Correlation between the risk of malignancy and dapagliflozin: a meta-analysis
10.3760/cma.j.cn114015-20210315-00304
- VernacularTitle:达格列净与恶性肿瘤发生风险相关性的meta分析
- Author:
Wenhui HUANG
1
;
Qiuhong CHEN
1
;
Honglin XUE
1
;
Yunchen ZHANG
1
Author Information
1. 解放军联勤保障部队第九〇九医院药剂科，福建省漳州市 363000
- Publication Type:Journal Article
- Keywords:
Sodium-glucose transporter 2 inhibitors;
Diabetes mellitus, type 2;
Neoplasms;
Risk;
Meta-analysis;
Randomized controlled trial;
Dapagliflozin
- From:
Adverse Drug Reactions Journal
2021;23(6):304-311
- CountryChina
- Language:Chinese
-
Abstract:
Objective:To systematically evaluate correlation between the risk of malignancy and dapagliflozin in type 2 diabetes mellitus.Methods:The databases such as PubMed, the Cochrane Library, American Clinical Trial Registry, Embase, JAMA, Wiley-Blackwell, Springer Link, Elsevier, Ovid, Taylor & Francis Online, CNKI, Wanfang, and VIP (up to March 2021) were searched. The randomized controlled trials (RCTs) on dapagliflozin with outcome indicators including malignancy occurrence were collected. Data extraction and quality analysis were performed for the enrolled literature, and meta-analysis was conducted using RevMan 5.3 software.Results:A total of 22 studies were enrolled in the analysis, all of which were multicenter RCTs, and the quality evaluation results were all grade A. Thirty-one thousand four hundred and fifty-one patients were involved in the 22 studies, of which 16 267 were in the experimental group (dapagliflozin 5 or 10 mg daily) and 15 184 in the control group (placebo or other hypoglycemic drugs). The course of treatment in the 22 studies ranged from 24 weeks to 5.2 years and it was 24 weeks in 15 studies (68.2%). A total of 1 302 patients developed malignancy during the trials, including 661 in the experimental group and 641 in the control group. The results of the meta-analysis showed that, regardless in the overall study of different dapagliflozin doses or in studies of dapagliflozin 5 or 10 mg/d, the differences in the risk of malignancy between the experimental group and the control group were not statistically significant [overall study: 4.2% (661/15 911) vs. 4.1% (648/15 884), RR=1.02, 95 %CI: 0.92-1.13, P=0.72; dapagliflozin 5 mg/d: 0.8% (10/1 181) vs. 0.6% (7/1 172), RR=1.35, 95 %CI: 0.57-3.17, P=0.49; dapagliflozin 10 mg/d: 4.4% (651/14 730) vs. 4.4% (641/14 712), RR=1.01, 95 %CI: 0.91-1.13, P=0.78]; the differences in the risk of breast cancer were not statistically significant [overall study: 0.2% (25/12 216) vs. 0.2% (25/12 215), RR=1.00, 95 %CI: 0.59-1.69, P=1.00; dapagliflozin 5 mg/d: 0.6% (2/348) vs. 0 (0/347), RR=3.00, 95 %CI: 0.31-28.65, P=0.34; dapagliflozin 10 mg/d: 0.2% (23/11 868) vs. 0.2% (25/11 868), RR=0.93, 95 %CI: 0.54-1.59, P=0.78]; the differences in the risk of bladder cancer were not significantly significant [overall study: 0.1% (16/12 021) vs. 0.2% (28/12 019), RR=0.59, 95 %CI: 0.33-1.07), P=0.08; dapagliflozin 5 mg/d: 0.7% (1/137) vs. 0 (0/137), RR=3.00, 95 %CI: 0.12-73.00, P=0.50; dapagliflozin 10 mg/d: 0.1% (15/11 884) vs. 0.2% (28/11 882), RR=0.55, 95 %CI: 0.30-1.02, P=0.06]. Conclusion:Dapagliflozin may not increase the risk of malignancy in patients with type 2 diabetes mellitus, but its long-term safety needs further study.
