Upstate News

June 8, 2005
Doretta Royer 315 464-4833

Researchers at SUNY Upstate participate in federal study assessing drug-induced liver injury

SYRACUSE, N.Y. – Read any prescription or non-prescription label and more than likely it will include a warning that the drug may induce liver damage. How much damage and why it happens in some people is something SUNY Upstate Medical University researchers and other hope to document in a new federal study.

SUNY Upstate researcher Robert A. Levine, M.D., is participating in a five-year National Institutes of Health study that may lead to a better understanding of the causes of drug-induced liver injury (DILI) and of the risk factors associated with DILI. Ultimately, the study hopes to pave the way for the design of safer drugs in the future.

The study, “A Multi-Center, Longitudinal Study of Drug and Complimentary and Alternative Medicine (CAM)-Induced Liver Injury,” is funded by the NIH’s National Institute of Diabetes & Digestive & Kidney. Levine, professor of medicine, serves as a principal site investigator for the New York-New England Consortium of the Drug-Induced Liver Injury Network (DILIN). DILIN will create a detailed database, registry and tissue bank from patients who have experienced DILI, including injury due to herbals and other alternative medicines. People who have been exposed to drugs, but who have not developed liver damage, also will be involved in the study. Blood, urine and, in some instances, liver tissue samples will be sent to Duke University School of Medicine for analysis.

According to Levine, severe drug-induced liver disease is an infrequent event and its rarity and idiosyncratic nature make it a hard problem for pharmaceutical companies to address, especially in clinical trials of limited duration with few patients.

“This study begins during a time of increased public scrutiny regarding the serious adverse events of drug treatments,” Levine said. “Liver injury continues to be the major form of drug toxicity. It is important to address the issue vigorously with the new NIH DILIN approach by identifying cases of drug-induced liver damage and control patients, the latter who are exposed to the same drug agent, but who do not develop liver damage.”

The investigation will involve retrospective and prospective studies. The retrospective study will establish a registry of 50 to 100 people in the country who have been identified with drug-induced liver injury due to four of the most common drugs causing a signature presentation of liver damage: phenytoin (Dilantin), isoniazid, amoxicillin/clavulanic acid (Augmentin,) and valproic acid (Depakote). These people will have been identified in the preceding six months with severe liver injury and elevated ALT enzymes and bilirubin three times the upper limit of normal level. In addition, control patients taking these drugs, but who have not had liver injury, will abe registered since the goal of the DILIN is to look for genetic, environmental and medical differences between the two groups of people so that researchers can understand the why these reactions occur.

The prospective study is for people who develop acute liver injury at any time in the future. This study will look at all drugs, including herbals and other alternative medicines, that have been ingested by the study volunteer over a period of up to 12 months or longer.

Study volunteers will be required to visit SUNY Upstate’s DILIN clinic for a two-hour evaluation, including a detailed medical history, exam and collection of blood and urine samples. Follow-up appointments and tests will be made if the liver injury persists for six months (ultrasound of the liver will be performed) or 12 months or longer (liver biopsy recommended). Volunteers will also be given the option to be followed up by someone on the study team contacting them once a year, for up to 20 years. Volunteers may drop out of the study at any time and they may also be offered opportunities to take part in other studies.

Individuals who are interested in participating should contact their primary physician or a pharmacist for a referral. For more information about the study or to enroll, call 315-464-5794 or 315-464-9077.

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