Hypertension
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
DRUGAmiloride
Amiloride claim is used as the exposure group.
DRUGTriamterene
Triamterene 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/1IdoLUI5-bz\_1D\_0IflZovJO9e1\_3kFLc\_JLEFM030No/edit?usp=sharing or Appendix A 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 hypertension diagnosis recorded in 365 days prior to cohort entry date
Exclusion criteria
* 1\. Prior history of dementia measured anytime prior to cohort entry date * 2\. Prior use of amiloride or triamterene any time prior to cohort entry date
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to Dementia Onset | Median follow up times: 1) 119 days (exp), 111 days (ref) 2) 859 days (exp), 852 days (ref) 3) 333 days (exp), 286 days (ref) 4) 120 days (exp), 111 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 |
|---|---|
| Amiloride Exposure group
Amiloride: Amiloride claim is used as the exposure group. | 7,305 |
| Triamterene Reference group
Triamterene: Triamterene claim is used as the reference group. | 7,305 |
| Total | 14,610 |
Baseline characteristics
| Characteristic | Amiloride | Triamterene | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 7305 Participants | 7305 Participants | 14610 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous | 74.06 years STANDARD_DEVIATION 6.61 | 74.22 years STANDARD_DEVIATION 6.77 | 74.14 years STANDARD_DEVIATION 6.69 |
| Dementia risk factors Anxiety | 1104 Participants | 1108 Participants | 2212 Participants |
| Dementia risk factors Bipolar disorder | 121 Participants | 143 Participants | 264 Participants |
| Dementia risk factors Coronary artery disease | 3087 Participants | 3182 Participants | 6269 Participants |
| Dementia risk factors Depression | 1168 Participants | 1130 Participants | 2298 Participants |
| Dementia risk factors Diabetes | 5784 Participants | 5819 Participants | 11603 Participants |
| Dementia risk factors Obesity | 1979 Participants | 1961 Participants | 3940 Participants |
| Dementia risk factors Schizophrenia | 42 Participants | 53 Participants | 95 Participants |
| Race/Ethnicity, Customized Asian | 123 Participants | 120 Participants | 243 Participants |
| Race/Ethnicity, Customized Black | 825 Participants | 782 Participants | 1607 Participants |
| Race/Ethnicity, Customized Hispanic | 126 Participants | 135 Participants | 261 Participants |
| Race/Ethnicity, Customized Native American | 23 Participants | 21 Participants | 44 Participants |
| Race/Ethnicity, Customized Other | 124 Participants | 124 Participants | 248 Participants |
| Race/Ethnicity, Customized Unknown | 65 Participants | 69 Participants | 134 Participants |
| Race/Ethnicity, Customized White | 6019 Participants | 6054 Participants | 12073 Participants |
| Sex: Female, Male Female | 4253 Participants | 4219 Participants | 8472 Participants |
| Sex: Female, Male Male | 3052 Participants | 3086 Participants | 6138 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 7,305 | 0 / 7,305 |
| other Total, other adverse events | 0 / 7,305 | 0 / 7,305 |
| 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) 119 days (exp), 111 days (ref) 2) 859 days (exp), 852 days (ref) 3) 333 days (exp), 286 days (ref) 4) 120 days (exp), 111 days (ref)
Population: Study cohort after 1:1 propensity score matching
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Amiloride | Time to Dementia Onset | Analysis 1 | 12.6 Incidence rate per 1000 person year |
| Amiloride | Time to Dementia Onset | Analysis 2 | 20.9 Incidence rate per 1000 person year |
| Amiloride | Time to Dementia Onset | Analysis 3 | 12.2 Incidence rate per 1000 person year |
| Amiloride | Time to Dementia Onset | Analysis 4 | 2.4 Incidence rate per 1000 person year |
| Triamterene | Time to Dementia Onset | Analysis 4 | 4.3 Incidence rate per 1000 person year |
| Triamterene | Time to Dementia Onset | Analysis 1 | 14.8 Incidence rate per 1000 person year |
| Triamterene | Time to Dementia Onset | Analysis 3 | 17.4 Incidence rate per 1000 person year |
| Triamterene | Time to Dementia Onset | Analysis 2 | 21.5 Incidence rate per 1000 person year |