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

Abstract

Aims To gain information on serious adverse events in a large number of 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 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. Results 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. Conclusions This study successfully followed a large cohort of patients treated with perindopril and failed to demonstrate any unexpected hazards.

Telmisartan versus angiotension-converting enzyme inhibitors in the treatment of hypertension: a meta-analysis of randomized controlled trials

“…The incidence of cough in ACEIs treatment was 8.8% in 2043 patients, parallel to the findings of the post-marketing surveillance of over 47 000 patients in France, which revealed that 11.3% in women and 7.8% in men treated with perindopril had a cough. 48 Strengths and limitations of the meta-analysis In contrast to an earlier review that identified three studies, 49 we examined 28 clinical trials, using a wider range of clinically relevant outcome variables, and focused on direct comparison of treatments with telmisartan and ACEIs as monotherapy, precluding the interference of other drugs. To avoid the potential influence of differences in administration procedures, we performed separate meta-analyses on fixed dose or titration-to-response.…”

Antihypertensive efficacy of the ACE-inhibitor perindopril in the elderly

“…However, a number of the studies included in this review had either small sample sizes or reflected open studies without proper placebo-controls. For example, the ACE-inhibitor perindopril has been studied extensively in Europe and North America, is well toler-ated 6,7 and demonstrates consistent antihypertensive efficacy over a 24-h dosing interval. 8,9 However, the data on its use in the elderly population is limited to open studies only.…”

Perindopril: the evidence of its therapeutic impact in hypertension

“…A large, open-label, postmarketing surveillance study in France involving patients with hypertension (DBP 95-114 mmHg) treated with perindopril (2, 4, or 8 mg/day) showed that blood pressure reduction was maintained after 1 year of treatment (Speirs et al 1998 The efficacy of perindopril 4 and 8 mg has been evaluated in a large, 12-week, community-based, open-label study involving 13 220 patients with hypertension. All patients received perindopril 4 mg for the first 6 weeks; the dose was titrated to 8 mg after 6 weeks in inadequately responsive patients.…”

“…In a 12-month postmarketing survey involving 42 245 evaluable patients (92% of the original cohort) treated with perindopril 2-8 mg/day for 12 months, the most common spontaneously reported clinical event was cough, in 9.6% (Speirs et al 1998). …”