FOSINOPRIL NATIONAL SURVEY: A POST‐MARKETING SURVEILLANCE STUDY OF FOSINOPRIL (STARILTM) IN GENERAL PRACTICE IN THE UK

Abstract

SUMMARYThis open, non‐comparative, PMS study of fosinopril (StarilTM) involved 12,067 hypertensive patients assessed at baseline and after two and six months of treatment; 10,791 patients provided evaluable data with 5.2 months average treatment totalling 4667 patient‐years. Adverse events were reported in 24% of patients, the most common being mild‐to‐moderate cough (6.05%). Events considered possibly related to fosinopril were reported in 15% of patients, the frequency being lower in younger patients, males and those receiving fosinopril monotherapy. Patient well‐being improved during the study. At the end of the study, most patients were taking fosinopril 10 mg once daily. Mean reductions in systolic and diastolic blood pressures were ‐11.0% and ‐11.7%, respectively; 71.3% of patients were ‘responders’. No important differences were observed between subgroups. This study found fosinopril to be effective, well tolerated in a broad range of hypertensive patients, and with no previously unrecognised adverse events reported.