OBJECTIVE: To evaluate extended-release doxazosin gastrointestinal therapeutic system (GITS) as add-on therapy in patients with treated, but uncontrolled hypertension. METHODS: A 16-week, open, noncomparative, multicenter, prospective study of patients with hypertension (> or = 140/> or = 90 mm Hg). Doxazosin GITS 4 mg/d was added to entry medication and increased to 8 mg/d at Week 4 in cases of inadequate blood pressure (BP) control. RESULTS: A total of 3631 patients (40% women) with mean age of 62.4 +/- 0.2 years were included. Proportion of patients reaching goal (< 140/< 90 mm Hg) after 4 weeks of add-on therapy with doxazosin GITS was 39% and increased to 61% at Week 16. Systolic and diastolic BP (mean +/- SEM) decreased, respectively, from 161.6 +/- 0.2 and 95.1 +/- 0.1 mm Hg at baseline to 142.2 +/- 0.2 and 84.1 +/- 0.1 mm Hg at Week 4 (P < 0.0001) and 136.8 +/- 0.2 and 80.6 +/- 0.2 mm Hg at Week 16 (P < 0.0001). Adverse events occurred in 108 patients (3.0%), with 57 (1.6%) related to the study treatment. In 17 patients (0.5%), serious adverse events were described, but only one was related to the study drug. CONCLUSIONS: Doxazosin GITS as add-on therapy achieved target blood pressure and was well tolerated in patients with hypertension uncontrolled by previous regimens. Doxazosin GITS efficacy and tolerability was achieved in combination with all classes of antihypertensives tested.
OBJECTIVE: To evaluate extended-release doxazosin gastrointestinal therapeutic system (GITS) as add-on therapy in patients with treated, but uncontrolled hypertension. METHODS: A 16-week, open, noncomparative, multicenter, prospective study of patients with hypertension (> or = 140/> or = 90 mm Hg). Doxazosin GITS 4 mg/d was added to entry medication and increased to 8 mg/d at Week 4 in cases of inadequate blood pressure (BP) control. RESULTS: A total of 3631 patients (40% women) with mean age of 62.4 +/- 0.2 years were included. Proportion of patients reaching goal (< 140/< 90 mm Hg) after 4 weeks of add-on therapy with doxazosin GITS was 39% and increased to 61% at Week 16. Systolic and diastolic BP (mean +/- SEM) decreased, respectively, from 161.6 +/- 0.2 and 95.1 +/- 0.1 mm Hg at baseline to 142.2 +/- 0.2 and 84.1 +/- 0.1 mm Hg at Week 4 (P < 0.0001) and 136.8 +/- 0.2 and 80.6 +/- 0.2 mm Hg at Week 16 (P < 0.0001). Adverse events occurred in 108 patients (3.0%), with 57 (1.6%) related to the study treatment. In 17 patients (0.5%), serious adverse events were described, but only one was related to the study drug. CONCLUSIONS:Doxazosin GITS as add-on therapy achieved target blood pressure and was well tolerated in patients with hypertension uncontrolled by previous regimens. Doxazosin GITS efficacy and tolerability was achieved in combination with all classes of antihypertensives tested.