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Nejm 2006 3552099 2112 nejm study methods study 2

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Unformatted text preview: dy efficacy of tolvaptan in patients with euvolemic or hypervolemic hyponatremia. (NEJM 2006; 355:2099-2112) (NEJM Study methods Study • 2 identical studies for comparing results identical • Conducted at 42 centers in US and 50 Conducted international centers • Participants received oral tolvaptan 15mg Participants or placebo for 30days. • Primary end points- change in Serum Na Primary from baseline to day 4 and day 30. Study Demographics Study SALT- 1 SALT SALT - 2 SALT Results- change in area under the Results change curve for serum sodium- Day 4 Change in serum sodium - day 30 Change Efficacy analysis Efficacy Serum sodium levels during Serum study Serum sodium levels in marked Serum HN Adverse events Adverse Conclusions Conclusions • Tolvaptan was superior to placebo in the Tolvaptan treatment of hy...
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