Biomarkers of idiosyncratic drug-induced liver injury in patients taking Diclofenac (Biomarkers Diclofenac)

1st February 2011

Status: Ended

Specialism: Liver.

Team: Professor Guruprasad Aithal.

Diclofenac is one of the commonly used NSAID in the UK and is associated with clinically significant drug induced liver injury leading to referral to hospital occurs in 6.3 per 100,000 diclofenac users. As there are no specific treatment that reverses liver injury in these cases, early diagnosis and prompt withdrawal of the offending agent is a critical step in the management. However, there are no validated and reliable methods of monitoring; evidence that regular liver enzyme monitoring prevents clinically significant liver toxicity is limited. There is an urgent need of better biomarkers that are accurate in their prediction of serious clinical outcome if drug is continued as well as detectable in an early stage when prompt drug-withdrawal guarantees complete resolution.

The study aims to recruit 50 patients over an 18 month period; those included must have been receiving diclofenac for at least seven day prior to study entry. Descriptive statistics will be used to describe the frequency of diclofenac adducts and biomarkers of liver injury. This information will be useful for power calculations in future validation studies. Blood samples will be collected on one occasion after 1 hour after diclofenac intake and sera and plasma will be stored and used for investigations.

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guruprasad-aithal Professor Guruprasad Aithal Professor Aithal has been a Consultant Hepatobiliary Physician at Nottingham University Hospitals NHS trust since 2001. He is the Head of the NIHR Nottingham Digestive Diseases Biomedical Research Centre, and the Head of Division for the Nottingham…
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