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Clinical adverse effects of sodium-glucose cotransporter 2 inhibitors: Protocol for a systematic review and

Hao Li1, Fang-Hong Shi, Shi-Ying Huang

  • 1Department of Pharmacy, Shanghai Children's Medical Center, Shanghai Jiao Tong University School of Medicine Department of Pharmacy, Renji Hospital, School of Medicine, Shanghai Jiaotong University, Shanghai, P.R. China.

Medicine
|August 11, 2018
PubMed
Abstract

Insights

This systematic review assesses the safety of Sodium-glucose cotransporter 2 (SGLT2) inhibitors in type 2 diabetes. The analysis focuses on clinical adverse events (AEs) to provide a comprehensive safety profile.

Area of Science:

  • Pharmacology
  • Endocrinology
  • Clinical Medicine

Background:

  • Sodium-glucose cotransporter 2 (SGLT2) inhibitors are a new oral antidiabetic drug class.
  • These drugs increase urinary glucose excretion by reducing renal glucose reabsorption.
  • Concerns exist regarding the overall safety profile of SGLT2 inhibitors.

Purpose of the Study:

  • To systematically review and meta-analyze the clinical adverse effects of SGLT2 inhibitors.
  • To assess the safety of SGLT2 inhibitors in patients with type 2 diabetes mellitus.
  • To provide a comprehensive picture of adverse events associated with SGLT2 inhibitors.

Main Methods:

  • Systematic review and meta-analysis following PRISMA guidelines.
  • Searched Medline, EMbase, Cochrane Library, and ClinicalTrials.gov (1946-June 2018).
  • Included double-blinded, placebo-controlled, randomized controlled trials reporting safety data; analyzed adverse events (AEs) occurring in ≥3% of patients or those of concern to the FDA.

Main Results:

  • The meta-analysis will evaluate adverse events (AEs) occurring in ≥3% of patients.
  • AEs of concern to the FDA will also be evaluated.
  • Results will be compared between SGLT2 inhibitors and placebo.

Conclusions:

  • This study will offer a comprehensive overview of the adverse events associated with SGLT2 inhibitors.
  • The findings will contribute to a better understanding of the safety profile of these antidiabetic drugs.

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