Randomized, double blinded, placebo-controlled trial to evaluate the efficacy and safety of tolvaptan in Chinese patients with hyponatremia caused by SIADH
| Autor: | Jia-Jun Zhao, Xiaohui Guo, Gang-yi Yang, Zhen-Wen Zhang, Nanwei Tong, Jian-Hua Ma, Shi Chen, Ming-Cai Qiu, Feng Gu, Zhi-min Liu |
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| Rok vydání: | 2014 |
| Předmět: |
Adult
Male medicine.medical_specialty Tolvaptan Placebo-controlled study Placebo Gastroenterology Thirst Inappropriate ADH Syndrome Young Adult Double-Blind Method Internal medicine Clinical endpoint Humans Medicine Pharmacology (medical) Adverse effect Aged Pharmacology business.industry Sodium Benzazepines Middle Aged medicine.disease Treatment Outcome Endocrinology Female medicine.symptom business Hyponatremia Antidiuretic Hormone Receptor Antagonists Antidiuretic medicine.drug |
| Zdroj: | The Journal of Clinical Pharmacology. 54:1362-1367 |
| ISSN: | 0091-2700 |
| Popis: | To study the effect of tolvaptan on non-acute, non-hypovolemic hyponatremia in inappropriate secretion of antidiuretic hormone (SIADH) syndrome in Chinese patients. Hyponatremic SIADH patients received placebo (N = 18) or tolvaptan (N = 19) at an initial dose of 15 mg/day with further titration to 30 mg/day and 60 mg/day based on serum sodium concentrations. Randomized, double-blind, placebo-controlled trial. Primary endpoint was the change of the serum sodium from baseline to days 4 and 7. Analysis of covariance (ANCOVA) was used for statistical analysis. At day 4, average daily changes in serum sodium levels from baseline was 1.9 ± 2.9 mmol/L (1.9 ± 2.9 mEq/L) in the placebo group and 8.1 ± 3.6 mmol/L (8.1 ± 3.6 mEq/L) in the tolvaptan group; at day 7, the values were 2.5 ± 3.9 mmol/L (2.5 ± 3.9 mEq/L) and 8.6 ± 3.9 mmol/L (8.6 ± 3.9 mmEq/L) for the placebo and tolvaptan groups (ANCOVA, P |
| Databáze: | OpenAIRE |
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