Effects of ipragliflozin, a selective sodium-glucose co-transporter 2 inhibitor, on blood pressure in Japanese patients with type 2 diabetes mellitus: a pooled analysis of six randomized, placebo-controlled clinical trials.

Our aim was to examine the effects of ipragliflozin, a selective sodium-glucose co-transporter 2 inhibitor, on blood pressure in Japanese patients with type 2 diabetes mellitus (T2DM). We conducted a pooled analysis of double-blind trials of Japanese T2DM patients, randomized to 50 mg ipragliflozin or placebo, with patient-level data for the change in systolic blood pressure (SBP) and diastolic blood pressure (DBP) from baseline to end of treatment (12-24 weeks). Data from six trials were analyzed: ipragliflozin was administered as monotherapy in two; in combination with metformin, pioglitazone, or sulfonylurea in one each; and in combination with prior therapy in patients with renal impairment in one. Overall, 628 and 368 patients were treated with ipragliflozin and placebo, respectively. The placebo-adjusted mean changes (95 % confidence interval) in SBP and DBP (mmHg) were -2.8 (-4.4, -1.3, P < 0.001) and -1.6 (-2.7, -0.6, P < 0.002), respectively, in all patients. The reductions in SBP and DBP were significantly greater in patients with baseline SBP ≥140 mmHg [-5.5 (-9.1, -1.8) and -2.9 (-5.3, -0.5), respectively] than in patients with SBP <140 mmHg [-2.1 (-3.8, -0.4) and -1.3 (-2.5, -0.1), respectively]. The reductions in SBP and DBP were also significantly greater in the ipragliflozin group than in the placebo group in patients treated with [-2.8 (-5.1, -0.4) and -2.4 (-4.0, -0.8), respectively] or without [-3.0 (-5.0, -1.0) and -1.0 (-2.4, 0.4), respectively] concomitant antihypertensive therapy. In conclusion, this pooled analysis showed that ipragliflozin was associated with significant reductions in SBP and DBP compared with placebo.

RCT Entities:   Population Interventions Outcomes