Serotonin-norepinephrine Reuptake Inhibitors and Acute Kidney Injury

NCT02320240 | Completed

• 1 other identifier: Q12-08
• Study Type: observational
• Target: 3,255,526
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Depression; Acute Kidney Injury

Keywords

antidepressants; acute kidney injury; SNRI; renal failure; duloxetine; CNODES

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

SNRI Exposure Group

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; Drug: Venlafaxine; Drug: Desvenlafaxine

SSRI Exposure Group

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; Drug: Escitalopram; Drug: Fluoxetine; Drug: Fluvoxamine; Drug: Paroxetine; Drug: Sertraline

Interventions

Duloxetine DRUG

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.

SNRI Exposure Group

Venlafaxine DRUG

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.

SNRI Exposure Group

Desvenlafaxine DRUG

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.

SNRI Exposure Group

Citalopram DRUG

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.

SSRI Exposure Group

Escitalopram DRUG

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.

SSRI Exposure Group

Fluoxetine DRUG

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.

SSRI Exposure Group

Fluvoxamine DRUG

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.

SSRI Exposure Group

Paroxetine DRUG

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.

SSRI Exposure Group

Sertraline DRUG

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.

SSRI Exposure Group

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The cohort will be formed of all patients in the databases aged 12 or older (or 65 or older in some of the databases) with a first prescription of an antidepressant of the SNRI or SSRI class of any dose between January 1, 1997 and March 31, 2010. The databases to be included are eight administrative databases from Canada (Alberta, Manitoba, Nova Scotia, Ontario, Quebec, and Saskatchewan), the United States (US MarketScan), and the United Kingdom (CPRD).

You may qualify if:

• A first prescription of an antidepressant of the SNRI or SSRI class of any dose between January 1, 1997 and March 31, 2010.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Canadian Network for Observational Drug Effect Studies, CNODES: lead
• Drug Safety and Effectiveness Network, Canada: collaborator
• Canadian Institutes of Health Research (CIHR): collaborator

Study Sites (1)

Lady Davis Institute for Medical Research, Jewish General Hospital

Montreal, Quebec, H3T1E2, Canada

Location

Related Publications (1)

• Renoux C, Lix LM, Patenaude V, Bresee LC, Paterson JM, Lafrance JP, Tamim H, Mahmud SM, Alsabbagh MW, Hemmelgarn B, Dormuth CR, Ernst P; Canadian Network of Observational Drug Effect Studies (CNODES) Investigators. Serotonin-Norepinephrine Reuptake Inhibitors and the Risk of AKI: A Cohort Study of Eight Administrative Databases and Meta-Analysis. Clin J Am Soc Nephrol. 2015 Oct 7;10(10):1716-22. doi: 10.2215/CJN.11271114. Epub 2015 Jul 31.

  PMID: 26231193 RESULT

Related Links

• This organization's website describing general functions, other CNODES projects, and investigator profiles.

MeSH Terms

Conditions

Depression; Acute Kidney Injury; Renal Insufficiency

Interventions

Duloxetine Hydrochloride; Venlafaxine Hydrochloride; Desvenlafaxine Succinate; Citalopram; Escitalopram; Fluoxetine; Fluvoxamine; Paroxetine; Sertraline

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Thiophenes; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Cyclohexanols; Hexanols; Fatty Alcohols; Alcohols; Phenethylamines; Ethylamines; Amines; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Lipids; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Propylamines; Nitriles; Benzofurans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Oximes; Hydroxylamines; Piperidines; 1-Naphthylamine; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Officials

• Pierre Ernst, MD, MSc

  Lady Davis Institute for Medical Research, Jewish General Hospital - McGill University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 16, 2014
• First Posted: December 19, 2014
• Study Start: June 1, 2013
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: March 14, 2016

Record last verified: 2016-03

Locations

CA (1)