Safety profile of nicorandil - Prescription-event monitoring (PEM) study

Purpose - A PEM study of nicorandil (Ikorel(TM)) was undertaken to assess t he drug's overall safety in everyday clinical practice. Methods - The prescription data used covered the period December 1994 to Oc tober 1996. The event data, which were based on a minimum observation perio d of 6 months, came from questionnaires returned by the prescribing general practitioners. Incidence densities (IDs) were calculated for all events oc curring during month 1, months 2-6, and the overall treatment period. Selec ted events were followed up. Results - The study was based on a cohort of 13 260 patients and 86 760 pat ient-months of nicorandil treatment. Major indications for use were angina (8744) and ischaemic heart disease (846). Adverse reactions (258) were repo rted 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 stoppi ng treatment (excluding those confounded by indication) were headache (477; 3.5%), dizziness (88; 0.65%) and 'not effective' (491; 3.6%). The number o f patients still being prescribed nicorandil after 6 months was 74.3%. In t hose cases where an opinion on effectiveness was given, nicorandil was repo rted to be effective in 80% (8713) of patients. The event of headache/migraine had the highest ID in the first month of tre atment (49.4 per 1000 patient-months) and was not confounded by indication. Follow-up of selected events was reassuring overall; rare side effects inc luded 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 reco mmended dosage. Copyright (C) 1999 John Wiley & Sons, Ltd.