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Diabetic Peripheral Neuropathy: An Unmet Clinical Need of Diagnosis and Treatment. Intern Diab Meeting Melbourne, Australia

MELBOURNE, Australia — Pharmaceutical options for diabetic peripheral neuropathy are sorely required, says one expert in the field.

Speaking at the International Diabetes Federation World Diabetes Congress 2013 in Melbourne last month, Rayaz A. Malik, MBChB, FRCP, PhD, from the Central Manchester University Teaching Hospitals and University of Manchester, United Kingdom, said: ”We have no licensed treatment for diabetic neuropathy. We have witnessed failure after failure of numerous clinical trials despite great experimental data. None of these drugs has been translated into therapies we can prescribe to our patients.”

One issue is that many of the trials of such agents have included patients who already have quite advanced neuropathy. The lack of simple, objective, sensitive tests to assess early nerve damage and repair is a limiting factor, said Dr. Malik. ”The currently advocated tests, such as neurophysiology, focus on the large fibers, instead of the more abundant and clinically relevant small fibers,” he noted.

”We need to critically look at the way we run these clinical trials and the end points used. If you have a test that is not sensitive enough for assessing early improvement, then despite million-dollar trial programs, the drug fails.”

Neuropathy: A Microvascular Complication, Often Painful

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Dr. Rayaz A. Malik

Dr. Malik, who specializes in treating diabetic peripheral neuropathy, explained that type 1 and type 2 diabetes are the commonest causes of painful neuropathy in the Western world, with 50% of patients with diabetes suffering from neuropathy, which can be painless or painful. Others causes of neuropathy include HIV neuropathy and chemotherapy-induced neuropathy (CIPN).

Around 20% of patients with diabetic neuropathy will suffer from pain, ”which can be anything from mild discomfort to debilitating, can’t-sleep-at-night pain, predominantly in the lower limbs and feet — sharp, jabbing pains, to the point where some patients can’t even have bed sheets over their feet.” He estimates that 5% of patients are ”very badly affected.”

As well as the pain, other complications of neuropathy include falls and foot ulcers, with the latter leading to digit, foot, or limb amputation if not managed correctly. The development of infections and ulcers can be reduced with good screening and surveillance programs.

Dr. Malik said it has become clear that neuropathy is ”a microvascular complication” of diabetes, ”just like nephropathy and retinopathy,” and recent data have indicated that cardiovascular risk factors such as blood pressure and lipids are in fact stronger predictors of whether a patient will develop peripheral neuropathy than glucose control.

”Glucose control is advocated but at best has been shown to prevent progression in type 1 diabetes (in the DCCT studies) but not in type 2 diabetes [data from UKPDS, ACCORD, ADVANCE, and VADT].”

Improved blood-pressure control has been shown to work ”in 2 small trials,” he added, one with the ACE inhibitor trandolapril (Mavik, Abbott Laboratories) (Lancet.1998;352:1978-1981) and the other with a combination of the ACE inhibitor delapril and the calcium-channel blocker manidipine (Hypertension. 2011;58:776-783).

New UK Guidance for Diabetic Neuropathy Pain

There are treatments for the pain associated with neuropathy, however, although this is merely symptom relief and does not address the underlying nerve damage.

The therapeutic choices for pain relief are tricyclic antidepressants, selective serotonin-norepinephrine reuptake inhibitors (SNRIs) such as duloxetine, and the antiepileptics gabapentin and pregabalin (Lyrica, Pfizer), Dr. Malik explained

From Medscape Medical News.

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