title: Risk of diarrhea in patients with type 2 diabetes mellitus treated with sitagliptin: a meta-analysis of 30 randomized clinical trials.
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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Department of Pharmacy, First Affiliated Hospital of College of Medicine, Zhejiang University, Hangzhou, People's Republic of China.
authors.forename: Qingwei
authors.initials: Q
authors.lastname: Zhao
authors.affiliation: Department of Pharmacy, First Affiliated Hospital of College of Medicine, Zhejiang University, Hangzhou, People's Republic of China.
authors.forename: Dongsheng
authors.initials: D
authors.lastname: Hong
authors.affiliation: Department of Pharmacy, First Affiliated Hospital of College of Medicine, Zhejiang University, Hangzhou, People's Republic of China.
authors.forename: Dongsheng
authors.initials: D
authors.lastname: Zheng
authors.affiliation: College of Pharmaceutical Science, Zhejiang Chinese Medical University, Hangzhou, People's Republic of China.
authors.forename: Yao
authors.initials: Y
authors.lastname: Xiao
authors.affiliation: Department of Pharmacy, First Affiliated Hospital of College of Medicine, Zhejiang University, Hangzhou, People's Republic of China.
authors.forename: Baohua
authors.initials: B
authors.lastname: Wu
mesh_terms: D003924:Diabetes Mellitus, Type 2 / Q000188:drug therapy*; D003967:Diarrhea / Q000139:chemically induced / Q000150:complications*; D006801:Humans; D007004:Hypoglycemic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D016017:Odds Ratio; D011719:Pyrazines / Q000009:adverse effects / Q000627:therapeutic use*; D016032:Randomized Controlled Trials as Topic; D018570:Risk Assessment; D000068900:Sitagliptin Phosphate; D014230:Triazoles / Q000009:adverse effects / Q000627:therapeutic use*
chemical_list: D007004:Hypoglycemic Agents; D011719:Pyrazines; D014230:Triazoles; D000068900:Sitagliptin Phosphate
keywords: adverse reaction; data analysis; dipeptidyl peptidase-4 inhibitors; incidence; odds ratio; subgroup analysis