Peripheral Artery Disease
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
DRUGPentoxifylline
Pentoxifylline claim is used as the exposure group.
DRUGCilostazol
Cilostazol 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
Inclusion criteria
Please see https://docs.google.com/spreadsheets/d/17QJ294pffmOCFYLeq0eSvn7hlj6MOb-0dJCr1RL3kfk/edit?usp=sharing or Appendix A (https://drive.google.com/drive/folders/1-lR6dR\_aP44GoryjCad\_NwRhjPpsIKDU?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\. Enrollment in Medicare Part A, B, and D with no HMO coverage for 365 days prior to and including cohort entry date * 3\. At least two claims with peripheral artery disease diagnosis measured 365 days prior to drug initiation
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 * 3\. Prior history of Pentoxifylline or Cilostazol use anytime prior to cohort entry date
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to Dementia Onset | Median follow up times: 1) 180 days (exp), 170 days (ref) 2) 677 days (exp), 612 days (ref) 3) 211 days (exp), 173 days (ref) 4) 180 days (exp), 171 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 |
|---|---|
| Pentoxifylline Exposure group
Pentoxifylline: Pentoxifylline claim is used as the exposure group. | 1,687 |
| Cilostazol Reference group
Cilostazol: Cilostazol claim is used as the reference group. | 1,687 |
| Total | 3,374 |
Baseline characteristics
| Characteristic | Pentoxifylline | Cilostazol | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 1687 Participants | 1687 Participants | 3374 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous | 76.2 years STANDARD_DEVIATION 7.2 | 76.1 years STANDARD_DEVIATION 7.3 | 76.1 years STANDARD_DEVIATION 7.2 |
| Dementia risk factors Anxiety | 244 Participants | 242 Participants | 486 Participants |
| Dementia risk factors Bipolar Disorder | 15 Participants | 18 Participants | 33 Participants |
| Dementia risk factors Coronary Artery Disease | 793 Participants | 767 Participants | 1560 Participants |
| Dementia risk factors Depression | 236 Participants | 243 Participants | 479 Participants |
| Dementia risk factors Diabetes | 819 Participants | 807 Participants | 1626 Participants |
| Dementia risk factors Hypertension | 1501 Participants | 1521 Participants | 3022 Participants |
| Dementia risk factors Obesity | 320 Participants | 298 Participants | 618 Participants |
| Race/Ethnicity, Customized Black | 156 Participants | 151 Participants | 307 Participants |
| Race/Ethnicity, Customized Hispanic | 67 Participants | 66 Participants | 133 Participants |
| Race/Ethnicity, Customized Other | 86 Participants | 80 Participants | 166 Participants |
| Race/Ethnicity, Customized White | 1378 Participants | 1390 Participants | 2768 Participants |
| Sex: Female, Male Female | 869 Participants | 848 Participants | 1717 Participants |
| Sex: Female, Male Male | 818 Participants | 839 Participants | 1657 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 1,687 | 0 / 1,687 |
| other Total, other adverse events | 0 / 1,687 | 0 / 1,687 |
| 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) 180 days (exp), 170 days (ref) 2) 677 days (exp), 612 days (ref) 3) 211 days (exp), 173 days (ref) 4) 180 days (exp), 171 days (ref)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Pentoxifylline | Time to Dementia Onset | Analysis 1 | 28.1 Incidence rate per 1000 person year |
| Pentoxifylline | Time to Dementia Onset | Analysis 2 | 37.9 Incidence rate per 1000 person year |
| Pentoxifylline | Time to Dementia Onset | Analysis 3 | 30.8 Incidence rate per 1000 person year |
| Pentoxifylline | Time to Dementia Onset | Analysis 4 | 5.2 Incidence rate per 1000 person year |
| Cilostazol | Time to Dementia Onset | Analysis 4 | 10.0 Incidence rate per 1000 person year |
| Cilostazol | Time to Dementia Onset | Analysis 1 | 32.6 Incidence rate per 1000 person year |
| Cilostazol | Time to Dementia Onset | Analysis 3 | 43.9 Incidence rate per 1000 person year |
| Cilostazol | Time to Dementia Onset | Analysis 2 | 44.8 Incidence rate per 1000 person year |