Progress has been made in the development of more effective treatments for painful diabetic neuropathy in the last 5 years. The improved clinical trial design, use of clinically relevant end points with drugs that have plausible pharmacological mechanisms and hence greater efficacy with lesser side effects, has led the FDA to approve pregabalin and duloxetine for painful diabetic neuropathy in 2005. Positive data have also been published for acetyl-L-carnitine (51), a-lipoic acid (14), and C-peptide (66) for symptoms and some deficits in patients with diabetic neuropathy. Long-term data for the benefits of a-lipoic acid in relation to nerve function should be available by 2006/2007. Although two recent phase-3 clinical trials with the protein kinase-C P-inhibitor, ruboxistaurin, have failed to improve neuropathic symptoms the Phase-3 trial to define the effects on nerve function continues and is because of report in 2008. A number of phase-2 and -3 studies are planned or are underway with new agents both for symptomatic neuropathy (NMDA receptor antagonists) and to improve deficits (aldose reductase inhibitor's).
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