항이뇨호르몬분비이상증후군 환자에서 Tolvaptan과 3% 염화나트륨의 저나트륨혈증 개선 효과 평가
Comparison Between Tolvaptan and Three Percent Sodium Chloride in Hyponatremia of Syndrome of Inappropriate Secretion of Anti-Diuretic Hormone Patients
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Background : The syndrome of inappropriate secretion of anti-diuretic Hormone (SIADH) is a disease, characterized by water retention and hyponatremia. According to the American Journal of Medicine treatment guideline, the administration of hypertonic saline (3% sodium chloride, 3% NaCl) is recommended for patients, who don’t respond to water restriction. Vasopressin V2 receptor antagonists such as tolvaptan can be administered to patients whose blood sodium concentration is not normalized by 3% NaCl or who have moderate to severe hyponatremia. However, the study that directly compared the effects of the two drugs was insufficient to evaluate the effect of vasopressin receptor antagonist and 3% NaCl. The purpose of this study was to compare and evaluate the effect of the tolvaptan tablet and 3% NaCl injection. Methods: From June 2015 through August 2016, all patients diagnosed as SIADH, with hyponatremia ([Na+]<135 mEq/L), were administered tolvaptan (T-group) or 3% NaCl (N-group). We analyzed electronic medical records retrospectively. Results : The mean daily dose of each drug was 14.5 mg of tolvaptan, 428.2 ml of 3% NaCl, and the serum sodium levels significant increased after administration in the T-group (n=26) and the N-group (n=79) (p<0.0001, respectively). In particular, an average increase of 11.6 mEq/L in the T-group and 6.5 mEq/L in the N-group was achieved during the first 24 hours (p<0.0001), and 12.6 mEq/L in the T-group and 9.5 mEq/L in the N group for 48 hours (p<0.0001), showing significant increases in the T-group. There was no significant difference in the proportion of patients with normalized serum sodium level following treatment (96.2% for the T-group, 81.0% for the N-group, p=0.111), and the mean number of days to normalization was significantly shorter for the T-group 1.4 days and 3.7 days for the N-group (p<0.0001). Side effects were nausea and vomiting in 3.9% (one patient) of the T-group, sensory abnormality and weakness in 2.5% (two patients) of the N-group. Average price per patient during treatment was 62,368 won in the T-group, and 11,682 won in the N-group (p<0.0001). Conclusion : Both drugs showed improvement in hyponatremia in SIADH patients, and tolvaptan made more rapid increase in sodium level in the blood compared to 3% NaCl. However, since the change in serum sodium due to tolvaptan is close to the recommended upper limit (within 12 mEq/L per 24 hours), there is risk of potential side effects. Thus, careful monitoring of sodium levels and dose adjustments are needed and also, it is necessary to select a medicine in consideration of the cost.
Abstract
Background : The syndrome of inappropriate secretion of anti-diuretic Hormone (SIADH) is a disease, characterized by water retention and hyponatremia. According to the American Journal of Medicine treatment guideline, the administration of hypertonic saline (3% sodium chloride, 3% NaCl) is recommended for patients, who don’t respond to water restriction. Vasopressin V2 receptor antagonists such as tolvaptan can be administered to patients whose blood sodium concentration is not normalized by 3% NaCl or who have moderate to severe hyponatremia. However, the study that directly compared the effects of the two drugs was insufficient to evaluate the effect of vasopressin receptor antagonist and 3% NaCl. The purpose of this study was to compare and evaluate the effect of the tolvaptan tablet and 3% NaCl injection. Methods: From June 2015 through August 2016, all patients diagnosed as SIADH, with hyponatremia ([Na+]<135 mEq/L), were administered tolvaptan (T-group) or 3% NaCl (N-group). We analyzed electronic medical records retrospectively. Results : The mean daily dose of each drug was 14.5 mg of tolvaptan, 428.2 ml of 3% NaCl, and the serum sodium levels significant increased after administration in the T-group (n=26) and the N-group (n=79) (p<0.0001, respectively). In particular, an average increase of 11.6 mEq/L in the T-group and 6.5 mEq/L in the N-group was achieved during the first 24 hours (p<0.0001), and 12.6 mEq/L in the T-group and 9.5 mEq/L in the N group for 48 hours (p<0.0001), showing significant increases in the T-group. There was no significant difference in the proportion of patients with normalized serum sodium level following treatment (96.2% for the T-group, 81.0% for the N-group, p=0.111), and the mean number of days to normalization was significantly shorter for the T-group 1.4 days and 3.7 days for the N-group (p<0.0001). Side effects were nausea and vomiting in 3.9% (one patient) of the T-group, sensory abnormality and weakness in 2.5% (two patients) of the N-group. Average price per patient during treatment was 62,368 won in the T-group, and 11,682 won in the N-group (p<0.0001). Conclusion : Both drugs showed improvement in hyponatremia in SIADH patients, and tolvaptan made more rapid increase in sodium level in the blood compared to 3% NaCl. However, since the change in serum sodium due to tolvaptan is close to the recommended upper limit (within 12 mEq/L per 24 hours), there is risk of potential side effects. Thus, careful monitoring of sodium levels and dose adjustments are needed and also, it is necessary to select a medicine in consideration of the cost.
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