The efficacy and safety of azilsartan medoxomil (AZL-M) were evaluated in African-American patients with hypertension in a 6-week, double-blind, randomized, placebo-controlled trial, for which the primary end point was change from baseline in 24-hour mean systolic blood pressure (BP). There were 413 patients, with a mean age of 52 years, 57% women, and baseline 24-hour BP of 146/91 mm Hg. Treatment differences in 24-hour systolic BP between AZL-M 40 mg and placebo (-5.0 mm Hg; 95% confidence interval, -8.0 to -2.0) and AZL-M 80 mg and placebo (-7.8 mm Hg; 95% confidence interval, -10.7 to -4.9) were significant (P≤.001 vs placebo for both comparisons). Changes in the clinic BPs were similar to the ambulatory BP results. Incidence rates of adverse events were comparable among the treatment groups, including those of a serious nature. In African-American patients with hypertension, AZL-M significantly reduced ambulatory and clinic BPs in a dose-dependent manner and was well tolerated.
Angiotensin Receptor Antagonists/pharmacology , Blood Pressure Monitoring, Ambulatory/methods , Blood Pressure/drug effects , Hypertension/drug therapy , Adult , Black or African American , Angiotensin Receptor Antagonists/administration & dosage , Angiotensin Receptor Antagonists/adverse effects , Antihypertensive Agents/therapeutic use , Benzimidazoles/administration & dosage , Benzimidazoles/adverse effects , Benzimidazoles/pharmacology , Blood Pressure Monitoring, Ambulatory/statistics & numerical data , Double-Blind Method , Female , Humans , Hypertension/classification , Hypertension/ethnology , Male , Middle Aged , Oxadiazoles/administration & dosage , Oxadiazoles/adverse effects , Oxadiazoles/pharmacology , Treatment Outcome , United States/ethnology
