title: Efficacy/safety of olmesartan medoxomil versus losartan potassium in naïve versus previously treated subjects with hypertension.
abstract: BACKGROUND
  A predefined exploratory analysis of a prospective, randomized, double-blind, forced-titration study of olmesartan medoxomil (OM) versus losartan potassium (LOS) in subjects with hypertension not previously or previously treated with antihypertensive medication is reported.
  
  
  METHODS
  The study included a 3-4-week placebo run-in and an 8-week active treatment period: OM (weeks 1-4, OM 20 mg; weeks 5-8, OM 40 mg); placebo + OM (weeks 1-2, placebo; weeks 3-4, OM 20 mg; weeks 5-8, OM 40 mg); and LOS (weeks 1-4, LOS 50 mg; weeks 5-8, LOS 100 mg). Analyses focused on comparison of OM and placebo + OM combined versus LOS. Efficacy endpoints were mean change from baseline in seated cuff diastolic blood pressure (SeDBP) at week 8 (primary); seated cuff systolic blood pressure (SeSBP) at weeks 4 and 8, and SeDBP at week 4 (secondary), and BP target achievement (tertiary).
  
  
  RESULTS
  The randomized population (n = 941) had a mean ± SD age of 51.9 ± 9.7 years, 54.5% were male, and 20.1% were naïve to antihypertensive medication. For treatmentnaïve subjects, baseline seated BP (SeBP) (±SD) was 157.4 (±10.9)/101.8 (±4.3) mmHg with OM and 156.3 (±10.8)/101.1 (±3.9) mmHg with LOS, while non-naïve subjects had 158.4 (±10.2)/100.9 (±4.0) mmHg with OM and 158.8 (±10.1)/101.3 (±4.2) mmHg with LOS. OM monotherapy produced significantly greater changes in least-squares mean (±SE) SeDBP compared with LOS in both treatment-naïve (-9.7 [1.0] vs. -6.6 [1.0] mmHg; P = 0.0232 vs. LOS) and non-naïve subjects (-9.6 [0.5] vs. -7.3 [0.5] mmHg; P = 0.0013 vs. LOS). A significantly greater proportion of patients achieved the SeBP goal of <140/90 mmHg with OM compared with LOS in treatment-naïve (34.1% vs. 19.0%, respectively; P = 0.0109) and non-naïve subjects (31.0% vs. 19.6%; P = 0.0008).
  
  
  CONCLUSIONS
  Overall, OM monotherapy resulted in significantly greater SeBP reductions and greater SeBP goal achievement than LOS, irrespective of previous medication use. Both OM and LOS therapy were well tolerated.
authors: Trinity Hypertension Research Institute, Punzi Medical Center, Carrollton, TX 75006, USA. punzimedcenter@aol.com
authors: Henry A
authors: HA
authors: Punzi
authors: Andrew
authors: A
authors: Lewin
authors: Wei
authors: W
authors: Li
authors: Kathleen J
authors: KJ
authors: Chavanu
mesh_terms: D000328:Adult; D000368:Aged; D000959:Antihypertensive Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D001794:Blood Pressure / Q000187:drug effects; D015897:Comorbidity; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D005006:Ethnicity; D005260:Female; D006801:Humans; D006973:Hypertension / Q000188:drug therapy*; D007093:Imidazoles / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D019808:Losartan / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D000068557:Olmesartan Medoxomil; D011446:Prospective Studies; D013777:Tetrazoles / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*
chemical_list: D000959:Antihypertensive Agents; D007093:Imidazoles; D013777:Tetrazoles; D000068557:Olmesartan Medoxomil; D019808:Losartan