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Nortriptyline and the Risk of Serious Adverse Events
Sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Summary
This is a population-based retrospective, new-user, active comparator cohort study assessing whether initiating a new outpatient prescription of high-dose nortriptyline (\>10-150 mg/day), compared with low dose (10 mg/day), is associated with an increased 30-day risk of serious adverse events among older adults with low kidney function (estimated glomerular filtration rate \[eGFR\] \<45 ml/min/1.73m2) who are not receiving dialysis and have no history of kidney transplantation. The primary outcome is a 30-day composite of all-cause emergency department visit, all-cause hospitalization, or all-cause mortality.
Official title: Nortriptyline Dose and the Risk of Serious Adverse Events in Older Adults With Low Kidney Function: A Population-Based Cohort Study Research Protocol
Key Details
Gender
All
Age Range
66 Years - Any
Study Type
OBSERVATIONAL
Enrollment
5000
Start Date
2008-01-01
Completion Date
2025-12-31
Last Updated
2026-04-14
Healthy Volunteers
No
Conditions
Interventions
Nortriptyline Hydrochloride
The primary exposure of interest will be oral nortriptyline at a dose of \>10-150 mg/day. For the primary comparison, oral nortriptyline at 10 mg/day will serve as the referent group to reduce confounding by indication.