INTRODUCTION: 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). CONCLUSION: 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.
RCT Entities:
INTRODUCTION: A predefined exploratory analysis of a prospective, randomized, double-blind, forced-titration study of olmesartanmedoxomil (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). CONCLUSION: 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.