Efficacy and safety of nicorandil therapy in patients with acute heart failure.

BACKGROUND

Nicorandil is a vasodilator that both opens potassium channels and has nitrate effects. The administration of nitrate is the gold standard for the treatment of acute heart failure (AHF). However, there have been few reports regarding the usefulness of nicorandil for the treatment of AHF. Therefore, we evaluated the efficacy of intravenous administration of nicorandil in patients with AHF.

METHODS

A total of 31 AHF patients were enrolled, and randomized into either the nicorandil group (n=16) or control group (n=15). Nicorandil was started with a bolus injection of 100 μg/kg, and the continuous injection of 60-100 μg/kg/h within 30 min after admission, which continued for 5 days. There were no limitations in the treatment of AHF except for nicorandil use. B-type natriuretic peptide (BNP) and N-terminal-pro-BNP (NT-pro-BNP) were measured on admission (Day 1), Day 3, and Day 7.

RESULTS

BNP significantly decreased in the nicorandil group on Day 3 (502.4 ± 406.9 pg/ml) from Day 1 (1397.0 ± 1617.5 pg/ml), however, no significant decrease was observed in the control group. NT-pro-BNP tended to decrease on Day 3 (7316.7 ± 10,187.5 pg/ml, p=0.06) and significantly decreased on Day 7 (5702.9 ± 6468.8 pg/ml) from Day 1 (11,270.0 ± 12,388.5 pg/ml) in the nicorandil group, however there were no changes in the control group. When patients from nicorandil group were classified into a high systolic blood pressure (SBP) group (baseline SBP >140 mm Hg, n=10) and low SBP group (baseline SBP <140 mmHg, n=6), a significant decrease was observed in SBP from Day 1 to Day 3 in both groups.

CONCLUSIONS

Intravenous administration of nicorandil can decrease serum cardiac stress markers, and was shown to be effective in AHF patients. Furthermore, nicorandil improved the hemodynamics in the patients with high SBP, and the drug could be safely administered to AHF patients with low SBP.