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- Title
Comparison of doxazosin GITS and standard doxazosin in the treatment of high blood pressure.
- Authors
Os, I.
- Abstract
Objective: To examine (1) the relative therapeutic equivalence of 4 mg doxazosin gastrointestinal therapeutic system (DOX GITS) and 4 mg doxazosin standard (DOX-S4) and (2) the efficacy and safety of 4 mg DOX GITS versus 2 mg doxazosin standard (DOX-S2). Patients: Male or fe male patients aged 18 - 80 diagnosed with mild-to-moderate essential hypertension (sitting diastolic blood pressure (DBP) 95 - 110 mmHg and systolic blood pressure (SBP) < 180 mmHg) were randomized into the study. Methods: This double-blind, parallel, 9-week trial compared DOX-GITS with doxazosin standard (DOX-S) in 310 hypertensive patients. Following a 2-week placebo run-in phase, patients were randomized to receive DOX-GITS at 4 mg/d or DOX-S at 2 or 4 mg/d. DOX GITS dos age remained un changed at 4 mg through out the study. Titration in the DOX-S groups was initiated at Week 0 with 1 mg DOX-S and in creased to 2 mg DOX-S at Week 1. Dos age in the DOX-S4 group was increased to 4 mg DOX-S at Week 3. Therapeutic equivalence was measured by the change from base line in sitting diastolic BP (DBP). Efficacy was assessed using the change from baseline for all blood pres sure measures. Safety analysis included evaluation of laboratory tests at clinic vis its and ad verse events (AEs). Results: Therapeutic equivalences between DOX GITS and DOX-S4 and DOX-S2 were established at all study visits except for a significant difference in favor of DOX GITS at Week 1 (p = 0.019) when the dose of DOX-S was 1 mg. All groups had a significant de crease in BP at all study visits compared with base line. The pro portion of patients who reached goal sit ting DBP (< 90 mmHg) was similar among the three treatment groups, except at Week 1, when more patients in the DOX GITS group had obtained the goal compared with those in the DOX-S2 group (40.6% vs. 22.3%; p = 0.005). The proportion of patients who reached sit ting SBP (< 140 mmHg) goal was similar among groups. AE pro files among the groups were similar. Conclusion: DOX GITS was as effective as DOX-S in patients with mild-to-moderate hypertension. The im proved pharmacokinetic profile of the GITS formulation compared with the standard formulation allows a therapeutic dose to be delivered earlier and without dose titration. Both formulations of doxazosin were well tolerated.
- Publication
International Journal of Clinical Pharmacology & Therapeutics, 2006, Vol 44, Issue 3, p99
- ISSN
0946-1965
- Publication type
Academic Journal
- DOI
10.5414/CPP44099