OBJECTIVE: To compare the relative efficacy and safety of olmesartan medoxomil (OM) with atenolol, captopril and losartan in phase III trials on mild to severely hypertensive patients. DESIGN: Multi-centre, randomized, double-blind, parallel group, with dose-titration studies lasting 12 or 24 weeks. METHODS: Two studies respectively compared 10 mg OM once daily (o.d.) with: (1) 50 mg atenolol o.d. in moderate to severe hypertensives receiving 25 mg hydrochlorothiazide o.d. over 12 weeks; and (2) 50 mg losartan o.d. in mild to moderate hypertensives over 24 weeks, both with dose doubling at week4 if required. Study 3 compared 5 mg OM o.d. plus placebo o.d.with 12.5 mg captopril twice daily in mild to moderate hypertensives over 12 weeks, with dose doubling at weeks 4 and 8 if required. The primary outcome measure for all studies was the change from baseline to week 12 in trough mean sitting diastolic blood pressure (DBP). Safety was monitored throughout all studies. RESULTS: (1) Atenolol and OM both reduced BP effectively in moderate to severe hypertensives. OM was significantly superior to: (2) losartan (95% confidence interval for baseline to week 12 change in DBP < 0, lower limit < -3.6 mmHg); and (3) captopril (95% confidence interval for baseline to week 12 change in DBP < 0, lower limit < -4.8 mmHg) in BP reduction for mild to moderate hypertensives. Treatment with OM was safe and well tolerated. CONCLUSION: At the doses tested, olmesartan medoxomil o.d. is as effective as atenolol, and more effective than both losartan and captopril in reducing blood pressure in the hypertensive population.
RCT Entities:
OBJECTIVE: To compare the relative efficacy and safety of olmesartanmedoxomil (OM) with atenolol, captopril and losartan in phase III trials on mild to severely hypertensivepatients. DESIGN: Multi-centre, randomized, double-blind, parallel group, with dose-titration studies lasting 12 or 24 weeks. METHODS: Two studies respectively compared 10 mg OM once daily (o.d.) with: (1) 50 mg atenolol o.d. in moderate to severe hypertensives receiving 25 mg hydrochlorothiazide o.d. over 12 weeks; and (2) 50 mg losartan o.d. in mild to moderate hypertensives over 24 weeks, both with dose doubling at week4 if required. Study 3 compared 5 mg OM o.d. plus placebo o.d.with 12.5 mg captopril twice daily in mild to moderate hypertensives over 12 weeks, with dose doubling at weeks 4 and 8 if required. The primary outcome measure for all studies was the change from baseline to week 12 in trough mean sitting diastolic blood pressure (DBP). Safety was monitored throughout all studies. RESULTS: (1) Atenolol and OM both reduced BP effectively in moderate to severe hypertensives. OM was significantly superior to: (2) losartan (95% confidence interval for baseline to week 12 change in DBP < 0, lower limit < -3.6 mmHg); and (3) captopril (95% confidence interval for baseline to week 12 change in DBP < 0, lower limit < -4.8 mmHg) in BP reduction for mild to moderate hypertensives. Treatment with OM was safe and well tolerated. CONCLUSION: At the doses tested, olmesartanmedoxomil o.d. is as effective as atenolol, and more effective than both losartan and captopril in reducing blood pressure in the hypertensive population.