Yasunari Hiramine1, Haruki Uojima2, Hiroyuki Nakanishi3, Akira Hiramatsu4, Takuya Iwamoto5, Mutsuumi Kimura6, Hideto Kawaratani7, Shuji Terai8, Hitoshi Yoshiji7, Hirofumi Uto9, Isao Sakaida5, Namiki Izumi3, Kiwamu Okita10, Kazuhiko Koike11. 1. Department of Internal Medicine, Kagoshima Kouseiren Hospital, 22-25 Tenpozancho, Kagoshima, 890-0061, Japan. hiramine0630@yahoo.co.jp. 2. Department of Gastroenterology, Internal Medicine, Kitasato University School of Medicine, 1-15-1 Kitasato, Minami-ku, Sagamihara, Kanagawa, 252-0375, Japan. 3. Department of Gastroenterology and Hepatology, Musashino Red Cross Hospital, 1-26-1 Kyonancho, Musashino-shi, Tokyo, 180-8610, Japan. 4. Department of Gastroenterology and Metabolism, Applied Life Sciences, Institute of Biomedical and Health Sciences, Hiroshima University, 1-2-3 Kasumi, Minami-ku, Hiroshima, 734-8551, Japan. 5. Department of Gastroenterology and Hepatology, Yamaguchi University Graduate School of Medicine, 1-1-1 Minamikogushi, Ube-shi, Yamaguchi, 755-8505, Japan. 6. Department of Hepatology, Sapporo Kosei General Hospital, 8-5 Kitasanzyo-higashi, Chuo-ku, Sapporo, Hokkaido, 060-0033, Japan. 7. Third Department of Internal Medicine, Nara Medical University, 840 Shijocho, Kashihara-shi, Nara, 634-8521, Japan. 8. Division of Gastroenterology and Hepatology, Graduate School of Medical and Dental Sciences, Niigata University, 1-757 Asahimachi-dori, Chuo-ku, Niigata, 951-8510, Japan. 9. Center for Digestive and Liver Diseases, Miyazaki Medical Center Hospital, 2-16 Takamatsu-cho, Miyazaki, 880-0003, Japan. 10. Shunan Memorial Hospital, 1-10-1 Ikunoyaminami, Kudamatsu-shi, Yamaguchi, 744-0033, Japan. 11. Department of Gastroenterology, The University of Tokyo, 7-3-1 Hongo, Bunkyo-ku, Tokyo, 113-8655, Japan.
Abstract
BACKGROUND: Although tolvaptan is an effective treatment for hepatic edema, there are no established criteria for assessment of the therapeutic effect. The present study evaluates the association between body weight change and clinical symptoms to identify an effective indicator of tolvaptan response. METHODS: The study comprised 460 patients. The first data set contained 147 patients with hepatic edema who received tolvaptan in Kagoshima Kouseiren Hospital, a representative institution of this study. From these data, an optimal cutoff value of body weight change, which accurately indicated symptom reduction, was identified. The response rates obtained based on the cutoff value were evaluated by receiver-operating characteristic (ROC) analysis and kappa coefficients. The kappa coefficient was then validated internally using the bootstrap method and externally using the validation data set of 313 patients from four other hospitals. RESULTS: A cutoff value for body weight loss of 1.5 kg/week produced the largest area under the ROC curve (0.961; sensitivity, 89.8%; specificity, 92.0%) and a high kappa coefficient (0.831). The correlation between symptom reduction and body weight loss of 1.5 kg/week was evaluated internally and externally, and the cutoff value was validated. CONCLUSIONS: The cutoff value of body weight change that most accurately reflected symptom reduction was 1.5 kg/week; this value is expected to be an effective indicator of response to tolvaptan in clinical practice.
BACKGROUND: Although tolvaptan is an effective treatment for hepatic edema, there are no established criteria for assessment of the therapeutic effect. The present study evaluates the association between body weight change and clinical symptoms to identify an effective indicator of tolvaptan response. METHODS: The study comprised 460 patients. The first data set contained 147 patients with hepatic edema who received tolvaptan in Kagoshima Kouseiren Hospital, a representative institution of this study. From these data, an optimal cutoff value of body weight change, which accurately indicated symptom reduction, was identified. The response rates obtained based on the cutoff value were evaluated by receiver-operating characteristic (ROC) analysis and kappa coefficients. The kappa coefficient was then validated internally using the bootstrap method and externally using the validation data set of 313 patients from four other hospitals. RESULTS: A cutoff value for body weight loss of 1.5 kg/week produced the largest area under the ROC curve (0.961; sensitivity, 89.8%; specificity, 92.0%) and a high kappa coefficient (0.831). The correlation between symptom reduction and body weight loss of 1.5 kg/week was evaluated internally and externally, and the cutoff value was validated. CONCLUSIONS: The cutoff value of body weight change that most accurately reflected symptom reduction was 1.5 kg/week; this value is expected to be an effective indicator of response to tolvaptan in clinical practice.
Authors: P Angeli; S Fasolato; E Mazza; L Okolicsanyi; G Maresio; E Velo; A Galioto; F Salinas; M D'Aquino; A Sticca; A Gatta Journal: Gut Date: 2010-01 Impact factor: 23.059