To print: Select File and then Print from your browser's menu --------------------------------------------------------------------------------------- Title: Liver Injury Rate With Duloxetine Similar to Other Therapeutic Agents: Presented at AAPM URL: http://www.pslgroup.com/dg/21D7A2.htm Doctor's Guide February 19, 2008
By Ed Susman KISSIMMEE, FL -- February 19, 2008 -- While risk of liver injury for patients taking the antidepressant duloxetine appears higher than placebo, the overall hepatic risk is no greater for the selective serotonin and norepinephrine reuptake inhibitor than for other therapeutic agents. "Possible hepatic signals arising from spontaneously reported Food and Drug Administration data during the first 2 years of duloxetine exposure in the market have not been confirmed upon further investigation of individual case reports," said Jerry Hall, MD, Clinical Research Physician, Eli Lilly and Company, Indianapolis, Indiana, United States. Dr. Hall presented the study findings at a poster session on February 15 here during the American Academy of Pain Medicine (AAPM) 24th Annual Meeting. The researchers examined reports from more than 29,000 individuals in clinical trials, patients who spontaneously reported drug-associated events to the FDA, and reports from external databases. The researchers categorised postmarketing spontaneous reports possibly related to hepatic events as to clinical relevance and the probability that they were related to duloxetine. Adverse events recorded in the FDA Adverse Event Reporting System database for duloxetine were compared with those for all drugs and other antidepressants. The researchers also used an insurance claims database to compare hepatic-related events for duloxetine and for venlafaxine. "Clinical trial data revealed that duloxetine was associated with transient elevations of transaminases greater than 3 times the upper limit of normal in about 1% of patients," said Dr. Hall. He said that the increases in the laboratory liver function tests usually peaked at 8 weeks of use; the elevations did not correlate with bilirubin elevations and were not more likely to occur in patients already having pre-existing elevations. "Based on spontaneous reports and epidemiology of hepatic events, there were very few cases of true hepatic injury possibly or probably related to duloxetine," Dr. Hall said. "The calculated cumulative reporting rate of hepatic-related events was .00799%, similar to that in the literature for drugs in general of -0.7 to 40.6/100.000 person-years," he said. "The calculated cumulative reporting rate is consistent with 'very rarely reported' per the Council for International Organizations of Medicine." Overall, serious hepatic adverse events were not significantly different from those seen with placebo, said Dr. Hall. There were 77 reported treatment-emergent hepatic adverse events among 8,504 patients (0.91%) taking duloxetine compared with 34 events in 6,123 patients taking placebo (0.56%). That difference reached statistical significance at the P = .020 level. An expert panel that investigated fatalities determined there were 13 deaths, 8 of which were considered unlikely to be associated with duloxetine treatment. Two deaths were considered possibly related to duloxetine, and 3 were lacking sufficient information, which precluded a full review. Funding for the study was provided by Eli Lilly and Company. Dr. Hall said 5 million people have been prescribed duloxetine over the past 2 years, with 1.5 million person-years of use. [Presentation title: Duloxetine Hepatic Effects: 2006 Review. Abstract 110] --------------------------------------------------------------------------------------------- Copyright © 1999 P\S\L Consulting Group Inc. All rights reserved. Republication or redistribution of P\S\L content is expressly prohibited without the prior written consent of P\S\L. P\S\L shall not be liable for any errors, omissions or delays in this content or any other content on its sites, newsletters or other publications, nor for any decisions or actions taken in reliance on such content. --------------------------------------------------------------------------------------------- This news story was printed from *Doctor's Guide to the Internet* located at http://www.docguide.com --------------------------------------------------------------------------------------- Return to News Story Page This site is maintained by webmaster@pslgroup.com Please contact us with any comments, problems or bugs. All contents Copyright (c) 1998 P\S\L Consulting Group Inc. All rights reserved.