BP reduction with the sodium glucose co-transporter 2 inhibitor (SGLT-2i) empagliflozin (EMPA) in type 2 diabetes (T2D) is similar in treatment naïve as in those on one or ≥2 antihypertensive agents – further insights from a dedicated 24h ABPM study

Objective: EMPA is a new glucose-lowering agent of the SGLT2i class, which reduces body weight and also lowers BP. We assessed the EMPA-related BP lowering effect under background antihypertensive treatment.

Methods: This was a 12-week study involving 823 T2D patients (mean ± SD age 60.2 ± 9.0 years, HbA1c 7.9 ± 0.7%, office systolic (S)/diastolic (D) BP 142.1 ± 12.3/83.9 ± 7.0 mmHg, in the full analysis set). EMPA was given at 10 mg (n = 276) or 25 mg (n = 276) daily; 271 patients were randomized to placebo. Patients were under no (A), 1 (B) or ≥2 antihypertensive drugs (C) (n = 62, 353 and 408, respectively).

Results: HbA1c and weight were significantly reduced with EMPA 10 mg (mean [SE] -0.62% [0.05], -1.5 kg [0.2]) and EMPA 25 mg (-0.65 [0.05], -2.0 [0.2]) relative to placebo (all p < 0.001). Relative to placebo, EMPA reduced 24h mean SBP/DBP at the 10 mg dose (A: -3.9/-2.6 [both p = NS], B: -4.7/-2.0 [both p < 0.01], and C: -2.4 [p < 0.05]/-0.7 [p = NS] mmHg, respectively) and at the 25 mg dose (A: -3.8/-2.5 [both p = NS], B: -4.3/-1.8 [both p < 0.01], and C: -4.2/-1.5 [both p < 0.01] mmHg, respectively). There was no interaction between treatment and number of background antihypertensive drugs (p = 0.448 and p = 0.498 for changes from baseline in SBP and DBP, respectively).

Conclusion: EMPA reduces BP in patients with T2D regardless of whether they are untreated or more or less intensively treated for hypertension.