Jardiance shows positive outcomes in African American adults. It reduces the A1c by 0.8%, body weight by 2.7 pounds and more interestingly the systolic blood pressure by 8 mmHg, similar to a standard blood pressure medication.
A group of 150 African American participants were randomized to receive Jardiance 25 mg daily or placebo for 6-months.
The SGLT2 inhibitor would be a great choice for patients with concomitant hyperglycemia and systolic hypertension.
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Circulation
Randomized
February 2019
Background
Empagliflozin, a sodium-glucose co-transporter 2 (SGLT2) inhibitor indicated for type 2 diabetes (T2D), can lower blood pressure (BP) and reduce cardiovascular mortality in patients with T2D and pre-existing cardiovascular disease. Its effects in African Americans have been understudied.
Methods
In this 24-week study, 150 African Americans with T2D and hypertension had hemoglobin A1c (HbA1c; primary endpoint), office and 24-hour ambulatory BP, body weight, and safety assessments.
After a 2-week, open-label, placebo run-in, patients were randomized to once-daily empagliflozin (10 mg for the first 4 weeks, then force-titrated to 25 mg until Week 24) or placebo. A mixed effect model for repeated measures was performed on the primary and two key secondary endpoints and analysis of covariance for non-repeated measures with last observation carried forward was performed for two other key secondary endpoints. Hierarchical testing was applied for these endpoints.
Results
Overall, 52.7% of participants were male, mean age 56.8 years; mean duration of T2D, 9.3 years. Baseline values of key parameters: HbA1c 8.59%; ambulatory SBP 146.3 mmHg; ambulatory diastolic BP 89.4 mmHg.
- By Week 24, the adjusted mean change in HbA1c in the empagliflozin group was -0.77 compared with an increase of +0.07 in the placebo group; placebo-corrected difference, -0.78% (p=0.0002).
- Reductions in body weight by Week 24 were -2.38 empagliflozin and -0.80 placebo; placebo-corrected difference, -1.23 kg (p=0.0382).
- Empagliflozin significantly reduced 24-hour ambulatory SBP versus placebo by Weeks 12 and 24 (placebo-corrected difference, -5.21 mmHg [p=0.0117] and -8.39 mmHg [95% CI, -13.74, -3.04; p=0.0025], respectively). DBP was also reduced.
Conclusions
In African Americans with T2D, empagliflozin reduced HbA1c, body weight, and BP. The effect of empagliflozin on BP increased from 12 to 24 weeks, suggesting a full antihypertensive effect takes ≥6 months to be fully realized. At Week 24, the placebo-subtracted BP effect was similar to standard antihypertensive monotherapies, suggesting empagliflozin may be beneficial for this high-risk population.
