Masayuki Takeda1, Osamu Yokoyama2, Masaki Yoshida3, Osamu Nishizawa4, Kinya Hirata5, Ryuhei Nakaoka6, Yasushi Takita7, Masahiro Murakami8. 1. Department of Urology, Division of Clinical Research, Graduate Faculty of Interdisciplinary Research, University of Yamanashi, Yamanashi, Japan. 2. Department of Urology, Faculty of Medical Science, University of Fukui, Fukui, Japan. 3. Department of Urology, National Center for Geriatrics and Gerontology, Obu, Japan. 4. Department of Urology, North Alps Medical Center Azumi Hospital, Kitaazumigun Ikedamachi, Japan. 5. Clinical Development Department Tokyo, Nippon Shinyaku, Tokyo, Japan. 6. Biostatistics and Data Management Department, Nippon Shinyaku, Kyoto, Japan. 7. Asia-Pacific Statistical Science, Medicines Development Unit-Japan, Eli Lilly Japan, Kobe, Japan. 8. Medicines Development Unit, Eli Lilly and Company, Indianapolis, Indiana, USA.
Abstract
OBJECTIVES: To evaluate the safety and efficacy of tadalafil plus α1 -blocker combination therapy in Japanese patients with lower urinary tract symptoms suggestive of benign prostatic hyperplasia. METHODS: The present multicenter, randomized, double-blind, placebo-controlled, two-period cross-over study compared the effects of tadalafil and a placebo added to ongoing α1 -blocker therapy. A total of 171 Japanese patients were randomized. RESULTS:Tadalafil combined with an α1 -blocker did not decrease blood pressure in the orthostatic test. The only statistically significant differences in vital signs between the combination and monotherapy groups were diastolic blood pressure and pulse (P = 0.0194 and 0.0313, respectively). However, these changes were not considered clinically meaningful. Treatment-related adverse events occurred in 28.1% (47/167) and 24.2% (39/161) of patients in the combination therapy and α1 -blocker monotherapy groups, respectively. Additionally, 56.7% (89/157) of patients preferred combination therapy to monotherapy, though this was not statistically significant (P = 0.0937). There was a statistically significant reduction in the International Prostate Symptom Score voiding subscore in the combination therapy group (P = 0.0442). CONCLUSIONS: Concurrent treatment with tadalafil and an α1 -blocker seems to be safe and well tolerated in Japanese patients with lower urinary tract symptoms suggestive of benign prostatic hyperplasia. Adding tadalafil to baseline α1 -blocker therapy does not translate in adverse effects on the blood pressure. Patients tend to prefer combination therapy over monotherapy, and there seems to be a clinical benefit when using combination therapy.
RCT Entities:
OBJECTIVES: To evaluate the safety and efficacy of tadalafil plus α1 -blocker combination therapy in Japanese patients with lower urinary tract symptoms suggestive of benign prostatic hyperplasia. METHODS: The present multicenter, randomized, double-blind, placebo-controlled, two-period cross-over study compared the effects of tadalafil and a placebo added to ongoing α1 -blocker therapy. A total of 171 Japanese patients were randomized. RESULTS:Tadalafil combined with an α1 -blocker did not decrease blood pressure in the orthostatic test. The only statistically significant differences in vital signs between the combination and monotherapy groups were diastolic blood pressure and pulse (P = 0.0194 and 0.0313, respectively). However, these changes were not considered clinically meaningful. Treatment-related adverse events occurred in 28.1% (47/167) and 24.2% (39/161) of patients in the combination therapy and α1 -blocker monotherapy groups, respectively. Additionally, 56.7% (89/157) of patients preferred combination therapy to monotherapy, though this was not statistically significant (P = 0.0937). There was a statistically significant reduction in the International Prostate Symptom Score voiding subscore in the combination therapy group (P = 0.0442). CONCLUSIONS: Concurrent treatment with tadalafil and an α1 -blocker seems to be safe and well tolerated in Japanese patients with lower urinary tract symptoms suggestive of benign prostatic hyperplasia. Adding tadalafil to baseline α1 -blocker therapy does not translate in adverse effects on the blood pressure. Patients tend to prefer combination therapy over monotherapy, and there seems to be a clinical benefit when using combination therapy.