Steven G Chrysant1, Thomas C Marbury, Tonous N Silfani. 1. Oklahoma Cardiovascular and Hypertension and the University of Oklahoma School of Medicine, Oklahoma City 73132, USA. schrysant@yahoo.com
Abstract
OBJECTIVE:Olmesartan medoxomil is an angiotensin II receptor blocker with similar antihypertensive efficacy as the calcium channel blocker amlodipine besylate in patients with mild-to-moderate hypertension. In addition to a drug's ability to lower blood pressure, the effectiveness of the agent in enabling patients to achieve specific blood pressure targets is an important clinical consideration. This secondary analysis of a randomized, double-blind study compared the efficacy of olmesartan medoxomil with that of amlodipine besylate in achieving ambulatory blood pressure goals among patients with mild-to-moderate hypertension. METHODS: Following a 4-week placebo run-in, 440 study participants aged >or=18 years were randomized to olmesartan medoxomil (20 mg/day), amlodipine besylate (5 mg/day), or placebo for 8 weeks. The proportion of participants achieving specific systolic and diastolic ambulatoryblood pressure goal levels was calculated by dividing the number of participants who had achieved a particular blood pressure goal by the total number of patients in the intent-to-treat population. RESULTS: After 8 weeks of treatment, a mean 24-h ambulatory blood pressure of <130/80 or <130/85 mmHg was achieved by significantly more participants in the olmesartan medoxomil group (18.1 and 30.4%, respectively) than in the amlodipine besylate (7.0 and 14.0%, respectively) or placebo (1.9% for both) groups. The target daytime ambulatory blood pressure of <135/85 mmHg was achieved by more participants in the olmesartan medoxomil group than in the amlodipine besylate group (15.8 vs. 5.8%, respectively; P<0.01). CONCLUSION: In a previous publication of the same study, we demonstrated that starting doses of olmesartan medoxomil and amlodipine besylate produced similar mean reductions in blood pressure. In this subanalysis of the blood pressure data from that primary publication, however, olmesartan medoxomil therapy was shown to result in a greater proportion of patients achieving specific ambulatory blood pressure goals than therapy with amlodipine besylate. As blood pressure goal attainment may be of more direct clinical relevance than numerical blood pressure lowering, the achievement of blood pressure goals should be a key efficacy parameter assessed in clinical trials of antihypertensive medications.
RCT Entities:
OBJECTIVE:Olmesartan medoxomil is an angiotensin II receptor blocker with similar antihypertensive efficacy as the calcium channel blocker amlodipine besylate in patients with mild-to-moderate hypertension. In addition to a drug's ability to lower blood pressure, the effectiveness of the agent in enabling patients to achieve specific blood pressure targets is an important clinical consideration. This secondary analysis of a randomized, double-blind study compared the efficacy of olmesartan medoxomil with that of amlodipine besylate in achieving ambulatory blood pressure goals among patients with mild-to-moderate hypertension. METHODS: Following a 4-week placebo run-in, 440 study participants aged >or=18 years were randomized to olmesartan medoxomil (20 mg/day), amlodipine besylate (5 mg/day), or placebo for 8 weeks. The proportion of participants achieving specific systolic and diastolic ambulatory blood pressure goal levels was calculated by dividing the number of participants who had achieved a particular blood pressure goal by the total number of patients in the intent-to-treat population. RESULTS: After 8 weeks of treatment, a mean 24-h ambulatory blood pressure of <130/80 or <130/85 mmHg was achieved by significantly more participants in the olmesartan medoxomil group (18.1 and 30.4%, respectively) than in the amlodipine besylate (7.0 and 14.0%, respectively) or placebo (1.9% for both) groups. The target daytime ambulatory blood pressure of <135/85 mmHg was achieved by more participants in the olmesartan medoxomil group than in the amlodipine besylate group (15.8 vs. 5.8%, respectively; P<0.01). CONCLUSION: In a previous publication of the same study, we demonstrated that starting doses of olmesartan medoxomil and amlodipine besylate produced similar mean reductions in blood pressure. In this subanalysis of the blood pressure data from that primary publication, however, olmesartan medoxomil therapy was shown to result in a greater proportion of patients achieving specific ambulatory blood pressure goals than therapy with amlodipine besylate. As blood pressure goal attainment may be of more direct clinical relevance than numerical blood pressure lowering, the achievement of blood pressure goals should be a key efficacy parameter assessed in clinical trials of antihypertensive medications.