Safety profile of nicorandil—prescription-event monitoring (PEM) study

Abstract

Purpose A PEM study of nicorandil (IkorelTM) was undertaken to assess the drug's overall safety in everyday clinical practice. Methods The prescription data used covered the period December 1994 to October 1996. The event data, which were based on a minimum observation period of 6 months, came from questionnaires returned by the prescribing general practitioners. Incidence densities (IDs) were calculated for all events occurring during month 1, months 2–6, and the overall treatment period. Selected events were followed up. Results The study was based on a cohort of 13 260 patients and 86 760 patient‐months of nicorandil treatment. Major indications for use were angina (8744) and ischaemic heart disease (846). Adverse reactions (258) were reported in 175 (1.3%) of patients—the most frequent being headache (58; 0.4%) and unspecified side effects (36; 0.3%). The most common reasons for stopping treatment (excluding those confounded by indication) were headache (477; 3.5%), dizziness (88; 0.65%) and ‘not effective’ (491; 3.6%). The number of patients still being prescribed nicorandil after 6 months was 74.3%. In those cases where an opinion on effectiveness was given, nicorandil was reported to be effective in 80% (8713) of patients. The event of headache/migraine had the highest ID in the first month of treatment (49.4 per 1000 patient‐months) and was not confounded by indication. Follow‐up of selected events was reassuring overall; rare side effects included angioneurotic oedema and photosensitivity (3 cases each). Conclusion This PEM study provides information on the ‘real‐world’ use of nicorandil and shows generally that the drug is safe when used in the recommended dosage. Copyright © 1999 John Wiley & Sons, Ltd.

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

“…In addition, there were no significant changes in the vital signs or ECG. The adverse reactions seen during the treatment with nicorandil were similar to those reported previously, 22,29 so it was evident that nicorandil has a sufficient safety profile in Chinese patients.…”

Use of nicorandil is associated with increased risk of incident atrial fibrillation

“…Several studies have assessed the efficacy and safety of nicorandil, but none have assessed cardiovascular risks associated with nicorandil use. In a previous cohort study, Dunn N and colleagues conducted a prescription-event monitoring (PEM) study of nicorandil to access the safety profile of nicorandil [ 13 ]. The study was based on a cohort of 13,260 patients, and ischemic heart diseases were the second most frequently reported events during nicorandil treatment, ranked by incidence density for each event during the first month of treatment per 1000 patient-months.…”

Nicorandil-Induced Hyperkalemia in a Uremic Patient

“…Arnold et al have evaluated hemodynamic dose response of nicorandil in 42 patients, and they reported three patients developed transient symptomatic hypotension and bradycardia [ 9 ]. In the Safety Profile of Nicorandil-Prescription-Event Monitoring (PEM) cohort study, only 6 possible cases of bradycardia were reported among 13,260 patients from December 1994 to October 1996 [ 10 ]. However, hyperkalemia was not mentioned in these previous studies.…”