Long-term safety of cabergoline in hyperprolactinaemia
Research type
Research Study
Full title
Long-term safety of cabergoline in hyperprolactinaemia
IRAS ID
272082
Contact name
Craig E Stiles
Contact email
Sponsor organisation
Queen Mary, university of London Joint Research Management Office (JRMO)
Duration of Study in the UK
1 years, 0 months, 1 days
Research summary
Cabergoline is a drug that was previously used in Parkinson's disease, its use was discontinued as at high doses it causes heart-valve disease.
Cabergoline continues to be used at much smaller doses for the treatment of benign pituitary tumours called 'prolactinoma'. These tumours produce a hormone which switches off lady's menstrual periods, they can also grow large and cause blindness. Cabergoline is very effective at restoring periods (and therefore fertility) and also in shrinking these tumours.
Currently, the medicines and healthcare products regulatory agency insist that anyone taking cabergoline must have a heart scan every 6-12 months to ensure that there is no heart valve damage.
Studies have been largely reassuring that the low doses of cabergoline used do not cause any damage, however, some studies have shown that there may still be a link. However, these studies have relied solely on heart scans to diagnose heart valve problems and sometimes overcall the significance of findings in the absence of a medical problems which causes the patient any symptoms.
Our research proposal aims to electronically examine the records of a large population of patients (~2 million) who are already entered into a large GP database, determine who has taken cabergoline for a prolactinoma and establish whether they are more likely to develop heart problems than other patients of the same age/sex/gender/ethnicity who haven’t taken cabergoline.
Where a cabergoline patient has developed heart problems, we will examine any heart scans (echocardiograms) performed at St Bartholomew’s hospital to establish whether the heart valves have undergone changes that have the characteristic appearance of those associated with cabergoline treatment.REC name
East of England - Cambridge Central Research Ethics Committee
REC reference
20/EE/0013
Date of REC Opinion
12 Jun 2020
REC opinion
Further Information Favourable Opinion