title: Are there different predictors of analgesic response between antidepressants and anticonvulsants in painful diabetic neuropathy?
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 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.
authors: Pain Medicine Center, Department of Neurology, Hospital San Raffaele, Milano, Italy.|Pain Pathophysiology and Therapy, University of Southern Switzerland, Manno, Switzerland.
authors: P
authors: P
authors: Marchettini
authors: Regional Medical Affairs, Lilly Deutschland GmbH, Bad Homburg, Germany.
authors: S
authors: S
authors: Wilhelm
authors: Global Statistical Sciences, Lilly Austria, Vienna, Austria.
authors: H
authors: H
authors: Petto
authors: Diabetes Research Unit, Royal Hallamshire Hospital, Sheffield, UK.
authors: S
authors: S
authors: Tesfaye
authors: Neurologische Klinik und Poliklinik, Technische Universität, München, Germany.
authors: T
authors: T
authors: Tölle
authors: INSERM U987 Centre d'Evaluation et de Traitement de la Douleur, Hôpital Ambroise Paré, Boulogne Billancourt, France.
authors: D
authors: D
authors: Bouhassira
authors: Zentrum für Anästhesiologie, Intensivmedizin, Schmerztherapie & Palliativmedizin, Benedictus Krankenhaus, Tutzing.|Klinik für Anästhesiologie, Technische Universität München, Germany.
authors: R
authors: R
authors: Freynhagen
authors: Department of Neurology & Psychiatry, Sapienza University, Roma, Italy.
authors: G
authors: G
authors: Cruccu
authors: Departamento de Neurología, Clínica Creu Blanca, Barcelona, Spain.
authors: A
authors: A
authors: Lledó
authors: Section of Rheumatology, Institute of Infection & Immunity, Cardiff University, UK.
authors: E
authors: E
authors: Choy
authors: Department of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden.
authors: E
authors: E
authors: Kosek
authors: Department of Neuroscience, CIBER of Mental Health, CIBERSAM, University of Cádiz, Spain.
authors: J A
authors: JA
authors: Micó
authors: Spital Linth, Rheumatologie, Uznach, Switzerland.
authors: M
authors: M
authors: Späth
authors: Lilly Research Laboratories, Indianapolis, USA.
authors: V
authors: V
authors: Skljarevski
authors: Medical Affairs, Eli Lilly & Company, Basingstoke, UK.
authors: A
authors: A
authors: Lenox-Smith
authors: INSERM U-987 Centre de la Douleur, Hôpital Hotel Dieu, Université Paris Descartes, Paris, France.
authors: S
authors: S
authors: Perrot
mesh_terms: D000339:Affect; D000367:Age Factors; D000368:Aged; D000700:Analgesics / Q000009:adverse effects / Q000627:therapeutic use*; D000927:Anticonvulsants / Q000009:adverse effects / Q000627:therapeutic use*; D000928:Antidepressive Agents / Q000009:adverse effects / Q000627:therapeutic use*; D001007:Anxiety / Q000150:complications / Q000523:psychology; D003863:Depression / Q000150:complications / Q000523:psychology; D003929:Diabetic Neuropathies / Q000150:complications* / Q000188:drug therapy* / Q000523:psychology; D000068736:Duloxetine Hydrochloride / Q000009:adverse effects / Q000627:therapeutic use; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D010146:Pain / Q000188:drug therapy* / Q000523:psychology; D000069583:Pregabalin / Q000009:adverse effects / Q000627:therapeutic use; D011569:Psychiatric Status Rating Scales; D016896:Treatment Outcome
chemical_list: D000700:Analgesics; D000927:Anticonvulsants; D000928:Antidepressive Agents; D000069583:Pregabalin; D000068736:Duloxetine Hydrochloride