Post-marketing surveillance of enalapril: experience in 11,710 hypertensive patients in general practice.
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%).
Cooper
W D
WD
Sheldon
D
D
Brown
D
D
Kimber
G R
GR
Isitt
V L
VL
Currie
W J
WJ
D000293:Adolescent; D000328:Adult; D000368:Aged; D000799:Angioedema / Q000139:chemically induced; D003371:Cough / Q000139:chemically induced; D004656:Enalapril / Q000009:adverse effects / Q000627:therapeutic use*; D005069:Evaluation Studies as Topic; D005194:Family Practice; D005260:Female; D006801:Humans; D006973:Hypertension / Q000188:drug therapy*; D007022:Hypotension / Q000139:chemically induced; D008297:Male; D008875:Middle Aged; D011358:Product Surveillance, Postmarketing; D006113:United Kingdom
D004656:Enalapril