Empagliflozin Reduces Blood Pressure in Patients With Type 2 Diabetes and Hypertension

• Published in: Diabetes care Vol. 38; no. 3; pp. 420 - 428
• Main Authors: Tikkanen, Ilkka, Narko, Kirsi, Zeller, Cordula, Green, Alexandra, Salsali, Afshin, Broedl, Uli C., Woerle, Hans J.
• Format: Journal Article
• Language: English
• Published: United States American Diabetes Association 01.03.2015
• Subjects: Analysis of Variance; Antihypertensive Agents - administration & dosage; Antihypertensive Agents - adverse effects; Benzhydryl Compounds - administration & dosage; Benzhydryl Compounds - adverse effects; Blood pressure; Blood Pressure - drug effects; Blood Pressure Monitoring, Ambulatory; Diabetes; Diabetes Mellitus, Type 2 - drug therapy; Diabetes Mellitus, Type 2 - physiopathology; Diabetic Angiopathies - drug therapy; Diabetic Angiopathies - physiopathology; Double-Blind Method; Drug Administration Schedule; Female; Glucosides - administration & dosage; Glucosides - adverse effects; Glycated Hemoglobin A - drug effects; Humans; Hypertension; Hypertension - drug therapy; Hypertension - physiopathology; Hypoglycemic Agents - administration & dosage; Hypoglycemic Agents - adverse effects; Male; Middle Aged; Patients; Placebo effect; Prescription drugs; Treatment Outcome; Weight Loss - drug effects
• ISSN: 0149-5992; 1935-5548; 1935-5548
• DOI: 10.2337/dc14-1096

To investigate the efficacy, safety, and tolerability of empagliflozin in patients with type 2 diabetes and hypertension. Patients (N = 825) with type 2 diabetes and hypertension (mean seated systolic blood pressure [SBP] 130-159 mmHg and diastolic blood pressure [DBP] 80-99 mmHg) were randomized (double blind) to 10 mg or 25 mg empagliflozin or placebo once daily for 12 weeks. At week 12, adjusted mean difference versus placebo in change from baseline in mean 24-h SBP (ambulatory blood pressure monitoring [ABPM]) was -3.44 mmHg (95% CI -4.78, -2.09) with 10 mg empagliflozin and -4.16 mmHg (-5.50, -2.83) with 25 mg empagliflozin (both P < 0.001). At week 12, adjusted mean difference versus placebo in change from baseline in mean 24-h DBP (ABPM) was -1.36 mmHg (95% CI -2.15, -0.56) with 10 mg empagliflozin and -1.72 mmHg (95% CI -2.51, -0.93) with 25 mg empagliflozin (both P < 0.001). Changes in office BP were consistent with ABPM. Adjusted mean difference versus placebo in change from baseline in HbA1c at week 12 was -0.62% (95% CI -0.72, -0.52) (-6.8 mmol/mol [95% CI -7.9, -5.7]) with 10 mg empagliflozin and -0.65% (95% CI -0.75, -0.55) (-7.1 mmol/mol [95% CI -8.2, -6.0]) with 25 mg empagliflozin (both P < 0.001). Empagliflozin was well tolerated. One patient on placebo and one patient on 10 mg empagliflozin reported events consistent with volume depletion. Empagliflozin was associated with significant and clinically meaningful reductions in BP and HbA1c versus placebo and was well tolerated in patients with type 2 diabetes and hypertension.