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Clinical trial

Use of Hydrochlorothiazide and the Risk of Skin Cancer

ID
Name
Q19-05
Description
The purpose of this study is to determine whether the use of hydrochlorothiazide is associated with an increased risk of skin cancer compared with the use of angiotensin-converting enzyme (ACE) inhibitors. More specifically, the investigators will assess the risk of non-melanoma and melanoma skin cancer. The investigators hypothesize that the use of hydrochlorothiazide is associated with an increased risk of skin cancer compared with ACE inhibitors. The investigators will carry out separate population-based cohort studies using administrative health databases from seven Canadian provinces and the United States. The study cohort will be defined by the initiation of hydrochlorothiazide or an ACE inhibitor, with follow-up until an incident diagnosis of non-melanoma or melanoma skin cancer. The results from the separate sites will be combined to provide an overall assessment of the risk of non-melanoma and melanoma skin cancer in users of hydrochlorothiazide.
Trial arms
Trial start
2019-05-27
Estimated PCD
2021-03-05
Trial end
2021-03-05
Status
Completed
Treatment
Hydrochlorothiazide
Exposure to hydrochlorothiazide will be defined as a prescription for hydrochlorothiazide alone or in combination with non-ACE inhibitor antihypertensive drugs at cohort entry date.
Arms:
Hydrochlorothiazide
Other names:
ATC C03AA03
Angiotensin-converting enzyme (ACE) inhibitors
Exposure to ACE inhibitors will be defined as a prescription for an ACE inhibitor alone or in combination with non-hydrochlorothiazide antihypertensive drugs at cohort entry date.
Arms:
Angiotensin-converting enzyme (ACE) inhibitors
Other names:
ATC C09A, C09B
Size
2953748
Primary endpoint
Non-melanoma skin cancer
Patients will be followed starting 366 days after study cohort entry until an incident diagnosis of non-melanoma skin cancer, censoring or for up to 275 months, whichever occurs first.
Melanoma skin cancer
Patients will be followed starting 366 days after study cohort entry until an incident diagnosis of melanoma skin cancer, censoring or for up to 275 months, whichever occurs first.
Eligibility criteria
Inclusion Criteria: * Patients aged 40 years or older (or 66 years or older in Alberta, Nova Scotia and Ontario) newly-treated with hydrochlorothiazide or an ACE inhibitor between April 1, 1995 and March 31, 2018 (or the latest date of data availability at each site) Exclusion Criteria: * Patients with less than one year of health coverage before cohort entry * Patients with a previous prescription of any antihypertensive drug at any time before cohort entry * Patients with a diagnosis of any type of skin cancer (non-melanoma and melanoma) at any time before cohort entry * Patients with a diagnosis of HIV at any time before cohort entry * Patients with a history of solid organ transplant at any time before cohort entry * Patients with less than one year of follow-up after cohort entry
Protocol
{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'COHORT', 'timePerspective': 'RETROSPECTIVE'}, 'enrollmentInfo': {'count': 2953748, 'type': 'ACTUAL'}}
Updated at
2023-06-29

1 organization

2 products

3 indications

Organization
Canadian Network for Observational Drug Effect Studies
Product
Hydrochlorothiazide
Indication
Skin Cancer
Indication
Melanoma
Indication
Hypertension
Product
Angiotensin-converting enzyme inhibitors