Asthma
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
DRUGMontelukast
Montelukast claim is used as the exposure group.
DRUGFluticasone
Fluticasone claim is used as the reference group.
Sponsors
National Institute on Aging (NIA)
Rutgers University
Johns Hopkins University
Brigham and Women's Hospital
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
Please see https://docs.google.com/spreadsheets/d/1u8YFpnMHI5HprhyuY14tIgd1COZcsAWKFlbYCT7aL\_A/edit?usp=sharing or Appendix A (https://drive.google.com/file/d/1uC\_G8TJ1ujoJbas1p1gFaYFzY7Hw7xMq/view?usp=sharing) for full code and algorithm definitions. Medicare timeframe: 2008 to 2018 (end of data availability). Inclusion Criteria: * 1\. Aged \>/= 65 years on the index date * 2\. No prior use of Montelukast and Fluticasone anytime prior to cohort entry date * 3\. Enrollment in Medicare Part A, B, and D with no HMO coverage for 365 days prior to and including cohort entry date * 4\. At least two claims with asthma diagnosis measured 365 days prior to drug init
Exclusion criteria
* 1\. Prior history of dementia measured anytime prior to cohort entry date * 2\. 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) 161 days (exp), 120 days (ref) 2) 504 days (exp), 638 days (ref) 3) 212 days (exp), 130 days (ref) 4) 162 days (exp), 120 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
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Montelukast Exposure group
Montelukast: Montelukast claim is used as the exposure group. | 12,572 |
| Fluticasone Reference group
Fluticasone: Fluticasone claim is used as the reference group. | 12,572 |
| Total | 25,144 |
Baseline characteristics
| Characteristic | Montelukast | Fluticasone | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 12572 Participants | 12572 Participants | 25144 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous | 72.8 years STANDARD_DEVIATION 6.1 | 72.8 years STANDARD_DEVIATION 6.1 | 72.8 years STANDARD_DEVIATION 6.1 |
| Dementia risk factors Anxiety | 2235 Participants | 2234 Participants | 4469 Participants |
| Dementia risk factors Bipolar disorder | 126 Participants | 120 Participants | 246 Participants |
| Dementia risk factors Coronary artery disease | 3338 Participants | 3264 Participants | 6602 Participants |
| Dementia risk factors Diabetes | 4098 Participants | 4087 Participants | 8185 Participants |
| Dementia risk factors Hypertension | 9867 Participants | 9909 Participants | 19776 Participants |
| Dementia risk factors Obesity | 2804 Participants | 2808 Participants | 5612 Participants |
| Dementia risk factors Schizophrenia | 8 Participants | 3 Participants | 11 Participants |
| Race/Ethnicity, Customized Black | 831 Participants | 881 Participants | 1712 Participants |
| Race/Ethnicity, Customized Hispanic | 218 Participants | 203 Participants | 421 Participants |
| Race/Ethnicity, Customized Other | 910 Participants | 838 Participants | 1748 Participants |
| Race/Ethnicity, Customized White | 10613 Participants | 10650 Participants | 21263 Participants |
| Sex: Female, Male Female | 8878 Participants | 8808 Participants | 17686 Participants |
| Sex: Female, Male Male | 3694 Participants | 3764 Participants | 7458 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 12,569 | 0 / 12,569 |
| other Total, other adverse events | 0 / 12,569 | 0 / 12,569 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
Primary
Time to Dementia Onset
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.
Time frame: Median follow up times: 1) 161 days (exp), 120 days (ref) 2) 504 days (exp), 638 days (ref) 3) 212 days (exp), 130 days (ref) 4) 162 days (exp), 120 days (ref)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Montelukast | Time to Dementia Onset | Analysis 1 | 9.1 Incidence rate per 1000 person year |
| Montelukast | Time to Dementia Onset | Analysis 2 | 14.5 Incidence rate per 1000 person year |
| Montelukast | Time to Dementia Onset | Analysis 3 | 11.4 Incidence rate per 1000 person year |
| Montelukast | Time to Dementia Onset | Analysis 4 | 3.5 Incidence rate per 1000 person year |
| Fluticasone | Time to Dementia Onset | Analysis 4 | 1.8 Incidence rate per 1000 person year |
| Fluticasone | Time to Dementia Onset | Analysis 1 | 5.6 Incidence rate per 1000 person year |
| Fluticasone | Time to Dementia Onset | Analysis 3 | 8.6 Incidence rate per 1000 person year |
| Fluticasone | Time to Dementia Onset | Analysis 2 | 14.2 Incidence rate per 1000 person year |