Ertugliflozin (ERTU), an SGLT2 inhibitor, improves glycemic control in adult patients (pts) with T2DM. Elderly pts with T2DM are underrepresented in clinical studies, often present with multiple co-morbidities and are more susceptible to adverse events (AEs). Pooled analyses based on 7 phase 3 studies from the VERTIS program evaluated the safety and efficacy of ERTU in subgroups of pts aged <65 and ≥65 years. Pts with T2DM received ERTU (5 or 15 mg ± sitagliptin [SITA] 100 mg) or control (placebo [PBO], glimepiride or SITA). Safety data were evaluated up to 104 weeks. Efficacy was assessed in a subset of 3 PBO-controlled studies at 26 weeks. Baseline (BL) characteristics were similar between pts aged <65 (n=3605) and ≥65 years (n=1254), with the exception of mean BL estimated glomerular filtration rates (90.2 mL/min/1.73 m2 in pts <65 and 71.4 mL/min/1.73 m2 in pts ≥65). The safety profile of ERTU was similar in both age groups, except for a higher incidence of volume depletion AEs with ERTU relative to control (2.4% vs. 1.1%) in pts ≥65. Excluding pts with BL moderate renal impairment, incidence of renal-related AEs was similar across groups in pts ≥65 (ERTU [0.6%] vs. control [0.8%]), suggesting age alone does not increase risk of renal-related AEs. In the 3 PBO-controlled studies, documented hypoglycemia (4.4% vs.6.0%) and severe hypoglycemia rates (0.4% vs. 0.4%) with ERTU were comparable in pts <65 and ≥65. Efficacy of ERTU by age group is shown in the Figure.
R.E. Pratley: Consultant; Self; Sanofi US. Other Relationship; Self; AstraZeneca, Eli Lilly and Company, GlaxoSmithKline plc., Janssen Global Services, LLC., Janssen Research & Development, Lexicon Pharmaceuticals, Inc., Ligand Pharmaceuticals, Inc., Merck Sharp & Dohme Corp., Mundipharma, Novo Nordisk Inc., Pfizer Inc., Sanofi, Takeda Development Center Americas, Inc. S. Dagogo-Jack: Board Member; Self; Jana Care Inc. Consultant; Self; Janssen Pharmaceuticals, Inc., Merck & Co., Inc., Sanofi-Aventis. Research Support; Self; AstraZeneca, Novo Nordisk Inc. Stock/Shareholder; Self; Dance Biopharm Holdings Inc. B. Charbonnel: Consultant; Self; AstraZeneca, Merck Sharp & Dohme Corp., Novo Nordisk A/S, Sanofi, Servier. Speaker's Bureau; Self; AstraZeneca, Eli Lilly and Company, Merck Sharp & Dohme Corp., Novo Nordisk A/S, Sanofi, Takeda Pharmaceutical Company Limited. S.M. Patel: Stock/Shareholder; Spouse/Partner; Janssen Pharmaceuticals, Inc. Stock/Shareholder; Self; Merck & Co., Inc. M.A. Hickman: Employee; Self; Pfizer Inc. J. Liu: Employee; Self; Merck & Co., Inc. L. Tarasenko: Employee; Self; Pfizer Inc. M.C. Ellison: Employee; Self; Merck & Co., Inc. I. Gantz: Employee; Self; Merck & Co., Inc. S.G. Terra: Employee; Self; Pfizer Inc.
Merck Sharp & Dohme Corp; Pfizer Inc.
