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Original Research

Risk of diarrhea in patients with type 2 diabetes mellitus treated with sitagliptin: a meta-analysis of 30 randomized clinical trials

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Pages 2283-2294 | Published online: 11 Nov 2014
 

Abstract

Background

Sitagliptin is an important drug used for diabetes treatment and is used as a monotherapy in diabetic patients. However, there are also reported cases of diarrhea with sitagliptin use. Unfortunately, data concerning the relationship of diarrhea with sitagliptin use in various conditions have yet to be identified. Therefore, the overall incidence and risk of diarrhea with sitagliptin use have not been well defined.

Methods

We conducted searches on Embase, PubMed, and the Cochrane Library databases for relevant randomized controlled trials. Registered relevant trials at the clinical trials registration website were also searched. Statistical analyses were conducted to calculate the overall incidence, odds ratios, and 95% confidence intervals (CI) by using either random-effects or fixed-effect models according to the heterogeneity of the included studies.

Results

A total of 8,891 subjects with diabetes from 30 randomized clinical trials were included in the meta-analysis. The overall incidence of sitagliptin-associated diarrhea was 4.48% (95% CI: 3.59%–5.58%). Compared with the controls, the use of sitagliptin was not associated with a significantly increased risk of diarrhea with an odds ratio of 1.10 (95% CI: 0.78%–1.55%; P=0.58). No evidence of publication bias was observed.

Conclusion

Our study has shown that there is no difference in diarrhea risk between sitagliptin and controlled therapies. Moreover, sitagliptin is not a medicine that potentially increases the risk of diabetic diarrhea. More studies are recommended to further investigate this association.

Supplementary materials

Figure S1 Embase search strategy.

Abbreviation: exp, extensive search.
Figure S1 Embase search strategy.

Figure S2 PubMed search strategy.

Figure S2 PubMed search strategy.
Figure S2 PubMed search strategy.

Figure S3 Cochrane Library search strategy.

Abbreviations: ab, abstract; kw, keyword; ti, title.
Figure S3 Cochrane Library search strategy.

Table S1 PRISMA 2009 checklist

Reference

  • Moher D Liberati A Tetzlaff J Altman DG the PRISMA Group Preferred reporting items for systematic reviews and meta-analyses: the PRISMA statement Plos Med 2009 6 7 e1000097 19621072

Acknowledgments

This work was supported by the Zhejiang TCM KEY research fund projects (number 2013ZZ009), Zhejiang TCM research fund projects (number 2013ZA078), and Zhejiang Provincial Education Department Research Fund Project (number Y201225107).

Disclosure

There are no financial/commercial conflicts of interest involving any of the authors of this study.