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

Tesfaye, Solomon; Sloan, Gordon; Petrie, Jennifer; White, David; Bradburn, Mike; Julious, Steven A.; Rajbhandari, Satyan; Sharma, Sanjeev; Rayman, Gerry; Gouni, Ravikanth; Alam, Uazman; Cooper, Cindy; Loban, Amanda; Sutherland, Katie; Glover, Rachel; Waterhouse, Simon; Turton, Emily; Horspool, Michelle; Gandhi, Rajiv; Maguire, Deirdre; Jude, Edward B.; Ahmed, Syed Haris; Vas, Prashanth; Hariman, Christian; McDougall, Claire; Devers, Marion; Tsatlidis, Vasileios; Johnson, Martin; Rice, Andrew S.C.; Bouhassira, Didier; Bennett, David; Selvarajah, Dinesh

doi:10.1016/s0140-6736(22)01472-6

Cited by 89 publications

(47 citation statements)

References 29 publications

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“…These American Academy of Neurology recommendations offer a supplement to a recent American Diabetes Association pain monograph, although some areas of disagreement exist, particularly around SNRI/opioid dual-mechanism agents (61). A recent head-to-head trial suggested therapeutic equivalency for TCAs, SNRIs, and gabapentinoids in the treatment of pain in DPN (62). The trial also supported the role of combination therapy over monotherapy for the treatment of pain in DPN.…”

Section: Neuropathic Painmentioning

confidence: 89%

“…Tricyclic Antidepressants. Tricyclic antidepressants have been studied for treatment of pain, and most of the relevant data was acquired from trials of amitriptyline and include two high-quality studies and two medium-quality studies supporting the treatment of pain in DPN (60,62). Anticholinergic side effects may be dose limiting and restrict use in individuals $65 years of age.…”

Section: Neuropathic Painmentioning

confidence: 99%

See 1 more Smart Citation

12. Retinopathy, Neuropathy, and Foot Care:Standards of Care in Diabetes—2023

ElSayed¹,

Aleppo²,

Aroda³

et al. 2022

Diabetes Care

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The American Diabetes Association (ADA) “Standards of Care in Diabetes” includes the ADA’s current clinical practice recommendations and is intended to provide the components of diabetes care, general treatment goals and guidelines, and tools to evaluate quality of care. Members of the ADA Professional Practice Committee, a multidisciplinary expert committee, are responsible for updating the Standards of Care annually, or more frequently as warranted. For a detailed description of ADA standards, statements, and reports, as well as the evidence-grading system for ADA’s clinical practice recommendations and a full list of Professional Practice Committee members, please refer to Introduction and Methodology. Readers who wish to comment on the Standards of Care are invited to do so at professional.diabetes.org/SOC.

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Section: Neuropathic Painmentioning

confidence: 89%

Section: Neuropathic Painmentioning

confidence: 99%

12. Retinopathy, Neuropathy, and Foot Care:Standards of Care in Diabetes—2023

ElSayed¹,

Aleppo²,

Aroda³

et al. 2022

Diabetes Care

View full text Add to dashboard Cite

show abstract

“…Combination therapies for patients who did not respond to monotherapy at 6 weeks had similar efficacy across primary and secondary outcomes. 43 This trial provides evidence for using combination therapy of first-line medications for patients with PDN if they have suboptimal response to monotherapy. It is also important to assess and treat comorbid mood and sleep disorders, and consider topical or nonpharmacological interventions.…”

Section: What Is the Approach To Symptomatic Treatment Of Painful Neu...mentioning

confidence: 99%

“…37,41,42 Clinicians should assess the efficacy of first-line therapy after the medication has been titrated to an efficacious dose for 6-12 weeks. 37,43 The OPTION-DM trial, a multicentre, randomized, double-blind trial, compared the efficacy of combination therapies (amitriptyline with pregabalin, pregabalin with amitriptyl ine or duloxetine with pregabalin) for the primary outcome of pain relief and for secondary outcomes (including quality of life, mood and sleep) among patients with PDN. Combination ther apies for patients who did not respond to monotherapy at 6 weeks had similar efficacy across primary and secondary outcomes.…”

Section: How Is the Cause Of An Acquired Distal Symmetric Polyneuropa...mentioning

confidence: 99%

Diagnosis and management of patients with polyneuropathy

Mirian¹,

Aljohani²,

Grushka³

et al. 2023

CMAJ

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“…Consequently, current treatments for the condition target neuropathic symptoms rather than the underlying mechanistic changes (2). These pharmacotherapeutic agents are unsatisfactory, resulting in only modest pain relief which is often offset by intolerable side effects (4). A further understanding of the pathophysiology of neuropathic pain in diabetes is therefore essential for us to identify new targets for therapeutic interventions.…”

Section: Introductionmentioning

confidence: 99%

Preservation of thalamic neuronal function may be a prerequisite for pain perception in diabetic neuropathy: A magnetic resonance spectroscopy study

et al. 2023

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IntroductionIn this study, we used proton Magnetic Resonance Spectroscopy (1H-MRS) to determine the neuronal function in the thalamus and primary somatosensory (S1) cortex in different subgroups of DPN, including subclinical- and painful-DPN.MethodOne-hundred and ten people with type 1 diabetes [20 without DPN (no-DPN); 30 with subclinical-DPN; 30 with painful-DPN; and 30 with painless-DPN] and 20 healthy volunteers, all of whom were right-handed men, were recruited and underwent detailed clinical and neurophysiological assessments. Participants underwent Magnetic Resonance Imaging at 1.5 Tesla with two 1H-MRS spectra obtained from 8 ml cubic volume voxels: one placed within left thalamus to encompass the ventro-posterior lateral sub-nucleus and another within the S1 cortex.ResultsIn the thalamus, participants with painless-DPN had a significantly lower NAA:Cr ratio [1.55 + 0.22 (mean ± SD)] compared to all other groups [HV (1.80 ± 0.23), no-DPN (1.85 ± 0.20), sub-clinical DPN (1.79 ± 0.23), painful-DPN (1.75 ± 0.19), ANOVA p < 0.001]. There were no significant group differences in S1 cortical neurometabolites.ConclusionIn this largest cerebral MRS study in DPN, thalamic neuronal dysfunction was found in advanced painless-DPN with preservation of function in subclinical- and painful-DPN. Furthermore, there was a preservation of neuronal function within the S1 cortex in all subgroups of DPN. Therefore, there may be a proximo-distal gradient to central nervous system alterations in painless-DPN, with thalamic neuronal dysfunction occurring only in established DPN. Moreover, these results further highlight the manifestation of cerebral alterations between painful- and painless-DPN whereby preservation of thalamic function may be a prerequisite for neuropathic pain in DPN.

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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

Cited by 89 publications

References 29 publications

12. Retinopathy, Neuropathy, and Foot Care:Standards of Care in Diabetes—2023

12. Retinopathy, Neuropathy, and Foot Care:Standards of Care in Diabetes—2023

Diagnosis and management of patients with polyneuropathy

Preservation of thalamic neuronal function may be a prerequisite for pain perception in diabetic neuropathy: A magnetic resonance spectroscopy study

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