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 HbA_1c 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 HbA_1c versus placebo and was well tolerated in patients with type 2 diabetes and hypertension.