkaloids. These findings underscore the need for cardiac monitoring in patients receiving natural inhibitors.