T3 Safety Study

• Research type

  Research Study

• Full title

  Cardiovascular morbidity and mortality in Liothyronine-treated patients: a linked record cohort study

• IRAS ID

  262331

• Contact name

  Colin Dayan

• Contact email

  DayanCM@Cardiff.ac.uk

• Sponsor organisation

  Cardiff University

• Duration of Study in the UK

  0 years, 11 months, 30 days

• Research summary

  The study will determine the long-term safety of the drug T3 used in the treatment of hypothyroidism. Hypothyroidism or thyroid hormone deficiency affects 1-2 million people in the UK and untreated patients suffer significant ill-health. Levothyroxine (T4) is the conventional treatment for hypothyroidism and most patients who are treated with T4 respond well to treatment and enjoy a good quality of life. However, a small proportion of patients remain unwell with T4 and therefore some practitioners treat such patients with an alternative form of treatment called T3. Although many patients who receive T3 report significant improvement in well-being, the long-term safety of the drug has not been established and current UK and international guidelines do not recommend its routine use in practice.
  The current study will evaluate the long-term risk of death, heart disease, and strokes, in patients who were treated with T3 in an independent medical clinic that was run by the late Dr Skinner from the 1990s to 2013. The clinic dataset comprises over 4,000 patients representing one of the largest single records of T3-treated patients worldwide. In this study, risks for death, heart disease and strokes will be compared between: (i) patients treated with T3, (ii) patients treated conventionally with T4, and (iii) individuals without thyroid disease. This will be investigated by linking the clinic data with NHS hospital admission and mortality records via NHS Digital and the Wales Secure Anonymised Information Linkage (SAIL) Databank. The data-linkage approach has been designed such that researchers will not know the identity of individual patients and patients will be given an opportunity to opt out from their data being used for the study.
  

• REC name

  Wales REC 1

• REC reference

  20/WA/0030

• Date of REC Opinion

  3 Apr 2020

• REC opinion

  Further Information Favourable Opinion