PERINDOPRIL POSTMARKETING SURVEILLANCE - A 12 MONTH STUDY IN 47,351 HYPERTENSIVE PATIENTS

Aims To gain information on serious adverse events in a large number o f patients exposed to perindopril. Methods Four thousand seven hundred and eighty-eight general practitioners throughout France collaborated in the recruitment of 47 351 patients for a 12 month postmarketing st udy. Data collection was undertaken by company representatives under t he supervision of nine regional medical officers. Computerised data en try was performed by six pharmaceutical officers. Serious adverse even ts were later individually reviewed medically. Results Withdrawals due to adverse events occurred in 6.1% of female and 3.2% of males patien ts. The ascertainment of adverse events in this study approved satisfa ctory, 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 a dverse reactions-anaphylaxis and blood dyscrasias-were rare. Conclusio ns This study successfully followed a large cohort of patients treated with perindopril and failed to demonstrate any unexpected hazards.