Thomas Hardy, MD, clinical researcher, Lilly Research Laboratories, Indianapolis, Indiana, United States, and associates analysed pooled data in 867 patients who had been randomised in a 2:1 ratio to 52 weeks' treatment with duloxetine 60 mg BID or routine care after completing 12-week placebo-controlled, acute-phase studies.

All subjects were 18 years of age or older and experienced pain due to bilateral peripheral neuropathy caused by type 1 or 2 diabetes.

After 52 weeks, there was an increase in haemoglobin A1c levels in both the duloxetine and routine care groups, according to the study's results, which were released on June 10^th. However, the mean increase was greater in the duloxetine-treated group (0.5% vs 0.2%, respectively, P < .001).

The researchers also documented a modest increase in fasting blood glucose levels and a small increase in total cholesterol levels in duloxetine-treated patients, while the routine care group showed a slight decrease.

A small decease in high-density lipoprotein (HDL) cholesterol levels was observed in the both groups, but the reduction was significantly smaller with duloxetine than with routine care (mean change: -0.014 vs -0.078 mmol/L, respectively, P = .002).

Changes in weight and lipid parameters with long-term duloxetine treatment on average were small and of uncertain significance, Dr. Hardy said.

The rate of diabetes-related adverse events was similar in the 2 groups.

Dr. Hardy cautioned that the study may be limited by the fact that the management of diabetes and lipid disorders was left to the discretion of the investigators and may have varied between treatment groups.

Also, the routine care group included a number of different therapies. Therefore, direct comparison of the metabolic effects of duloxetine and other possible treatments for DPNP in this study is difficult.

About 30% to 60% of diabetics develop long-term complications of peripheral neuropathy, and up to 10% to 20 % of patients with peripheral neuropathy experience pain.

The study was sponsored by Lilly.


[Presentation title: Duloxetine's Long-Term Effects on Glycemic Control in Patients With Diabetic Peripheral Neuropathic Pain. Abstract 796-P]

Copyright © 2009 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.