Antihypertensive efficacy and safety of olmesartan and ramipril in elderly patients with mild to moderate systolic and diastolic essential hypertension.

Abstract

OBJECTIVE:

To compare the efficacy and safety of olmesartan medoxomil (O) and ramipril (R) in elderly patients with essential arterial hypertension.

METHODS:

After a 2-week placebo washout, 351 elderly hypertensive patients aged 65-89 years (office sitting diastolic blood pressure, DBP, 90-109 mmHg and office sitting systolic blood pressure, SBP, 140-179 mmHg) were randomized double-blind to 12-week treatment with O 10 mg or R 2.5 mg once daily. After the first 2 and 6 weeks, doses could be doubled in non-normalized (blood pressure <140/90 mmHg for non-diabetic and <130/80 mmHg for diabetic) subjects, up to 40 mg for O and 10 mg for R. Office blood pressures were assessed at randomization, after 2, 6 and 12 weeks of treatment; 24-h ambulatory blood pressure (ABP) was recorded at randomization and after 12 weeks.

RESULTS:

At week 12, in the intention-to-treat population (170 patients O and 175 R) the rate of normalized subjects was significantly larger in the O group (38.8% vs 26.3% R; p = 0.013). Baseline-adjusted mean sitting office blood pressure reduction at final visit was not significantly greater under O [SBP: 16.6 (95% confidence interval 14.0/19.2) mmHg vs 13.0 (10.4/15.6) mmHg R, p = 0.206; DBP: 11.8 (10.3/13.3) mmHg vs 10.5 (9.0/12.0) mmHg, p = 0.351]. In the subgroup of patients with valid ABP recordings (38 O and 47 R), the reduction in 24-h average blood pressure was significantly (p < 0.01) larger with O [SBP: 8.9 (9.8/8.1) and DBP: 5.7 (6.3/5.1) mmHg] than with R [6.7 (7.9/5.6) and 4.4 (5.1/3.7) mmHg]. The superiority of O was particularly evident in the last 4 h from the dosing interval. The proportion of patients with drug-related adverse events was comparable in the two groups (4.0% O vs 4.5% R), as well as the number of patients discontinuing study drug because of a side-effect (8 O vs 7 R).

CONCLUSIONS:

In elderly patients with essential arterial hypertension, O provides an effective, prolonged and well tolerated blood pressure control, with significantly better blood pressure normalization than R and represents a useful option among first-line drug treatments of hypertension in this age group.

• Authors: Jean-Michel Mallion, Stefano Omboni, John Barton, Walter Van Mieghem, Krzysztof Narkiewicz, Peter-Klaus Panzer, Juan García Puig, Christodoulos Stefanadis, Robert Zweiker, Study Group
• Journal: Blood pressure. Supplement (Blood Press Suppl) Vol. 1 Pg. 3-11 (Apr 2011) ISSN: 0803-8023 [Print] Sweden
• PMID: 21091270 (Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Angiotensin II Type 1 Receptor Blockers
• Angiotensin-Converting Enzyme Inhibitors
• Antihypertensive Agents
• Imidazoles
• Tetrazoles
• Olmesartan Medoxomil
• Ramipril

Topics

• Aged
• Aged, 80 and over
• Angiotensin II Type 1 Receptor Blockers (therapeutic use)
• Angiotensin-Converting Enzyme Inhibitors (therapeutic use)
• Antihypertensive Agents (administration & dosage, adverse effects, therapeutic use)
• Blood Pressure (drug effects)
• Blood Pressure Determination
• Blood Pressure Monitoring, Ambulatory
• Diastole (drug effects)
• Double-Blind Method
• Female
• Humans
• Hypertension (drug therapy, physiopathology)
• Imidazoles (administration & dosage, adverse effects, therapeutic use)
• Male
• Olmesartan Medoxomil
• Ramipril (administration & dosage, adverse effects, therapeutic use)
• Systole (drug effects)
• Tetrazoles (administration & dosage, adverse effects, therapeutic use)