Modulation of Dapagliflozin-Associated Genital Tract Infections by Saxagliptin—A Pooled Safety Analysis

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Incidence of genital tract infections (GTIs), a common adverse event during SGLT2 inhibitor therapy, may be modified by concomitant DPP-4 inhibitor treatment. We evaluated GTI incidence across randomized trials of dapagliflozin (DAPA) ± saxagliptin (SAXA) as add-on to metformin (MET). Safety data were pooled from seven randomized phase 3 trials; patients with type 2 diabetes (N=3134) receiving DAPA 5/10 mg, SAXA 5 mg or DAPA 5/10 mg + SAXA 5 mg as add-on to MET for 24-52 weeks were included. Data from patients with 52 weeks of follow-up across five of the studies were pooled separately (long-term [LT]-study pool; N=1719). In the 7-study pool, GTI incidence was lower with add-on DAPA 10 mg + SAXA 5 mg to MET vs. add-on of DAPA 10 mg alone (3.6% vs. 6.6%); the most common events in both groups were vulvovaginal mycotic infections (DAPA + SAXA, 1.5%; DAPA, 2.0%) and balanoposthitis (DAPA + SAXA, 0.9%; DAPA, 1.8%) (Table). This finding was confirmed in the individual studies with the exception of one study comparing GTI incidence with low-dose DAPA 5 mg + SAXA 5 mg (3.1%) vs. DAPA 5 mg (1.4%). With LT treatment, GTI incidence decreased over time with DAPA 10 mg + SAXA 5 mg and DAPA 10 mg (month 6, 3.1% and 5.3%; month 12, 0.9% and 2.1%). In conclusion, add-on of DAPA 10 mg + SAXA 5 mg to MET led to lower GTI incidence than with DAPA 10 mg alone; this effect was maintained after 12 months of treatment. Disclosure S. Del Prato: Advisory Panel; Self; AstraZeneca, Boehringer Ingelheim Pharmaceuticals, Inc., Eli Lilly and Company, GlaxoSmithKline plc., Intarcia Therapeutics, Inc., Merck & Co., Inc., Novartis Pharmaceuticals Corporation, Novo Nordisk A/S, Servier, Sanofi, Takeda Pharmaceuticals U.S.A., Inc.. Research Support; Self; Merck & Co., Inc., Novartis Pharmaceuticals Corporation, Boehringer Ingelheim Pharmaceuticals, Inc., AstraZeneca. Speaker's Bureau; Self; Boehringer Ingelheim Pharmaceuticals, Inc., Novartis Pharmaceuticals Corporation, Takeda Pharmaceuticals U.S.A., Inc.. Advisory Panel; Self; Janssen Biotech, Inc., Abbott. E.K. Johnsson: Employee; Self; AstraZeneca. R. Garcia-Sanchez: Employee; Self; AstraZeneca. C. Morgan: Employee; Self; AstraZeneca. P. Sartipy: Employee; Self; AstraZeneca. Stock/Shareholder; Self; AstraZeneca, Novo Nordisk A/S. R. Kurlyandskaya: Employee; Self; AstraZeneca. N. Iqbal: Employee; Self; AstraZeneca. C. Mathieu: Research Support; Self; Novo Nordisk A/S. Advisory Panel; Self; Novo Nordisk A/S. Speaker's Bureau; Self; Novo Nordisk A/S. Research Support; Self; Sanofi. Speaker's Bureau; Self; Sanofi. Advisory Panel; Self; Sanofi. Research Support; Self; Merck Sharp & Dohme Corp.. Speaker's Bureau; Self; Merck Sharp & Dohme Corp.. Advisory Panel; Self; Merck Sharp & Dohme Corp.. Research Support; Self; Eli Lilly and Company. Speaker's Bureau; Self; Eli Lilly and Company. Advisory Panel; Self; Eli Lilly and Company. Research Support; Self; Novartis AG. Speaker's Bureau; Self; Novartis AG. Advisory Panel; Self; Novartis AG, Bristol-Myers Squibb Company. Speaker's Bureau; Self; AstraZeneca. Advisory Panel; Self; AstraZeneca, Pfizer Inc., Janssen Pharmaceuticals, Inc., Boehringer Ingelheim GmbH. Speaker's Bureau; Self; Boehringer Ingelheim GmbH. Advisory Panel; Self; Hanmi Pharmaceutical. Research Support; Self; Roche Diagnostics Corporation. Advisory Panel; Self; Roche Diagnostics Corporation. Research Support; Self; Medtronic. Advisory Panel; Self; Medtronic, MannKind Corporation. Research Support; Self; Intrexon. Advisory Panel; Self; Intrexon, Dianax, UCB, Inc.. Research Support; Self; Abbott.

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