Osamu Yokoyama1, Akichika Ozeki2, Nahoko Suzuki3, Masahiro Murakami4. 1. Department of Urology, Faculty of Medical Science, University of Fukui, Fukui, Japan. 2. Medicines Development Unit Japan, Biometics, Asia Pacific Statistical Science-Japan, Eli Lilly Japan K.K., Kobe, Japan. 3. Medicines Development Unit Japan, Biometics, Japan Scientific Communications Biomedicines, Eli Lilly Japan K.K., Tokyo, Japan. 4. Medicines Development Unit, Eli Lilly and Company, Indianapolis, Indiana, USA.
Abstract
OBJECTIVES: To determine whether early changes in International Prostate Symptom Score predict final improvement in the quality of life and treatment satisfaction of patients with lower urinary tract symptoms from benign prostatic hyperplasia receivingtadalafil. METHODS: This post-hoc analysis of three randomized-controlled trials of tadalafil for lower urinary tract symptoms from benign prostatic hyperplasia used subpopulations based on treatment status (tadalafil, placebo) and region (Japan, Asia). Logistic regression, principal component analysis and hierarchical clustering analysis were applied to individual International Prostate Symptom Score and Patient Global Impression of Improvement response scores. RESULTS: From logistic regression, most individual International Prostate Symptom Score items predicted either International Prostate Symptom Score remitter or responder status; only International Prostate Symptom Score Quality of Life predicted Patient Global Impression of Improvement responder status in tadalafil-treated patients. Among tadalafil-treated patients, principal component analysis showewd that improvement of International Prostate Symptom Score items 2, 4, 7 and International Prostate Symptom Score Quality of Life at early visits were associated with Patient Global Impression of Improvement (final visit), whereas International Prostate Symptom Score items 1, 3, 5 and 6 at early visits were associated with total International Prostate Symptom Score at the final visit. No clear predictive items for Patient Global Impression of Improvement and total International Prostate Symptom Score existed for placebo-treated patients. Hierarchical clustering analysis showed that the closest association was between International Prostate Symptom Score Quality of Life and International Prostate Symptom Score item 7 in placebo- and tadalafil-treated patients, which supports the principal component analysis results. CONCLUSIONS: Early changes of storage and voiding symptoms by tadalafil might lead to treatment satisfaction and overall International Prostate Symptom Score improvement, respectively. This finding could help physicians predict tadalafil treatment outcomes for patients with lower urinary tract symptoms from benign prostatic hyperplasia.
RCT Entities:
OBJECTIVES: To determine whether early changes in International Prostate Symptom Score predict final improvement in the quality of life and treatment satisfaction of patients with lower urinary tract symptoms from benign prostatic hyperplasia receiving tadalafil. METHODS: This post-hoc analysis of three randomized-controlled trials of tadalafil for lower urinary tract symptoms from benign prostatic hyperplasia used subpopulations based on treatment status (tadalafil, placebo) and region (Japan, Asia). Logistic regression, principal component analysis and hierarchical clustering analysis were applied to individual International Prostate Symptom Score and Patient Global Impression of Improvement response scores. RESULTS: From logistic regression, most individual International Prostate Symptom Score items predicted either International Prostate Symptom Score remitter or responder status; only International Prostate Symptom Score Quality of Life predicted Patient Global Impression of Improvement responder status in tadalafil-treated patients. Among tadalafil-treated patients, principal component analysis showewd that improvement of International Prostate Symptom Score items 2, 4, 7 and International Prostate Symptom Score Quality of Life at early visits were associated with Patient Global Impression of Improvement (final visit), whereas International Prostate Symptom Score items 1, 3, 5 and 6 at early visits were associated with total International Prostate Symptom Score at the final visit. No clear predictive items for Patient Global Impression of Improvement and total International Prostate Symptom Score existed for placebo-treated patients. Hierarchical clustering analysis showed that the closest association was between International Prostate Symptom Score Quality of Life and International Prostate Symptom Score item 7 in placebo- and tadalafil-treated patients, which supports the principal component analysis results. CONCLUSIONS: Early changes of storage and voiding symptoms by tadalafil might lead to treatment satisfaction and overall International Prostate Symptom Score improvement, respectively. This finding could help physicians predict tadalafil treatment outcomes for patients with lower urinary tract symptoms from benign prostatic hyperplasia.
Authors: Yassine Kamal Lyauk; Daniël M Jonker; Trine Meldgaard Lund; Andrew C Hooker; Mats O Karlsson Journal: AAPS J Date: 2020-08-27 Impact factor: 4.009