Perindopril postmarketing surveillance: a 12 month study in 47,351 hypertensive patients

To gain information on serious adverse events in a large number of patients exposed to perindopril.

Four thousand seven hundred and eighty-eight general practitioners throughout France collaborated in the recruitment of 47,351 patients for a 12 month postmarketing study. Data collection was undertaken by company representatives under the supervision of nine regional medical officers. Computerised data entry was performed by six pharmaceutical officers. Serious adverse events were later individually reviewed medically.

Withdrawals due to adverse events occurred in 6.1% of female and 3.2% of males patients. The ascertainment of adverse events in this study approved satisfactory, as shown by the reported incidence of cough, which was 11.3% in women and 7.8% in men, this being compatible with the best estimates of the true incidence of cough during ACE-inhibitor therapy. Serious adverse reactions-anaphylaxis and blood dyscrasias-were rare.

This study successfully followed a large cohort of patients treated with perindopril and failed to demonstrate any unexpected hazards.