Efficacy of oral nicorandil in patients with end-stage renal disease: a retrospective chart review after coronary angioplasty in Japanese patients receiving hemodialysis.

BACKGROUND: Patients receiving hemodialysis for end-stage renal disease (ESRD) are at high risk for death from ischemic heart disease (IHD). Nicorandil, a hybrid compound of adenosine triphosphate-sensitive potassium channel opener and nitric oxide donor, has been reported to improve the clinical prognosis of patients with IHD.

OBJECTIVE: This study sought to investigate the efficacy of oral nicorandil in reducing the risks for cardiovascular events (CVEs) and CVE-related death in patients receiving hemodialysis for ESRD after undergoing percutaneous coronary intervention (PCI) for angina pectoris.

METHODS: For this retrospective chart review, we used data from telephone interviews and medical charts from 3 hospitals in Japan. Data from patients aged <80 years who were receiving hemodialysis for ESRD and who had undergone successful PCI for angina between January 1999 and December 2004 were included in the analysis. Patients were stratified based on status of nicorandil treatment before PCI, as follows: patients receiving nicorandil 5 mg PO TID (the recommended dosage in Japan) for >1 month before PCI (nicorandil group) or those who did not receive nicorandil (control group). We investigated 6-year follow-up data on the primary end point, defined as CVEs (ie, unplanned hospital admission for worsening anginal status, or CVE-related death). The secondary end point was CVE-related death. After the data were initially analyzed, we performed a propensity-matched analysis to minimize selection bias.

RESULTS: Data from 356 patients were included in the study (235 men, 121 women; mean [SD] age, 69 [9] years; mean [SD] weight, 52.3 [9.1] kg; nicorandil group, 198 patients; control group, 158 patients). According to the estimated propensity scores, 107 patients from each group were matched. There were no differences between the 2 groups in the baseline characteristics. On propensity-matched patient analysis, the estimated rates of patients who were CVE-free at 6 years were 33.5% in the nicorandil group and 21.8% in the control group on Kaplan-Meier analysis (hazard ratio [HR] = 0.53; 95% CI, 0.36-0.78; P < 0.002), and the rates of 6-year survival (ie, patients who did not experience CVE-related death) were 92.7% in the nicorandil group and 85.8% in the control group (HR = 0.27; 95% CI, 0.07-0.89; P = 0.047). Cox multivariate analysis found that nico-randil treatment status was an independent predictor of CVEs (HR = 0.40; 95% CI, 0.18-0.91; P = 0.028) and CVE-related death (HR = 0.38; 95% CI, 0.14-0.78; P = 0.030).

CONCLUSION: Results obtained in this retrospective study suggest the potential efficacy of nicorandil treatment in improving clinical outcomes in patients with IHD receiving hemodialysis following PCI.