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 much 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. Enlarged prostate, also known as Benign prostatic hyperplasia (BPH) is fairly common as men grow older. A significant proportion of the males with prostate enlargement receives drugs known as 5- alpha reductase inhibitors (5-ARIs) for ongoing treatment of BPH. These drugs help to shrink the size of the prostate and reduce symptoms like difficulty urinating. Because 5ARI use is common in people with BPH it is important to understand serious adverse effects caused by 5ARI. The objective of this study is to determine whether 5ARI use increases the risk of blood clots (VTE) among male adult patients with BPH.
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, more attention has been focused on medications that play a role in the development of drug-induced venous thrombosis. A significant proportion of the adult population receives 5- alpha reductase inhibitors (5-ARIs) for ongoing treatment of BPH. Therefore, potential serious adverse consequences associated with these treatments should be investigated. This will be a nested case control study among a population of men who received at least one 5ARI or alpha blocker prescription for treatment of BPH during 1995- 2015 in the UK-based Clinical Practice Research Datalink. Cases of VTE (pulmonary embolism [PE] or deep venous thrombosis [DVT]) and matched controls will be derived from the base population. The risk of VTE in relation to timing of drug exposure, duration of use and types of drug will be assessed. Descriptive analyses as well as conditional logistic regression will be used to evaluate the relationship between 5ARIs 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 its use in the prolonged care of BPH patients.
Incident Venous Thromboembolism.
Susan Jick - Chief Investigator - BCDSP - Boston Collaborative Drug Surveillance Program
Lade Ayodele - Corresponding Applicant - Decision Resources Group