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Source
Brief title
Health condition
Type 2 diabetes, hypertension, skin cancer
Sponsors and support
Intervention
Outcome measures
Primary outcome
Hazard ratio of skin cancer risk exposing to hydrochlorothiazide compared with no expose to hydrochlorothiazide
Secondary outcome
Existence of exposure-time-response relationship
Background summary
Hydrochlorothiazide is one of the conventional first-line antihypertensive drugs, however, its safety concern regarding its photosensitizing characteristic and risk of cutaneous squamous cell carcinoma is uncertain.
To determine the safety profile of HCTZ use regarding cSCC risk, we aim to perform a prospective cohort study of patients with type 2 diabetes using a datalink of the annual benchmarking database in Dutch primary care (Zwolle Outpatient Diabetes project Integrating Available Care [ZODIAC], 1998–2014), the Dutch National Cancer Registration, and the Dutch personal Records Database. All the eligible patients will be included and the only exclusion criteria will be those who had a history of skin cancer prior to or at baseline. Patients who were ever exposed to hydrochlorothiazide will be compared with patients who were never exposed to hydrochlorothiazide.
Study objective
Patients with Type 2 diabetes who were treated with hydrochlorothiazide might be associated with an increased risk for developing skin cancer.
Study design
Hazard ratio will be calculated for during the maximally 18 follow-up years.
Intervention
Exposure to hydrochlorothiazide
Inclusion criteria
Type 2 diabetes patients treated in the primary care
Exclusion criteria
Type 2 diabtes patientes who had a history of skin cancer before cohort entry
Design
Recruitment
IPD sharing statement
Plan description
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
NTR-new | NL8368 |
Other | university medical center groningen : METC 13.0765 |