The risk of urinary tract infection and upper respiratory tract infection induced by saxagliptin: a Meta-analysis

Abstract

Objective To evaluate the risk of urinary tract infection (UTI)and upper respiratory tract infection (UPI) induced by saxagliptin 5 mg/d. Methods The related databases were searched (until June 2016) for randomized controlled trials (RCTs). The RCT about the risk of urinary tract infection and upper respiratory tract infection induced by saxagliptin between the patients with type 2 diabetes using saxagliptin 5 mg/d alone or with other hypoglycemic agents (test group) and the patients using placebo (control group) were collected. The main outcome of all RCTs were UTI and URTI rates. The literature was in Chinese and English only. The data and the quality of the enrolled literature was extracted and evaluated, respectively. The soft ware RevMan 5.3 was used for the Meta-analysis. The results were expressed as relative risk (RR) and 95% confidence interval (CI). Results A total of 16 reports which included 17 RCTs comprised 6 236 patients [3 226 cases in the test group (T), 3 010 cases in the control group (C)] with a course of treatment from 12 to 206 weeks were enrolled into the Meta-analysis. The studies on the risk of UTI and URTI which were induced by saxagliptin 5 mg/d comprised 6 088 patients (T: 3 152, C: 2 936) and 4 851 patients (T: 2 461, C: 2 390), respectively. The studies about the risk of UTI and URTI which were induced by saxagliptin 5 mg/d plus metformin comprised 1 741 patients (T: 879, C: 862). The results of quality evaluation of 16 articles showed 13 of Grade A and 3 of Grade B. Meta-analysis showed that there were no significant differences between saxagliptin 5 mg/d monotherapy or combined with other antidiabetic drugs and the placebo in the risk of UTI [6.66% (210/3 152)vs. 5.82% (171/2 936), RR=1.15, 95%CI: 0.94-1.40, P=0.17) and URTI [8.00% (197/2 461) vs. 7.66% (183/2 390), RR=1. 04, 95%CI: 0.86-1.26, P=0.71)]. There was no significant difference between saxagliptin 5 mg/d combined with metformin and the placebo in the risk of URT [7.17% (63/879) vs. 6.15% (53/862), RR=1.16, 95%CI: 0.82-1.65, P=0.40]. Conclusion The results of this study shows that there is no evidence of saxagliptin 5 mg/d to increase the risk of UTI and URTI in patients with type 2 diabetes mellitus. Key words: Urinary tract infections; Respiratory tract infections; Meta-analysis; Saxagliptin