Document Detail


Antihypertensive efficacy and safety of olmesartan and ramipril in elderly patients with mild to moderate systolic and diastolic essential hypertension.
MedLine Citation:
PMID:  21091270     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
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;
Publication Detail:
Type:  Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't     Date:  2010-11-23
Journal Detail:
Title:  Blood pressure. Supplement     Volume:  1     ISSN:  0803-8023     ISO Abbreviation:  Blood Press Suppl     Publication Date:  2011 Apr 
Date Detail:
Created Date:  2011-01-25     Completed Date:  2011-04-26     Revised Date:  2013-08-15    
Medline Journal Info:
Nlm Unique ID:  9300787     Medline TA:  Blood Press Suppl     Country:  England    
Other Details:
Languages:  eng     Pagination:  3-11     Citation Subset:  IM    
Affiliation:
Cardiology and Arterial Hypertension, CHU de Grenoble, Grenoble, France. JMMallion@chu-grenoble.fr
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MeSH Terms
Descriptor/Qualifier:
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
Ramipril / administration & dosage,  adverse effects,  therapeutic use*
Systole / drug effects
Tetrazoles / administration & dosage,  adverse effects,  therapeutic use*
Chemical
Reg. No./Substance:
0/Angiotensin II Type 1 Receptor Blockers; 0/Angiotensin-Converting Enzyme Inhibitors; 0/Antihypertensive Agents; 0/Imidazoles; 0/Tetrazoles; 6M97XTV3HD/olmesartan medoxomil; 87333-19-5/Ramipril
Investigator
Investigator/Affiliation:
M Baghestanian / ; B Eber / ; R Zweiker / ; V Riegelnik / ; W Van Mieghem / ; J M Mallion / ; G DuCailar / ; P K Panzer / ; W R Kresse / ; O Carewicz / ; J Iserloh / ; K H Krause / ; E Prechtel / ; I F K Naudts / ; A Schmidt / ; U Zimmerman / ; E Borbas / ; D Kremastinos / ; H Triantafyllidi / ; C Stefanadis / ; J Barton / ; K Narkiewicz / ; M Chrostowska / ; P Napora / ; B Gornikiewicz-Brzezicka / ; I Graczak / ; J Klimkiewicz / ; M Jesewska / ; J L Palma Gamiz / ; J Olivan / ; J Garcia Puig / ; B Gil Extremera / ; P Jimenez Lopez / ; J Sobrino Martinez / ; M Jesus Adrian / ; A Coca / ; M Doménech /

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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