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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 phase 2b dose-response study

par Chapple, Christopher;Lorenz, Jerzy;Mortensen, Raymond;Pauthner, Harald;Reis, Mario O.;Schulman, Claude ;Van Der Putten-Slob, Ingrid
Référence European urology. Supplement, 4, 2, page (25-32)
Publication Publié, 2005-02

Article révisé par les pairs

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Résumé :

This phase 2b randomised, placebo-controlled trial (RCT) was a dose-response study to assess the efficacy and safety of three different doses of a new formulation of tamsulosin (the oral controlled absorption system: OCAS) and to determine which dose(s) should be further evaluated in a phase 3a RCT. After a two-week single-blind, placebo run-in period, older men (≥45 years) with lower urinary tract symptoms (LUTS: total International Prostate Symptom Score (I-PSS) ≥13) suggestive of benign prostatic hyperplasia (BPH: maximum flow rate 4-12 ml/s) were randomised to 12 weeks of treatment with placebo or tamsulosin OCAS 0.4, 0.8 or 1.2 mg once daily. The primary efficacy variable was the mean change from baseline to endpoint in total I-PSS. Tolerability was mainly assessed by documenting adverse events (AEs) reported by the patient. A total of 839 patients were randomised to placebo (N = 213) or tamsulosin OCAS 0.4 mg (N = 206), 0.8 mg (N = 209) or 1.2 mg (N = 211). At endpoint, all three tamsulosin OCAS doses reduced the total I-PSS to a significantly greater extent than placebo (6.0 points or 34.5%). There were no clinically relevant differences between 0.4 mg (7.6 points or 42.4%), 0.8 mg (8.1 points or 46.6%) or 1.2 mg (8.2 points or 45.2%). The same applied for the improvement in the patient's urinary condition, both in the opinion of the patients and investigators. The incidence of AEs increased with increasing tamsulosin OCAS dose and was highest with the 1.2 mg dose. The two most frequently reported AEs were those commonly associated with α1-adrenoceptor antagonists: dizziness and abnormal ejaculation. The incidence of dizziness was comparable for the 0.4 mg dose (0.5%) and placebo (1.4%) but higher with 0.8 and 1.2 mg (5.8% and 4.3%, respectively). The incidence of abnormal ejaculation was only marginally higher with 0.4 mg (2.0%) than placebo (0.9%) and showed a clear dose-response relationship with the higher doses of 0.8 mg (4.4%) and 1.2 mg (8.1%). All three tamsulosin OCAS doses tested were effective in relieving urinary symptoms and improving disease-specific quality of life in LUTS/BPH patients. The 0.8 mg and, in particular, the 0.4 mg doses were better tolerated than the 1.2 mg dose. Therefore, these two doses were selected for further evaluation in a phase 3a placebo- and comparator (tamsulosin modified release capsules) controlled trial. © 2004 Elsevier B.V. All rights reserved.