Achieving the composite endpoint of HbA1c, body weight, and systolic blood pressure reduction with canagliflozin in patients with type 2 diabetes.

OBJECTIVE: In addition to achieving glycemic control, weight loss and blood pressure (BP) reduction are important components of type 2 diabetes mellitus (T2DM) management, as many patients with T2DM are overweight/obese and/or have hypertension. Canagliflozin, an SGLT2 inhibitor, has demonstrated improvements in HbA1c, body weight (BW), and systolic BP across a broad range of patients with T2DM. This analysis evaluated achievement of composite endpoints of HbA1c, BW, and systolic BP targets with canagliflozin versus placebo. METHODS: This post hoc analysis evaluated the proportion of T2DM patients achieving the composite endpoint of HbA1c reduction ≥0.5%, BW reduction ≥3%, and systolic BP reduction ≥4mmHg with canagliflozin 100 and 300mg compared with placebo using pooled data from four 26-week, phase 3 studies (N = 2313; NCT01081834, NCT01106677, NCT01106625, NCT01106690). The proportion of patients achieving the composite endpoint of HbA1c <7.0%, BW reduction ≥3%, and BP <130/80 mmHg was also evaluated. RESULTS: At week 26, greater proportions of patients met individual HbA1c, BW, and systolic BP targets with canagliflozin versus placebo. A greater proportion of patients treated with canagliflozin 100 or 300 mg versus placebo also achieved the composite endpoint of HbA1c reduction ≥0.5%, BW reduction ≥3%, and systolic BP reduction ≥4 mmHg at week 26 (21.1%, 25.3%, and 5.7%, respectively; odds ratios [95% CI] of 4.5 [3.1, 6.5] and 5.6 [3.8, 8.2]). A greater proportion of patients also achieved the composite endpoint of HbA1c <7.0%, BW reduction ≥3%, and BP <130/80 mmHg with canagliflozin 100 and 300 mg versus placebo (14.7%, 20.9%, and 3.3%, respectively; odds ratios [95% CI] of 5.2 [3.2, 8.4] and 8.4 [5.2, 13.5]). Canagliflozin was generally well tolerated, with a safety profile similar to that seen in other phase 3 studies. CONCLUSIONS: Patients with T2DM were more likely to achieve clinically important reductions in HbA1c, BW, and systolic BP with canagliflozin versus placebo.

Real-world evaluation of Hba1c, blood pressure, and weight loss among patients with type 2 diabetes mellitus treated with canagliflozin: an analysis of electronic medical records from a network of hospitals in Florida.

OBJECTIVE: Clinical trials and real-world studies reported that canagliflozin (CANA) improved HbA1c, blood pressure (BP), and weight in patients with type 2 diabetes mellitus (T2DM). This study examines if previous results hold regionally and within specific patient sub-groups. METHODS: Adults with T2DM and ≥12 months of clinical activity before the first CANA prescription (index) were identified in electronic medical records (January 1, 2012-February 15, 2017) from a network of hospitals in Florida. Quality measures were described at baseline and 3, 6, 9, and 12 months post-index. Selected thresholds were HbA1c < 7%, BP < 140/90 mmHg, and weight loss ≥5%. Sub-groups included patients ≥65 years old, with African American race, with CANA dose increase, initiating CANA in an endocrinology setting, and initiating CANA in a primary care setting. RESULTS: Overall, 1,259 patients (mean age = 56.7 years; 51.2% female, 70.4% White) were identified. Among patients with a baseline HbA1c ≥ 7%, 16.1% had an HbA1c < 7% 3 months following CANA initiation, and the mean HbA1c decreased from 8.8% to 8.1%. Among patients with a baseline systolic BP ≥140 mmHg or diastolic BP ≥ 90 mmHg, 59.3% attained a systolic BP < 140 mmHg and 77.3% a diastolic BP < 90 mmHg after 3 months. HbA1c and BP responses were sustained through 12 months. The proportion of patients with a weight loss from baseline ≥5% increased from 17.0% at 3 months to 31.1% at 12 months. Consistent trends were observed for all sub-groups. CONCLUSIONS: In CANA-treated patients and patient sub-groups from a network of Florida hospitals, improvements in quality measures and response durability were similar to clinical trials and other real-world studies.