Cited by 132Pain Mechanisms and TreatmentsPain Management and TreatmentMusculoskeletal pain and rehabilitation

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Neuropathic pain phenotyping as a predictor of treatment response in painful diabetic neuropathy: Data from the randomized, double-blind, COMBO-DN study

Bouhassira, Didier, Wilhelm, Stefan, Schacht, Alexander, Perrot, Serge, Kosek, Eva, Cruccu, Giorgio, Freynhagen, Rainer, Tesfaye, Solomon, Lledó, Alberto, Choy, Ernest, Marchettini, Paolo, Micó, Juan Antonio, Spaeth, Michael, Skljarevski, Vladimir, Tölle, Thomas·2014·Pain

DOI 10.1016/j.pain.2014.08.020

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Abstract

Sensory profiles are heterogeneous in neuropathic pain disorders, and subgroups of patients respond differently to treatment. To further explore this, patients in the COMBO-DN study were prospectively assessed by the Neuropathic Pain Symptom Inventory (NPSI) at baseline, after initial 8-week therapy with either duloxetine or pregabalin, and after subsequent 8-week combination/high-dose therapy. Exploratory post hoc cluster analyses were performed to identify and characterize potential subgroups through their scores in the NPSI items. In patients not responding to initial 60 mg/d duloxetine, adding 300 mg/d pregabalin for combination treatment was particularly effective regarding the dimensions pressing pain and evoked pain, whereas maximizing the duloxetine dose to 120 mg/d appeared more beneficial regarding paresthesia/dysesthesia. In contrast, adding 60 mg/d duloxetine to 300 mg/d pregabalin in case of nonresponse to initial pregabalin led to numerically higher decreases in all NPSI dimensions/items compared to maximizing the pregabalin dose to 600 mg/d. Cluster analysis revealed 3 patient clusters (defined by baseline scores for the 10 NPSI sensory items) with different pain profiles, not only in terms of overall pain severity, but also across NPSI items. Mean Brief Pain Inventory average pain improved in all clusters during combination/high-dose therapy. However, in patients with severe pain, the treatment effect showed a trend in favor of high-dose monotherapy, whereas combination therapy appeared to be more beneficial in patients with moderate and mild pain (not significant). These complementary exploratory analyses further endorse the idea that sensory phenotyping might lead to a more stratified treatment and potentially to personalized pain therapy.

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Authors: Bouhassira, D., Wilhelm, S., Schacht, A., Perrot, S., Kosek, E., Cruccu, G., Freynhagen, R., Tesfaye, S., Lledó, A., Choy, E., Marchettini, P., Micó, J. A., Spaeth, M., Skljarevski, V., & Tölle, T.
Affiliations: Inserm (FR)
Eli Lilly (Germany) (DE)
Karolinska Institutet (SE)
Sapienza University of Rome (IT)
Technical University of Munich (DE)
Royal Hallamshire Hospital (GB)
Cardiff University (GB)
IRCCS Ospedale San Raffaele (IT)
Universidad de Cádiz (ES)
Spital Linth (CH)
Eli Lilly (United States) (US)
Corresponding author: Wilhelm, Stefan
ORCID: Bouhassira, Didier
Wilhelm, Stefan
Schacht, Alexander
Perrot, Serge
Kosek, Eva
Cruccu, Giorgio
Freynhagen, Rainer
Tesfaye, Solomon
Choy, Ernest
Micó, Juan Antonio
Spaeth, Michael
Tölle, Thomas
Venue: Pain
Publisher: Ovid Technologies (Wolters Kluwer Health)
Published: 2014-10
Volume: 155
Issue: 10
Pages: 2171-2179
ISSN: 0304-3959 (ISSN-L)
DOI: 10.1016/j.pain.2014.08.020
OpenAlex: W2024753057
Cited by: 132
References: 28
Citations by year: 2026: 5 · 2025: 6 · 2024: 11 · 2023: 10 · 2022: 9 · 2021: 11 · 2020: 16 · 2019: 13 · 2018: 14 · 2017: 10 · 2016: 14 · 2015: 11 · 2014: 2
FWCI: 8.20
Type: journal article
Language: en
Open access: closed
Licence: www.elsevier.com/tdm/userlicense/1.0/ (tdm)
Locations: Pain (publishedVersion)
PubMed (publishedVersion)
IRIS Research product catalog (Sapienza University of Rome) (submittedVersion)
mediaTUM (Technical University of Munich) (submittedVersion)
Funders: Eli Lilly and Company
Topics: Health Sciences › Medicine › Physiology (medical) › Pain Mechanisms and Treatments
Health Sciences › Medicine › Anesthesiology and Pain Medicine › Pain Management and Treatment
Health Sciences › Health Professions › Physical Therapy, Sports Therapy and Rehabilitation › Musculoskeletal pain and rehabilitation
Keywords: diabetic neuropathic pain, treatment response prediction, duloxetine, pregabalin, combination therapy, Neuropathic Pain Symptom Inventory, sensory profile, patient subgroups
MeSH terms: Duloxetine Hydrochloride, Pregabalin, Aged, Aged, 80 and over, Analgesics, Diabetic Neuropathies, Double-Blind Method, Female, Humans, Male, Middle Aged, Neuralgia, Severity of Illness Index, Treatment Outcome

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Neuropathic pain phenotyping as a predictor of treatment response in painful diabetic neuropathy: Data from the randomized, double-blind, COMBO-DN study

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