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

摘要

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.Electronic supplementary materialThe online version of this article (doi:10.1007/s13340-016-0283-x) contains supplementary material, which is available to authorized users.