CompletedNot Applicable

Sertraline and the Risk of Serious Adverse Events

Canada6,893 participantsStarted 2008-01

Plain-language 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.

Who can participate

Age range66 Years

SexALL

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Exclusion criteria

✕. Individuals with missing administrative database number, missing or invalid age (\<0 or \>105 years), missing or invalid sex, death on or before the index date, non-Ontario resident (for Ontario data).
✕. Individuals less than 66 years of age on the index date.
✕. Those with evidence of any study drug prescription 180 days before the index date (to restrict to new users only).
✕. Individuals with other Selective Serotonin Reuptake Inhibitors (Citalopram, Escitalopram, Fluoxetine, Fluvoxamine, Paroxetine) prescription in the previous 180 days before the index date or on the index date.
✕. Individuals with more than one study drug prescription on the index date, as this complicates the ability to ascertain the prescribed dose accurately.
✕. Individuals with end-stage renal disease, chronic dialysis, or a kidney transplant prior to the index date.
✕. Evidence with hospital discharge or emergency department visit in the two days prior to or on the index date to ensure a new outpatient prescription.
✕. Individuals with no serum creatinine lab value in the 0-365 days prior to the index date.

What they're measuring

A composite outcome of all-cause hospitalization, all-cause emergency department visit, or all-cause mortality.

Timeframe: Older adults exposed to high-dose (50mg/day) vs low-dose (25 mg/day) Sertraline between Jan 1, 2008, and Jan 1,2025 will enter the cohort and will be followed until study outcome (first event), death, or 30 days from the cohort entry date

Trial details

NCT IDNCT07387120

SponsorLondon Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2025-01

View on ClinicalTrials.gov More Chronic Kidney Disease (CKD) trials