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Common diabetic peripheral neuropathic pain treatments equivalent in OPTION-DM

Author: Eleanor McDermid

medwireNews: Combination therapy with three commonly used medications has achieved similar levels of pain relief for people with diabetic peripheral neuropathic pain in the randomized OPTION-DM trial.

The trial published in The Lancet tested amitriptyline, pregabalin, and duloxetine, titrated to the maximum tolerated dose.

But because “the best outcome for any monotherapy is 50% pain relief in fewer than half of patients, which is often accompanied by dose-limiting side-effects,” Solomon Tesfaye (Royal Hallamshire Hospital, Sheffield, UK) and co-investigators combined the treatments if needed, adding pregabalin to amitriptyline or vice versa, and pregabalin to duloxetine.

The 130 trial participants included in the primary analysis were assigned to test all three treatment pathways in a randomized order, with each pathway lasting 16 weeks. Including an initial 2-week titration period, they received a total 50 weeks of treatment.

The participants had diabetes (17% type 1) with an average duration of 15.1 years and neuropathic pain for an average of 4.9 years, with a baseline pain score of 6.6 on a scale of 0–10. Their 7-day average pain scores improved by an average of 2.9, 2.8, and 2.5 with amitriptyline, duloxetine, and pregabalin, respectively, increasing to 3.4, 3.5, and 3.3 when escalated to combination therapy.

Only 35–40% of participants achieved at least a 50% improvement in pain score with monotherapy; this rose to 44–48% with combination treatment. A similar proportion achieved a pain score of less than 3, indicating mild pain. There were no statistically significant differences between the treatments.

In a linked commentary, Melissa Elafros and Brian Callaghan, both from the University of Michigan in Ann Arbor, USA, say that the trial provides “much better evidence of similar efficacy across these three classes” than the previous indirect comparisons from meta-analyses.

“As a result, physicians should use factors other than efficacy (side-effects, cost, and other comorbidities) when determining which medication to start and add on for treatment of [diabetic peripheral neuropathic pain],” they advise.

And they stress that OPTION-DM also provides the first good evidence for use of these medications in combination.

The researchers also looked at life quality measures, which the commentators describe as “an important knowledge gap.” The findings showed similar improvements in outcomes on the Short Form-36, the Hospital Anxiety and Depression Scale, and the Insomnia Severity Index, irrespective of the treatment pathway.

Elafros and Callaghan say that these “are all key patient-oriented outcomes,” and that physicians can therefore now “confidently advise patients that our current treatments will help them in many meaningful ways.”

They note the need for future studies to compare the efficacy of sodium channel blockers, and also the need for more efficacious interventions, given the “disappointing” low numbers of participants achieving substantial pain relief with monotherapy.

In the meantime, the commentators conclude that “combination therapy of existing medications should be standard practice on the basis of these results.”

medwireNews is an independent medical news service provided by Springer Healthcare Ltd. © 2022 Springer Healthcare Ltd, part of the Springer Nature Group

Lancet 2022; doi:10.1016/S0140-6736(22)01472-6
Lancet 2022; doi:10.1016/S0140-6736(22)01526-4

Image Credits: © blueclue / Getty Images / iStock

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Eleanor McDermid

medwireNews Deputy Bureau Chief