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Dapagliflozin for the Treatment of Type 2 Diabetes

ANNALS OF PHARMACOTHERAPY (2012)

期刊

ANNALS OF PHARMACOTHERAPY

卷 46, 期 4, 页码 590-598

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HARVEY WHITNEY BOOKS CO

DOI: 10.1345/aph.1Q538

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dapagliflozin; SGLT2 inhibitor; sodium-glucose cotransporter 2 inhibitor; type 2 diabetes mellitus

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Pharmacology & Pharmacy

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OBJECTIVE: To review the literature and describe the pharmacologic, pharmacokinetic, and pharmacodynamic properties; clinical safety; and efficacy of dapagliflozin, a new drug currently under review by the Food and Drug Administration (FDA) for the treatment of type 2 diabetes. DATA SOURCES: A MEDLINE (1995-November 2011) and ClinicalTrials.gov search was conducted using the terms dapagliflozin, sodium-glucose cotransporter 2 inhibitor, and SGLT2 inhibitor. Reference citations from publications identified were also reviewed. STUDY SELECTION AND DATA EXTRACTION: All English-language studies, including abstracts, evaluating dapagliflozin use in humans were included in this review. DATA SYNTHESIS: Dapagliflozin is the first-in-class oral sodium-glucose cotransporter 2 (SGLT2) inhibitor that represents a new potential therapeutic option for the treatment of type 2 diabetes mellitus. Its mechanism of action is insulin- and insulin-sensitivity independent. Preliminary data suggest that dapagliflozin decreases hemoglobin A(1c), fasting plasma glucose, and postprandial plasma glucose, while also promoting weight loss. In Phase 1, 2, and 3 clinical trials, dapagliflozin has exhibited a safety and tolerability profile similar to that of placebo. CONCLUSIONS: Dapagliflozin is a novel oral antihyperglycemic agent that has demonstrated promise as monotherapy and as synergistic combination therapy with currently available agents in Phase 3 clinical trials. On January 19, 2012, the FDA issued a complete response letter to AstraZeneca and Bristol-Myers Squibb regarding the new drug application for dapagliflozin. The FDA is requesting additional clinical data from ongoing studies and potentially new clinical trials-to better describe the risk-benefit profile of the drug. Both manufacturers remain committed to the development of dapagliflozin, and there are currently 8 Phase 3 trials ongoing. Dapagliflozin has the potential to be the next new oral agent in the diabetes drug armamentarium.

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The safety of sotagliflozin in the therapy of diabetes mellitus type 1 and type 2: A meta-analysis of randomized trials

Feifei Zhou, Nannan Du, Lulin Zhou, Chenxi Wang, He Ren, Qiang Sun

Summary: This meta-analysis demonstrates that sotagliflozin has an acceptable safety profile in patients with diabetes, with adverse events including genital mycotic infection, related-to-acidosis events, diarrhea, volume depletion, and severe nocturnal hypoglycemia events. The subgroup analysis of sotagliflozin dosage is of great clinical significance for guiding the use of sotagliflozin in patients with diabetes in the future.

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