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Objective: to evaluate the effectiveness and safety of doxazosin GITS when added to hypertensive patients non responders to monotherapy. Material and Methods: open label, non-comparative, multicentric, prospective study on hypertensive patients coming to the doctor’s office. Hypertensive patients not controlled (DBP 90 mmHg and/or SBP 140 mmHg) with one antihypertensive drug according to the VI revision of the Joint National Committee (JNC), were included in this study. Doxazosin GITS has been taken in addition to their antihypertensive medication. The initial dose of Doxazosin GITS was 4 mg/day and could be increased at 4 weeks interval to a maximum dose of 8 mg/day. During all the follow-up visits blood pressure and heart rate values have been determined. Adverse events occurrence and concomitant medication have been also recorded. Results: 3631 patients with an average age 62.4 11.0 years, female gender 60% were included in the study and 3267 (90%) completed it. Effectiveness analysis was done in 3546 (97.7%) patient, 85 (2.3%) patients were excluded due to blood pressure values not recorded at basal or follow up visits. After 4 weeks treatment with Doxazosin GITS 39% patients achieved therapeutic goal based on the VI revision of the JNC. This percentage was increased to 61% after 16 weeks. The mean values of systolic blood pressure (SBP) and diastolic blood pressure (DBP) changed from 161.6 11.9 and 95.1 5.9 mmHg at baseline to 142.2 11.9 and 84.1 5.9 mmHg after 4 weeks (p 0.0001) and 136.8 11.9 and 80.6 5.9 mmHg after 16 weeks (p 0.0001). Patient distribution according to their entry antihypertensive showed that 42.5% were taking ACE inhibitors, 17.2% diuretics, 16.6% calcium blockers, 16.6% angiotensin II receptor blockers and 6.8% -blockers. In all groups it was observed a significant increase in the percentage of controlled patients as well as significant reductions of PAS and PAD values when adding treatment with Doxazosin GITS. Safety analysis showed that 107 (2.9%) patient had an adverse event, 1.6% related to the drug. 16 (0.4%) patients reported serious adverse events, only one of them related to the drug. Conclusions: 1. Doxazosin GITS is an effective added drug in patients not controlled in monotherapy. 2. Doxazosin GITS is an effective, safe drug used as add-on therapy with every antihypertensive treatment.

american journal of hypertension

Postmarketing surveillance study to evaluate the safety and effectiveness of doxazosin gits when added to hypertensive patients not controlled with monotherapy