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PEM report number 1. Nicardipine
Author(s) -
Inman William,
Kubota Kiyoshi,
Wilton Lynda,
Pearce Gillian
Publication year - 1993
Publication title -
pharmacoepidemiology and drug safety
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.023
H-Index - 96
eISSN - 1099-1557
pISSN - 1053-8569
DOI - 10.1002/pds.2630020404
Subject(s) - medicine , nicardipine , diltiazem , palpitations , anesthesia , adverse effect , tachycardia , heart rate , isradipine , amlodipine , dihydropyridine , blood pressure , calcium
Abstract Patients (10,910) who had been treated with nicardipine by 5952 general practitioners between November 1986 and May 1988 have been studied by Prescription–Event Monitoring (PEM) for a period of one year. The events recorded on green forms were compared with three other calcium antagonists. The most frequent daily dose was 60 mg (59%). Nitrates had been co‐prescribed for 31% of the patients, diuretics for 28% and beta‐blockers for 23%. The rates of events occurring during the first month of treatment with nicardipine were compared with the mean rates recorded during the second to sixth month of treatment with 32 other drugs, including amlodipine, isradipine and diltiazem. The comparison was restricted to those events which had been experienced by 10 or more patients during the first month of treatment (rates in excess of one per 1000). A ‘signal’ was noted when this rate exceeded the second to sixth month average rate by a factor of three or more. Strong signals were recorded for all the well known side‐effects of nicardipine which include flushing (the commonest side‐effect), palpitations, tachycardia, faintness, headache, dizziness and tremor. Acute rashes, which were identified as an adverse reaction in the diltiazem study, were not seen in excess with nicardipine and heart block, which had been a rare but an important effect of diltiazem, was seen in only two patients. Accepting the limitations of a study of roughly 10,000 patients, which would be virtually certain to detect any event with a true frequency greater than about one in 3000, we have found no serious problems during the course of this PEM study.