Effects of esaxerenone add-on therapy versus angiotensin II receptor blocker dose escalation on albuminuria and blood pressure in hypertensive patients with type 2 diabetes: An exploratory randomized study.

In 30 seconds

This 24-week, prospective, randomized, open-label, multicenter exploratory trial in Japan compared adding esaxerenone with increasing the angiotensin II receptor blocker (ARB) dose in hypertensive patients with type 2 diabetes and albuminuria despite standard-dose ARB therapy. Among 39 patients in the final analysis, esaxerenone add-on therapy achieved a greater reduction in urinary albumin-to-creatinine ratio: the adjusted between-group ratio was 0.71 (95% confidence interval, 0.58-0.87; p = 0.002). Blood pressure was also significantly lower with esaxerenone, but oxidative stress did not differ significantly between groups.

Key findings

• The adjusted between-group ratio for urinary albumin-to-creatinine ratio was 0.71 (95% confidence interval, 0.58-0.87; p = 0.002), favoring esaxerenone add-on therapy.
• Systolic and diastolic blood pressures were significantly lower with esaxerenone add-on therapy than with ARB dose escalation.
• Estimated glomerular filtration rate decreased more with esaxerenone; serum potassium did not differ significantly between groups.
• Diacron-reactive oxygen metabolites showed no significant between-group difference.

Why it matters

Residual albuminuria is a clinical challenge in people with type 2 diabetes and hypertension receiving renin-angiotensin system inhibition. This exploratory trial suggests that adding esaxerenone may reduce albuminuria and blood pressure more than increasing the ARB dose, while also highlighting a greater decline in estimated glomerular filtration rate and no demonstrated oxidative-stress benefit.

What to keep in mind

The trial was exploratory, open-label, and short-term, with 39 patients in the final analysis population; the findings may not establish longer-term effects.