Gabapentinoids, serotonin norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants, and sodium channel blockers were more likely than placebo to improve diabetic neuropathy pain, according to a new practice guideline from the American Academy of Neurology (AAN).
Those classes typically had comparable effect sizes around the 0.5 standardized mean difference (SMD) cutoff for a medium effect size, reported Brian Callaghan, MD, MS, of University of Michigan in Ann Arbor, and co-authors:
- Gabapentinoids (SMD 0.44, 95% CI 0.21–0.67)
- SNRIs (SMD 0.47, 95% CI 0.34–0.60)
- Sodium channel blockers (SMD 0.56, 95% CI 0.25–0.87)
- SNRI/opioid dual mechanism agents (SMD 0.62, 95% CI 0.38–0.86)
The new guideline updated the AAN's 2011 guidance on treating painful diabetic neuropathy and focused on oral and topical drugs.
"New studies on sodium channel blockers published since the last guideline have resulted in these drugs now being recommended and considered as effective at providing pain relief as the other drug classes recommended in this guideline," Callaghan said in a statement.
Peripheral neuropathy is a common complication of diabetes. It occurs more frequently in patients with longer duration of diabetes or poor glycemic control. Diabetic neuropathy often goes untreated.
In clinical trials, about 30% pain reduction is considered a success, the AAN guideline authors observed. Patients should be made aware of the expected efficacy of neuropathy interventions, because some may expect complete pain relief, they added.
The guidance also recommended that clinicians should:
- Assess patients with diabetes for peripheral neuropathic pain
- Evaluate neuropathy patients for concurrent mood disorders, especially depression, and sleep disorders, including obstructive sleep apnea
- Offer tricyclic antidepressants, SNRIs, gabapentinoids, or sodium channel blockers to reduce pain, and consider other factors besides efficacy such as potential adverse effects, patient comorbidities, and cost
- Not prescribe valproic acid (Depakene) for patients with childbearing potential, and not prescribe it for other patients unless multiple other drugs have failed
- Try medications from another effective class if patients don't experience meaningful improvement or have significant adverse effects with their first treatment
- Consider other ways to reduce pain including topical treatments like capsaicin, glyceryl trinitrate spray, or Citrullus colocynthis; nontraditional treatments like Ginkgo biloba; or interventions like cognitive behavioral therapy, exercise, tai chi, or mindfulness, depending on patient preferences
The guidelines also recommended against use of opioids to treat neuropathy, including SNRI/opioid dual mechanism agents like tramadol (Ultram) and tapentadol (Nucynta), and to consider offering patients currently using these drugs a safe taper and non-opioid treatment options.
The risk profile of tramadol is poor, with respiratory depression, addiction, and overdose reflected in a black box warning, though the drug originally was marketed as less opioid-like and less risky, the guideline authors noted. Tapentadol, a Schedule II opioid, also is associated with severe adverse events, including life threatening respiratory depression, addiction, overdose, and death.
Opioids are often prescribed for peripheral neuropathy, but no clinical trials show that they work in the long term. "Current evidence suggests that the risks of the use of opioids for painful diabetic neuropathy therapy outweigh the benefits, so they should not be prescribed," Callaghan said.
The AAN also published a quality measurement set to accompany the guidance to help improve care for all polyneuropathy patients, not just those with painful diabetic neuropathy.
Disclosures
The guideline was developed with financial support from the American Academy of Neurology (AAN).
Callaghan reported relationships with Ann Arbor Veterans Affairs, DynaMed, AAN, the Vaccine Injury Compensation Program, and NIH. Co-authors reported relationships with academic centers, nonprofit groups, publishing companies, government agencies, and pharmaceutical firms.
Primary Source
Neurology
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