Claus G Roehrborn1, Franklin C Lowe2, Marc Gittelman3, Jan M Wruck4, Anna E Verbeek5,6. 1. University of Texas Southwestern Medical Center, Dallas, TX, USA. 2. Weiler Hospital, Albert Einstein College of Medicine, Bronx, NY, USA. 3. South Florida Medical Research, Uromedix/Division of 21st Century Oncology, Aventura, FL, USA. 4. Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT, USA. 5. Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT, USA. Annelies.Verbeek@Sanofi.com. 6. Sanofi, 55 Corporate Drive, Bridgewater, NJ, 08807, USA. Annelies.Verbeek@Sanofi.com.
Abstract
BACKGROUND: Lower urinary tract symptoms (LUTS) attributed to benign prostatic hyperplasia (BPH) are common in men, considerably affecting quality of life. AIMS: The self-directed use of over-the-counter (OTC) tamsulosin (0.4 mg) and potential safety risks were evaluated in an open-label, uncontrolled, exploratory, 8-week OTC-simulated study. METHODS: Men (≥ 18 years) were recruited via mass advertising about bothersome LUTS. In a working retail environment, respondents reviewed the product and decided whether it was appropriate for them to use (self-selection phase). After purchasing the product, participants' ability to use it as directed by the proposed drug facts label (DFL) was assessed (home-use phase). RESULTS: Of 1446 eligible men, 679 completed the self-selection phase, and 73.9% (502/679) self-selected to use tamsulosin correctly according to the DFL. Of 369 participants who purchased tamsulosin and entered the home-use phase, 321 took one or more doses of tamsulosin and participated in at least one telephone interview. In total, 85.4% (274/321) of participants adhered to the 'Stop Use' and 'Directions' instructions in the DFL. Overall, 139 (39.6%) participants experienced one or more adverse events (AEs); 65 (18.5%) were deemed drug-related, including dizziness (11 [3.1%]), ejaculation disorder (6 [1.7%]), and semen volume decrease (6 [1.7%]). No unexpected AEs were reported. CONCLUSIONS: Of the men interested in self-managing their LUTS, a majority had moderate-to-severe LUTS of long duration. Most men were able to appropriately self-select and use tamsulosin in concordance with DFL instructions and directions. No unexpected AEs were reported during self-directed use. With further label refinement, an over-the-counter tamsulosin option might be feasible. TRIAL REGISTRATION: ClinicalTrials.gov NCT01726270.
BACKGROUND: Lower urinary tract symptoms (LUTS) attributed to benign prostatic hyperplasia (BPH) are common in men, considerably affecting quality of life. AIMS: The self-directed use of over-the-counter (OTC) tamsulosin (0.4 mg) and potential safety risks were evaluated in an open-label, uncontrolled, exploratory, 8-week OTC-simulated study. METHODS:Men (≥ 18 years) were recruited via mass advertising about bothersome LUTS. In a working retail environment, respondents reviewed the product and decided whether it was appropriate for them to use (self-selection phase). After purchasing the product, participants' ability to use it as directed by the proposed drug facts label (DFL) was assessed (home-use phase). RESULTS: Of 1446 eligible men, 679 completed the self-selection phase, and 73.9% (502/679) self-selected to use tamsulosin correctly according to the DFL. Of 369 participants who purchased tamsulosin and entered the home-use phase, 321 took one or more doses of tamsulosin and participated in at least one telephone interview. In total, 85.4% (274/321) of participants adhered to the 'Stop Use' and 'Directions' instructions in the DFL. Overall, 139 (39.6%) participants experienced one or more adverse events (AEs); 65 (18.5%) were deemed drug-related, including dizziness (11 [3.1%]), ejaculation disorder (6 [1.7%]), and semen volume decrease (6 [1.7%]). No unexpected AEs were reported. CONCLUSIONS: Of the men interested in self-managing their LUTS, a majority had moderate-to-severe LUTS of long duration. Most men were able to appropriately self-select and use tamsulosin in concordance with DFL instructions and directions. No unexpected AEs were reported during self-directed use. With further label refinement, an over-the-counter tamsulosin option might be feasible. TRIAL REGISTRATION: ClinicalTrials.gov NCT01726270.
Authors: Karin S Coyne; Chris C Sexton; Christine L Thompson; Ian Milsom; Debra Irwin; Zoe S Kopp; Christopher R Chapple; Steven Kaplan; Andrea Tubaro; Lalitha P Aiyer; Alan J Wein Journal: BJU Int Date: 2009-03-05 Impact factor: 5.588
Authors: Nancy N Maserejian; Shan Chen; Gretchen R Chiu; Carrie G Wager; Varant Kupelian; Andre B Araujo; John B McKinlay Journal: Urology Date: 2013-07-19 Impact factor: 2.649