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Efficacy/safety of olmesartan medoxomil versus losartan potassium in patients by stage 1 or 2 hypertension.
Postgrad Med. 2012 May; 124(3):59-70.PM

Abstract

An exploratory subgroup analysis of a prospective, randomized, double-blind, forced-titration study comparing the efficacy and safety of once-daily olmesartan medoxomil (OM) and losartan potassium (LOS) in patients with stage 1 or stage 2 hypertension is reported. After a 3- to 4-week placebo run-in period, eligible patients received once-daily OM (weeks 1-4, 20 mg; weeks 5-8, 40 mg), placebo plus OM (weeks 1-2, placebo; weeks 3-4, OM 20 mg; weeks 5-8, OM 40 mg), or LOS (weeks 1-4, 50 mg; weeks 5-8, 100 mg). A subset of patients underwent ambulatory blood pressure (BP) monitoring. Efficacy endpoints by hypertension stage were mean change from baseline in seated cuff diastolic BP (SeDBP) at week 8 (primary); seated cuff systolic BP (SeSBP) at week 4 and week 8, and SeDBP at week 4 (secondary); and the change from baseline in mean 24-hour ambulatory BP at week 8, and BP target achievement (tertiary). At week 8, patients with stage 1 and stage 2 hypertension had least-squares mean SeDBP reductions from baseline of 9.9 and 9.5 mm Hg, respectively, for OM treatment, and 6.9 and 7.3 mm Hg for LOS treatment (P = 0.0095 and P = 0.0035, respectively). Overall, 63.6% of patients with stage 1 hypertension treated with OM versus 47.3% treated with LOS (P = 0.0095) achieved an SeBP of < 140/90 mm Hg, while 36.1% of patients with stage 2 hypertension treated with OM versus 25.2% treated with LOS (P = 0.0022) achieved an SeBP of < 140/90 mm Hg. At week 8, OM-treated patients with stage 2 hypertension had a significantly greater reduction in least-squares mean 24-hour ambulatory BP versus LOS-treated patients. Olmesartan and LOS were well tolerated, and the most common treatment-emergent adverse event was headache. Once-daily, maximum doses of OM in patients with stage 1 or stage 2 hypertension achieved superior BP reductions versus LOS, with similar tolerability.

Authors+Show Affiliations

Department of Internal Medicine, Wayne State University School of Medicine, Detroit, MI, USA. jflack@med.wayne.eduNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Comparative Study
Journal Article
Multicenter Study
Randomized Controlled Trial

Language

eng

PubMed ID

22691900

Citation

Flack, John M., et al. "Efficacy/safety of Olmesartan Medoxomil Versus Losartan Potassium in Patients By Stage 1 or 2 Hypertension." Postgraduate Medicine, vol. 124, no. 3, 2012, pp. 59-70.
Flack JM, Graff A, Li W, et al. Efficacy/safety of olmesartan medoxomil versus losartan potassium in patients by stage 1 or 2 hypertension. Postgrad Med. 2012;124(3):59-70.
Flack, J. M., Graff, A., Li, W., & Chavanu, K. J. (2012). Efficacy/safety of olmesartan medoxomil versus losartan potassium in patients by stage 1 or 2 hypertension. Postgraduate Medicine, 124(3), 59-70. https://doi.org/10.3810/pgm.2012.05.2549
Flack JM, et al. Efficacy/safety of Olmesartan Medoxomil Versus Losartan Potassium in Patients By Stage 1 or 2 Hypertension. Postgrad Med. 2012;124(3):59-70. PubMed PMID: 22691900.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Efficacy/safety of olmesartan medoxomil versus losartan potassium in patients by stage 1 or 2 hypertension. AU - Flack,John M, AU - Graff,Alan, AU - Li,Wei, AU - Chavanu,Kathleen J, PY - 2012/6/14/entrez PY - 2012/6/14/pubmed PY - 2012/10/25/medline SP - 59 EP - 70 JF - Postgraduate medicine JO - Postgrad Med VL - 124 IS - 3 N2 - An exploratory subgroup analysis of a prospective, randomized, double-blind, forced-titration study comparing the efficacy and safety of once-daily olmesartan medoxomil (OM) and losartan potassium (LOS) in patients with stage 1 or stage 2 hypertension is reported. After a 3- to 4-week placebo run-in period, eligible patients received once-daily OM (weeks 1-4, 20 mg; weeks 5-8, 40 mg), placebo plus OM (weeks 1-2, placebo; weeks 3-4, OM 20 mg; weeks 5-8, OM 40 mg), or LOS (weeks 1-4, 50 mg; weeks 5-8, 100 mg). A subset of patients underwent ambulatory blood pressure (BP) monitoring. Efficacy endpoints by hypertension stage were mean change from baseline in seated cuff diastolic BP (SeDBP) at week 8 (primary); seated cuff systolic BP (SeSBP) at week 4 and week 8, and SeDBP at week 4 (secondary); and the change from baseline in mean 24-hour ambulatory BP at week 8, and BP target achievement (tertiary). At week 8, patients with stage 1 and stage 2 hypertension had least-squares mean SeDBP reductions from baseline of 9.9 and 9.5 mm Hg, respectively, for OM treatment, and 6.9 and 7.3 mm Hg for LOS treatment (P = 0.0095 and P = 0.0035, respectively). Overall, 63.6% of patients with stage 1 hypertension treated with OM versus 47.3% treated with LOS (P = 0.0095) achieved an SeBP of < 140/90 mm Hg, while 36.1% of patients with stage 2 hypertension treated with OM versus 25.2% treated with LOS (P = 0.0022) achieved an SeBP of < 140/90 mm Hg. At week 8, OM-treated patients with stage 2 hypertension had a significantly greater reduction in least-squares mean 24-hour ambulatory BP versus LOS-treated patients. Olmesartan and LOS were well tolerated, and the most common treatment-emergent adverse event was headache. Once-daily, maximum doses of OM in patients with stage 1 or stage 2 hypertension achieved superior BP reductions versus LOS, with similar tolerability. SN - 1941-9260 UR - https://www.unboundmedicine.com/medline/citation/22691900/Efficacy/safety_of_olmesartan_medoxomil_versus_losartan_potassium_in_patients_by_stage_1_or_2_hypertension_ L2 - https://www.tandfonline.com/doi/full/10.3810/pgm.2012.05.2549 DB - PRIME DP - Unbound Medicine ER -