Safety and Efficacy of Tolvaptan in Korean Patients with Hyponatremia Caused by the Syndrome of Inappropriate Antidiuretic Hormone

Background: The aim of this multicenter study was to evaluate the safety and efficacy of tolvaptan (TLV) in Korean patients with the syndrome of inappropriate secretion of antidiuretic hormone (SIADH).Methods: Of 51 enrolled patients with SIADH, 39 patients (16 female patients, aged 70.8 +/- 11.3 years) were included in an intention to treat analysis. All patients received 15 mg/day as the initial dose, and the dose was then increased up to 60 mg/day (as needed) until day 4.Results: Serum sodium increased significantly from baseline during the first 24 hours (126.8 +/- 4.3 vs. 133.7 +/- 3.8 mmol/L, P < 0.001), rose gradually between days 1 and 4 (133.7 +/- 3.8 vs. 135.6 +/- 3.6 mmol/L, P < 0.05), and then plateaued until day 11 (136.7 +/- 4.5 mmol/L). The correlation between the change in serum sodium for the first 24 hours and initial serum sodium concentration was significant (r = -0.602, P < 0.001). In severe hyponatremia (< 125 mmol/L), the change was significantly higher (11.1 +/- 4.8 mmol/L) than in moderate (6.4 +/- 2.5 mmol/L, P < 0.05) or mild hyponatremia (4.3 +/- 3.3 mmol/L, P < 0.01). In addition, logistic regression analysis showed that body weight (odds ratio [OR], 0.858; 95% confidence interval [CI], 0.775-0.976; P = 0.020) and body mass index (BMI) (OR, 0.692; 95% CI, 0.500-0.956; P = 0.026) were associated with rapid correction. No serious adverse events were reported, but in 13% of patients hyponatremia was overcorrected.Conclusion: TLV is effective in correcting hyponatremia and well-tolerated in Korean patients with SIADH. However, those with low body weight, low BMI or severe hyponatremia, could be vulnerable to overcorrection with the initial dose of 15 mg TLV.This study was funded by Korea Otsuka Pharmaceutical Co., Ltd. in 2012

WAY-POINT BASED BIOMEDICAL AGENT DELIVERY SYSTEM FOR LESION AND METHOD FOR GENERATING DATA OF WAY-POINT ROUTE

본 발명은 영상 데이터를 생성하는 내시경, 내시경이 생성한 영상 데이터를 표시하는 영상 표시부, 사용자 조작명령을 입력받아 움직임 제어명령을 생성하는 마스터부, 및 조향 와이어를 포함하는 조향 카테터가 구비되어 구동할 수 있는 슬레이브부를 포함하는, 강내 병변부 치료물질 전달 시스템 및 강내 병변부의 치료물질 도포가 필요한 부위의 웨이-포인트 경로 데이터 생성 방법에 관한 것이다