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Sertraline and the Risk of Serious Adverse Events
Sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Summary
The goal of this population-based cohort study is to assess the safety of initiating a new outpatient prescription of 50 mg/day of Sertraline, a higher dose, compared to 25 mg/day, a lower dose, in adults aged 65+ with low kidney function. The primary question is whether initiating a new outpatient prescription of a higher dose of Sertraline (50mg/day) compared to a lower dose (25 mg/day) in older adults with low kidney function (an eGFR \<45 mL/min per 1.73 m2, but not receiving dialysis or having a history of kidney transplantation) is associated with a higher 30-day risk. The outcome measured will be a composite of all-cause hospitalization, all-cause emergency department visit, or all-cause mortality.
Official title: Sertraline 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
6893
Start Date
2008-01-01
Completion Date
2027-12-31
Last Updated
2026-09-14
Healthy Volunteers
No
Interventions
Sertraline 50 mg
The primary exposure of interest will be oral Sertraline at a dose of 50 mg/day.
Sertraline 25 mg
The primary exposure of interest will be oral Sertraline at a dose of 25 mg/day.
Locations (1)
London Health Sciences Centre Research Institute
London, Ontario, Canada