Neuropathic pain phenotyping as a predictor of treatment response in painful diabetic neuropathy: Data from the randomized, double-blind, COMBO-DN study
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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Using diagnostic algorithms and screening tools for neuropathic pain should help reduce diagnostic heterogeneity.
“The use of diagnostic algorithms for neuropathic pain53 and screening tools54 should contribute to reducing diagnostic heterogeneity (Table 4).”
From Pharmacotherapy for neuropathic pain in adults: a systematic review and meta-analysis (2015) · cites this paper as [53]
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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
- Venue
- Pain
- Published
- 2014-10
- Volume
- 155
- Issue
- 10
- Pages
- 2171-2179
- ISSN
- 0304-3959 (ISSN-L)
- 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
- 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 › Pain Mechanisms and Treatments
- Health Sciences › Medicine › Anesthesiology and Pain Medicine › Pain Management and Treatment
- Health Sciences › Medicine › Pharmacology › 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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