Safety of Ertugliflozin in Patients with Type 2 Diabetes Mellitus: Pooled Analysis of Seven Phase 3 Randomized Controlled Trials

• Published in: Diabetes therapy 2020-06, Vol.11 (6), p.1347-1367
• Main Authors: Patel, Shrita, Hickman, Anne, Frederich, Robert, Johnson, Susan, Huyck, Susan, Mancuso, James P., Gantz, Ira, Terra, Steven G.
• Format: Article
• Language: English
• Subjects: Cardiology; Care and treatment; Complications and side effects; Diabetes; Diabetic acidosis; Diabetic ketoacidosis; Diagnosis; Drug therapy; Endocrinology; Gangrene; Hypoglycemia; Inhibitor drugs; Insulin; Internal Medicine; Ketoacidosis; Medicine; Medicine & Public Health; Original Research; Risk factors; Type 2 diabetes; Urinary tract infections
• ISSN: 1869-6953; 1869-6961
• DOI: 10.1007/s13300-020-00803-3

Introduction The sodium-glucose cotransporter 2 (SGLT2) inhibitor ertugliflozin is approved for the treatment of adults with type 2 diabetes mellitus (T2DM). This analysis was conducted on safety data pooled from phase 3 studies using ertugliflozin 5 mg or 15 mg versus placebo or an active comparator. Methods The placebo pool ( n  = 1544) comprised data from three similarly designed 26-week placebo-controlled studies. The broad pool ( n  = 4849) comprised these three placebo-controlled studies plus four placebo- or active-controlled studies with treatment durations of up to 104 weeks. Results In the placebo pool, there were no notable differences across groups in the incidence of adverse events (AEs), serious AEs, or AEs resulting in discontinuation from study medication, while associations were observed with genital mycotic infection in both females (3.0%, 9.1%, and 12.2% in the placebo, ertugliflozin 5 mg, and ertugliflozin 15 mg groups, respectively) and males (0.4%, 3.7%, 4.2%), thirst (0.2%, 1.3%, 1.0%), and increased urination (1.0%, 2.7%, 2.4%). In the broad pool, volume depletion was increased with ertugliflozin in patients with estimated glomerular filtration rate