To answer 3 questions: What is the incidence of drug induced liver disorders in a population during ordinarily circumstances?Which drugs are associated with an increased risk of liver disorders?Are there genetic mutations which could explain (…
ID
Source
Brief title
Condition
- Hepatic and hepatobiliary disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Incidence of drug induced liver disorders in an unselected population in
general circumstances.
Relative risk of certain liver disorders when using certain medications.
Genetic role in hepatotoxicity.
Secondary outcome
Risk profile of different medications
Background summary
There is little information on the incidence of liver disorders in the general
(unselected) population. Liver disorders caused by drugs are one of the most
dreaded side effects. In the last years the most frequent cause of drug
withdrawal or suspension in the European Union were liver disorders.
Study objective
To answer 3 questions:
What is the incidence of drug induced liver disorders in a population during
ordinarily circumstances?
Which drugs are associated with an increased risk of liver disorders?
Are there genetic mutations which could explain (partially) this
hepatotoxicity?
Study design
We want to perform a retrospective cohort study using the Integrated Primary
Care Information (IPCI) database. This longitudinal observational database is a
general practitioner (GP) research database, containing over 800.000
computer-based patient records, obtained from a group of more than 150 GP*s
throughout the Netherlands. This database was established in 1992 by the
Department of Medical Informatics of the Erasmus University Medical Centre
Rotterdam in the Netherlands, with the specific purpose to conduct
epidemiological and pharmaco-economic studies and post-marketing surveillance.
Study burden and risks
Filling out a questionnaire and taking of 3x10cc bloedsamples .
Dr. Molewaterplein 40/50
3000CA Rotterdam
NL
Dr. Molewaterplein 40/50
3000CA Rotterdam
NL
Listed location countries
Age
Inclusion criteria
Patients who present themselves to the GP with clinical symptoms and complaints which could be related to liver damage, and who have at least òr an ALAT value of >2 times the normal value, òr who have a combination of a raised ASAT, alkalic phosfatase, and bilirubin, where at least one of these 3 had to be >2 times the normal value
Exclusion criteria
cancer/carcinoma, liver injury or another form of hepatitis, cholelithiasis, cholecystitis, acute or chronic pancreatitis, heart failure, alcohol abusus, HIV infection, medical history< 1 yr in IPCI database
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL26253.078.09 |