P Marchettini1,2, S Wilhelm3, H Petto4, S Tesfaye5, T Tölle6, D Bouhassira7, R Freynhagen8,9, G Cruccu10, A Lledó11, E Choy12, E Kosek13, J A Micó14, M Späth15, V Skljarevski16, A Lenox-Smith17, S Perrot18. 1. Pain Medicine Center, Department of Neurology, Hospital San Raffaele, Milano, Italy. 2. Pain Pathophysiology and Therapy, University of Southern Switzerland, Manno, Switzerland. 3. Regional Medical Affairs, Lilly Deutschland GmbH, Bad Homburg, Germany. 4. Global Statistical Sciences, Lilly Austria, Vienna, Austria. 5. Diabetes Research Unit, Royal Hallamshire Hospital, Sheffield, UK. 6. Neurologische Klinik und Poliklinik, Technische Universität, München, Germany. 7. INSERM U987 Centre d'Evaluation et de Traitement de la Douleur, Hôpital Ambroise Paré, Boulogne Billancourt, France. 8. Zentrum für Anästhesiologie, Intensivmedizin, Schmerztherapie & Palliativmedizin, Benedictus Krankenhaus, Tutzing. 9. Klinik für Anästhesiologie, Technische Universität München, Germany. 10. Department of Neurology & Psychiatry, Sapienza University, Roma, Italy. 11. Departamento de Neurología, Clínica Creu Blanca, Barcelona, Spain. 12. Section of Rheumatology, Institute of Infection & Immunity, Cardiff University, UK. 13. Department of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden. 14. Department of Neuroscience, CIBER of Mental Health, CIBERSAM, University of Cádiz, Spain. 15. Spital Linth, Rheumatologie, Uznach, Switzerland. 16. Lilly Research Laboratories, Indianapolis, USA. 17. Medical Affairs, Eli Lilly & Company, Basingstoke, UK. 18. INSERM U-987 Centre de la Douleur, Hôpital Hotel Dieu, Université Paris Descartes, Paris, France.
Abstract
BACKGROUND: To investigate baseline demographics and disease characteristics as predictors of the analgesic effect of duloxetine and pregabalin on diabetic peripheral neuropathic pain (DPNP). METHODS: Based on data from the COMBO-DN study, a multinational clinical trial in DPNP, the potential impact of baseline characteristics on pain relief after 8-week monotherapy with 60 mg/day duloxetine or 300 mg/day pregabalin was assessed using analyses of covariance. Subgroups of interest were characterized regarding their baseline characteristics and efficacy outcomes. RESULTS:A total of 804 patients were evaluated at baseline. A significant interaction with treatment was observed in the mood symptom subgroups with a larger pain reduction in duloxetine-treated patients having no mood symptoms [Hospital Anxiety and Depression Scale (HADS) depression or anxiety subscale score <11; -2.33 (duloxetine); -1.52 (pregabalin); p = 0.024]. There were no significant interactions between treatment for subgroups by age (<65 or ≥65 years), gender, baseline pain severity [Brief Pain InventoryModified Short Form (BPI-MSF) average pain <6 or ≥6], diabetic neuropathy duration (≤2 or >2 years), baseline haemoglobin A1c (HbA1c) (<8% or ≥8%), presence of comorbidities and concomitant medication use. CONCLUSIONS: Our analyses suggest that the efficacy of duloxetine and pregabalin for initial 8-week treatment in DPNP was consistent across examined subgroups based on demographics and disease characteristics at baseline except for the presence of mood symptoms. Duloxetine treatment appeared to be particularly beneficial in DPNP patients having no mood symptoms.
RCT Entities:
BACKGROUND: To investigate baseline demographics and disease characteristics as predictors of the analgesic effect of duloxetine and pregabalin on diabetic peripheral neuropathic pain (DPNP). METHODS: Based on data from the COMBO-DN study, a multinational clinical trial in DPNP, the potential impact of baseline characteristics on pain relief after 8-week monotherapy with 60 mg/day duloxetine or 300 mg/day pregabalin was assessed using analyses of covariance. Subgroups of interest were characterized regarding their baseline characteristics and efficacy outcomes. RESULTS: A total of 804 patients were evaluated at baseline. A significant interaction with treatment was observed in the mood symptom subgroups with a larger pain reduction in duloxetine-treated patients having no mood symptoms [Hospital Anxiety and Depression Scale (HADS) depression or anxiety subscale score <11; -2.33 (duloxetine); -1.52 (pregabalin); p = 0.024]. There were no significant interactions between treatment for subgroups by age (<65 or ≥65 years), gender, baseline pain severity [Brief Pain Inventory Modified Short Form (BPI-MSF) average pain <6 or ≥6], diabetic neuropathy duration (≤2 or >2 years), baseline haemoglobin A1c (HbA1c) (<8% or ≥8%), presence of comorbidities and concomitant medication use. CONCLUSIONS: Our analyses suggest that the efficacy of duloxetine and pregabalin for initial 8-week treatment in DPNP was consistent across examined subgroups based on demographics and disease characteristics at baseline except for the presence of mood symptoms. Duloxetine treatment appeared to be particularly beneficial in DPNP patients having no mood symptoms.