medwireNews: Empagliflozin significantly reduces glycated hemoglobin (HbA1c), blood pressure (BP), and bodyweight versus placebo in African–American patients with type 2 diabetes and hypertension, phase III trial data show.
Keith Ferdinand (Tulane University School of Medicine, New Orleans, Louisiana, USA) and colleagues say their findings indicate that “SGLT2 [sodium-glucose co-transporter 2] inhibitors in general, and empagliflozin in particular, are attractive choices” for the treatment of these patients, who have previously been “underrepresented in major hyperglycemia trials.”
The 24-week study included 150 African Americans (mean age 56.8 years, 53% men) with type 2 diabetes (mean duration 9.3 years) and hypertension who were randomly assigned to receive treatment with once-daily empagliflozin (10 mg for 4 weeks, followed by escalation to 25 mg until week 24; n=78) or placebo (n=72).
At the end of the treatment period, HbA1c had fallen by a mean 0.71% from a baseline of 8.66% among patients receiving empagliflozin and increased by 0.07% from a baseline of 8.51% among those receiving placebo. Relative to placebo, there was a significantly greater reduction in HbA1c of 0.78% with empagliflozin.
Patients receiving empagliflozin also had a placebo-corrected 1.23 kg reduction in bodyweight, with mean weight loss at 2.21 kg and 0.98 kg for empagliflozin and placebo, respectively, from baseline values of 105.05 kg and 101.35 kg, respectively.
Baseline mean 24-hour ambulatory systolic (S)BP was 146.8 mmHg in the empagliflozin group and 145.8 mmHg in the placebo group. By week 12 it had fallen to 140.2 mmHg with empagliflozin and 145.4 mmHg with placebo, and then further still, to 135.8 mmHg and 144.2 mmHg, respectively, by week 24. This gave significant placebo-corrected differences of 5.21 mmHg and 8.39 mmHg between the two groups at weeks 12 and 24, respectively.
The researchers point out that the “effect of empagliflozin was observed even though patients were already receiving at least one antihypertensive medication in addition to study treatment.”
Similar results were recorded for trough ambulatory and trough seated SBP, as well as for diastolic (D)BP, but the team notes that for DBP the outcomes were exploratory only.
Ferdinand and co-authors say that the increasing effect of empagliflozin on BP over time suggests that “the full BP effect may require several months of therapy to be fully manifested.”
They add that by week 24 the “the placebo-subtracted BP effect was similar to standard antihypertensive monotherapies.”
Writing in Circulation, the investigators note that their study is the “first placebo-controlled clinical trial of an SGLT2 inhibitor in an African American population with [type 2 diabetes] and hypertension,” and they conclude that it “supports the use of empagliflozin in these patients.
By Laura Cowen
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