Gout
Conditions
Brief summary
This study aims to evaluate the comparative risk of dementia/Alzheimer's disease onset between patients treated with medications that target specific metabolic pathways and patients treated with alternative medications for the same indication.
Detailed description
This is a non-randomized, non-interventional study that is part of the DREAM Study of Brigham and Women's Hospital. DREAM is led by Dr. Madhav Thambisetty, MD, PhD, Chief of the Clinical and Translational Neuroscience Section, Laboratory of Behavioral Neuroscience, National Institute on Aging (NIA) intramural research program. This study aims to evaluate the comparative risk of dementia/Alzheimer's disease onset between patients treated with medications that target specific metabolic pathways and patients treated with alternative medications for the same indication using healthcare claims data.
Interventions
DRUGProbenecid
Probenecid claim is used as the exposure group.
DRUGAllopurinol
Allopurinol claim is used as the reference group.
Sponsors
Brigham and Women's Hospital
National Institute on Aging (NIA)
Rutgers University
Johns Hopkins University
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
Please see https://docs.google.com/spreadsheets/d/1N3IVoirGdWS7OiKiOWWgPHhgsSxX7SWDIhpeeZ-Ft7c/edit?usp=sharing or Appendix A for full code and algorithm definitions. Medicare timeframe: 2007 to 2017 (end of data availability). Inclusion Criteria: * 1\. No prior use of urate-lowering agents, including probenecid and allopurinol anytime prior to cohort entry date * 2\. Enrollment in Medicare Part A, B, and D with no HMO coverage for 365 days prior to and including cohort entry date
Exclusion criteria
* 1\. Prior history of dementia measured anytime prior to cohort entry date * 2\. No prior history of gout recorded in the 365 days prior to cohort entry date * 3\. Prior history of nursing home admission in the 365 days prior to the cohort entry date
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to Dementia Onset | Median follow up times: 1) 36 days (exp), 214 days (ref) 2) 1095 days (exp), 1095 days (ref) 3) 565 days (exp), 372 days (ref) 4) 36 days (exp), 248 days (ref) | Time to dementia onset, i.e., Alzheimer's disease, vascular dementia, senile, presenile, or unspecified dementia, or dementia in other diseases classified elsewhere. Please refer to uploaded protocol for full definition due to size limitations. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORMadhav Thambisetty, MD, PhD
National Institute on Aging (NIA)
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 8115 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants |
| Age, Continuous | 75.16 years STANDARD_DEVIATION 7.23 |
| Dementia risk factors Anxiety | 1332 Participants |
| Dementia risk factors Bipolar disorder | 43 Participants |
| Dementia risk factors Coronary Artery Disease | 6418 Participants |
| Dementia risk factors Depression | 692 Participants |
| Dementia risk factors Diabetes | 3379 Participants |
| Dementia risk factors Hypertension | 7346 Participants |
| Dementia risk factors Obesity | 2040 Participants |
| Dementia risk factors Schizophrenia | 45 Participants |
| Race/Ethnicity, Customized Asian | 256 Participants |
| Race/Ethnicity, Customized Black | 1145 Participants |
| Race/Ethnicity, Customized Hispanic | 97 Participants |
| Race/Ethnicity, Customized Native American | 25 Participants |
| Race/Ethnicity, Customized Other | 142 Participants |
| Race/Ethnicity, Customized Unknown | 19 Participants |
| Race/Ethnicity, Customized White | 12811 Participants |
| Sex: Female, Male Female | 3735 Participants |
| Sex: Female, Male Male | 8690 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 8,115 | 0 / 8,115 |
| other Total, other adverse events | 0 / 8,115 | 0 / 8,115 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
None listed