POSTMARKETING SURVEILLANCE OF LISINOPRIL IN GENERAL-PRACTICE IN THE UK

A total of 4676 patients and 1759 patients were treated with lisinopri l and nifedipine respectively in a post-marketing surveillance study c onducted in general practice in the UK. Patients were followed up for 12 months. Most of the lisinopril patients had hypertension, but a sma ll number (180) had heart failure. Most of the nifedipine patients had uncomplicated hypertension, but some (22.57%) had other cardiovascula r disease with or without hypertension. Lisinopril and nifedipine were equally effective in reducing blood pressure. During the study, 1.5% of hypertensive patients assigned to lisinopril died compared with 1.8 % of patients assigned to nifedipine, and 15.1% of lisinopril patients compared with 19.7% of patients in the nifedipine group withdrew beca use of adverse events. Cough, malaise and fatigue, nausea and vomiting were more frequent causes of withdrawal from lisinopril than nifedipi ne. Conversely, headaches, pat[or and flushing, oedema and palpitation s caused more frequent withdrawals from nifedipine. Anaemia was more o ften encountered on nifedipine treatment than on lisinopril. In hypert ensive patients, the frequency of first-dose hypotension was similar o n both treatments. Serious events occurred in 0.8% and 0.5% of patient s given lisinopril and nifedipine respectively. Lisinopril was well to lerated by heart failure patients: 16 patients (8.88%) died and an inc idence of 4.44% of serious adverse events was reported, a pattern to b e anticipated in such patients; dizziness, giddiness, dyspnoea, cough, nausea and vomiting were the most frequent causes of withdrawal; the incidence of first-dose hypotension was low (2.22%). Overall, this sur vey found no adverse events not already recognised in controlled clini cal trials, and shows lisinopril to be an effective and well-tolerated treatment for hypertension and heart failure.