Double-Blind, Multicenter, Active-Controlled, Randomized Clinical Trial to Assess the Safety and Efficacy of Orally Administered Nicorandil in Patients With Stable Angina Pectoris in China

Abstract

Background The efficacy and safety of nicorandil were evaluated in Chinese patients with stable angina pectoris (AP) in a double-blind, multicenter, active-controlled, randomized clinical trial. Methods and ResultsAfter a 2-week washout period, 232 patients with stable AP were randomized to receive either nicorandil (5 mg tid; 115 patients) or isosorbide mononitrate (ISMN: 20 mg bid; 117 patients) for 2 weeks. Exercise capacity, number of weekly anginal attacks, nitroglycerin (NTG) consumption, and safety were evaluated. Nicorandil and ISMN significantly prolonged the time to 1 mm ST-segment depression in an exercise tolerance test. Both drugs improved the total exercise time and the time to onset of chest pain. There was no significant difference between the 2 groups. Nicorandil significantly decreased the number of anginal attacks and NTG consumption. ISMN decreased the number of anginal attacks significantly; however, there was no significance in NTG consumption, and the ratio of anginal attack reduction was at least 50% was significantly higher with nicorandil. Nicorandil was well tolerated and there was no safety profile difference compared with ISMN. Thus, nicorandil may have equivalent or better antianginal effect than ISMN. Conclusions Nicorandil is beneficial as treatment for AP. (Circ J 2007; 71: 826 -833)

Effect of Intra-Coronary Nicorandil Administration Prior to Reperfusion in Acute ST Segment Elevation Myocardial Infarction

“…22 In conclusion, administration of intracoronary nicorandil in ASTEMI patients undergoing PCI was safe, reduced the occurrence of no-reflow, slow reflow, and reperfusion arrhythmia, and improved the MPG and TIMI flow during PCI. Intracoronary nicorandil administration improved the clinical outcomes of patients with ASTEMI by preventing reperfusion injury, improving the microcirculation in the myocardium, ischemic preconditioning and suppressing the development of ventricular arrhythmia.…”

Nicorandil, Gastrointestinal Adverse Drug Reactions and Ulcerations: A Systematic Review

“…Gastralgia and nausea only were reported by 10 patients (5.1%) during a one-year period of exposure to nicorandil [25]. In a multi-centre randomised parallel trial, where 57 participants were randomised to nicorandil, no gastrointestinal events were witnessed [26]; no significant reactions were noted in similar studies comparing nicorandil with other calcium channel blockers [27], isosorbide 5-mononitrate, isosorbide dinitrite [28][29][30][31] or-blockers [32][33][34][35][36] or when nicorandil was added to a baseline therapy in settings of unstable angina [37] or acute myocardial infarction [38][39][40][41][42][43].…”

Reduction of isoproterenol-induced cardiac hypertrophy and modulation of myocardial connexin43 by a KATP channel agonist

“…Clinical reports from Japan and Europe have shown that nicorandil has equivalent anti-angina effects to nitrates, calcium-channel blockers and β-blockers (28)(29)(30). A double-blind, multicenter, active-controlled, randomized clinical trial previously assessed the safety and efficacy of nicorandil in patients with stable angina pectoris (AP) in China, suggesting that nicorandil is an effective drug for AP (31). Numerous clinical and experimental studies in non-hypertrophied myocardium have demonstrated a protective effect of nicorandil against ischemic injury through activation of the potassium channel (32)(33)(34).…”