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
DRUGPropranolol or Carvedilol
Propranolol or Carvedilol claim is used as the exposure group.
DRUGAtenolol, Bisoprolol or Sotalol
Atenolol, Bisoprolol or Sotalol 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/1ltZHHv6AvMkPBbSp\_9c0dtQ0XMmBc00d4jaRId5ovaA/edit?usp=sharing or Appendix A (https://drive.google.com/drive/folders/1a-1uRt73kVywEoV8L0cEmDNgaqYEIudT?usp=sharing) for full code and algorithm definitions. Medicare timeframe: 2008 to 2019 (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 1 inpatient claim or 2 outpatient claims with hypertension diagnosis recorded in 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 use of Propranolol, Carvedilol and Atenolol, Bisoprolol, Sotalol * 4\. Use of Propranolol, Carvedilol and Atenolol, Bisoprolol, Sotalol concomitantly on index date
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to Dementia Onset | Median follow up times: 1) 298 days (exp), 249 days (ref) 2) 995 days (exp), 981 days (ref) 3) 515 days (exp), 448 days (ref) 4) 307 days (exp), 253 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 |
|---|---|
| Propranolol or Carvedilol Exposure group
Propranolol or Carvedilol: Propranolol or Carvedilol claim is used as the exposure group. | 222,015 |
| Atenolol, Bisoprolol or Sotalol Reference group
Atenolol, Bisoprolol or Sotalol: Atenolol, Bisoprolol or Sotalol claim is used as the reference group. | 222,015 |
| Total | 444,030 |
Baseline characteristics
| Characteristic | Atenolol, Bisoprolol or Sotalol | Propranolol or Carvedilol | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 222015 Participants | 222015 Participants | 444030 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous | 74.75 years STANDARD_DEVIATION 6.78 | 74.77 years STANDARD_DEVIATION 6.82 | 74.77 years STANDARD_DEVIATION 6.8 |
| Dementia risk factors Anxiety | 32295 Participants | 32757 Participants | 65052 Participants |
| Dementia risk factors Bipolar Disorder | 2263 Participants | 2299 Participants | 4562 Participants |
| Dementia risk factors Coronary artery disease | 96613 Participants | 96483 Participants | 193096 Participants |
| Dementia risk factors Depression | 32329 Participants | 32918 Participants | 65247 Participants |
| Dementia risk factors Diabetes | 168200 Participants | 168274 Participants | 336474 Participants |
| Dementia risk factors Obesity | 48375 Participants | 48216 Participants | 96591 Participants |
| Dementia risk factors Schizophrenia | 1064 Participants | 1045 Participants | 2109 Participants |
| Race/Ethnicity, Customized Asian | 8042 Participants | 7954 Participants | 15996 Participants |
| Race/Ethnicity, Customized Black | 22557 Participants | 22448 Participants | 45005 Participants |
| Race/Ethnicity, Customized Hispanic | 7209 Participants | 7289 Participants | 14498 Participants |
| Race/Ethnicity, Customized North American Native | 1426 Participants | 1347 Participants | 2773 Participants |
| Race/Ethnicity, Customized Other | 4273 Participants | 4242 Participants | 8515 Participants |
| Race/Ethnicity, Customized Unknown | 1567 Participants | 1537 Participants | 3104 Participants |
| Race/Ethnicity, Customized White | 176941 Participants | 177198 Participants | 354139 Participants |
| Sex: Female, Male Female | 127873 Participants | 128266 Participants | 256139 Participants |
| Sex: Female, Male Male | 94142 Participants | 93749 Participants | 187891 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 222,015 | 0 / 222,015 |
| other Total, other adverse events | 0 / 222,015 | 0 / 222,015 |
| 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) 298 days (exp), 249 days (ref) 2) 995 days (exp), 981 days (ref) 3) 515 days (exp), 448 days (ref) 4) 307 days (exp), 253 days (ref)
Population: Study cohort after 1:1 propensity score matching
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Propranolol or Carvedilol | Time to Dementia Onset | Analysis 1 | 22.96 Incidence rate per 1000 person year |
| Propranolol or Carvedilol | Time to Dementia Onset | Analysis 2 | 26.82 Incidence rate per 1000 person year |
| Propranolol or Carvedilol | Time to Dementia Onset | Analysis 4 | 7.21 Incidence rate per 1000 person year |
| Propranolol or Carvedilol | Time to Dementia Onset | Analysis 3 | 23.03 Incidence rate per 1000 person year |
| Atenolol, Bisoprolol or Sotalol | Time to Dementia Onset | Analysis 4 | 6.47 Incidence rate per 1000 person year |
| Atenolol, Bisoprolol or Sotalol | Time to Dementia Onset | Analysis 1 | 19.84 Incidence rate per 1000 person year |
| Atenolol, Bisoprolol or Sotalol | Time to Dementia Onset | Analysis 2 | 25.84 Incidence rate per 1000 person year |
| Atenolol, Bisoprolol or Sotalol | Time to Dementia Onset | Analysis 3 | 20.21 Incidence rate per 1000 person year |