TY - JOUR T1 - Post-marketing surveillance of enalapril: experience in 11 710 hypertensive patients in general practice JF - The Journal of the Royal College of General Practitioners JO - J R Coll Gen Pract SP - 346 LP - 349 VL - 37 IS - 301 AU - Warren D. Cooper AU - David Sheldon AU - Derek Brown AU - Graham R. Kimber AU - Valerie L. Isitt AU - William J.C. Currie Y1 - 1987/08/01 UR - http://bjgp.org/content/37/301/346.abstract N2 - Post-marketing surveillance in general practice represents an important part of the monitoring of adverse events associated with newly introduced drugs. Such a study of the angiotensin-converting enzyme inhibitor enalapril maleate has been undertaken in 11 710 patients with essential hypertension. Serious adverse events occurred in 1.7% of patients, though most of these were not thought to be related to the treatment. The incidence rates of death (0.09%), stroke (0.11%) and myocardial infarction (0.15%) were compatible with rates predicted from age, sex and blood pressure considerations. Other events reported were hypotension (0.3%), angioneurotic oedema (0.03%), rash (0.5%), taste disturbance (0.2%) and cough (1.0%). The degree of blood pressure reduction attained was similar to that previously reported from pre-marketing development studies, as was the overall nature and frequency of both serious and non-serious adverse events. The most frequently reported event during enalapril therapy was of an improvement in well-being (19.8%). ER -