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AAN issues new guidelines for treatment of painful diabetic neuropathy
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Based on an extensive evidence review, the American Academy of Neurology recently released a new guideline recommending the use of the anticonvulsant drug pregabalin for the treatment of painful diabetic neuropathy.
“It is estimated that diabetic nerve pain affects 16% of the more than 25 million people living with diabetes in the United States, and is often unreported and more often untreated, with an estimated two out of five cases not receiving care,” lead guideline author Vera Bril, MD, FRCP, of the University of Toronto, said in a press release.
In 2007, the American Academy of Neurology (AAN), the American Association of Neuromuscular and Electrodiagnostic Medicine and the American Academy of Physical Medicine and Rehabilitation convened an expert panel to assess treatment options for diabetic neuropathy. They searched Medline and Embase for articles pertaining to the condition and graded evidence according to the AAN classification of evidence scheme. Research examining the safety and efficacy of anticonvulsants, antidepressants, opioid and other medications were included, as were nonpharmacologic treatments, such as electrical stimulation, magnetic field treatment, low-intensity laser treatment and Reiki massage.
Strong evidence suggests that the anticonvulsant pregabalin (Lyrica, Pfizer) is effective in decreasing pain associated with diabetic neuropathy, may improve quality of life and lessens sleep interference, the experts said. However, these benefits may be marginal, and physicians should carefully consider a patient’s case before prescribing the medication. The guideline recommends prescribing between 300 mg and 600 mg daily.
Gabapentin (Neurontin, Parke-Davis) and sodium valproate (Depacon, Abbott) are also effective, but should not be used by women of child-bearing age due to the teratogenic side effects of sodium valproate, according to the guideline. The anticonvulsants oxcarbazepine (Trileptal, Novartis), lamotrigine (Lamictal, GlaxoSmithKline) and lacosamide (Vimpat, Schwarz Pharma) should not be considered as treatments.
The guideline also said moderate evidence supports the efficacy of antidepressants amitriptyline (Mylan), venlafaxine (Effexor, Wyeth) and duloxetine (Cymbalta, Eli Lilly), and experts recommend considering these drugs as treatment options. The opioids dextromethorphan, morphine sulfate, tramadol (Ultram, Ortho-McNeill) and oxycodone are also acceptable treatment options, although physicians should be wary of novel pain syndromes, such as rebound headache, and increased tolerance when prescribing.
Additionally, moderate evidence backs the use of capsaicin (Qutenza, NeurogesX) and isosorbide dinitrate spray (Isordil) for treatment of the condition. However, the guideline suggests that clonidine (Clonidine Transdermal System, Mylan), pentoxifylline (Trental, Sanofi Aventis) and mexiletine should probably not be considered as treatment options. The expert panel also suggests that percutaneous electrical nerve stimulation may be effective.
“We were pleased to see that so many of these pain treatments had high-quality studies that support their use,” Bril said. “Still, it is important that more research be done to show how well these treatments can be tolerated over time since diabetic nerve pain is a chronic condition that affects a person’s quality of life and ability to function.”
The guideline was presented this week at the American Academy of Neurology’s Annual Meeting in Honolulu and was simultaneously published online in Neurology.
Disclosure: Dr. Bril has received research support from Talecris Biotherapeutics, Eisai Inc., Pfizer, Eli Lilly and Johnson & Johnson.
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These guidelines are based on an extensive, evidence-based review in which an expert panel graded trials on several factors, such as number of patients enrolled in well-designed, well-executed trials and methods used for evaluation. The authors are to be congratulated for identifying therapeutic measures available for the management of neuropathic pain. For the practicing endocrinologist treating people with diabetes, there are a number of issues that need to be considered, which evidence-based reviews such as this one, by design, cannot address. For example, people with diabetes have pain for a number of reasons that are misinterpreted as neuropathic pain. When using drugs, one needs to consider the number needed to treat, and tricyclics, which are not approved for use in diabetic neuropathic pain, have the lowest value (almost 1.5:1) whereas newer-generation antiepileptic drugs and serotonin-norepinephrine reuptake inhibitors (SNRIs), which are FDA-approved, have numbers around three to five. Moreover, we need to take into consideration the numbers needed to harm that can be as low as 2.7 for tricyclics, but as high as 15 for SNRIs and 26 for newer-generation antiepileptics. We must choose drugs that primum non nocere. In addition, there are huge differences in cost. For example, the co-pay for gabapentin is $10; for some of the others, this can be 50% of the cost — close to $400 per month. Finally, in choosing treatment, one needs to consider the insurance coverage and the need for preapproval, which can be overwhelming. In addition, when you treat neuropathic pain, you do not address the underlying disorder. The American Association of Clinical Endocrinologists believes that studies are sufficiently robust to say that certain treatments do address the underlying disorder. Therefore, these therapies would be more appropriate. The AAN, however, decided the evidence was insufficient. Finally, a new study by researchers in Toronto published in Diabetes Care suggests an approval for alpha-lipoic acid because of its potential to reverse or mitigate the course of underlying disease. Thus, in the era of evidence-based treatment, we should not forget the absence of evidence is not the evidence of absence.
– Aaron I. Vinik, MD, PhD, FCP, MACP EVMS
Strelitz Diabetes Research Center, Norfolk, VA
Disclosures: Dr. Vinik is a consultant or a speaker for Abott, Ansar, AstraZeneca, Bristol Myer Squibb, Eli Lilly, GlaxoSmithKline Beecham, Merck, Novartis, Pfizer, R.W. Johnson Pharmaceutical Research Institute, Sanofi-Aventis, Takeda and Tercica. He also receives grant support from Abbott, GlaxoSmithKline, Sanofi Aventis, Arcion Therapeutics, Eli Lilly, Merck and Pfizer.
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