Steroid Use and the risk of Venous Thromboembolism in Asthma Patients

Study type
Protocol
Date of Approval
Study reference ID
17_138
Lay Summary

Blood clots which occur in the veins of the legs or in the lungs, also known as venous thromboembolism (VTE), continue to pose important health problems, however a lot remains unknown about what causes them. In recent years, more attention is being focused on medications that play a role in the development of this disease. Asthma is a fairly common disease and a significant proportion of the adult population receives steroids for ongoing treatment of asthma. Because steroid use is common in people with asthma it is important to understand serious adverse effects caused by steroids. The objective of this study is to determine whether steroid use increases the risk of blood clots (VTE) among adult patients with asthma.

Technical Summary

Venous thromboembolism (VTE) continues to pose an important disease burden, however a lot remains unknown about the risk factors that cause it. In recent years, attention has been focused on medications that play a role in development of drug-induced VTE. A significant proportion of the adult population receives steroids for ongoing management of asthma, therefore, potential serious adverse consequences of these treatments should be investigated. This will be a nested case control study among a population of people with asthma who received at least one steroid prescription during 1995- 2015 in the UK-based CPRD. Cases of VTE (pulmonary embolism [PE] or deep venous thrombosis [DVT]), and 4 matched controls for each case will be derived from the base population. We will assess the risk of VTE in relation to timing of drug exposure, duration of use and types of steroids. Descriptive analyses as well as conditional logistic regression will be used to evaluate the relationship between steroid use and the risk of VTE. The proposed study in a large population-based database of high quality will efficiently evaluate the safety of this pharmacologic agent, which will guide the development of guidelines for the use of steroids in prolonged care of asthma.

Health Outcomes to be Measured

Incident Venous Thromboembolism.

Collaborators

Susan Jick - Chief Investigator - BCDSP - Boston Collaborative Drug Surveillance Program
Lade Ayodele - Corresponding Applicant - Decision Resources Group