Objective: To evaluate the effectiveness and safety of perindopril in a subgroup of 3010 elderly (≥65 years) hypertensive patients, who participated in a large US general practice-based community trial. Methods: All patients received open-label perindopril 4mg once a day for 6 weeks. After 6 weeks the dosage was either maintained (group I) or increased to 8 mg/day (group II) based on the physician's assessment of blood pressure (BP) response. Patients were then followed for another 6 weeks for a total study duration of 12 weeks. Results: Demographic and baseline clinical characteristics revealed a higher proportion of women, longer duration of hypertension and higher baseline systolic BP (SBP) among elderly than young (<65 years, n = 7332) hypertensive patients. A clinically relevant BP reduction of similar magnitude was obtained in elderly and young patients with perindopril monotherapy. At week 12, the mean reduction in BP from baseline was 18.4/8.7mm Hg in the elderly and 17.5/11.3mm Hg in the young. Elderly patients with hypertension not responding adequately to the 4 mg/day dosage at week 6 had a BP reduction of 6.3/3.6mm Hg (group II). Up-titration to an 8 mg/day dosage for another 6 weeks gave an additional 8.9/3.5mm Hg reduction resulting in a total reduction of 15.2 / 7.1 mm Hg from baseline. A similar magnitude of increase in response to up-titration of perindopril was seen in young patients. BP control (<140/90mm Hg) on perindopril monotherapy was achieved in 41.4% of elderly and 51.9% of young patients. In both age groups, up-titration to an 8.0 mg/day dosage in group II patients increased BP control by approximately 5-fold at week 12 (28.2% in the elderly and 36.4% in the young). A similar increased response on BP reduction and BP control (<140/90mm Hg) with up-titration was seen in elderly subgroups of African American and diabetic patients. The 7th Report of the Joint National Committee on Prevention, Detection, Evaluation and Treatment of High Blood Pressure recommended target goal of <130/ 80mm Hg was achieved with perindopril monotherapy in 15.6% of hypertensive diabetic patients. Perindopril reduced BP effectively and safely in very elderly (≥75 years) hypertensive patients. Perindopril was well tolerated in elderly patients including high-risk groups. The incidence of cough (7-10%), the most common symptom, was similar in all age groups. The low incidence of postural hypotension (≤0.2%) observed in the elderly and very elderly further supports the good tolerance and safety profile of the drug. Data analysis from this study suggests that community physicians, in general, are less aggressive in controlling BP in the elderly and more inclined to treat or control diastolic BP than SBP. Conclusion: Perindopril treatment is effective and well tolerated in elderly patients with hypertension.
Bibliographical noteFunding Information:
The authors gratefully acknowledge the contributions of physicians who participated in this community trial. We also thank Sherrill Martin for administrative support in preparing the manuscript. The study was sponsored by Solvay Pharmaceuticals Inc. All Solvay authors are full-time employees in Clinical Operations and Medical Affairs. No honoraria were received by the academic authors toward the preparation of this study.