Diabetologie und Stoffwechsel 2014; 9 - FV44
DOI: 10.1055/s-0034-1374901

Empagliflozin improves blood pressure in patients with type 2 diabetes (T2DM) and hypertension

I Tikkanen 1, K Narko 2, C Zeller 3, A Green 4, A Salsali 5, UC Broedl 5, HJ Woerle 5
  • 1Department of Medicine, Helsinki University Central Hospital, Minerva Institute for Medical Research, Helsinki, Finland
  • 2Boehringer Ingelheim Finland Ky, Helsinki, Finland
  • 3Boehringer Ingelheim Pharma GmbH & Co. KG, Biberach, Germany
  • 4inVentiv Health Clinical, Maidenhead, United Kingdom
  • 5Boehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim, Germany

Background, methods: Efficacy, safety and tolerability of empagliflozin (EMPA) were investigated in patients with T2DM and hypertension in a randomized, double-blind Phase III trial. Patients received EMPA 10 mg (n = 276), 25 mg (n = 276) or placebo (PBO; n = 272) qd for 12 weeks. Co-primary endpoints were changes from baseline in HbA1c and mean 24-hour systolic blood pressure (SBP) by ambulatory BP monitoring (ABPM) at week 12. Key secondary endpoint was change from baseline in mean 24-hour diastolic BP (DBP) at week 12. Other secondary endpoints included changes from baseline in office SBP and DBP and proportions of patients reaching controlled BP (< 130/80 mmHg) at week 12.

Results: Mean (SE) changes from baseline in HbA1c were +0.03 (0.04)% with PBO versus -0.59 (0.04)% and -0.62 (0.04)% with EMPA 10 mg and 25 mg, respectively, in 24-hour SBP were +0.48 (0.49) versus -2.95 (0.48) and -3.68 (0.48) mmHg, respectively, and in 24-hour DBP were +0.32 (0.29) versus -1.04 (0.28) and -1.40 (0.28) mmHg, respectively (all p < 0.001). Office SBP and DBP results were consistent with ABPM results. More patients receiving EMPA 10 mg and 25 mg with uncontrolled BP at baseline were controlled at week 12 vs. PBO (18% and 16% vs. 8%, respectively; p < 0.01). Adverse events were reported by 48.9%, 51.4%, and 52.6% of patients on EMPA 10 mg, 25 mg, and PBO, respectively. Volume depletion occurred in 0.4%, 0%, and 0.4% of patients on EMPA 10 mg, 25 mg or PBO, respectively.

Conclusion: EMPA led to significant and clinically meaningful reductions in BP, and was well tolerated in patients with T2DM and hypertension.