Effectiveness of Pregabalin as Monotherapy or Combination Therapy for Neuropathic Pain in Patients Unresponsive to Previous Treatments in a Spanish Primary Care Setting

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• 作者：Emilio Blanco Tarrio (1)
  Rafael Gálvez Mateos (2)
  Enric Zamorano Bayarri (3)
  Vanessa López Gómez (4)
  Maria Pérez Páramo (4)
  
• 刊名：Clinical Drug Investigation
• 出版年：2013
• 出版时间：September 2013
• 年：2013
• 卷：33
• 期：9
• 页码：633-645
• 全文大小：519 KB
• 参考文献：1. Breivik H, Collett B, Ventafridda V, et al. Survey of chronic pain in Europe: prevalence, impact on daily life, and treatment. Eur J Pain. 2006;10:287-33. CrossRef
  2. IASP. Part III: pain terms, a current list with definitions and notes on usage. In: Merskey HB, N, editor. Classification of chronic pain. 2nd ed. Seattle: IASP Press; 1994. p. 209-13.
  3. Dworkin RH, Backonja M, Rowbotham MC, et al. Advances in neuropathic pain: diagnosis, mechanisms, and treatment recommendations. Arch Neurol. 2003;60:1524-4. CrossRef
  4. Campbell JN, Meyer RA. Mechanisms of neuropathic pain. Neuron. 2006;52:77-2. CrossRef
  5. Gilron I, Watson CP, Cahill CM, et al. Neuropathic pain: a practical guide for the clinician. CMAJ. 2006;175:265-5. CrossRef
  6. Horowitz SH. The diagnostic workup of patients with neuropathic pain. Med Clin North Am. 2007;91:21-0. CrossRef
  7. Stacey BR. Management of peripheral neuropathic pain. Am J Phys Med Rehabil. 2005;84:S4-6.
  8. Gilron I, Bailey J, Weaver DF, et al. Patients-attitudes and prior treatments in neuropathic pain: a pilot study. Pain Res Manage. 2002;7:199-03.
  9. Gore M, Brandenburg NA, Dukes E, et al. Pain severity in diabetic peripheral neuropathy is associated with patient functioning, symptom levels of anxiety and depression, and sleep. J Pain Symptom Manage. 2005;30:374-5. CrossRef
  10. Meyer-Rosberg K, Kvarnstrom A, Kinnman E, et al. Peripheral neuropathic pain—a multidimensional burden for patients. Eur J Pain. 2001;5:379-9. CrossRef
  11. Castro MM, Daltro C. Sleep patterns and symptoms of anxiety and depression in patients with chronic pain. Arq Neuropsiquiatr. 2009;67:25-. CrossRef
  12. Galvez R, Marsal C, Vidal J, et al. Neuropathic pain as a cause of anxiety, depression and sleep disturbance in standard condition of care: DONEGA naturalistic study [in Spanish]. Rev Soc Esp Dolor. 2006;2:81-5.
  13. Siddall PJ, Cousins MJ. Persistent pain as a disease entity: implications for clinical management. Anesth Analg. 2004;99:510-0. CrossRef
  14. Galvez R, Marsal C, Vidal J, et al. Cross-sectional evaluation of patient functioning and health-related quality of life in patients with neuropathic pain under standard care conditions. Eur J Pain. 2007;11:244-5. CrossRef
  15. Argoff CE. The coexistence of neuropathic pain, sleep, and psychiatric disorders: a novel treatment approach. Clin J Pain. 2007;23:15-2. CrossRef
  16. Backonja MM, Serra J. Pharmacologic management part 1: better-studied neuropathic pain diseases. Pain Med. 2004;5(Suppl 1):S28-7. CrossRef
  17. Backonja MM, Serra J. Pharmacologic management part 2: lesser-studied neuropathic pain diseases. Pain Med. 2004;5(Suppl 1):S48-9. CrossRef
  18. Stute P, Soukup J, Menzel M, et al. Analysis and treatment of different types of neuropathic cancer pain. J Pain Symptom Manage. 2003;26:1123-1. CrossRef
  19. Torrance N, Ferguson AJ, Afolabi E. Neuropathic pain in the community: more under-treated than refractory? Pain. 2013;154:690-. CrossRef
  20. Pena-Arrebola A. Peripheral neuropathic pain in rehabilitation. Review and up-date of its treatment [in Spanish]. Rehabilitación (Madr). 2007;41:30-. CrossRef
  21. Mantyselka P, Kumpusalo E, Ahonen R, et al. Pain as a reason to visit the doctor: a study in Finnish primary health care. Pain. 2001;89:175-0. CrossRef
  22. Perez C, Saldana MT, Navarro A, et al. Prevalence and characterization of neuropathic pain in a primary-care setting in Spain: a cross-sectional, multicentre, observational study. Clin Drug Investig. 2009;29:441-0. CrossRef
  23. Blanco E, Galvez R, Zamorano E, López V, Pérez M, et al. Prevalencia del dolor neuropático (DN), según DN4, en atención primaria. Semergen. 2012;38(4):203-1. CrossRef
  24. Aguilera-Munoz J, Arizaga-Cuesta E, Carpio-Rodas A, et al. Guidelines for the clinical management of neuropathic pain (II) [in Spanish]. Rev Neurol. 2005;40:303-6.
  25. Dworkin RH, O’Connor AB, Backonja M, et al. Pharmacologic management of neuropathic pain: evidence-based recommendations. Pain. 2007;132:237-1. CrossRef
  26. Attal N, Cruccu G, Baron R, et al. EFNS guidelines on the pharmacological treatment of neuropathic pain: 2010 revision. Eur J Neurol. 2010;17:1113–e88.
  27. Tan T, Barry P, Reken S, et al. Pharmacological management of neuropathic pain in non-specialist settings: summary of NICE guidance. BMJ. 2010;340:c1079. CrossRef
  28. Bril V, England J, Franklin GM, et al. Evidence-based guideline: treatment of painful diabetic neuropathy: Report of the American Academy of Neurology, the American Association of Neuromuscular and Electrodiagnostic Medicine, and the American Academy of Physical Medicine and Rehabilitation. Neurology. 2011;76:1758-5. CrossRef
  29. Vranken JH, Dijkgraaf MG, Kruis MR, et al. Pregabalin in patients with central neuropathic pain: a randomized, double-blind, placebo-controlled trial of a flexible-dose regimen. Pain. 2008;136:150-. CrossRef
  30. Gilron I, Wajsbrot D, Therrien F, et al. Pregabalin for peripheral neuropathic pain: a multicenter, enriched enrollment randomized withdrawal placebo-controlled trial. Clin J Pain. 2011;27:185-3. CrossRef
  31. van Seventer R, Bach FW, Toth CC, et al. Pregabalin in the treatment of post-traumatic peripheral neuropathic pain: a randomized double-blind trial. Eur J Neurol. 2010;17:1082-. CrossRef
  32. Xochilcal-Morales M, Castro EM, Guajardo-Rosas J, et al. A prospective, open-label, multicentre study of pregabalin in the treatment of neuropathic pain in Latin America. Int J Clin Pract. 2010;64:1301-. CrossRef
  33. Roth T, van Seventer R, Murphy TK. The effect of pregabalin on pain-related sleep interference in diabetic peripheral neuropathy or postherpetic neuralgia: a review of nine clinical trials. Curr Med Res Opin. 2010;26:2411-. CrossRef
  34. Semel D, Murphy TK, Zlateva G, et al. Evaluation of the safety and efficacy of pregabalin in older patients with neuropathic pain: results from a pooled analysis of 11 clinical studies. BMC Fam Pract. 2010;11:85. CrossRef
  35. Boschen MJ. A meta-analysis of the efficacy of pregabalin in the treatment of generalized anxiety disorder. Can J Psychiatry. 2011;56(9):558-6.
  36. Feltner DE, Liu-Dumaw M, Schweizer E, et al. Efficacy of pregabalin in generalized social anxiety disorder: results of a double-blind, placebo-controlled, fixed-dose study. Int Clin Psychopharmacol. 2011;26(4):213-0. CrossRef
  37. Di Nicola M, Tedeschi D, Martinotti G, et al. Pregabalin augmentation in treatment-resistant obsessive-compulsive disorder: a 16-week case series. J Clin Psychopharmacol. 2011;31(5):675-. CrossRef
  38. Oulis P, Florakis AA, Tzanoulinos G, et al. Adjunctive pregabalin to quetiapine in acute mania. Clin Neuropharmacol. 2009;32(3):174. CrossRef
  39. Pae CU. Pregabalin augmentation to antidepressants in patients with major depressive disorder. Prog Neuropsychopharmacol Biol Psychiatry. 2009;33(3):577-. CrossRef
  40. Martinotti G. Pregabalin in clinical psychiatry and addiction: pros and cons. Expert Opin Investig Drugs. 2012;21(9):1243-. CrossRef
  41. Freynhagen R, Grond S, Schupfer G, et al. Efficacy and safety of pregabalin in treatment refractory patients with various neuropathic pain entities in clinical routine. Int J Clin Pract. 2007;61:1989-6. CrossRef
  42. Plested M, Budhia S, Gabriel Z. Pregabalin, the lidocaine plaster and duloxetine in patients with refractory neuropathic pain: a systematic review. BMC Neurol. 2010;10:116. CrossRef
  43. Navarro A, Saldana MT, Perez C, et al. Patient-reported outcomes in subjects with neuropathic pain receiving pregabalin: evidence from medical practice in primary care settings. Pain Med. 2010;11:719-1. CrossRef
  44. Navarro A, Saldana MT, Perez C, et al. A cost-consequences analysis of the effect of pregabalin in the treatment of peripheral neuropathic pain in routine medical practice in primary care settings. BMC Neurol. 2011;11:7. CrossRef
  45. Bouhassira D, Attal N, Alchaar H, et al. Comparison of pain syndromes associated with nervous or somatic lesions and development of a new neuropathic pain diagnostic questionnaire (DN4). Pain. 2005;114:29-6. CrossRef
  46. Perez C, Galvez R, Huelbes S, et al. Validity and reliability of the Spanish version of the DN4 (Douleur Neuropathique 4 questions) questionnaire for differential diagnosis of pain syndromes associated to a neuropathic or somatic component. Health Qual Life Outcomes. 2007;5:66. CrossRef
  47. Daut RL, Cleeland CS, Flanery RC. Development of the Wisconsin Brief Pain Questionnaire to assess pain in cancer and other diseases. Pain. 1983;17:197-10. CrossRef
  48. Cleeland CS, Ryan KM. Pain assessment: global use of the Brief Pain Inventory. Ann Acad Med Singapore. 1994;23:129-8.
  49. Seres JL. The fallacy of using 50% pain relief as the standard for satisfactory pain treatment outcome. Pain Forum. 1999;8:183-. CrossRef
  50. Farrar JT, Young JP Jr, LaMoreaux L, Werth JL, Poole RM. Clinical importance of changes in chronic pain intensity measured on an 11-point numerical pain rating scale. Pain. 2001;94(2):149-8. CrossRef
  51. Badia X, Muriel C, Gracia A, et al. Validation of the Spanish version of the Brief Pain Inventory in patients with oncological pain [in Spanish]. Med Clin (Barc). 2003;120:52-. CrossRef
  52. Ruiz MA, Pardo A, Rejas J, et al. Development and validation of the “Treatment Satisfaction with Medicines Questionnaire-(SATMED-Q). Value Health. 2008;11:913-6. CrossRef
  53. Rodriguez MJ, García AJ. Costes del dolor neuropático según etiología en las Unidades del Dolor en Espa?a. Rev Esp Soc Dolor. 2007;6:404-5.
  54. Dieleman JP, Kerklaan J, Huygen FJ, et al. Incidence rates and treatment of neuropathic pain conditions in the general population. Pain. 2008;137:681-. CrossRef
  55. Attal N, Fermanian C, Fermanian J, et al. Neuropathic pain: are there distinct subtypes depending on the aetiology or anatomical lesion? Pain. 2008;138:343-3. CrossRef
  56. Burns TM, Dyck PJ, Aksamit AJ, et al. The natural history and long-term outcome of 57 limb sarcoidosis neuropathy cases. J Neurol Sci. 2006;244:77-7. CrossRef
  57. Vranken JH. Mechanisms and treatment of neuropathic pain. Cent Nerv Syst Agents Med Chem. 2009;9:71-. CrossRef
  58. Johnston SC. Identifying confounding by indication through blinded prospective review. Am J Epidemiol. 2001;154:276-4. CrossRef
  59. Lu CY. Observational studies: a review of study designs, challenges and strategies to reduce confounding. Int J Clin Pract. 2009;63:691-. CrossRef
  
• 作者单位：Emilio Blanco Tarrio (1)
  Rafael Gálvez Mateos (2)
  Enric Zamorano Bayarri (3)
  Vanessa López Gómez (4)
  Maria Pérez Páramo (4)
  
  1. Centro de Salud de Béjar, Salamanca, Spain
  2. Pain Unit, Hospital Virgen de las Nieves, Granada, Spain
  3. CAP Sant Antoni de Vilamajor, ABS Alt Mogent, Barcelona, Spain
  4. Medical Unit, Pfizer, Avda. de Europa, 20 B, Parque Empresarial La Moraleja, 28108, Alcobendas, Madrid, Spain
  
• ISSN：1179-1918

文摘

Background and Objective Patients from a previous study of neuropathic pain (NP) in the Spanish primary care setting still had symptoms despite treatment. Subsequently, patients were treated as prescribed by their physician and followed up for 3?months. Since pregabalin has been shown to be effective in NP, including refractory cases, the objective of this study was to assess the effectiveness of pregabalin therapy in patients with NP refractory to previous treatments. Methods This was a post hoc analysis of pregabalin-na?ve NP patients treated with pregabalin in a 3-month follow-up observational multicenter study to assess symptoms and satisfaction with treatment. Patients were evaluated with the Douleur Neuropathique en 4 questions (DN4), the Brief Pain Inventory (BPI) and the Treatment Satisfaction for Medication Questionnaire (SATMED-Q) overall satisfaction domain. Results 1,670 patients (mean age 58?years, 59?% women), previously untreated or treated with ? drug other than pregabalin, were treated with pregabalin (37?% on monotherapy). At 3?months, pain intensity and its interference with activities decreased by half (p?<?0.0001), while the number of days with no or mild pain increased by a mean of 4.5?days (p?<?0.0001). Treatment satisfaction increased twofold (p?<?0.0001). Patients with a shorter history of pain and those with neuralgia and peripheral nerve compression syndrome (PCS) as etiologies had the highest proportion on monotherapy and showed the greatest improvements in pain-related parameters in their respective group categories. Conclusion Treatment with pregabalin (as monotherapy or combination therapy) provides benefits in pain and treatment satisfaction in patients with NP, including refractory cases. Shorter disease progression and neuralgia and PCS etiologies are favorable factors for pregabalin treatment response.