A SECOND PHASE III MULTICENTER PLACEBO CONTROLLED STUDY OF 2 DOSAGES OF MODIFIED RELEASE TAMSULOSIN IN PATIENTS WITH SYMPTOMS OF BENIGN PROSTATIC HYPERPLASIA
1998; Lippincott Williams & Wilkins; Volume: 160; Issue: 5 Linguagem: Inglês
10.1016/s0022-5347(01)62386-3
ISSN1527-3792
AutoresPerinchery Narayan, Ashutosh Tewari,
Tópico(s)Hormonal and reproductive studies
ResumoNo AccessJournal of UrologyClinical Urology: Original Articles1 Nov 1998A SECOND PHASE III MULTICENTER PLACEBO CONTROLLED STUDY OF 2 DOSAGES OF MODIFIED RELEASE TAMSULOSIN IN PATIENTS WITH SYMPTOMS OF BENIGN PROSTATIC HYPERPLASIA PERINCHERY NARAYAN and ASHUTOSH TEWARI PERINCHERY NARAYANPERINCHERY NARAYAN More articles by this author and ASHUTOSH TEWARIASHUTOSH TEWARI More articles by this author View All Author Informationhttps://doi.org/10.1016/S0022-5347(01)62386-3AboutFull TextPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract Purpose: In a double-blind, phase III clinical trial we evaluate the safety and efficacy of 0.4 and 0.8 mg. tamsulosin daily for the treatment of patients with symptoms of moderate to severe benign prostatic hyperplasia. Materials and Methods: Patients meeting the basic requirements of the study underwent a 4-week single-blind placebo evaluation period. A total of 735 patients were randomized to double-blind therapy with tamsulosin or placebo. Treatment duration was 13 weeks. Efficacy and safety were evaluated at 5 visits during the double-blind treatment period. Results: When efficacy data between baseline and end point were compared there was a significant reduction in total American Urological Association symptom score (25%) in each tamsulosin group compared with placebo (p = 0.01) and the percentage of patients with a 30% or more reduction in peak urinary flow rate was significantly greater in the tamsulosin versus placebo group (p <0.05). Improvements in American Urological Association symptom scores and maximum flow rate occurred at 1 week of treatment. None of the patients experienced a first dose effect. There were no significant changes in blood pressure on standing at any visit during the study except for a decrease in systolic blood pressure of 20 mm. Hg or more between the 0.8 mg. dose and placebo groups at visit 4 (p = 0.036). Positive orthostatic tests were significantly more frequent in the 0.8 mg. group compared with placebo at visit 4 (p = 0.012). The treatment groups did not differ significantly in incidence of electrocardiogram abnormalities at each post-baseline visit and at end point. Conclusions: Tamsulosin was safe and effective, and clinically and statistically superior to placebo in relieving symptoms of benign prostatic hyperplasia in men with moderate to severe symptoms at baseline. There was no evidence of a first dose effect and no clinically significant orthostatic hypertension. In addition, response to treatment was rapid. References 1 : Pharmacological receptors in the prostate. Brit. J. Urol.1973; 45: 663. Google Scholar 2 : The use of alpha-adrenergic blockers in benign prostatic obstruction. Brit. J. Urol.1976; 48: 255. Medline, Google Scholar 3 : Benign prostatic hyperplasia: diagnosis and treatment. In: . 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Google Scholar MEMBERS OF UNITED STATES 93-01 STUDY GROUP; From the Divisions of Urology, University of Florida and Veterans Administration Medical Center, Gainesville, Florida© 1998 by American Urological Association, Inc.FiguresReferencesRelatedDetailsCited byOelke M, Shinghal R, Sontag A, Baygani S and Donatucci C (2014) Time to Onset of Clinically Meaningful Improvement with Tadalafil 5 mg Once Daily for Lower Urinary Tract Symptoms Secondary to Benign Prostatic Hyperplasia: Analysis of Data Pooled from 4 Pivotal, Double-Blind, Placebo Controlled StudiesJournal of Urology, VOL. 193, NO. 5, (1581-1589), Online publication date: 1-May-2015.Homsy Y, Arnold P and Zhang W (2011) Phase IIb/III Dose Ranging Study of Tamsulosin as Treatment for Children With Neuropathic BladderJournal of Urology, VOL. 186, NO. 5, (2033-2039), Online publication date: 1-Nov-2011.Kojima Y, Sasaki S, Kubota Y, Imura M, Oda N, Kiniwa M, Hayashi Y and Kohri K (2011) Up-Regulation of α1a and α1d-Adrenoceptors in the Prostate by Administration of Subtype Selective α1-Adrenoceptor Antagonist Tamsulosin in Patients With Benign Prostatic HyperplasiaJournal of Urology, VOL. 186, NO. 4, (1530-1536), Online publication date: 1-Oct-2011.ROEHRBORN C and SCHWINN D (2018) α1-Adrenergic Receptors and Their Inhibitors in Lower Urinary Tract Symptoms and Benign Prostatic HyperplasiaJournal of Urology, VOL. 171, NO. 3, (1029-1035), Online publication date: 1-Mar-2004.NARAYAN P, EVANS C and MOON T (2018) Long-term Safety and Efficacy of Tamsulosin for the Treatment of Lower Urinary Tract Symptoms Associated With Benign Prostatic HyperplasiaJournal of Urology, VOL. 170, NO. 2, (498-502), Online publication date: 1-Aug-2003.WILT T, MacDONALD R and NELSON D (2018) TAMSULOSIN FOR TREATING LOWER URINARY TRACT SYMPTOMS COMPATIBLE WITH BENIGN PROSTATIC OBSTRUCTION: A SYSTEMATIC REVIEW OF EFFICACY AND ADVERSE EFFECTSJournal of Urology, VOL. 167, NO. 1, (177-183), Online publication date: 1-Jan-2002.SCHULMAN C, LOCK T, BUZELIN J, BOEMINGHAUS F, STEPHENSON T and TALJA M (2018) LONG-TERM USE OF TAMSULOSIN TO TREAT LOWER URINARY TRACT SYMPTOMS/BENIGN PROSTATIC HYPERPLASIAJournal of Urology, VOL. 166, NO. 4, (1358-1363), Online publication date: 1-Oct-2001. Volume 160Issue 5November 1998Page: 1701-1706 Advertisement Copyright & Permissions© 1998 by American Urological Association, Inc.MetricsAuthor Information PERINCHERY NARAYAN More articles by this author ASHUTOSH TEWARI More articles by this author Expand All Advertisement PDF downloadLoading ...
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