Postmarketing surveillance of captopril for hypertension.

Abstract

1. A scheme for augmented spontaneous reporting of adverse drug events using advanced view data systems was developed and applied to study 67,698 consecutive patients prescribed captopril in general practice for the treatment of hypertension. 2. Captopril was an effective hypotensive agent in this population, as only 1.9% of patients were withdrawn because of apparent inefficacy. 3. Adverse effects of captopril resulted in withdrawal of treatment in 8.9% of recipients, and such effects were more frequent in elderly and female recipients. 4. Skin reactions‐usually maculopapular rashes‐tended to occur early during therapy whereas cough occurred much later and was reported more frequently in non‐smokers. 5. Some 1.1% of recipients died during follow‐up. There was no evidence of any unusual or unexpected causes of death which might be partially or totally captopril‐related in the study cohort. 6. The study confirms the feasibility of large scale postmarketing surveillance studied in general practice and allowed risk benefit assessments to be made on the use of captopril for treating hypertension.

Incidence of discontinuation of angiotensin-converting enzyme inhibitors due to cough, in a primary healthcare centre in Singapore

“…Our hypothesis that the incidence of discontinuation of ACE inhibitors due to cough is much higher in the local population than that reported in other studies (1)(2)(3)7,8) was confirmed in the present study, which showed that approximately 30% of the patients discontinued ACE inhibitors due to cough. In postmarketing studies, the incidence of cough was reported to be as low as 1%.…”

“…In postmarketing studies, the incidence of cough was reported to be as low as 1%. (7,8) In the Physicians' Desk Reference, the reported incidence of cough associated with enalapril is 1.3%. (1) In a prospective clinical trial, the incidence of ACE inhibitor-induced cough is reported to be 18.6%.…”

“…This incidence is much higher than that reported in previous studies. (1)(2)(3)7,8) Local physicians may consider using ARBs as a first-line medication, if clinically indicated.…”

“…(5) We hypothesise that the local incidence of ACE inhibitor discontinuation due to cough is higher than that reported in the Caucasian population. (7,8) We believe that the objective data derived from our study will aid local physicians in their selection of drugs for their patients. Appropriate counselling can also be given to patients initiated on ACE inhibitors.…”

“…(7,8) We believe that the objective data derived from our study will aid local physicians in their selection of drugs for their patients. Appropriate counselling can also be given to patients initiated on ACE inhibitors.…”