Key result
Post-marketing surveillance of 13,295 hypertensive patients confirmed the safety of captopril.
Why the study?
Does captopril demonstrate safety in hypertensive patients in a post-marketing surveillance setting?
Observational (n=13,295)
Does captopril demonstrate safety in hypertensive patients in a post-marketing surveillance setting?
Early post-marketing surveillance data using electronic data capture confirmed the safety of captopril in over 13,000 hypertensive patients.
Supports captopril safety in hypertension; leaves open need for randomized confirmation.
1 The methodology and interim results of a post marketing surveillance of captopril, the first orally active angiotensin converting enzyme inhibitor are presented. 2 Utilising viewdata technology, details of hypertensive patients were entered directly into a mainframe computer. This allowed day to day monitoring of events; a facility not available with paper-based methods. 3 The design of the study allowed analysis of results including some details of efficacy, concomitant therapy, any disease symptoms and reasons for withdrawal. These factors could be categorised according to sex and age. 4 This preliminary report is based on the first 13,295 patients entered from July 1983 with follow-up until January 1985. The results of the study confirm the safety of captopril in the patients studied.
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Chalmers et al. (1987) conducted an observational in hypertension (n=13,295). captopril was evaluated on safety. Post-marketing surveillance of 13,295 hypertensive patients confirmed the safety of captopril.
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