Once-daily eprosartan mesylate in the treatment of elderly patients with isolated systolic hypertension: data from a 13-week double-blind, placebo-controlled, parallel, multicenter study.

Abstract

This was a double-blind, randomized, placebo-controlled multicenter, titration-to-effect study of eprosartan in patients > or =60 years of age with isolated systolic hypertension. The study consisted of a 3 to 5-week placebo run-in period, a 13-week double-blind treatment period (6-week titration with eprosartan 600-1200 mg/day, 3-week maintenance, 4-week combination therapy with hydrochlorothiazide/HCTZ 12.5 mg), and a follow-up period within 5-7 days of last treatment dose. Overall, 283 patients (placebo/P: 135; eprosartan /E: 148) were randomized [female patients-P: 55.6%, E:54.7%; white-P:66.7%, E:67.6%). Mean sitting systolic blood pressure (SitSBP) at baseline was comparable (P: 170+/-0.8 mmHg; E: 171+/-0.8 mm Hg). At monotherapy end point, eprosartan produced a significant reduction in SitSBP (E: 16.1 mmHg vs P: 8.4 mmHg; P<0.0001). In all, 57.4% of patients responded to eprosartan monotherapy. Among nonresponders, the addition of HCTZ resulted in a decrease in SitSBP from baseline (E: 21.7 mmHg; P: 14.4 mmHg; P<0.002). Reductions were also noted in Standing SBP (monotherapy: P<0.001; combination therapy: P=0.03). No reductions in SitDBP >4 mmHg were found during the study. Age, gender, and race did not have any impact on the results. Post hoc analysis showed a reduction in pulse pressure from 87.3 to 78.2 mmHg with placebo and from 87.6 to 70.7 mmHg with eprosartan monotherapy. Treatment with eprosartan in once-daily doses up to 1200 mg alone or in combination with HCTZ was well tolerated, with dizziness and asthenia being the most common side effects.

• Authors: H A Punzi, C F Punzi
• Journal: Journal of human hypertension (J Hum Hypertens) Vol. 18 Issue 9 Pg. 655-61 (Sep 2004) ISSN: 0950-9240 [Print] England
• PMID: 15042114 (Publication Type: Clinical Trial, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Acrylates
• Angiotensin II Type 1 Receptor Blockers
• Antihypertensive Agents
• Imidazoles
• Sodium Chloride Symporter Inhibitors
• Thiophenes
• Hydrochlorothiazide
• eprosartan

Topics

• Acrylates (administration & dosage, adverse effects)
• Aged
• Aged, 80 and over
• Angiotensin II Type 1 Receptor Blockers (administration & dosage, adverse effects)
• Antihypertensive Agents (administration & dosage, adverse effects)
• Blood Pressure (drug effects)
• Double-Blind Method
• Drug Therapy, Combination
• Female
• Follow-Up Studies
• Heart Rate (drug effects)
• Humans
• Hydrochlorothiazide (administration & dosage, adverse effects)
• Hypertension (drug therapy, physiopathology)
• Imidazoles (administration & dosage, adverse effects)
• Male
• Middle Aged
• Sodium Chloride Symporter Inhibitors (administration & dosage, adverse effects)
• Thiophenes (administration & dosage, adverse effects)
• Treatment Outcome