Diabetes
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
DRUGSemaglutide
Semaglutide claim is used as the exposure group.
DRUGDPP-4 inhibitor
DPP4 inhibitors (sitagliptin, saxagliptin, linagliptin, and alogliptin) 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://drive.google.com/drive/folders/1VRjPaaelXFyBbA5gV6pwB\_ijSIMyIJ4N?usp=share\_link or Appendix A(https://drive.google.com/drive/folders/1OgKQlxsJi9UWRDd3Kbaux\_8adngoSnZY?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\. Diagnosis code for type 2 diabetes 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 use of any GLP receptor agonists (semaglutide, exenatide, liraglutide, albiglutide, dulaglutide, lixisenatide) or DPP4 inhibitors * 4\. Prior use of Semaglutide or DPP4 inhibitors concomitantly on index date
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to Dementia Onset | Median follow up times: 1) 98 days (exp), 134 days (ref) 2) 118 days (exp), 132 days (ref) 3) 90 days (exp), 308 days (ref) 4) 99 days (exp), 135 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 |
|---|---|
| Semaglutide Exposure group
Semaglutide: Semaglutide claim is used as the exposure group. | 7,129 |
| DPP4 Inhibitors (Sitagliptin, Saxagliptin, Linagliptin, and Alogliptin) Reference group
DPP-4 inhibitor: DPP4 inhibitors (sitagliptin, saxagliptin, linagliptin, and alogliptin) claim is used as the reference group. | 7,129 |
| Total | 14,258 |
Baseline characteristics
| Characteristic | Semaglutide | DPP4 Inhibitors (Sitagliptin, Saxagliptin, Linagliptin, and Alogliptin) | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 7129 Participants | 7129 Participants | 14258 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous | 70.71 years STANDARD_DEVIATION 4.52 | 70.70 years STANDARD_DEVIATION 4.65 | 70.71 years STANDARD_DEVIATION 4.6 |
| Dementia risk factors Anxiety | 1094 Participants | 1073 Participants | 2167 Participants |
| Dementia risk factors Bipolar Disorder | 131 Participants | 145 Participants | 276 Participants |
| Dementia risk factors Coronary artery disease | 2527 Participants | 2578 Participants | 5105 Participants |
| Dementia risk factors Depression | 1335 Participants | 1362 Participants | 2697 Participants |
| Dementia risk factors Hypertension | 6650 Participants | 6618 Participants | 13268 Participants |
| Dementia risk factors Obesity | 4005 Participants | 4030 Participants | 8035 Participants |
| Dementia risk factors Schizophrenia | 15 Participants | 20 Participants | 35 Participants |
| Race/Ethnicity, Customized Asian | 131 Participants | 141 Participants | 272 Participants |
| Race/Ethnicity, Customized Black | 547 Participants | 531 Participants | 1078 Participants |
| Race/Ethnicity, Customized Hispanic | 130 Participants | 116 Participants | 246 Participants |
| Race/Ethnicity, Customized North American Native | 44 Participants | 44 Participants | 88 Participants |
| Race/Ethnicity, Customized Other | 139 Participants | 132 Participants | 271 Participants |
| Race/Ethnicity, Customized Unknown | 195 Participants | 197 Participants | 392 Participants |
| Race/Ethnicity, Customized White | 5943 Participants | 5968 Participants | 11911 Participants |
| Sex: Female, Male Female | 3406 Participants | 3342 Participants | 6748 Participants |
| Sex: Female, Male Male | 3723 Participants | 3787 Participants | 7510 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 24 / 7,129 | 44 / 7,129 |
| other Total, other adverse events | 0 / 7,129 | 0 / 7,129 |
| 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) 98 days (exp), 134 days (ref) 2) 118 days (exp), 132 days (ref) 3) 90 days (exp), 308 days (ref) 4) 99 days (exp), 135 days (ref)
Population: Study cohort after 1:1 propensity score matching
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Semaglutide | Time to Dementia Onset | Analysis 1 | 4.40 Incidence rate per 1000 person year |
| Semaglutide | Time to Dementia Onset | Analysis 2 | 4.69 Incidence rate per 1000 person year |
| Semaglutide | Time to Dementia Onset | Analysis 3 | 2.80 Incidence rate per 1000 person year |
| Semaglutide | Time to Dementia Onset | Analysis 4 | 0.37 Incidence rate per 1000 person year |
| DPP4 Inhibitors | Time to Dementia Onset | Analysis 4 | 0.61 Incidence rate per 1000 person year |
| DPP4 Inhibitors | Time to Dementia Onset | Analysis 1 | 6.06 Incidence rate per 1000 person year |
| DPP4 Inhibitors | Time to Dementia Onset | Analysis 3 | 10.24 Incidence rate per 1000 person year |
| DPP4 Inhibitors | Time to Dementia Onset | Analysis 2 | 6.71 Incidence rate per 1000 person year |