Purpose Ð A PEM study of nicorandil (Ikorel TM ) was undertaken to assess the drug's overall safety in everyday clinical practice.
Methods Ð 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 Ð 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 Ð the most frequent being headache (58; 0.4%) and unspeci®ed side eects (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 eective' (491; 3.6%). The number of patients still being prescribed nicorandil after 6 months was 74.3%. In those cases where an opinion on eectiveness was given, nicorandil was reported to be eective in 80% (8713) of patients.
The event of headache/migraine had the highest ID in the ®rst 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 eects included angioneurotic oedema and photosensitivity (3 cases each).
Conclusion Ð 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.