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

Abstract

PURPOSE: A PEM study of nicorandil (Ikorel) 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.