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This article is from NEJM Journal Watch
Comparing Treatment Options for Painful Diabetic Neuropathy
Comparison of different treatment options for diabetic neuropathy pain
Reviewed by Bruce Soloway, MD
All three regimens, including combination therapy when monotherapy fails, are equally effective
.
For patients with diabetic peripheral neuropathy pain, most guidelines recommend initial treatment with amitriptyline, duloxetine, pregabalin, or gabapentin; However, these agents often do not provide complete symptom relief, and head-to-head comparisons are rare
for different regimens.
Clinicians sometimes add a second agent when monotherapy does not respond to patients, but this strategy has not been evaluated
in high-quality studies.
The investigators developed three 16-week regimens, each of which first adjusted the dose of the first drug to the maximum tolerated dose during the 6-week period, and then added a second drug during the second 10 weeks if the first drug did not respond well to relieve the condition.
The three schemes are: (1) amitriptyline plus pregabalin
.
(2) Duloxetine plus pregabalin
.
(3) Pregabalin plus amitriptyline
.
In this trial, a cross-over design of 130 people with diabetic neuropathy pain (mean duration of illness, 5 years) were randomised, first treated with one of the three regimens for 16 weeks, followed by one week of wash-out period, started with one of the other two regimens for 16 weeks, and finally treated with a third regimen for 16 weeks
.
Three scenarios result in 6 possible sequences
.
The mean pain intensity of patients decreased from 6.
6 at baseline (10-component scale) to 3.
3 in the last week of each regimen, with no significant difference
between the three regimens at any time point.
Approximately 35% of patients experienced adequate pain relief with monotherapy, and another 15% had adequate pain relief
with the addition of a second agent.
comments
The study supports the addition of a second agent
when monotherapy fails to adequately relieve diabetic neuropathy pain.
It is also suggested that commonly used drugs for the disease are equally effective
in monotherapy or combination therapy.
But there are three points worth mentioning
.
First, known side effects of these drugs were common in the trial (e.
g.
, amitriptyline caused dry mouth and sedation, pregabalin caused dizziness, and duloxetine caused nausea).
Second, the trial did not have a placebo group
.
Third, the investigators did not explore another reasonable strategy, sequential monotherapy (switching from one drug to another and then using combination therapy when ineffective).
Articles that are commented on
Tesfaye S et al.
Comparison of amitriptyline supplemented with pregabalin, pregabalin supplemented with amitriptyline, and duloxetine supplemented with pregabalin for the treatment of diabetic peripheral neuropathic pain (OPTION-DM): A multicentre, double-blind, randomised crossover trial.
Lancet 2022 Aug 27; 400:680.
(https://doi.
org/10.
1016/S0140-6736(22)01472-6)
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