Tamsulosin Oral Controlled Absorption System (OCAS) in Patients with Lower Urinary Tract Symptoms Suggestive of Benign Prostatic Hyperplasia (LUTS/BPH):

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Presentation transcript:

Tamsulosin Oral Controlled Absorption System (OCAS) in Patients with Lower Urinary Tract Symptoms Suggestive of Benign Prostatic Hyperplasia (LUTS/BPH): Efficacy and Tolerability in a Placebo and Active Comparator Controlled Phase 3a Study  Christopher R. Chapple, Salman H. Al-Shukri, Bernard Gattegno, Simon Holmes, José M. Martínez-Sagarra, Roberto M. Scarpa, Oncko B. van Vierssen Trip, Viktor Vik, Ingrid van der Putten-Slob  European Urology Supplements  Volume 4, Issue 2, Pages 33-44 (February 2005) DOI: 10.1016/j.eursup.2004.10.010 Copyright © 2004 Elsevier B.V. Terms and Conditions

Fig. 1 Flow diagram of the number of patients enrolled, randomised and completing the study per treatment group. European Urology Supplements 2005 4, 33-44DOI: (10.1016/j.eursup.2004.10.010) Copyright © 2004 Elsevier B.V. Terms and Conditions

Fig. 2 Mean change in total I-PSS from baseline to endpoint (ITT). European Urology Supplements 2005 4, 33-44DOI: (10.1016/j.eursup.2004.10.010) Copyright © 2004 Elsevier B.V. Terms and Conditions

Fig. 3 Effect of treatment on mean total I-PSS over time (ITT). European Urology Supplements 2005 4, 33-44DOI: (10.1016/j.eursup.2004.10.010) Copyright © 2004 Elsevier B.V. Terms and Conditions

Fig. 4 Percentage of patients with all dizziness and abnormal ejaculation MedDRA coded terms combined (SAF). Abnormal ejaculation: p=0.0140 for tamsulosin MR 0.4mg vs. placebo, p=0.0002 for tamsulosin OCAS 0.8mg vs. placebo and p=0.0399 for tamsulosin OCAS 0.8mg vs. tamsulosin OCAS 0.4mg. European Urology Supplements 2005 4, 33-44DOI: (10.1016/j.eursup.2004.10.010) Copyright © 2004 Elsevier B.V. Terms and Conditions

Fig. 5 Mean change in supine SBP and DBP from baseline to 12 weeks of treatment (SAF). European Urology Supplements 2005 4, 33-44DOI: (10.1016/j.eursup.2004.10.010) Copyright © 2004 Elsevier B.V. Terms and Conditions