Clinical trial NCT04969653: The Incidence of Venous Thromboembolism in Atopic Dermatitis
Official title: The Incidence of Venous Thromboembolism in Atopic Dermatitis: A Matched Cohort Analysis in UK Primary Care
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Venous Thromboembolism
Atopic Dermatitis
Pulmonary Embolism
Deep Vein Thrombosis
Allergic Rhinitis
Allergy to House Dust Mite
Allergy to Animal Dander
Food Allergy
Cows Milk Allergy
Lead sponsor: Momentum Data
Sponsor class: INDUSTRY
Collaborators: name: Pfizer
First posted: 2021-07-21
Enrollment: 754745
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This study will use routinely collected and collated data from OPCRD to provide a broadly representative sample of the population of the UK.

Brief summary: This study aims to investigate the incidence of venous thromboembolism in people who are diagnosed with atopic dermatitis.

Detailed description: The aim of this study is to examine whether venous thromboembolism is higher in people with atopic dermatitis compared and those without and to explore the risk in particular subgroups of people with AD such as those with higher body mass index or using oestrogen containing contraceptives. Such insights will be valuable for clinicians in advising patients with atopic dermatitis regarding venous thromboembolism prevention and detection and when selecting atopic dermatitis treatments.

Eligibility criteria: Inclusion Criteria:

* All eligible adult people (aged ≥ 18) registered with GP practices contributing data to OPCRD between January 1, 2010 and January 1, 2020, were eligible for inclusion in the study.

Exclusion Criteria:

* People with less than 5 years potential follow up. People with atopic dermatitis that was not active atopic dermatitis during the study period. People without atopic dermatitis but diagnosed with other skin conditions.

Primary outcomes:
measure: Number of Participants With Diagnosis of Venous Thromboembolism After the Start of Follow-up for Each Person.
timeFrame: 10 years from index date
Secondary outcomes:
measure: Number of Participants With Diagnosis of Pulmonary Embolism After the Start of Follow-up for Each Person
timeFrame: 10 years from index date
measure: Number of Participants With Diagnosis of Deep-vein Thrombosis After the Start of Follow-up for Each Person
timeFrame: 10 years from index date
measure: Number of Male Participants With Diagnosis of Risk of Venous Thromboembolism After the Start of Follow-up for Each Person
timeFrame: 10 years from index date
measure: Number of Female Participants With Diagnosis of Risk of Venous Thromboembolism After the Start of Follow-up for Each Person
timeFrame: 10 years from index date
measure: Number of Participants Aged 18-44 With Diagnosis of Venous Thromboembolism After the Start of Follow-up for Each Person
timeFrame: 10 years from index date
measure: Number of Participants Aged 45-64 With Diagnosis of Venous Thromboembolism After the Start of Follow-up for Each Person
timeFrame: 10 years from index date
measure: Number of Participants Aged ≥65 With Diagnosis of Venous Thromboembolism After the Start of Follow-up for Each Person
timeFrame: 10 years from index date
measure: Number of Participants BMI <30 With Diagnosis of Venous Thromboembolism After the Start of Follow-up for Each Person
timeFrame: 10 years from index date
measure: Number of Participants BMI ≥30 With Diagnosis of Venous Thromboembolism After the Start of Follow-up for Each Person
timeFrame: 10 years from index date
measure: Number of Female Participants Aged 18-44 Using Oestrogen Contraceptive With Diagnosis of Venous Thromboembolism After the Start of Follow-up for Each Person
timeFrame: 10 years from index date
measure: Number of Participants Having History of an Allergic Condition With Diagnosis of Venous Thromboembolism After the Start of Follow-up for Each Person
timeFrame: 10 years from index date
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Momentum Data Ltd
Study officials:
affiliation: Momentum Data Ltd
name: Andrew McGovern, MD
role: STUDY_DIRECTOR
References:
citation: Warren RB, Basey V, Lynam A, Curtis C, Ardern-Jones MR. The risk of venous thromboembolism in atopic dermatitis: a matched cohort analysis in UK primary care. Br J Dermatol. 2023 Sep 15;189(4):427-436. doi: 10.1093/bjd/ljad212.