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A randomized, double-blind, forced-titration study to compare olmesartan medoxomil versus losartan potassium in patients with stage 1 and 2 hypertension.
Postgrad Med. 2011 Jan; 123(1):80-7.PM

Abstract

OBJECTIVE

To evaluate the comparative efficacy and safety of once-daily olmesartan medoxomil (OM) and losartan potassium (LOS) in patients with hypertension.

METHODS

This was a multicenter, prospective, randomized, double-blind, active-comparator, forced-titration study. After a 3-week placebo run-in, 941 patients were randomized in an 8:1:9 ratio to once-daily treatment with OM (20 mg for 4 weeks, then OM 40 mg for 4 weeks [n = 420]), placebo plus OM (placebo for 2 weeks, then OM 20 mg for 2 weeks and OM 40 mg for 4 weeks [n = 52]), or LOS (50 mg for 4 weeks, then LOS 100 mg for 4 weeks [n = 469]). A subset of 246 patients underwent ambulatory blood pressure (BP) monitoring. The primary endpoint was mean change from baseline in trough seated cuff diastolic BP (SeDBP) at week 8. Secondary endpoints were mean changes from baseline in trough SeDBP at week 4 and seated systolic BP (SeSBP) at weeks 4 and 8. Tertiary endpoints included change from baseline in mean 24-hour ambulatory BP at weeks 4 and 8 and percentage of patients achieving seated cuff BP (SeBP) goal of < 140/90 mm Hg and mean 24-hour ambulatory BP target of < 130/80 mm Hg at weeks 4 and 8.

RESULTS

At week 8, least-squares (LS) mean (± standard error) SeDBP reductions from baseline were 9.7 ± 0.5 and 7.1 ± 0.5 mm Hg (treatment difference: -2.5 ± 0.6 mm Hg; P < 0.0001) and LS mean SeSBP reductions were 13.6 ± 0.7 and 9.7 ± 0.7 mm Hg (treatment difference: -3.9 ± 1.0 mm Hg; P = 0.0001) for OM versus LOS, respectively. A significantly greater proportion of patients receiving OM reached SeBP goal of < 140/90 mm Hg at week 8. There was a similar incidence of adverse events with OM and LOS.

CONCLUSION

Treatment with low- and high-dose OM achieved superior SeBP reductions compared with low- and high-dose LOS, resulting in significantly more patients achieving SeBP goal, with similar tolerability.

Authors+Show Affiliations

Division of Nephrology, University of Maryland School of Medicine, Baltimore, MD 21201, USA. mweir@medicine.umaryland.eduNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Comparative Study
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, N.I.H., Extramural

Language

eng

PubMed ID

21293087

Citation

Weir, Matthew R., et al. "A Randomized, Double-blind, Forced-titration Study to Compare Olmesartan Medoxomil Versus Losartan Potassium in Patients With Stage 1 and 2 Hypertension." Postgraduate Medicine, vol. 123, no. 1, 2011, pp. 80-7.
Weir MR, Punzi HA, Flack JM, et al. A randomized, double-blind, forced-titration study to compare olmesartan medoxomil versus losartan potassium in patients with stage 1 and 2 hypertension. Postgrad Med. 2011;123(1):80-7.
Weir, M. R., Punzi, H. A., Flack, J. M., Stoakes, K. A., Chavanu, K. J., Li, W., & Dubiel, R. (2011). A randomized, double-blind, forced-titration study to compare olmesartan medoxomil versus losartan potassium in patients with stage 1 and 2 hypertension. Postgraduate Medicine, 123(1), 80-7. https://doi.org/10.3810/pgm.2011.01.2248
Weir MR, et al. A Randomized, Double-blind, Forced-titration Study to Compare Olmesartan Medoxomil Versus Losartan Potassium in Patients With Stage 1 and 2 Hypertension. Postgrad Med. 2011;123(1):80-7. PubMed PMID: 21293087.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - A randomized, double-blind, forced-titration study to compare olmesartan medoxomil versus losartan potassium in patients with stage 1 and 2 hypertension. AU - Weir,Matthew R, AU - Punzi,Henry A, AU - Flack,John M, AU - Stoakes,Kathy A, AU - Chavanu,Kathleen J, AU - Li,Wei, AU - Dubiel,Robert, PY - 2011/2/5/entrez PY - 2011/2/5/pubmed PY - 2011/3/23/medline SP - 80 EP - 7 JF - Postgraduate medicine JO - Postgrad Med VL - 123 IS - 1 N2 - OBJECTIVE: To evaluate the comparative efficacy and safety of once-daily olmesartan medoxomil (OM) and losartan potassium (LOS) in patients with hypertension. METHODS: This was a multicenter, prospective, randomized, double-blind, active-comparator, forced-titration study. After a 3-week placebo run-in, 941 patients were randomized in an 8:1:9 ratio to once-daily treatment with OM (20 mg for 4 weeks, then OM 40 mg for 4 weeks [n = 420]), placebo plus OM (placebo for 2 weeks, then OM 20 mg for 2 weeks and OM 40 mg for 4 weeks [n = 52]), or LOS (50 mg for 4 weeks, then LOS 100 mg for 4 weeks [n = 469]). A subset of 246 patients underwent ambulatory blood pressure (BP) monitoring. The primary endpoint was mean change from baseline in trough seated cuff diastolic BP (SeDBP) at week 8. Secondary endpoints were mean changes from baseline in trough SeDBP at week 4 and seated systolic BP (SeSBP) at weeks 4 and 8. Tertiary endpoints included change from baseline in mean 24-hour ambulatory BP at weeks 4 and 8 and percentage of patients achieving seated cuff BP (SeBP) goal of < 140/90 mm Hg and mean 24-hour ambulatory BP target of < 130/80 mm Hg at weeks 4 and 8. RESULTS: At week 8, least-squares (LS) mean (± standard error) SeDBP reductions from baseline were 9.7 ± 0.5 and 7.1 ± 0.5 mm Hg (treatment difference: -2.5 ± 0.6 mm Hg; P < 0.0001) and LS mean SeSBP reductions were 13.6 ± 0.7 and 9.7 ± 0.7 mm Hg (treatment difference: -3.9 ± 1.0 mm Hg; P = 0.0001) for OM versus LOS, respectively. A significantly greater proportion of patients receiving OM reached SeBP goal of < 140/90 mm Hg at week 8. There was a similar incidence of adverse events with OM and LOS. CONCLUSION: Treatment with low- and high-dose OM achieved superior SeBP reductions compared with low- and high-dose LOS, resulting in significantly more patients achieving SeBP goal, with similar tolerability. SN - 1941-9260 UR - https://www.unboundmedicine.com/medline/citation/21293087/A_randomized_double_blind_forced_titration_study_to_compare_olmesartan_medoxomil_versus_losartan_potassium_in_patients_with_stage_1_and_2_hypertension_ L2 - https://www.tandfonline.com/doi/full/10.3810/pgm.2011.01.2248 DB - PRIME DP - Unbound Medicine ER -