A postmarketing, open-label study to evaluate the tolerability and effectiveness of replacing standard-formulation doxazosin with doxazosin in the gastrointestinal therapeutic system formulation in adult patients with hypertension

Anegón, M.; Esteban, Jesús; Jiménez‐García, Rodrigo; Burgoa, V. Sanz de; Martinez, J.; Miguel, Ángel Gil de

doi:10.1016/s0149-2918(02)85152-9

Cited by 8 publications

(8 citation statements)

References 15 publications

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“…It is explainable why doxazosin did not improve baseline values after 12 weeks: doxazosin induced favorable hemodynamic changes, which persisted for just a few hours (our results do not support the concept of once-daily administration of standard-formulation doxazosin 15,16 ). But the worse effects in comparison with the placebo group may be due to a deleterious effect of doxazosin after 12 weeks of treatment.…”

Section: Baseline Valuescontrasting

confidence: 68%

Hemodynamic Effects of α1-Adrenoceptor Antagonist, Doxazosin, in Patients With Chronic Congestive Heart Failure

Kieback¹,

Rödiger²,

Jaenecke³

et al. 2005

Journal of Cardiovascular Pharmacology

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Section: Baseline Valuescontrasting

confidence: 68%

Hemodynamic Effects of α1-Adrenoceptor Antagonist, Doxazosin, in Patients With Chronic Congestive Heart Failure

Kieback¹,

Rödiger²,

Jaenecke³

et al. 2005

Journal of Cardiovascular Pharmacology

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“…The patients analysed in this study were a subgroup of patients aged 65 years and over included in a drug surveillance study to evaluate the safety of modified‐release doxazosin in hypertensive patients who had previously received treatment with the standard formulation (DLM study). The methodology and overall results of the DLM study have been published elsewhere 12 …”

Section: Methodsmentioning

confidence: 99%

Safety and Effectiveness of Replacing Standard Doxazosin With Doxazosin in the Gastrointestinal Therapeutic System (Gits) Formulation in Elderly Hypertensive Patients

Jiménez-García

Anegón

Esteban

et al. 2003

Int J Clinical Practice

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SUMMARYThe objective of this paper is to evaluate the safety and effectiveness of using doxazosin standard formulation in elderly hypertensive patients who were either uncontrolled or newly diagnosed, and replacing standard doxazosin with doxazosin in the gastrointestinal therapeutic system (GITS) formulation. We designed a postmarketing surveillance, open‐label non‐comparative, multicentre, clinical study covering primary care patients aged 65 years or older diagnosed with essential uncontrolled arterial hypertension. The study covered a period of 6–9 months, divided into two phases. Phase I involved a minimum of three and maximum of six months in treatment with standard doxazosin; phase II began with the changeover from standard doxazosin to the GITS formulation and lasted 12 weeks. Of the 1705 patients initially enrolled, 1292 (75.8%) completed the study. Reduction in systolic blood pressure was 22.3 mmHg (13.7%) in phase I, and 3.9 mmHg (2.77%) in phase II; reduction in diastolic blood pressure was 12.4 mmHg (13.2%) in phase I, and 2.4 mmHg (2.9%) in phase II. The percentage of controlled patients was 40.5% (691/1705) by the end of phase I and 45.3% (776/1705) by the end of phase II. A total of 154 patients suffered adverse events (AE), 127 during phase I and 27 in phase II. We conclude that doxazosin in its two formulations is effective and safe for the purpose of lowering blood pressure in elderly patients.

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“…17,19 Patients tolerating the standard formulation also tolerated the switch to doxazosin GITS, and both formulations were similarly effective and safe.…”

Section: Doxazosin Gits In Hypertensionmentioning

confidence: 99%

“…15,16 As a result, doxazosin GITS therapy can be initiated at a therapeutic dose of 4 mg compared with the usual initial dose of 1 mg with standard doxazosin, thus simplifying the dose titration schedule. Doxazosin GITS is as effective as standard doxazosin in the treatment of hypertension [16][17][18][19][20] or BPH. 18,[21][22][23] Although the blood pressure-lowering effect of doxazosin is a therapeutic advantage in patients with comorbid BPH and hypertension, it has been erroneously perceived as less desirable in normotensive men.…”

Section: Introductionmentioning

confidence: 99%

Clinical ease of using doxazosin in BPH patients with and without hypertension

Steers

Kirby

2005

Prostate Cancer Prostatic Dis

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Clinical studies have demonstrated that doxazosin therapy reduced blood pressure (BP) in patients with benign prostatic hyperplasia (BPH) who were hypertensive at baseline but not in patients who were physiologically or pharmacologically normotensive at baseline. In patients with BPH and uncontrolled hypertension, despite treatment with other antihypertensive drugs, the addition of doxazosin resulted in improved control with significant reductions in BP. The new formulation, doxazosin gastrointestinal therapeutic system (GITS), is initiated at a therapeutic dose, simplifying dose titration. Based on its efficacy and pharmacokinetic and tolerability profiles, doxazosin GITS is an effective and welltolerated treatment for normotensive and hypertensive patients with BPH. Prostate Cancer and Prostatic Diseases (2005) 8, 152-157.

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A postmarketing, open-label study to evaluate the tolerability and effectiveness of replacing standard-formulation doxazosin with doxazosin in the gastrointestinal therapeutic system formulation in adult patients with hypertension

Cited by 8 publications

References 15 publications

Hemodynamic Effects of α1-Adrenoceptor Antagonist, Doxazosin, in Patients With Chronic Congestive Heart Failure

Hemodynamic Effects of α1-Adrenoceptor Antagonist, Doxazosin, in Patients With Chronic Congestive Heart Failure

Safety and Effectiveness of Replacing Standard Doxazosin With Doxazosin in the Gastrointestinal Therapeutic System (Gits) Formulation in Elderly Hypertensive Patients

Clinical ease of using doxazosin in BPH patients with and without hypertension

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