title: 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.affiliation: Cardiology and Arterial Hypertension, CHU de Grenoble, Grenoble, France. JMMallion@chu-grenoble.fr
authors.forename: Jean-Michel
authors.initials: JM
authors.lastname: Mallion
authors.forename: Stefano
authors.initials: S
authors.lastname: Omboni
authors.forename: John
authors.initials: J
authors.lastname: Barton
authors.forename: Walter
authors.initials: W
authors.lastname: Van Mieghem
authors.forename: Krzysztof
authors.initials: K
authors.lastname: Narkiewicz
authors.forename: Peter-Klaus
authors.initials: PK
authors.lastname: Panzer
authors.forename: Juan García
authors.initials: JG
authors.lastname: Puig
authors.forename: Christodoulos
authors.initials: C
authors.lastname: Stefanadis
authors.forename: Robert
authors.initials: R
authors.lastname: Zweiker
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D047228:Angiotensin II Type 1 Receptor Blockers / Q000627:therapeutic use*; D000806:Angiotensin-Converting Enzyme Inhibitors / Q000627:therapeutic use*; D000959:Antihypertensive Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D001794:Blood Pressure / Q000187:drug effects; D001795:Blood Pressure Determination; D018660:Blood Pressure Monitoring, Ambulatory; D003971:Diastole / Q000187:drug effects; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D006973:Hypertension / Q000188:drug therapy* / Q000503:physiopathology; D007093:Imidazoles / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D008297:Male; D000068557:Olmesartan Medoxomil; D017257:Ramipril / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D013599:Systole / Q000187:drug effects; D013777:Tetrazoles / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*
chemical_list: D047228:Angiotensin II Type 1 Receptor Blockers; D000806:Angiotensin-Converting Enzyme Inhibitors; D000959:Antihypertensive Agents; D007093:Imidazoles; D013777:Tetrazoles; D000068557:Olmesartan Medoxomil; D017257:Ramipril