Status:
COMPLETED
Lorazepam and the Risk of Serious Adverse Events
Lead Sponsor:
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Conditions:
Chronic Kidney Disease (CKD)
Eligibility:
All Genders
66+ years
Brief Summary
This is a population-based cohort study assessing whether initiating a new outpatient prescription of a higher dose of lorazepam (\>1-4 mg/day) compared to a lower dose (0.5-1 mg/day) in older adults ...
Detailed Description
\*Summary\* Background: Benzodiazepine use in older adults is associated with a higher risk of falls, fractures, hospitalizations, emergency visits, and mortality. Despite warnings from Health Canad...
Eligibility Criteria
Inclusion
- The cohort will include older adults aged 66 years or greater 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 lorazepam at an outpatient pharmacy with a dose range of 0.5-4 mg/day and a day supply of ≥5 days from January 1, 2008, to September 1, 2024 for Ontario; dates in Alberta to be finalized based on data availability.
Exclusion
- 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), or non-Alberta residents (for Alberta 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 benzodiazepine and benzodiazepine-related drugs (alprazolam, bromazepam, chlordiazepoxide, clobazam, clonazepam, clorazepate, diazepam, ketazolam, midazolam, estazolam, flurazepam, nitrazepam, oxazepam, temazepam, triazolam, eszopiclone, zopiclone, and zolpidem) 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.
- Evidence of other related drugs (melatonin, trazodone, doxepin, and suvorexant) and non-oral formulations of the study drugs in the previous 180 days, including the index date.
- 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.
- Individuals with unstable baseline kidney function:
- If the most recent serum creatinine test prior to the index date was an inpatient test \[ER or hospitalization\] \<refer to this as test date 1\>, and there is not at least one 'outpatient' serum creatinine in the year before test date 1, OR
- If the most recent prior serum creatinine test prior to the index date was an inpatient test \[ER or hospitalization\] \<refer to this as test date 1\>, and while there is at least 'outpatient' serum creatinine test in the year before \<test date 1\>, the most recent outpatient test prior to \<test date 1\> differs by an eGFR 10 mL/min/1.73 m2 or more from the value on \<test date 1\>.
- In Ontario, it has been shown that outpatient serum creatinine measurements in the province, conducted on a single occasion, indicate stable values.
- Individuals receiving palliative care in the 0-365 days prior to the index date, in this setting, dosing is less relevant; rather, the focus is comfort care.
- The investigators restrict to the first prescription in individuals with more than one eligible prescription. Date of this prescription will be the index date (the Date from which the outcomes start being assessed).
Key Trial Info
Start Date :
January 1 2008
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
October 1 2024
Estimated Enrollment :
12308 Patients enrolled
Trial Details
Trial ID
NCT07179978
Start Date
January 1 2008
End Date
October 1 2024
Last Update
September 24 2025
Active Locations (1)
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1
London Health Sciences Centre Research Institute
London, Ontario, Canada