HypercholesterolemiaNCT02518516
High Potency Statins and Acute Kidney Injury
An observational study of Hypercholesterolemia, run by Canadian Network for Observational Drug Effect Studies, CNODES at 1 site in Canada.
Trial summary
Statins are a class of cholesterol lowering medications that are prescribed for the prevention and treatment of cardiovascular disease. The purpose of this study is to determine if there is an excess risk of acute kidney injury (AKI) with high potency statins compared to low potency statins. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Hypercholesterolemia
- What is being tested?
- Rosuvastatin (≥10 mg), Atorvastatin (≥20 mg) and Simvastatin (≥40 mg)
- How many people
- 2,067,639 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2011to Jan 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: In each jurisdiction, the investigators will assemble a study cohort that includes all patients with a new prescription for a statin, including simvastatin, lovastatin, pravastatin, fluvastatin, atorvastatin, and rosuvastatin between 1 January 1997 (or one year after the beginning of data availability) and 30 April 2008. The date of study cohort entry is defined by the prescription date of the newly-prescribed statin. Two separate cohorts will be created based on the presence or absence of a history of chronic kidney disease.
Who may be able to join
- Patients with a new prescription for a statin from the earliest availability of data at each site to the last date of availability of data +365 days
- Patients who are at least 40 years of age at cohort entry
- Patients with at least one year of history in the database
Who cannot join
- Patients under the age of 40 (<66 in jurisdictions with drug data for seniors only)
- Patients with less than one year of history in the database
- Patients who received any cholesterol lowering drugs (including fibrates, niacin and ezetimibe) or underwent dialysis or a kidney transplant in the previous year
Trial locations and contacts
1 site in 1 country.
Canada1 site
Dept. of Anesthesiology, Pharmacology & Therapeutics (APT), University of British Columbia
Vancouver, British Columbia, V6T 1Z3
About this study
Official title: Use of High Potency Statins and Rates of Admission for Acute Kidney Injury: Multicenter, Retrospective Observational Analysis of Administrative Databases
Statins are a class of cholesterol lowering medications that are prescribed for the prevention and treatment of cardiovascular disease. The purpose of this study is to determine if there is an excess risk of acute kidney injury (AKI) with high potency statins compared to low potency statins.
The investigators will carry out separate population based cohort studies using administrative health care databases in nine jurisdictions in Canada, the US, and the UK. Cohorts will be defined by the initiation of a statin, with follow-up until hospitalization for AKI. Analyses will be done separately for groups of patients with and without chronic kidney disease. The results from the separate sites will be combined in a meta-analysis to provide an overall assessment of the risk of AKI in new statin users.
Read the detailed description
The study objective is to determine whether the use of high potency statins, compared with the use of low potency statins, is associated with an increased risk of acute kidney injury (AKI) in routine clinical practice. The investigators will use a common-protocol approach to conduct retrospective cohort studies using health care data from nine jurisdictions (the Canadian provinces of Alberta, British Columbia, Manitoba, Nova Scotia, Ontario, Quebec, and Saskatchewan, as well as the United States (US) MarketScan and the United Kingdom (UK) Clinical Practice Research Datalink [CPRD]). The Canadian provincial databases contain information on physician billing, diagnoses and procedures from hospital discharge abstracts, and dispensations for prescription drugs at a population level. The CPRD is a clinical database that is representative of the UK population and contains the records for patients seen at over 680 general practitioner practices in the UK; these data will be linked to the Hospital Episode Statistics (HES) database, which contains in-hospital diagnosis and procedure data.
Study population
In each jurisdiction, the investigators will assemble a study cohort that includes all patients with a new prescription for a statin, including simvastatin, lovastatin, pravastatin, fluvastatin, atorvastatin, and rosuvastatin, from the earliest availability of data at each site to the last date of available data. The date of study cohort entry is defined by the prescription date of the newly-prescribed statin.
For the purpose of this study, two separate cohorts will be created based on the presence or absence of a history of chronic kidney disease at any time prior to and including the date of study cohort entry. Chronic kidney disease is defined as patients who have 1 hospitalization or 1 physician claim 3 years prior to study cohort entry with any of the following diagnoses and corresponding diagnostic codes: chronic or unspecified renal failure (ICD-9: 585, 586; ICD-10: N18, N19), hypertensive renal disease (ICD-9: 403.x1, 404.x2, 404.x3; ICD-10: I12.0, I13.1), nephritis and nephropathy (ICD-9: 582, 583; ICD-10: N03, N05), renal sclerosis or disorder from impaired renal function (ICD-9: 587, 588; ICD-10: S00-T98). Patients in each cohort will be followed from the date of study cohort entry until an event (defined below) or censoring due to death, departure from the database, 24 months after initiation of statin treatment, a dispensing for cerivastatin, or the end of the study period (31 March 2010 or the last date of data availability at that site), whichever occurs first. Data from Alberta, Ontario, and Nova Scotia will be restricted to patients aged 65 years and older as prescription data are not available for younger patients.
Case-control selection
The cohorts defined above will be analyzed using a nested case-control analysis, where cases are defined as a hospitalization for AKI. Risk set sampling will be used to randomly select up to 10 controls for each case, matched on sex, age (± one year; however, if no controls are available, within five years), cohort entry (± 90 days), and duration of follow-up.
Exposure assessment
The exposure categories will be separated by statin potency (high vs. low dose), and the duration of current and past exposure. For all cases and controls, exposure will be defined hierarchically; more specifically, patients who receive both a high and low potency statin within the same exposure category will be classified as high potency statin users. Current use of a high potency statin will be defined by the last prescription for a high dose statin within the 60 days prior to the index date.
Current users will be further classified into three mutually exclusive durations of current exposure (≤120, 121-365, and 366-730 days). Past exposure will be defined as a new prescription for a statin at least 120 days prior to the index date.
Statistical analyses
All analyses will be conducted separately among patients with and without a history of chronic kidney disease. Conditional logistic regression will be used to estimate the odds ratios and corresponding 95% confidence intervals (CIs) of the association of hospitalization for AKI, comparing current and past use of high potency statins to low potency statins. This is considered the primary analysis. Several sensitivity analyses will be performed to assess the robustness of study results and address some of the study limitations.
High dimensional propensity scores will be estimated for all patients in the cohorts using logistic regression. Fixed cohort analyses will also be conducted on the cohorts in each jurisdiction, where the statin exposure category will be defined by the initial prescription at cohort entry. Finally, all site-specific estimates will be meta-analyzed using fixed or random-effects models with inverse variance weighting. The amount of between-site heterogeneity will be estimated using the I square statistic.
- Conditions
- Hypercholesterolemia
- Being tested
- Rosuvastatin (≥10 mg), Atorvastatin (≥20 mg), Simvastatin (≥40 mg), Fluvastatin, Pravastatin
- Keywords
- Statins, HMG-CoA, Acute kidney injury, Kidney diseases, Renal failure
- Medical subject headings
- Hypercholesterolemia, Acute Kidney Injury, Kidney Diseases, Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rosuvastatin (≥10 mg)Drug
Current cumulative exposure to high dose rosuvastatin (ATC C10AA07) will be defined as a prescription for ≥10 mg of rosuvastatin dispensed prior to the index date in one of the following exposure duration categories (≤120 days, 121-365 days, or 366-730 days).
Past exposure to high dose rosuvastatin (ATC C10AA07) will be defined as a prescription for ≥10 mg of rosuvastatin dispensed >120 days of the index date (i.e. no exposure within 120 days of the index date).
Atorvastatin (≥20 mg)Drug
Current cumulative exposure to high dose atorvastatin (ATC C10AA05) will be defined as a prescription for ≥20 mg of atorvastatin dispensed prior to the index date in one of the following exposure duration categories (≤120 days, 121-365 days, or 366-730 days).
Past exposure to high dose atorvastatin (ATC C10AA05) will be defined as a prescription for ≥20 mg of atorvastatin dispensed >120 days prior to the index date (i.e. no exposure within 120 days of the index date).
Simvastatin (≥40 mg)Drug
Current cumulative exposure to high dose simvastatin (ATC C10AA01) will be defined as a prescription for ≥40 mg simvastatin dispensed prior to the index date in one of the following exposure duration categories (≤120 days, 121-365 days, or 366-730 days).
Past exposure to high dose simvastatin (ATC C10AA01) will be defined as a prescription for ≥40 mg simvastatin dispensed >120 days prior to the index date (i.e. no exposure within 120 days of the index date).
FluvastatinDrug
Current cumulative exposure to fluvastatin (ATC C10AA04) will be defined as a prescription for any dose of fluvastatin dispensed prior to the index date in one of the following exposure duration categories (≤120 days, 121-365 days, or 366-730 days).
Past exposure to fluvastatin (ATC C10AA04) will be defined as a prescription for any dose of fluvastatin dispensed >120 days prior to the index date (i.e. no exposure within 120 days of the index date).
PravastatinDrug
Current cumulative exposure to pravastatin (ATC C10AA03) will be defined as a prescription for any dose of pravastatin dispensed prior to the index date in one of the following exposure duration categories (≤120 days, 121-365 days, or 366-730 days).
Past exposure to pravastatin will be defined as a prescription for any dose of pravastatin (ATC C10AA03) dispensed >120 days prior to the index date (i.e. no exposure within 120 days of the index date).
LovastatinDrug
Current cumulative exposure to lovastatin (ATC C10AA02) will be defined as a prescription for any dose of lovastatin dispensed prior to the index date in one of the following exposure duration categories (≤120 days, 121-365 days, or 366-730 days).
Past exposure to lovastatin will be defined as a prescription for any dose of lovastatin (ATC C10AA02) dispensed >120 days prior to the index date (i.e. no exposure within 120 days of the index date).
Atorvastatin (<20mg)Drug
Current cumulative exposure to low dose atorvastatin (ATC C10AA05) will be defined as a prescription for <20 mg of atorvastatin dispensed prior to the index date in one of the following exposure duration categories (≤120 days, 121-365 days, or 366-730 days).
Past exposure to low dose atorvastatin (ATC C10AA05) will be defined as a prescription for <20 mg of atorvastatin dispensed >120 days prior to the index date (i.e. no exposure within 120 days of the index date).
Simvastatin (<40 mg)Drug
Current cumulative exposure to low dose simvastatin (ATC C10AA01) will be defined as a prescription for <40 mg simvastatin dispensed prior to the index date in one of the following exposure duration categories (≤120 days, 121-365 days, or 366-730 days).
Past exposure to low dose simvastatin (ATC C10AA01) will be defined as a prescription for <40 mg simvastatin dispensed >120 days prior to the index date (i.e. no exposure within 120 days of the index date).
| Study group | Role | What they receive |
|---|---|---|
| High potency statin users | Exposure will be defined as a new prescription for a high dose statin (rosuvastatin, high doses of atorvastatin, and high doses of simvastatin between 1 January 1997 and 30 of April 2008, or 1 year after the beginning of data availability. Receives: Drug: Rosuvastatin (≥10 mg); Drug: Atorvastatin (≥20 mg); Drug: Simvastatin (≥40 mg) | |
| Low potency statin users | Exposure will be defined as a new prescription for a low dose statin (all doses of fluvastatin, all doses of pravastatin, all doses of lovastatin; low doses of atorvastatin and simvastatin) between 1 January 1997 and 30 of April 2008, or 1 year after the beginning of data availability. Receives: Drug: Fluvastatin; Drug: Pravastatin; Drug: Lovastatin; Drug: Atorvastatin (<20mg); Drug: Simvastatin (<40 mg) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients hospitalized for acute kidney injury
Patients hospitalized for acute kidney injury (including but not limited to hypertensive renal disease with renal failure, chronic glomerulonephiritis, and renal sclerosis) with any of the following diagnostic codes: ICD-9 584, 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.
Measured: Patients will be followed from the date of study cohort entry until either hospitalization for acute kidney injury or censoring (whichever occurs first), or will be assessed for up to 24 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2015 (estimated)
- Study startJan 2011
- Primary completionJan 2013
- Study completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HypercholesterolemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 2,067,639 participants (actual)
Sponsor and investigators
- Lead sponsor
- Canadian Network for Observational Drug Effect Studies, CNODES
- Sponsor type
- University, hospital or other
- Collaborators
- Drug Safety and Effectiveness Network, Canada, Canadian Institutes of Health Research (CIHR)
- Responsible party
- Sponsor
- Investigators
- Colin Dormuth, M.Sc., Sc.D., Principal investigator, Departments of Anesthesiology, Pharmacology and Therapeutics, University of British Columbia, Vancouver,BC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02518516
- Sponsor's protocol ID
- CNODES_Demo_1
- Status last verified
- Aug 2015
- First submitted
- 4 Aug 2015
- Last updated
- 14 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Dormuth CR, Hemmelgarn BR, Paterson JM, James MT, Teare GF, Raymond CB, Lafrance JP, Levy A, Garg AX, Ernst P; Canadian Network for Observational Drug Effect Studies. Use of high potency statins and rates of admission for acute kidney injury: multicenter, retrospective observational analysis of administrative databases. BMJ. 2013 Mar 18;346:f880. doi: 10.1136/bmj.f880.
PubMed 23511950
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of High Potency Statins and Rates of Admission for Acute Kidney Injury: Multicenter, Retrospective Observational Analysis of Administrative Databases
- ClinicalTrials.gov ID
- NCT02518516
- Acronym / sponsor ID
- CNODES_Demo_1
- Conditions
- Hypercholesterolemia
- Keywords
- Statins, HMG-CoA, Acute kidney injury, Kidney diseases, Renal failure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,067,639 participants (actual)
- Lead sponsor
- Canadian Network for Observational Drug Effect Studies, CNODESUniversity, hospital or other
- Collaborators
- Drug Safety and Effectiveness Network, Canada, Canadian Institutes of Health Research (CIHR)
- Study start
- Jan 2011
- Primary completion
- Jan 2013 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 7 Aug 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Statins are a class of cholesterol lowering medications that are prescribed for the prevention and treatment of cardiovascular disease. The purpose of this study is to determine if there is an excess risk of acute kidney injury (AKI) with high potency statins compared to low potency statins.
The investigators will carry out separate population based cohort studies using administrative health care databases in nine jurisdictions in Canada, the US, and the UK. Cohorts will be defined by the initiation of a statin, with follow-up until hospitalization for AKI. Analyses will be done separately for groups of patients with and without chronic kidney disease. The results from the separate sites will be combined in a meta-analysis to provide an overall assessment of the risk of AKI in new statin users.
Detailed description
The study objective is to determine whether the use of high potency statins, compared with the use of low potency statins, is associated with an increased risk of acute kidney injury (AKI) in routine clinical practice. The investigators will use a common-protocol approach to conduct retrospective cohort studies using health care data from nine jurisdictions (the Canadian provinces of Alberta, British Columbia, Manitoba, Nova Scotia, Ontario, Quebec, and Saskatchewan, as well as the United States (US) MarketScan and the United Kingdom (UK) Clinical Practice Research Datalink [CPRD]). The Canadian provincial databases contain information on physician billing, diagnoses and procedures from hospital discharge abstracts, and dispensations for prescription drugs at a population level. The CPRD is a clinical database that is representative of the UK population and contains the records for patients seen at over 680 general practitioner practices in the UK; these data will be linked to the Hospital Episode Statistics (HES) database, which contains in-hospital diagnosis and procedure data.
Study population
In each jurisdiction, the investigators will assemble a study cohort that includes all patients with a new prescription for a statin, including simvastatin, lovastatin, pravastatin, fluvastatin, atorvastatin, and rosuvastatin, from the earliest availability of data at each site to the last date of available data. The date of study cohort entry is defined by the prescription date of the newly-prescribed statin.
For the purpose of this study, two separate cohorts will be created based on the presence or absence of a history of chronic kidney disease at any time prior to and including the date of study cohort entry. Chronic kidney disease is defined as patients who have 1 hospitalization or 1 physician claim 3 years prior to study cohort entry with any of the following diagnoses and corresponding diagnostic codes: chronic or unspecified renal failure (ICD-9: 585, 586; ICD-10: N18, N19), hypertensive renal disease (ICD-9: 403.x1, 404.x2, 404.x3; ICD-10: I12.0, I13.1), nephritis and nephropathy (ICD-9: 582, 583; ICD-10: N03, N05), renal sclerosis or disorder from impaired renal function (ICD-9: 587, 588; ICD-10: S00-T98). Patients in each cohort will be followed from the date of study cohort entry until an event (defined below) or censoring due to death, departure from the database, 24 months after initiation of statin treatment, a dispensing for cerivastatin, or the end of the study period (31 March 2010 or the last date of data availability at that site), whichever occurs first. Data from Alberta, Ontario, and Nova Scotia will be restricted to patients aged 65 years and older as prescription data are not available for younger patients.
Case-control selection
The cohorts defined above will be analyzed using a nested case-control analysis, where cases are defined as a hospitalization for AKI. Risk set sampling will be used to randomly select up to 10 controls for each case, matched on sex, age (± one year; however, if no controls are available, within five years), cohort entry (± 90 days), and duration of follow-up.
Exposure assessment
The exposure categories will be separated by statin potency (high vs. low dose), and the duration of current and past exposure. For all cases and controls, exposure will be defined hierarchically; more specifically, patients who receive both a high and low potency statin within the same exposure category will be classified as high potency statin users. Current use of a high potency statin will be defined by the last prescription for a high dose statin within the 60 days prior to the index date.
Current users will be further classified into three mutually exclusive durations of current exposure (≤120, 121-365, and 366-730 days). Past exposure will be defined as a new prescription for a statin at least 120 days prior to the index date.
Statistical analyses
All analyses will be conducted separately among patients with and without a history of chronic kidney disease. Conditional logistic regression will be used to estimate the odds ratios and corresponding 95% confidence intervals (CIs) of the association of hospitalization for AKI, comparing current and past use of high potency statins to low potency statins. This is considered the primary analysis. Several sensitivity analyses will be performed to assess the robustness of study results and address some of the study limitations.
High dimensional propensity scores will be estimated for all patients in the cohorts using logistic regression. Fixed cohort analyses will also be conducted on the cohorts in each jurisdiction, where the statin exposure category will be defined by the initial prescription at cohort entry. Finally, all site-specific estimates will be meta-analyzed using fixed or random-effects models with inverse variance weighting. The amount of between-site heterogeneity will be estimated using the I square statistic.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High potency statin users | – | Drug: Rosuvastatin (≥10 mg), Drug: Atorvastatin (≥20 mg), Drug: Simvastatin (≥40 mg)Exposure will be defined as a new prescription for a high dose statin (rosuvastatin, high doses of atorvastatin, and high doses of simvastatin between 1 January 1997 and 30 of April 2008, or 1 year after the beginning of data availability. |
| Low potency statin users | – | Drug: Fluvastatin, Drug: Pravastatin, Drug: Lovastatin, Drug: Atorvastatin (<20mg), Drug: Simvastatin (<40 mg)Exposure will be defined as a new prescription for a low dose statin (all doses of fluvastatin, all doses of pravastatin, all doses of lovastatin; low doses of atorvastatin and simvastatin) between 1 January 1997 and 30 of April 2008, or 1 year after the beginning of data availability. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- In each jurisdiction, the investigators will assemble a study cohort that includes all patients with a new prescription for a statin, including simvastatin, lovastatin, pravastatin, fluvastatin, atorvastatin, and rosuvastatin between 1 January 1997 (or one year after the beginning of data availability) and 30 April 2008. The date of study cohort entry is defined by the prescription date of the newly-prescribed statin. Two separate cohorts will be created based on the presence or absence of a history of chronic kidney disease.
Key inclusion criteria (3 listed)
- Patients with a new prescription for a statin from the earliest availability of data at each site to the last date of availability of data +365 days
- Patients who are at least 40 years of age at cohort entry
- Patients with at least one year of history in the database
Key exclusion criteria (3 listed)
- Patients under the age of 40 (<66 in jurisdictions with drug data for seniors only)
- Patients with less than one year of history in the database
- Patients who received any cholesterol lowering drugs (including fibrates, niacin and ezetimibe) or underwent dialysis or a kidney transplant in the previous year
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rosuvastatin (≥10 mg)Current cumulative exposure to high dose rosuvastatin (ATC C10AA07) will be defined as a prescription for ≥10 mg of rosuvastatin dispensed prior to the index date in one of the following exposure duration categories (≤120 days, 121-365 days, or 366-730 days). Past exposure to high dose rosuvastatin (ATC C10AA07) will be defined as a prescription for ≥10 mg of rosuvastatin dispensed >120 days of the index date (i.e. no exposure within 120 days of the index date). | Drug | High potency statin users |
| Atorvastatin (≥20 mg)Current cumulative exposure to high dose atorvastatin (ATC C10AA05) will be defined as a prescription for ≥20 mg of atorvastatin dispensed prior to the index date in one of the following exposure duration categories (≤120 days, 121-365 days, or 366-730 days). Past exposure to high dose atorvastatin (ATC C10AA05) will be defined as a prescription for ≥20 mg of atorvastatin dispensed >120 days prior to the index date (i.e. no exposure within 120 days of the index date). | Drug | High potency statin users |
| Simvastatin (≥40 mg)Current cumulative exposure to high dose simvastatin (ATC C10AA01) will be defined as a prescription for ≥40 mg simvastatin dispensed prior to the index date in one of the following exposure duration categories (≤120 days, 121-365 days, or 366-730 days). Past exposure to high dose simvastatin (ATC C10AA01) will be defined as a prescription for ≥40 mg simvastatin dispensed >120 days prior to the index date (i.e. no exposure within 120 days of the index date). | Drug | High potency statin users |
| FluvastatinCurrent cumulative exposure to fluvastatin (ATC C10AA04) will be defined as a prescription for any dose of fluvastatin dispensed prior to the index date in one of the following exposure duration categories (≤120 days, 121-365 days, or 366-730 days). Past exposure to fluvastatin (ATC C10AA04) will be defined as a prescription for any dose of fluvastatin dispensed >120 days prior to the index date (i.e. no exposure within 120 days of the index date). | Drug | Low potency statin users |
| PravastatinCurrent cumulative exposure to pravastatin (ATC C10AA03) will be defined as a prescription for any dose of pravastatin dispensed prior to the index date in one of the following exposure duration categories (≤120 days, 121-365 days, or 366-730 days). Past exposure to pravastatin will be defined as a prescription for any dose of pravastatin (ATC C10AA03) dispensed >120 days prior to the index date (i.e. no exposure within 120 days of the index date). | Drug | Low potency statin users |
| LovastatinCurrent cumulative exposure to lovastatin (ATC C10AA02) will be defined as a prescription for any dose of lovastatin dispensed prior to the index date in one of the following exposure duration categories (≤120 days, 121-365 days, or 366-730 days). Past exposure to lovastatin will be defined as a prescription for any dose of lovastatin (ATC C10AA02) dispensed >120 days prior to the index date (i.e. no exposure within 120 days of the index date). | Drug | Low potency statin users |
| Atorvastatin (<20mg)Current cumulative exposure to low dose atorvastatin (ATC C10AA05) will be defined as a prescription for <20 mg of atorvastatin dispensed prior to the index date in one of the following exposure duration categories (≤120 days, 121-365 days, or 366-730 days). Past exposure to low dose atorvastatin (ATC C10AA05) will be defined as a prescription for <20 mg of atorvastatin dispensed >120 days prior to the index date (i.e. no exposure within 120 days of the index date). | Drug | Low potency statin users |
| Simvastatin (<40 mg)Current cumulative exposure to low dose simvastatin (ATC C10AA01) will be defined as a prescription for <40 mg simvastatin dispensed prior to the index date in one of the following exposure duration categories (≤120 days, 121-365 days, or 366-730 days). Past exposure to low dose simvastatin (ATC C10AA01) will be defined as a prescription for <40 mg simvastatin dispensed >120 days prior to the index date (i.e. no exposure within 120 days of the index date). | Drug | Low potency statin users |
Primary outcome
Number of patients hospitalized for acute kidney injury
Time frame: Patients will be followed from the date of study cohort entry until either hospitalization for acute kidney injury or censoring (whichever occurs first), or will be assessed for up to 24 months.
Patients hospitalized for acute kidney injury (including but not limited to hypertensive renal disease with renal failure, chronic glomerulonephiritis, and renal sclerosis) with any of the following diagnostic codes: ICD-9 584, 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2016.
- Results publication: PubMed 23511950Dormuth CR, Hemmelgarn BR, Paterson JM, James MT, Teare GF, Raymond CB, Lafrance JP, Levy A, Garg AX, Ernst P; Canadian Network for Observational Drug Effect Studies. Use of high potency statins and rates of admission for acute kidney injury: multicenter, retrospective observational analysis of administrative databases. BMJ. 2013 Mar 18;346:f880. doi: 10.1136/bmj.f880.
- This organization's website describing general functions, other CNODES projects, and investigator profiles.Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Colin Dormuth, M.Sc., Sc.D. principal investigator
Departments of Anesthesiology, Pharmacology and Therapeutics, University of British Columbia, Vancouver,BC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypercholesterolemia, run by Canadian Network for Observational Drug Effect Studies, CNODES at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients hospitalized for acute kidney injury (time frame: Patients will be followed from the date of study cohort entry until either hospitalization for acute kidney injury or censoring (whichever occurs first), or will be assessed for up to 24 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02518516, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Mar 2016.