Safety of High-dose Canagliflozin for Type 2 Diabetes Mellitus: A Meta Analysis

doi:10.19803/j.1672-8629.2021.02.11

Abstract

Abstract: Objective To evaluate the safety of high-dose canagliflozin(CANA) in the treatment of type 2 diabetes mellitus(T2DM). Methods PubMed, Medline, Cochrane Library, Embase, CNKI, Wanfang Database, VIP and CBM were searched for randomized controlled trials (RCTs) published from the inception of the database to September 2019. Data on randomized controlled trials related to canagliflozin at a low dose of 100 mg/d and at a high dose of 300 mg/d used for treating type 2 diabetes mellitus was collected and analyzed using the RevMan5.3 software. Results A total of 14 RCTs and 6, 233 cases of patients were included. Meta analysis results showed that high doses of calpagliflozin were more likely to cause male genital fungal infections, and the difference was statistically significant [RR=1.38,95％CI(1.06,1.79),P=0.02]. The risk was also higher for volume depletion-related AEs and the difference was statistically significant[RR=1.44,95％CI(1.05,1.98),P=0.03]. LDL-C levels increased more significantly, and the difference was statistically significant [MD=0.05,95％CI(0.00,0.10),P=0.04]. The occurrence of ther difference was basically similar to that of low dose. Conclusion High-dose canaglif102in can in rease the risk of male genital fungal infections, volume depletion-related AEs. and elevated the LDL-C levels There is no significant difference in the occurrence of other adverse reactions. However, this conclusion needs to be verified by long-term RCTs.

Key words: canagliflozin, type 2 diabetes mellitus, Meta-analysis, adverse drug reactions, safety

CLC Number:

R977.15

CHEN Qiying, HUANG Dandan, CHEN Tianyu. Safety of High-dose Canagliflozin for Type 2 Diabetes Mellitus: A Meta Analysis[J]. Chinese Journal of Pharmacovigilance, 2021, 18(2): 150-154.

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