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Volumn 155, Issue 10, 2014, Pages 1943-1954

A randomized, double-blind, placebo-controlled trial and open-label extension study to evaluate the efficacy and safety of pregabalin in the treatment of neuropathic pain associated with human immunodeficiency virus neuropathy

Author keywords

HIV; Polyneuropathy; Pregabalin; Randomized controlled trial

Indexed keywords

PREGABALIN; ANALGESIC AGENT;

EID: 84908089295     PISSN: 03043959     EISSN: 18726623     Source Type: Journal    
DOI: 10.1016/j.pain.2014.05.027     Document Type: Article
Times cited : (41)

References (45)
  • 1
    • 79955617730 scopus 로고    scopus 로고
    • Impact of pregabalin treatment on pain, pain-related sleep interference and general well-being in patients with neuropathic pain: A non-interventional, multicentre, post-marketing study
    • E. Anastassiou, C.A. Iatrou, N. Vlaikidis, M. Vafiadou, G. Stamatiou, E. Plesia, L. Lyras, and A. Vadalouca Impact of pregabalin treatment on pain, pain-related sleep interference and general well-being in patients with neuropathic pain: a non-interventional, multicentre, post-marketing study Clin Drug Invest 31 2011 417 426
    • (2011) Clin Drug Invest , vol.31 , pp. 417-426
    • Anastassiou, E.1    Iatrou, C.A.2    Vlaikidis, N.3    Vafiadou, M.4    Stamatiou, G.5    Plesia, E.6    Lyras, L.7    Vadalouca, A.8
  • 2
    • 79951523634 scopus 로고    scopus 로고
    • Distal symmetric polyneuropathy and toxic neuropathy in HIV patients
    • B.D. Arasho, S.B. Jacob, and G. Zenebe Distal symmetric polyneuropathy and toxic neuropathy in HIV patients Ann Trop Med Public Health 3 2010 8 13
    • (2010) Ann Trop Med Public Health , vol.3 , pp. 8-13
    • Arasho, B.D.1    Jacob, S.B.2    Zenebe, G.3
  • 4
    • 84869843911 scopus 로고    scopus 로고
    • Randomized, placebo-controlled comparison of amitriptyline, duloxetine, and pregabalin in patients with chronic diabetic peripheral neuropathic pain: Impact on pain, polysomnographic sleep, daytime functioning, and quality of life
    • J. Boyle, M.E. Eriksson, L. Gribble, R. Gouni, S. Johnsen, D.V. Coppini, and D. Kerr Randomized, placebo-controlled comparison of amitriptyline, duloxetine, and pregabalin in patients with chronic diabetic peripheral neuropathic pain: impact on pain, polysomnographic sleep, daytime functioning, and quality of life Diabetes Care 35 2012 2451 2458
    • (2012) Diabetes Care , vol.35 , pp. 2451-2458
    • Boyle, J.1    Eriksson, M.E.2    Gribble, L.3    Gouni, R.4    Johnsen, S.5    Coppini, D.V.6    Kerr, D.7
  • 5
    • 84859766896 scopus 로고    scopus 로고
    • Placebo response changes depending on the neuropathic pain syndrome: Results of a systematic review and meta-analysis
    • M.S. Cepeda, J.A. Berlin, C.Y. Gao, F. Wiegand, and D.R. Wada Placebo response changes depending on the neuropathic pain syndrome: results of a systematic review and meta-analysis Pain Med 13 2012 575 595
    • (2012) Pain Med , vol.13 , pp. 575-595
    • Cepeda, M.S.1    Berlin, J.A.2    Gao, C.Y.3    Wiegand, F.4    Wada, D.R.5
  • 6
    • 0020603115 scopus 로고
    • Development of the Wisconsin Brief Pain Questionnaire to assess pain in cancer and other diseases
    • R.L. Daut, C.S. Cleeland, and R.C. Flanery Development of the Wisconsin Brief Pain Questionnaire to assess pain in cancer and other diseases PAIN® 17 1983 197 210
    • (1983) PAIN® , vol.17 , pp. 197-210
    • Daut, R.L.1    Cleeland, C.S.2    Flanery, R.C.3
  • 8
    • 33645045913 scopus 로고    scopus 로고
    • Placebo response in clinical trials of depression and its implications for research on chronic neuropathic pain
    • R.H. Dworkin, J. Katz, and M.J. Gitlin Placebo response in clinical trials of depression and its implications for research on chronic neuropathic pain Neurology 65 2005 S7 S19
    • (2005) Neurology , vol.65 , pp. 7-S19
    • Dworkin, R.H.1    Katz, J.2    Gitlin, M.J.3
  • 13
    • 84892701578 scopus 로고    scopus 로고
    • Sensory profiles of patients with neuropathic pain based on the neuropathic pain symptoms and signs
    • R. Freeman, R. Baron, D. Bouhassira, J. Cabrera, and B. Emir Sensory profiles of patients with neuropathic pain based on the neuropathic pain symptoms and signs PAIN® 155 2014 367 376
    • (2014) PAIN® , vol.155 , pp. 367-376
    • Freeman, R.1    Baron, R.2    Bouhassira, D.3    Cabrera, J.4    Emir, B.5
  • 14
    • 84921839484 scopus 로고    scopus 로고
    • A comprehensive drug safety evaluation of pregabalin in peripheral neuropathic pain
    • [Epub ahead of print]
    • Freynhagen R, Serpell M, Emir B, Whalen E, Parsons B, Clair A, Latymer M. A comprehensive drug safety evaluation of pregabalin in peripheral neuropathic pain. Pain Practice; 2013. http://dx.doi.org/10.1111/papr.12146. [Epub ahead of print].
    • (2013) Pain Practice
    • Freynhagen, R.1    Serpell, M.2    Emir, B.3    Whalen, E.4    Parsons, B.5    Clair, A.6    Latymer, M.7
  • 15
    • 19444362218 scopus 로고    scopus 로고
    • Efficacy of pregabalin in neuropathic pain evaluated in a 12-week, randomised, double-blind, multicentre, placebo-controlled trial of flexible- and fixed-dose regimens
    • R. Freynhagen, K. Strojek, T. Griesing, E. Whalen, and M. Balkenohl Efficacy of pregabalin in neuropathic pain evaluated in a 12-week, randomised, double-blind, multicentre, placebo-controlled trial of flexible- and fixed-dose regimens PAIN® 115 2005 254 263
    • (2005) PAIN® , vol.115 , pp. 254-263
    • Freynhagen, R.1    Strojek, K.2    Griesing, T.3    Whalen, E.4    Balkenohl, M.5
  • 17
    • 12744263350 scopus 로고    scopus 로고
    • Psychometric properties of the Medical Outcomes Study Sleep measure
    • R.D. Hays, S.A. Martin, A.M. Sesti, and K.L. Spritzer Psychometric properties of the Medical Outcomes Study Sleep measure Sleep Med 6 2005 41 44
    • (2005) Sleep Med , vol.6 , pp. 41-44
    • Hays, R.D.1    Martin, S.A.2    Sesti, A.M.3    Spritzer, K.L.4
  • 18
    • 84875473393 scopus 로고    scopus 로고
    • A clinically relevant rodent model of the HIV antiretroviral drug stavudine induced painful peripheral neuropathy
    • W. Huang, M. Calvo, K. Karu, H.R. Olausen, G. Bathgate, K. Okuse, D.L. Bennett, and A.S. Rice A clinically relevant rodent model of the HIV antiretroviral drug stavudine induced painful peripheral neuropathy PAIN® 154 2013 560 575
    • (2013) PAIN® , vol.154 , pp. 560-575
    • Huang, W.1    Calvo, M.2    Karu, K.3    Olausen, H.R.4    Bathgate, G.5    Okuse, K.6    Bennett, D.L.7    Rice, A.S.8
  • 19
    • 77956453757 scopus 로고    scopus 로고
    • The placebo response: Relationship to outcomes in trials of postherpetic neuralgia
    • G. Irving The placebo response: relationship to outcomes in trials of postherpetic neuralgia Clin Drug Invest 30 2010 739 748
    • (2010) Clin Drug Invest , vol.30 , pp. 739-748
    • Irving, G.1
  • 20
    • 0000187531 scopus 로고
    • Self-report scales and procedures for assessing pain in adults
    • D.C. Turk, R. Melzack, Guildford Press New York
    • M.P. Jensen, and P. Karoly Self-report scales and procedures for assessing pain in adults D.C. Turk, R. Melzack, Handbook of pain assessment 1992 Guildford Press New York 134 151
    • (1992) Handbook of Pain Assessment , pp. 134-151
    • Jensen, M.P.1    Karoly, P.2
  • 21
    • 34447136003 scopus 로고    scopus 로고
    • Distal sensory polyneuropathy in human immunodeficiency virus patients and nucleoside analogue antiretroviral agents
    • J. Jose, K. Saravu, B. Jimmy, and B.A. Shastry Distal sensory polyneuropathy in human immunodeficiency virus patients and nucleoside analogue antiretroviral agents Ann Indian Acad Neurol 10 2007 81 87
    • (2007) Ann Indian Acad Neurol , vol.10 , pp. 81-87
    • Jose, J.1    Saravu, K.2    Jimmy, B.3    Shastry, B.A.4
  • 22
    • 38549120670 scopus 로고    scopus 로고
    • Clinical trial outcome in neuropathic pain: Relationship to study characteristics
    • J. Katz, N.B. Finnerup, and R.H. Dworkin Clinical trial outcome in neuropathic pain: relationship to study characteristics Neurology 70 2008 263 272
    • (2008) Neurology , vol.70 , pp. 263-272
    • Katz, J.1    Finnerup, N.B.2    Dworkin, R.H.3
  • 23
    • 33645062724 scopus 로고    scopus 로고
    • Methodological issues in clinical trials of opioids for chronic pain
    • N. Katz Methodological issues in clinical trials of opioids for chronic pain Neurology 65 2005 S32 S49
    • (2005) Neurology , vol.65 , pp. 32-S49
    • Katz, N.1
  • 25
    • 79959671886 scopus 로고    scopus 로고
    • Fibromyalgia and neuropathic pain - Differences and similarities. A comparison of 3057 patients with diabetic painful neuropathy and fibromyalgia
    • J. Koroschetz, S.E. Rehm, U. Gockel, M. Brosz, R. Freynhagen, T.R. Tolle, and R. Baron Fibromyalgia and neuropathic pain - differences and similarities. A comparison of 3057 patients with diabetic painful neuropathy and fibromyalgia BMC Neurol 11 2011 55
    • (2011) BMC Neurol , vol.11 , pp. 55
    • Koroschetz, J.1    Rehm, S.E.2    Gockel, U.3    Brosz, M.4    Freynhagen, R.5    Tolle, T.R.6    Baron, R.7
  • 27
    • 84855374734 scopus 로고    scopus 로고
    • Post hoc analysis of pregabalin vs non-pregabalin treatment in patients with cancer-related neuropathic pain: Better pain relief, sleep and physical health
    • A. Manas, J.P. Ciria, M.C. Fernandez, M.L. Gonzalvez, V. Morillo, M. Perez, X. Masramon, and V. Lopez-Gomez Post hoc analysis of pregabalin vs. non-pregabalin treatment in patients with cancer-related neuropathic pain: better pain relief, sleep and physical health Clin Transl Oncol 13 2011 656 663
    • (2011) Clin Transl Oncol , vol.13 , pp. 656-663
    • Manas, A.1    Ciria, J.P.2    Fernandez, M.C.3    Gonzalvez, M.L.4    Morillo, V.5    Perez, M.6    Masramon, X.7    Lopez-Gomez, V.8
  • 29
    • 84908136396 scopus 로고    scopus 로고
    • Pfizer Inc. Accessed June 6, 2014
    • Pfizer Inc. LYRICA annex I: summary of product information (EU). Available at: http://www.ema.europa.eu/docs/en-GB/document-library/EPAR-Product-Information/human/000546/WC500046602.pdf. Accessed June 6, 2014.
    • LYRICA Annex I: Summary of Product Information (EU)
  • 30
    • 84877919998 scopus 로고    scopus 로고
    • Pfizer Inc. Accessed June 6, 2014
    • Pfizer Inc. LYRICA US prescribing information. Available at: http://labeling.pfizer.com/ShowLabeling.aspx?id=561. Accessed June 6, 2014.
    • LYRICA US Prescribing Information
  • 31
    • 78650828037 scopus 로고    scopus 로고
    • Pharmacological treatment of painful HIV-associated sensory neuropathy: A systematic review and meta-analysis of randomised controlled trials
    • T.J. Phillips, C.L. Cherry, S. Cox, S.J. Marshall, and A.S. Rice Pharmacological treatment of painful HIV-associated sensory neuropathy: a systematic review and meta-analysis of randomised controlled trials PLoS One 5 2010 e14433
    • (2010) PLoS One , vol.5 , pp. 14433
    • Phillips, T.J.1    Cherry, C.L.2    Cox, S.3    Marshall, S.J.4    Rice, A.S.5
  • 32
    • 50249189344 scopus 로고    scopus 로고
    • Placebo response in neuropathic pain trials
    • S.N. Quessy, and M.C. Rowbotham Placebo response in neuropathic pain trials PAIN® 138 2008 479 483
    • (2008) PAIN® , vol.138 , pp. 479-483
    • Quessy, S.N.1    Rowbotham, M.C.2
  • 34
    • 3843088696 scopus 로고    scopus 로고
    • Pregabalin for the treatment of painful diabetic peripheral neuropathy: A double-blind, placebo-controlled trial
    • J. Rosenstock, M. Tuchman, L. LaMoreaux, and U. Sharma Pregabalin for the treatment of painful diabetic peripheral neuropathy: a double-blind, placebo-controlled trial PAIN® 110 2004 628 638
    • (2004) PAIN® , vol.110 , pp. 628-638
    • Rosenstock, J.1    Tuchman, M.2    Lamoreaux, L.3    Sharma, U.4
  • 35
    • 70350617935 scopus 로고    scopus 로고
    • The case for publishing 'negative' clinical trials
    • M.C. Rowbotham The case for publishing 'negative' clinical trials PAIN® 146 2009 225 226
    • (2009) PAIN® , vol.146 , pp. 225-226
    • Rowbotham, M.C.1
  • 36
    • 1842734242 scopus 로고    scopus 로고
    • Pregabalin reduces pain and improves sleep and mood disturbances in patients with post-herpetic neuralgia: Results of a randomised, placebo-controlled clinical trial
    • R. Sabatowski, R. Galvez, D.A. Cherry, F. Jacquot, E. Vincent, P. Maisonobe, and M. Versavel Pregabalin reduces pain and improves sleep and mood disturbances in patients with post-herpetic neuralgia: results of a randomised, placebo-controlled clinical trial PAIN® 109 2004 26 35
    • (2004) PAIN® , vol.109 , pp. 26-35
    • Sabatowski, R.1    Galvez, R.2    Cherry, D.A.3    Jacquot, F.4    Vincent, E.5    Maisonobe, P.6    Versavel, M.7
  • 39
    • 81455128196 scopus 로고    scopus 로고
    • Treatment considerations in painful HIV-related neuropathy
    • H.S. Smith Treatment considerations in painful HIV-related neuropathy Pain Phys 14 2011 E505 E524
    • (2011) Pain Phys , vol.14 , pp. 505-E524
    • Smith, H.S.1
  • 40
    • 36549031246 scopus 로고    scopus 로고
    • Pregabalin for relief of neuropathic pain associated with diabetic neuropathy: A randomized, double-blind study
    • T. Tolle, R. Freynhagen, M. Versavel, U. Trostmann, and J.P. Young Jr. Pregabalin for relief of neuropathic pain associated with diabetic neuropathy: a randomized, double-blind study Eur J Pain 12 2008 203 213
    • (2008) Eur J Pain , vol.12 , pp. 203-213
    • Tolle, T.1    Freynhagen, R.2    Versavel, M.3    Trostmann, U.4    Young, J.P.5
  • 42
    • 33645732694 scopus 로고    scopus 로고
    • Efficacy and tolerability of twice-daily pregabalin for treating pain and related sleep interference in postherpetic neuralgia: A 13-week, randomized trial
    • R. van Seventer, H.A. Feister, J.P. Young Jr., M. Stoker, M. Versavel, and L. Rigaudy Efficacy and tolerability of twice-daily pregabalin for treating pain and related sleep interference in postherpetic neuralgia: a 13-week, randomized trial Curr Med Res Opin 22 2006 375 384
    • (2006) Curr Med Res Opin , vol.22 , pp. 375-384
    • Van Seventer, R.1    Feister, H.A.2    Young, J.P.3    Stoker, M.4    Versavel, M.5    Rigaudy, L.6
  • 45
    • 0020527558 scopus 로고
    • The Hospital Anxiety and Depression Scale
    • A.S. Zigmond, and R.P. Snaith The Hospital Anxiety and Depression Scale Acta Psychiatr Scand 67 1983 361 370
    • (1983) Acta Psychiatr Scand , vol.67 , pp. 361-370
    • Zigmond, A.S.1    Snaith, R.P.2


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