To print: Select File and then Print from your browser's menu --------------------------------------------------------------------------------------- Title: Duloxetine Effective for Diabetic Peripheral Pain in Patients of All Ages: Presented at EASD URL: http://www.pslgroup.com/dg/22BBB6.htm Doctor's Guide September 10, 2008
By Jill Stein ROME -- September 10, 2008 -- Duloxetine is as effective and well tolerated when used to treat peripheral neuropathic pain in elderly patients with diabetes as in younger patients with the disease, investigators reported here at the European Association for the Study of Diabetes (EASD) 2008. The study results were presented in a poster session on September 10. Duloxetine is a selective serotonin and norepinephrine reuptake inhibitor approved in many countries for the management of diabetic peripheral neuropathic pain as well as major depressive disorder, generalised anxiety disorder, and fibromyalgia. Joachim F. Wernicke, Eli Lilly and Company, Indianapolis, Indiana, and colleagues examined the safety and efficacy of duloxetine in an elderly population using data from 3 trials in which a total of 1,024 patients were randomised to 12 weeks of acute treatment with duloxetine 60 mg once daily, 60 mg twice daily, or placebo. Each of the phase 3 studies included an extension phase in which patients who had completed the acute phase were re-randomised to 52 weeks of treatment with conventional care or duloxetine 60 mg BID. Conventional care included drug and nondrug therapies that the investigator and the patient believed would be of benefit. The duloxetine group could receive most therapies except for antidepressants, anticonvulsants, and antipsychotics. The primary efficacy measure was the weekly mean 24-hour average pain score measured by a patient-rated 11-point Likert scale. For the analysis, patients were stratified by age (elderly, >=65 vs nonelderly, <65). Results showed no appreciable differences between the 2 age subgroups in overall rates of treatment-emergent adverse events in the acute phase. However, the investigators documented a significant association between use of duloxetine 60 mg QD and age >=65 years for nasopharyngitis (P = .047), with higher incidence in nonelderly compared with elderly patients (9.5% vs 1.8%). They also found an association between use of duloxetine 60 QD and age >=65 years for abdominal pain (P = .037), with a higher incidence in elderly versus nonelderly (5.7% vs 0.8%). Older patients were more likely to withdraw prematurely from drug treatment because of adverse events (P < .001) in all treatment groups. A therapy-by-age interaction in the overall rate of treatment-emergent adverse events due to age subgroup differences was documented for the extension phase of the trials in the conventional-care group. Duloxetine improved weekly mean 24-hour average pain compared with placebo in both older and younger patients (P < .01). Overall, the data indicate that duloxetine was usually well tolerated and effective for managing diabetic peripheral neuropathic pain with no consistent signal of any significant differences in safety or efficacy between older and younger patients, Dr. Wernicke and colleagues state in their poster. Thus, the drug may be worthwhile for the treatment of older patients with diabetic neuropathic pain, especially in the subgroup of patients in whom other medications are poorly tolerated, they said. Funding for this study was provided by Eli Lilly and Company. [Presentation title: Safety and Efficacy of Duloxetine in the Treatment of Diabetic Peripheral Pain in Elderly Patients. Abstract 1248] --------------------------------------------------------------------------------------------- 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.