Hypertension, Fracture
Conditions
Brief summary
This retrospective observational study aims to evaluate the short-term fracture risk associated with anti-hypertensive medication initiation using a self-controlled case series (SCCS) design and investigate temporal trends of initial anti-hypertensive regimen (monotherapy vs combination therapy) and subsequent fracture incidence. The investigators use the Korean Health Insurance Review and Assessment (HIRA) database to identify adults aged ≥65 with a new prescription for anti-hypertensive therapy and at least one incident non-traumatic fracture. In the SCCS analysis, the investigators estimate the within-person incidence rate of overall fractures during the 30-day period following anti-hypertensive initiation compared to control periods. Temporal trends will be recorded through 2013 - 2022. The primary outcome is overall non-traumatic fracture occurrence; the secondary outcome is incident proximal hip fracture. These outcomes are defined using diagnostic and procedural codes validated for use in claims data. This study aims to quantify both the immediate temporal association between treatment initiation and fracture risk, and the comparative safety of different initial anti-hypertensive regimens.
Interventions
DRUGMonotherapy
Antihypertensive medications, regardless of dose or formulation, will be classified by their pharmacologic class. A total of eight drug classes will be considered: angiotensin-converting enzyme (ACE) inhibitors, angiotensin II receptor blockers (ARBs), beta-blockers, dihydropyridine calcium channel blockers (DHP-CCBs), non-dihydropyridine calcium channel blockers (non-DHP-CCBs), loop diuretics, thiazide and thiazide-like diuretics, and potassium-sparing diuretics. Exposure groups will be defined as follows: * Monotherapy: prescription of a single antihypertensive drug class on the index date. * Dual therapy: prescription of two ore more antihypertensive drug classes on the same index date. To qualify for group assignment, all drugs must be initiated on the same day, and the drug of interest is limited to the class described in group/cohort. Out of the two, this intervention will be monotherapy.
DRUGCombination therapy
Antihypertensive medications, regardless of dose or formulation, will be classified by their pharmacologic class. A total of eight drug classes will be considered: angiotensin-converting enzyme (ACE) inhibitors, angiotensin II receptor blockers (ARBs), beta-blockers, dihydropyridine calcium channel blockers (DHP-CCBs), non-dihydropyridine calcium channel blockers (non-DHP-CCBs), loop diuretics, thiazide and thiazide-like diuretics, and potassium-sparing diuretics. Exposure groups will be defined as follows: * Monotherapy: prescription of a single antihypertensive drug class on the index date. * Dual therapy: prescription of two or more antihypertensive drug classes on the same index date. To qualify for group assignment, all drugs must be initiated on the same day, and the drug of interest is limited to the class described in group/cohort. Out of the two, this intervention will be combination therapy.
Sponsors
Ajou University School of Medicine
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
50 Years to 100 Years
Healthy volunteers
No
Inclusion criteria
* Individuals with at least 365 days of continuous observation prior to the index date (defined as the date of first antihypertensive medication prescription), with no prior antihypertensive use during that period * At least one diagnosis of hypertension (ICD-10 codes I10-I13, I15) recorded within 180 days before the index date
Exclusion criteria
(main cohort): * Any of the following occurring in the 365 days prior to the index date: Hospitalization (inpatient admission, including long-term care facility), transport-related trauma (ICD-10 codes V01-V99), Intentional self-harm (ICD-10 codes X60-X84, Y87), History of pathological fractures (e.g., M84.4, M90.7), Evidence of end-stage renal disease (ESRD), dialysis, kidney transplant, renal osteodystrophy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall fracture risk | 45 days after initiation of antihypertensive medication | First incidence of non-traumatic fracture in either proximal humerus, distal radius/ulna, thoraco-lumbar vertebrae, sacrum/pelvis, or proximal hip |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hip fracture | 45 days after initiation of antihypertensive medication | First incidence of non-traumatic proximal hip fracture |
Contacts
Primary ContactJong Min Lee, M.D.
Outcome results
None listed