878-P: Effect of Finerenone on Resistant Hypertension in Type 2 Diabetes Mellitus—A Randomized Controlled Trial in Indian Population

Background: Mineralocorticoid Receptor Antagonists are effective for resistant hypertension. However data of effect of finerenone, a novel non-steroidal mineralocorticoid receptor anatagonist in Indian patients with T2DM & resistant hypertension is limited. We assessed the efficacy of finerenone in these subjects.

Research Design & Methods: This was a 16-week randomized controlled trial in 84 subjects presenting with resistant hypertension in specialized diabetes care unit in India. They were randomly assigned to treatment with a daily 10 mg of finerenone (n = 42) or to an alternative antihypertensive regimen (n = 42), on top of any ongoing regimen and prevailing lifestyle prescriptions. Finerenone dose was increased to 20 mg daily after 4 weeks after assessment of potassium level. All subjects were seen at 0 weeks, 2 weeks, 4 weeks and then once every 4 weeks. The primary outcome was change in office blood pressure (BP) during follow-up, and secondary outcomes were changes in serum potassium, sodium, & creatinine levels.

Results: Finerenone was associated with significant decrease in office systolic BP (-22 vs. -12 mmHg; p = 0.016), and in diastolic BP (-12 vs. -4 mmHg; p = 0.006). After 2 month, 78% patients in finerenone arm & 46% in alternative arm were controlled (BP < 130/80 mmHg), with significant office BP reduction from 154 ± 16/89 ± 11 to 129 ± 10/79 ± 8, vs. 156 ± 8/88 ± 8 to 142 ± 12/81 ± 10 mmHg in the alternative group. After 4 months an additional 6 % patients in finerenone arm & 5 % patients in alternative arm were controlled with further intensive lifestyle intervention.There was no significant variation in potassium, sodium & creatinine levels in both groups. Hyperkalemia was seen in 2 patients in each arm and could be managed without much concern.

Conclusion: Finerenone was effective in reducing BP to optimal levels in T2DM Indian patients with resistant hypertension & well tolerated and no significant concern of change in potassium level.