Skip to main content
PMC home page
The BMJ logoLink to The BMJ
. 1988 Oct 1;297(6652):826–829. doi: 10.1136/bmj.297.6652.826

Postmarketing surveillance of enalapril. I: Results of prescription-event monitoring.

W H Inman 1, N S Rawson 1, L V Wilton 1, G L Pearce 1, C J Speirs 1
PMCID: PMC1834580  PMID: 2846101

Abstract

To identify and measure the incidence of adverse effects of the angiotensin converting enzyme inhibitor enalapril 13,713 patients were studied for one year by prescription-event monitoring. Precise information about the duration of treatment was available for 12,543 patients. The frequency of many events was calculated, including dizziness (483 patients; 3.9%), persistent dry cough (360; 2.9%), headache (310; 2.5%) hypotension (218; 1.7%), and syncope (155; 1.2%). Less common reactions included angioedema, urticaria, and muscle cramps. Altogether 1098 (8%) patients died and the notes of 913 of them (83%) were obtained for detailed scrutiny. With the exception of a few patients with renal failure who deteriorated during treatment (reported on separately), no death was attributed to enalapril. Enalapril was considered to be effective, even in patients with advanced cardiac failure. These results for enalapril are reassuring and provide further evidence of the value of prescription-event monitoring.

Full text

PDF
827

Selected References

These references are in PubMed. This may not be the complete list of references from this article.

  1. Cooper W. D., Sheldon D., Brown D., Kimber G. R., Isitt V. L., Currie W. J. Post-marketing surveillance of enalapril: experience in 11,710 hypertensive patients in general practice. J R Coll Gen Pract. 1987 Aug;37(301):346–349. [PMC free article] [PubMed] [Google Scholar]
  2. Coulter D. M., Edwards I. R. Cough associated with captopril and enalapril. Br Med J (Clin Res Ed) 1987 Jun 13;294(6586):1521–1523. doi: 10.1136/bmj.294.6586.1521. [DOI] [PMC free article] [PubMed] [Google Scholar]
  3. DiBianco R. Adverse reactions with angiotensin converting enzyme (ACE) inhibitors. Med Toxicol. 1986 Mar-Apr;1(2):122–141. doi: 10.1007/BF03259832. [DOI] [PubMed] [Google Scholar]
  4. Edwards I. R., Coulter D. M., Beasley D. M., MacIntosh D. Captopril: 4 years of post marketing surveillance of all patients in New Zealand. Br J Clin Pharmacol. 1987 May;23(5):529–536. doi: 10.1111/j.1365-2125.1987.tb03088.x. [DOI] [PMC free article] [PubMed] [Google Scholar]
  5. Frohlich E. D., Cooper R. A., Lewis E. J. Review of the overall experience of captopril in hypertension. Arch Intern Med. 1984 Jul;144(7):1441–1444. [PubMed] [Google Scholar]
  6. Inman W. H. Enalapril-induced cough. Lancet. 1986 Nov 22;2(8517):1218–1218. doi: 10.1016/s0140-6736(86)92223-3. [DOI] [PubMed] [Google Scholar]
  7. Irvin J. D., Viau J. M. Safety profiles of the angiotensin converting enzyme inhibitors captopril and enalapril. Am J Med. 1986 Oct 31;81(4C):46–50. doi: 10.1016/0002-9343(86)90945-9. [DOI] [PubMed] [Google Scholar]
  8. Jenkins A. C., Dreslinski G. R., Tadros S. S., Groel J. T., Fand R., Herczeg S. A. Captopril in hypertension; seven years later. J Cardiovasc Pharmacol. 1985;7 (Suppl 1):S96–101. [PubMed] [Google Scholar]
  9. Speirs C. J., Dollery C. T., Inman W. H., Rawson N. S., Wilton L. V. Postmarketing surveillance of enalapril. II: Investigation of the potential role of enalapril in deaths with renal failure. BMJ. 1988 Oct 1;297(6652):830–832. doi: 10.1136/bmj.297.6652.830. [DOI] [PMC free article] [PubMed] [Google Scholar]

Articles from BMJ : British Medical Journal are provided here courtesy of BMJ Publishing Group

RESOURCES