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
DRUGDihydropyridine calcium channel blocker
Dihydropyridine calcium channel blocker claim is used as the exposure group.
DRUGHydrochlorothiazide
Hydrochlorothiazide 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/1VlyY3zcxoRp0tH7yv8rSOEggSO6WQ0VYEjq-6KlSSt8/edit?usp=sharing or Appendix A for full code and algorithm definitions. Medicare timeframe: 2008 to 2018 (end of data availability). CRPD timeframe: 2007 to 2018 Inclusion Criteria: * 1\. Aged \> 65 years on the index date * 2\. For Medicare - 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 dihydropyridine CCBs, hydrochlorothiazide, or other antihypertensives anytime prior to cohort entry date
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to Dementia Onset | Median follow up times: 1) 189 days (exp), 171 days (ref) 2) 835 days (exp). 851 days (ref) 3) 388 days (exp), 348 days (ref) 4) 191 days (exp), 172 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 |
|---|---|
| Dihydropyridine Calcium Channel Blocker Exposure group
Dihydropyridine calcium channel blocker: Dihydropyridine calcium channel blocker claim is used as the exposure group. | 64,254 |
| Hydrochlorothiazide Reference group
Hydrochlorothiazide: Hydrochlorothiazide claim is used as the reference group. | 64,254 |
| Total | 128,508 |
Baseline characteristics
| Characteristic | Dihydropyridine Calcium Channel Blocker | Hydrochlorothiazide | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 64254 Participants | 64254 Participants | 128508 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous | 73.44 years STANDARD_DEVIATION 6.85 | 73.48 years STANDARD_DEVIATION 6.93 | 73.44 years STANDARD_DEVIATION 6.85 |
| Dementia risk factors Anxiety | 7268 Participants | 7252 Participants | 14520 Participants |
| Dementia risk factors Bipolar disorder | 747 Participants | 763 Participants | 1510 Participants |
| Dementia risk factors Coronary artery disease | 15043 Participants | 15080 Participants | 30123 Participants |
| Dementia risk factors Depression | 7885 Participants | 7906 Participants | 15791 Participants |
| Dementia risk factors Diabetes | 45146 Participants | 45024 Participants | 90170 Participants |
| Dementia risk factors Obesity | 9833 Participants | 9872 Participants | 19705 Participants |
| Dementia risk factors Schizophrenia | 468 Participants | 465 Participants | 933 Participants |
| Race/Ethnicity, Customized Asian | 3295 Participants | 3280 Participants | 6575 Participants |
| Race/Ethnicity, Customized Black | 8092 Participants | 8107 Participants | 16199 Participants |
| Race/Ethnicity, Customized Hispanic | 2463 Participants | 2466 Participants | 4929 Participants |
| Race/Ethnicity, Customized Native American | 471 Participants | 472 Participants | 943 Participants |
| Race/Ethnicity, Customized Other | 1941 Participants | 1962 Participants | 3903 Participants |
| Race/Ethnicity, Customized Unknown | 646 Participants | 655 Participants | 1301 Participants |
| Race/Ethnicity, Customized White | 47346 Participants | 47312 Participants | 94658 Participants |
| Sex: Female, Male Female | 35010 Participants | 34917 Participants | 69927 Participants |
| Sex: Female, Male Male | 29244 Participants | 29337 Participants | 58581 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 64,254 | 0 / 64,254 |
| other Total, other adverse events | 0 / 64,254 | 0 / 64,254 |
| 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) 189 days (exp), 171 days (ref) 2) 835 days (exp). 851 days (ref) 3) 388 days (exp), 348 days (ref) 4) 191 days (exp), 172 days (ref)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Dihydropyridine calcium channel blocker | Time to Dementia Onset | Analysis 1 | 17.1 Incidence rate per 1000 person year |
| Dihydropyridine calcium channel blocker | Time to Dementia Onset | Analysis 2 | 20.8 Incidence rate per 1000 person year |
| Dihydropyridine calcium channel blocker | Time to Dementia Onset | Analysis 3 | 15.6 Incidence rate per 1000 person year |
| Dihydropyridine calcium channel blocker | Time to Dementia Onset | Analysis 4 | 5.6 Incidence rate per 1000 person year |
| Hydrochlorothiazide | Time to Dementia Onset | Analysis 4 | 4.0 Incidence rate per 1000 person year |
| Hydrochlorothiazide | Time to Dementia Onset | Analysis 1 | 13.7 Incidence rate per 1000 person year |
| Hydrochlorothiazide | Time to Dementia Onset | Analysis 3 | 13.1 Incidence rate per 1000 person year |
| Hydrochlorothiazide | Time to Dementia Onset | Analysis 2 | 20.6 Incidence rate per 1000 person year |