Lower Blood Pressure (BP) with Canagliflozin (CANA) in Subjects with Type 2 Diabetes Mellitus (T2DM)

s / Can J Diabetes 37 (2013) S2eS4 S3 Interdisciplinary Management of the Complex Patient IM1 ORAL PRESENTATION Lower Blood Pressure (BP) with Canagliflozin (CANA) in Subjects with Type 2 Diabetes Mellitus (T2DM) RICHARD E. GILBERT*, MATTHEW WEIR, ANDRZEJ JANUSZEWICZ, FERNANDO LAVALLE GONZALEZ, GARY MEININGER Toronto, ON; Baltimore, MD; Warsaw, Poland; Monterrey, Mexico; Raritan, NJ Purpose: To evaluate BP lowering with canagliflozin, an SGLT2 inhibitor. Methods: Pooled data (n1⁄44158) from 6 randomized, double-blind, placebo-controlled phase 3 studies in subjects with T2DM were analyzed. Results: Relative to placebo, canagliflozin 100 mg and 300 mg provided modest reductions in systolic BP (SBP [mean, 95%CI]: 3.3 [ 4.2, 2.4] and 4.5 [ 5.4, 3.6] mm Hg) and diastolic BP (DBP [mean,95% CI]; 1.5 [ 2.1, 1.0] and 1.9 [ 2.4, 1.3] mm Hg) in the overall populations, respectively. In subjects with SBP 140 mm Hg at entry (n1⁄41267), reductions in SBP were seen with both canagliflozin doses vs. placebo (p<0.001) ( 3.2 [ 5.1, 1.3] and 5.6 [ 7.4, 3.8] mm Hg) for canagliflozin 100 and 300 mg, respectively; the placebo-subtracted decrease was slightly larger with canagliflozin 300 mg than was seen in the overall population and similar with canagliflozin 100 mg. In subjects with DBP 90 mm Hg (n1⁄4355), a reduction in DBP was seen with canagliflozin 300 mg vs. placebo (p1⁄40.028); the placebo-subtracted decrease was modestly larger with canagliflozin 300 mg ( 2.3 [ 4.3, 0.2]) than was seen in the overall population, and smaller with canagliflozin 100 mg ( 0.5 [ 2.6,1.6]). Placebo-subtracted BP decreases were similar among subjects on antihypertensives and those not on these agents. Changes in heart rate were 0.6, 0.4 and 0.1 beats/min with canagliflozin 100 mg and 300 mg, and placebo, respectively. With canagliflozin’s glucoretic effect, a low incidence of osmotic diuresis adverse events was seen in phase 3 studies. Summary: When compared with placebo, canagliflozin reduced BP in subjects with T2DM. Table Summary of BP Changes at Primary Assessment Time Point (mITT, LOCF)