Abstract 12482: Efficacy and Safety of Canagliflozin in Patients With Type 2 Diabetes Based on History of Cardiovascular Disease or Cardiovascular Risk Factors

Abstract

Introduction: Treatment of patients with type 2 diabetes mellitus (T2DM) and a history of cardiovascular (CV) disease or CV risk factors may present clinical challenges due to the presence of comorbid conditions and use of concomitant medications. Canagliflozin (CANA), an SGLT2 inhibitor, has been shown to improve glycemic control, body weight, and blood pressure (BP) with a favorable tolerability profile in a broad range of patients with T2DM. This post hoc analysis assessed the efficacy and safety of CANA in patients with T2DM based on CV disease history/risk factors. Methods: These analyses were based on pooled data from four 26-week, placebo (PBO)-controlled, Phase 3 studies that evaluated CANA 100 and 300 mg in patients with T2DM (N = 2313; mean A1C, 8.0%; body weight, 89 kg; systolic BP [SBP], 128 mmHg). Changes from baseline in A1C, body weight, and SBP at Week 26 were assessed in subgroups of patients based on history of CV disease (Y/N), history of hypertension (Y/N), baseline statin use (Y/N), and number of CV risk factors (0/1 vs ≥2). Safety was based on adverse event (AE) reports. Results: CANA 100 and 300 mg lowered A1C, body weight, and SBP versus PBO in patients with or without CV disease history/risk factors ( Table ). At Week 26, A1C reductions with CANA 100 and 300 mg relative to PBO were generally similar in patients with history of CV disease (–0.95% and –1.07%) versus no CV disease (–0.71% and –0.90%), history of hypertension (–0.72% and –0.89%) versus no hypertension (–0.73% and –0.95%), baseline statin use (–0.77% and –0.99%) versus no statin use (–0.69% and –0.85%), and ≥2 CV risk factors (–0.74% and –1.02%) versus 0/1 CV risk factor (–0.72% and –0.87%). Similar body weight and SBP reductions were also seen with CANA versus PBO across subgroups. Incidence of AEs, AEs leading to discontinuation, and serious AEs was similar across subgroups. Conclusions: CANA was efficacious and generally well tolerated in patients with T2DM regardless of CV disease history/risk factors.