ATD Study version 1.0
Research type
Research Study
Full title
Antithyroid Drug (ATD) Study
IRAS ID
250064
Contact name
Bijay Vaidya
Contact email
Sponsor organisation
Royal Devon and Exeter NHS Foundation Trust
Duration of Study in the UK
2 years, 11 months, 31 days
Research summary
Antithyroid drugs (ATDs) are the primary treatment for a large proportion of patients with hyperthyroidism (a condition where the thyroid gland produces too much of the hormone thyroxine). Of the 15,000 new UK patients treated each year, 1/500 have a drug reaction causing a very low white cell count leading to inflammation of the throat, mouth and lips, fever and sepsis. If treatment is stopped quickly a patient will usually recover after 5-10 days. Up to 10% of cases are fatal. Another potentially life-threatening effect is liver injury and 1/1000 patients taking the ATD Propylthiouracil will get this. Of these, 10% will have liver failure resulting in liver transplantation or death.
Although these side effects are serious and occasionally fatal, because they are rare, any one doctor will only see a small number of cases. Therefore, important patterns or information about who is affected and the best way to manage them could be being missed.
This is a 2-year UK-wide study aiming to collect information from 150 adult patients who have had a reaction leading to very low white blood cell count or liver injury caused by an ATD. Participants will be asked to consent to having their medical notes read and relevant information will be added to a study database. Participants will also be asked to provide a blood sample so that their DNA can be stored for future research.
We aim to answer the following questions:
Who is at risk of suffering a side effect?
How are these side effects treated?
Is treatment different in different places?
Is one treatment better than another?The results will be published in a scientific journal and will be presented at a conference. Participants and the public will be able to read the results on the ‘You and Your Hormones’ website.
REC name
West Midlands - South Birmingham Research Ethics Committee
REC reference
19/WM/0019
Date of REC Opinion
21 Feb 2019
REC opinion
Further Information Favourable Opinion