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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
• 2 identical studies for comparing results
• Conducted at 42 centers in US and 50
Conducted international centers
• Participants received oral tolvaptan 15mg
or placebo for 30days.
• Primary end points- change in Serum Na
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
study Serum sodium levels in marked
HN Adverse events
• Tolvaptan was superior to placebo in the
Tolvaptan treatment of hy...
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This note was uploaded on 12/24/2011 for the course STEP 1 taught by Professor Dr.aslam during the Fall '11 term at Montgomery College.
- Fall '11