At a glance
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Nortriptyline Dose and the Risk of Serious Adverse Events in Older Adults With Low Kidney Function: A Population-Based Cohort Study Research Protocol
In Brief
An observational study evaluating Nortriptyline Hydrochloride for Chronic Kidney Disease. Completed, enrolled 5,000 participants.
Signals
Detailed 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.
Study Details
Timeline
Arms & Interventions
Residents of Ontario, aged 66 years or older with low kidney function (an eGFR \<45 mL/min per 1.73 m² but not receiving dialysis or having a history of kidney transplantation) who have filled a new oral prescription for nortriptyline (low dose 10 mg/day) at an outpatient pharmacy under the Ontario Drug Benefit program from January 01, 2008, to December 01, 2025. The date when the prescription was filled will serve as the patient's entry or index date for the cohort, with each patient entering the cohort only once. If the investigators conduct the study in Alberta, the accrual period for Alberta will be determined.
Residents of Ontario, aged 66 years or older with low kidney function (an eGFR \<45 mL/min per 1.73 m² but not receiving dialysis or having a history of kidney transplantation) who have filled a new oral prescription for nortriptyline (high dose \>10-150 mg/day) at an outpatient pharmacy under the Ontario Drug Benefit program from January 01, 2008, to December 01, 2025. The date when the prescription was filled will serve as the patient's entry or index date for the cohort, with each patient entering the cohort only once. If the investigators conduct the study in Alberta, the accrual period for Alberta will be determined.
Interventions
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.