Serotonin-norepinephrine Reuptake Inhibitors and Acute Kidney Injury

Study Overview
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Brief Summary
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The purpose of this study is to determine if there is an excess risk of acute kidney injury (AKI) with Serotonin-norepinephrine reuptake inhibitors (SNRIs) as compared to Selective serotonin reuptake inhibitors (SSRIs), two classes of medication used for the treatment of depression.

Detailed Description
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We plan to conduct retrospective population-based cohort studies within eight administrative databases from Canada, the United States, and the United Kingdom. Within each cohort, a nested case-control analysis will be performed to estimate incidence rate ratios (RR) of AKI associated with SNRIs compared to SSRIs using conditional logistic regression, with adjustment for high-dimensional propensity scores at baseline. The overall effect across sites will then be estimated using meta-analytic methods.

Official Title
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Serotonin-norepinephrine Reuptake Inhibitors and Acute Kidney Injury

Conditions
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Depression, Acute Kidney Injury

Intervention / Treatment
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* Drug: Duloxetine
* Drug: Venlafaxine
* Drug: Desvenlafaxine
* Drug: Citalopram
* Drug: Escitalopram
* Drug: Fluoxetine
* Drug: Fluvoxamine
* Drug: Paroxetine
* Drug: Sertraline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: A first prescription of an antidepressant of the SNRI or SSRI class of any dose between January 1, 1997 and March 31, 2010. Exclusion Criteria: They were <12 years old at the time of cohort entry. They had less than 1 year of information in the database prior to the date of cohort entry. They had a prescription of an SNRI or SSRI in the year before the date of cohort entry. They had a prescription for both an SNRI and an SSRI on the day of cohort entry. They had a history of chronic kidney disease (including kidney transplantation and dialysis) or AKI in the year preceding cohort entry. The subject was previously included in the cohort.

Ages Eligible for Study
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Minimum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| SNRI Exposure Group<br>Patients who received a new prescription for an SNRI (duloxetine, venlafaxine, or desvenlafaxine at any dosage) with no prescriptions for either SNRI or SSRI in the prior year. | Drug: Duloxetine<br>* Current exposure to Duloxetine will be defined as a prescription lasting until the index date or dispensed in the 60 days before the index date.<br>Drug: Venlafaxine<br>* Current exposure to Venlafaxine will be defined as a prescription lasting until the index date or dispensed in the 60 days before the index date.<br>Drug: Desvenlafaxine<br>* Current exposure to Desvenlafaxine will be defined as a prescription lasting until the index date or dispensed in the 60 days before the index date.<br>|
| SSRI Exposure Group<br>Patients who received a new prescription for an SSRI (citalopram, escitalopram, fluoxetine, fluvoxamine, paroxetine, or sertraline at any dosage) with no prescriptions for either SSRI or SNRI in the prior year. | Drug: Citalopram<br>* Current exposure to Citalopram will be defined as a prescription lasting until the index date or dispensed in the 60 days before the index date.<br>Drug: Escitalopram<br>* Current exposure to Escitalopram will be defined as a prescription lasting until the index date or dispensed in the 60 days before the index date.<br>Drug: Fluoxetine<br>* Current exposure to Fluoxetine will be defined as a prescription lasting until the index date or dispensed in the 60 days before the index date.<br>Drug: Fluvoxamine<br>* Current exposure to Fluvoxamine will be defined as a prescription lasting until the index date or dispensed in the 60 days before the index date.<br>Drug: Paroxetine<br>* Current exposure to Paroxetine will be defined as a prescription lasting until the index date or dispensed in the 60 days before the index date.<br>Drug: Sertraline<br>* Current exposure to Sertraline will be defined as a prescription lasting until the index date or dispensed in the 60 days before the index date.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acute Kidney Injury (AKI) | AKI will be defined as patients hospitalized with one of the following diagnosis codes for AKI in any of the listed diagnoses: ICD-9-CM codes 584, 584.5, 584.6, 584.7, 584.8, or 584.9; ICD-10 N17, N17.0, N17.1, N17.2, N17.8, or N17.9. | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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antidepressants, acute kidney injury, SNRI, renal failure, duloxetine, CNODES