Duloxetine use in chronic painful conditions - Individual patient data responder analysis

European Journal of Pain (United Kingdom)

Volumn 18, Issue 1, 2014, Pages 67-75

  Moore, R A ^a   Cai, N ^b   Skljarevski, V ^b   Tolle T R ^c  

^a UNIVERSITY OF OXFORD   (United Kingdom)

^b ELI LILLY AND COMPANY   (United States)

^c TECHNICAL UNIVERSITY OF MUNICH   (Germany)

Author keywords

[No Author keywords available]

Indexed keywords

DULOXETINE;

ARTICLE; CHRONIC PAIN; DIABETIC NEUROPATHY; DRUG EFFICACY; DRUG WITHDRAWAL; FIBROMYALGIA; HUMAN; LOW BACK PAIN; NEUROPATHIC PAIN; OSTEOARTHRITIS; PAIN ASSESSMENT; PERIPHERAL NEUROPATHY; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL (TOPIC); TREATMENT OUTCOME; TREATMENT RESPONSE; UNSPECIFIED SIDE EFFECT;

ANTIDEPRESSIVE AGENTS; CHRONIC PAIN; DIABETIC NEUROPATHIES; DOUBLE-BLIND METHOD; FIBROMYALGIA; HUMANS; INDIVIDUALITY; LOW BACK PAIN; OSTEOARTHRITIS; PAIN MEASUREMENT; THIOPHENES; TREATMENT OUTCOME;

EID: 84893302584     PISSN: 10903801     EISSN: 15322149     Source Type: Journal    
DOI: 10.1002/j.1532-2149.2013.00341.x     Document Type: Article

References (46)

1. Arnold, L.M., Lu, Y., Crofford, L.J., Wohlreich, M., Detke, M.J., Iyengar, S., Goldstein, D.J. (2004). A double-blind, multicenter trial comparing duloxetine with placebo in the treatment of fibromyalgia patients with or without major depressive disorder. Arthritis Rheum 50, 2974-2984.
2. Arnold, L.M., Rosen, A., Pritchett, Y.L., D'Souza, D.N., Goldstein, D.J., Iyengar, S., Wernicke, J.F. (2005). A randomized, double-blind, placebo-controlled trial of duloxetine in the treatment of women with fibromyalgia with or without major depressive disorder. Pain 119, 5-15.
3. Bansal, D., Bhansali, A., Hota, D., Chakrabarti, A., Dutta, P. (2009). Amitriptyline vs. pregabalin in painful diabetic neuropathy: A randomized double blind clinical trial. Diabet Med 26, 1019-1026.
4. Barthel, H.R., Peniston, J.H., Clark, M.B., Gold, M.S., Altman, R.D. (2010). Correlation of pain relief with physical function in hand osteoarthritis: Randomized controlled trial post hoc analysis. Arthritis Res Ther 12, R7.
5. Bradley, L.A., Wohlreich, M.M., Wang, F., Gaynor, P.J., Robinson, M.J., D'Souza, D.N., Mease, P.J. (2010). Pain response profile of patients with fibromyalgia treated with duloxetine. Clin J Pain 26, 498-504.
6. Chappell, A.S., Bradley, L.A., Wiltse, C., Detke, M.J., D'Souza, D.N., Spaeth, M. (2008). A six-month double-blind, placebo-controlled, randomized clinical trial of duloxetine for the treatment of fibromyalgia. Int J Gen Med 1, 91-102.
7. Chappell, A.S., Desaiah, D., Liu-Seifert, H., Zhang, S., Skljarevski, V., Belenkov, Y., Brown, J.P. (2011). A double-blind, randomized, placebo-controlled study of the efficacy and safety of duloxetine for the treatment of chronic pain due to osteoarthritis of the knee. Pain Pract 11, 33-41.
8. Chappell, A.S., Ossanna, M.J., Liu-Seifert, H., Iyengar, S., Skljarevski, V., Li, L.C., Bennett, R.M., Collins, H. (2009). Duloxetine, a centrally acting analgesic, in the treatment of patients with osteoarthritis knee pain: A 13-week, randomized, placebo-controlled trial. Pain 146, 253-260.
9. Cook, R.J., Sackett, D.L. (1995). The number needed to treat: A clinically useful measure of treatment effect. BMJ 310, 452-454.
10. Dworkin, R.H., O'Connor, A.B., Audette, J., Baron, R., Gourlay, G.K., Haanpää, M.L., Kent, J.L., Krane, E.J., Lebel, A.A., Levy, R.M., Mackey, S.C., Mayer, J., Miaskowski, C., Raja, S.N., Rice, A.S., Schmader, K.E., Stacey, B., Stanos, S., Treede, R.D., Turk, D.C., Walco, G.A., Wells, C.D. (2010). Recommendations for the pharmacological management of neuropathic pain: An overview and literature update. Mayo Clin Proc 85, S3-14.
11. Dworkin, R.H., Turk, D.C., Wyrwich, K.W., Beaton, D., Cleeland, C.S., Farrar, J.T., Haythornthwaite, J.A., Jensen, M.P., Kerns, R.D., Ader, D.N., Brandenburg, N., Burke, L.B., Cella, D., Chandler, J., Cowan, P., Dimitrova, R., Dionne, R., Hertz, S., Jadad, A.R., Katz, N.P., Kehlet, H., Kramer, L.D., Manning, D.C., McCormick, C., McDermott, M.P., McQuay, H.J., Patel, S., Porter, L., Quessy, S., Rappaport, B.A., Rauschkolb, C., Revicki, D.A., Rothman, M., Schmader, K.E., Stacey, B.R., Stauffer, J.W., von Stein, T., White, R.E., Witter, J., Zavisic, S. (2008). Interpreting the clinical importance of treatment outcomes in chronic pain clinical trials: IMMPACT recommendations. J Pain 9, 105-121.
12. Finnerup, N.B., Sindrup, S.H., Jensen, T.S. (2010). The evidence for pharmacological treatment of neuropathic pain. Pain 150, 573-581.
13. Frakes, E.P., Risser, R.C., Ball, T.D., Hochberg, M.C., Wohlreich, M.M. (2011). Duloxetine added to oral nonsteroidal anti-inflammatory drugs for treatment of knee pain due to osteoarthritis: Results of a randomized, double-blind, placebo-controlled trial. Curr Med Res Opin 27, 2361-2372.
14. Goldstein, D.J., Lu, Y., Detke, M.J., Lee, T.C., Iyengar, S. (2005). Duloxetine vs. placebo in patients with painful diabetic neuropathy. Pain 116, 109-118.
15. Hewitt, D.J., Ho, T.W., Galer, B., Backonja, M., Markovitz, P., Gammaitoni, A., Michelson, D., Bolognese, J., Alon, A., Rosenberg, E., Herman, G., Wang, H. (2011). Impact of responder definition on the enriched enrollment randomized withdrawal trial design for establishing proof of concept in neuropathic pain. Pain 152, 514-521.
16. Hoffman, D.L., Sadosky, A., Dukes, E.M., Alvir, J. (2010). How do changes in pain severity levels correspond to changes in health status and function in patients with painful diabetic peripheral neuropathy? Pain 149, 194-201.
17. Jensen, T.S., Baron, R. (2003). Translation of symptoms and signs into mechanisms in neuropathic pain. Pain 102, 1-8.
18. Kaur, H., Hota, D., Bhansali, A., Dutta, P., Bansal, D., Chakrabarti, A. (2011). A comparative evaluation of amitriptyline and duloxetine in painful diabetic neuropathy: A randomized, double-blind, cross-over clinical trial. Diabetes Care 34, 818-822.
19. Liu-Seifert, H., Zhang, S., D'Souza, D., Skljarevski, V. (2010). A closer look at the baseline observation carried forward (BOCF). Patient Prefer Adherence 4, 11-16.
20. Lunn, M.P., Hughes, R.A., Wiffen, P.J. (2009). Duloxetine for treating painful neuropathy or chronic pain. Cochrane Database Syst Rev (4), CD007115.
21. Moore, R.A., Derry, S., Wiffen, P.J., Aldington, D., Cole, P. (2012a). Amitriptyline for neuropathic pain and fibromyalgia in adults. Cochrane Database Syst Rev (12), CD008242.
22. Moore, R.A., Eccleston, C., Derry, S., Wiffen, P., Bell, R.F., Straube, S., McQuay, H., ACTINPAIN Writing Group of the IASP Special Interest Group on Systematic Reviews in Pain Relief, Cochrane Pain, Palliative and Supportive Care Systematic Review Group Editors. (2010a). 'Evidence' in chronic pain-establishing best practice in the reporting of systematic reviews. Pain 150, 386-389.
23. Moore, R.A., Moore, O.A., Derry, S., Peloso, P.M., Gammaitoni, A.R., Wang, H. (2010b). Responder analysis for pain relief and numbers needed to treat in a meta-analysis of etoricoxib osteoarthritis trials: Bridging a gap between clinical trials and clinical practice. Ann Rheum Dis 69, 374-379.
24. Moore, R.A., Smugar, S.S., Wangm, H., Pelosom, P.M., Gammaitoni, A. (2010c). Numbers-needed-to-treat analyses-Do timing, dropouts, and outcome matter? Pooled analysis of two randomized, placebo-controlled chronic low back pain trials. Pain 151, 592-597.
25. Moore, R.A., Straube, S., Derry, S., McQuay, H.J. (2010d). Chronic low back pain analgesic studies-A methodological minefield. Pain 149, 431-434.
26. Moore, R.A., Straube, S., Eccleston, C., Derry, S., Aldington, D., Wiffen, P., Bell, R.F., Hamunen, K., Phillips, C., McQuay, H. (2012b). Estimate at your peril: Imputation methods for patient withdrawal can bias efficacy outcomes in chronic pain trials using responder analyses. Pain 153, 265-268.
27. Moore, R.A., Straube, S., Paine, J., Derry, S., McQuay, H.J. (2011). Minimum efficacy criteria for comparisons between treatments using individual patient meta-analysis of acute pain trials: Examples of etori-coxib, paracetamol, ibuprofen, and ibuprofen/paracetamol combinations after third molar extraction. Pain 152, 982-989.
28. Moore, R.A., Straube, S., Paine, J., Phillips, C.J., Derry, S., McQuay, H.J. (2010e). Fibromyalgia: Moderate and substantial pain intensity reduction predicts improvement in other outcomes and substantial quality of life gain. Pain 149, 360-364.
29. Moore, R.A., Straube, S., Wiffen, P.J., Derry, S., McQuay, H.J. (2009). Pregabalin for acute and chronic pain in adults. Cochrane Database Syst Rev (3), CD007076.
30. Morris, J.A., Gardner, M.J. (1995). Calculating confidence intervals for relative risk, odds ratios and standardised ratios and rates. In Statistics with Confidence-Confidence Intervals and Statistical Guidelines, M.J. Gardner, D.G. Altman, eds. (London: BMJ) pp. 50-63.
31. Nüesch, E., Trelle, S., Reichenbach, S., Rutjes, A.W., Tschannen, B., Altman, D.G., Egger, M., Jüni, P. (2010). Small study effects in meta-analyses of osteoarthritis trials: Meta-epidemiological study. BMJ 341, c3515.
32. Panel on Handling Missing Data in Clinical Trials, National Research Council. (2010). The Prevention and Treatment of Missing Data in Clinical Trials (Washington, DC: National Academies Press).
33. Peloso, P.M., Gammaitoni, A., Smugar, S.S., Wang, H., Moore, R.A. (2011). Longitudinal numbers-needed-to-treat (NNT) for achieving various levels of analgesic response and improvement with etoricoxib, naproxen, and placebo in ankylosing spondylitis. BMC Musculoskelet Disord 12, 165.
34. Raskin, J., Pritchett, Y.L., Wang, F., D'Souza, D.N., Waninger, A.L., Iyengar, S., Wernicke, J.F. (2005). A double-blind, randomized multicenter trial comparing duloxetine with placebo in the management of diabetic peripheral neuropathic pain. Pain Med 6, 346-356.
35. Russell, I.J., Mease, P.J., Smith, T.R., Kajdasz, D.K., Wohlreich, M.M., Detke, M.J., Walker, D.J., Chappell, A.S., Arnold, L.M. (2008). Efficacy and safety of duloxetine for treatment of fibromyalgia in patients with or without major depressive disorder: Results for a 6-month, randomized, double-blind, placebo-controlled, fixed-dose trial. Pain 136, 432-444.
36. Semel, D., Murphy, T.K., Zlateva, G., Cheung, R., Emir, B. (2010). 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 11, 85.
37. Skljarevski, V., Desaiah, D., Liu-Seifert, H., Zhang, Q., Chappell, A.S., Detke, M.J., Iyengar, S., Atkinson, J.H., Backonja, M. (2010a). Efficacy and safety of duloxetine in patients with chronic low back pain. Spine (Phila Pa 1976) 35, E578-E585.
38. Skljarevski, V., Ossanna, M., Liu-Seifert, H., Zhang, Q., Chappell, A., Iyengar, S., Detke, M., Backonja, M. (2009). A double-blind, randomized trial of duloxetine versus placebo in the management of chronic low back pain. Eur J Neurol 16, 1041-1048.
39. Skljarevski, V., Zhang, S., Desaiah, D., Alaka, K.J., Palacios, S., Miazgowski, T., Patrick, K. (2010b). Duloxetine versus placebo in patients with chronic low back pain: A 12-week, fixed-dose, randomized, double-blind trial. J Pain 11, 1282-1290.
40. Straube, S., Derry, S., Moore, R.A., Paine, J., McQuay, H.J. (2010). Pre-gabalin in fibromyalgia-Responder analysis from individual patient data. BMC Musculoskelet Disord 11, 150.
41. Straube, S., Moore, R.A., Paine, J., Derry, S., Phillips, C.J., Hallier, E., McQuay, H.J. (2011). Interference with work in fibromyalgia: Effect of treatment with pregabalin and relation to pain response. BMC Musculo-skelet Disord 12, 125.
42. Sultan, A., Gaskell, H., Derry, S., Moore, R.A. (2008). Duloxetine for painful diabetic neuropathy and fibromyalgia pain: Systematic review of randomised trials. BMC Neurol 8, 29.
43. Tölle, T.R., Backonja, M. (2013). Pharmacological therapy for neuropathic pain. In Wall & Melzack's Textbook of Pain, Chapter 73, 6th edn M. Kolzenburg, S.B. McMahon, I. Tracey, D.C. Turk, eds. (London: Elsevier). In press.
44. Tramer, M.R., Reynolds, D.J., Moore, R.A., McQuay, H.J. (1997). Impact of covert duplicate publication on meta-analysis: A case study. BMJ 315, 635-640.
45. Watson, C.P., Vernich, L., Chipman, M., Reed, K. (1998). Nortriptyline versus amitriptyline in postherpetic neuralgia: A randomized trial. Neurology 51, 1166-1171.
46. Wernicke, J.F., Pritchett, Y.L., D'Souza, D.N., Waninger, A., Tran, P., Iyengar, S., Raskin, J. (2006). A randomized controlled trial of duloxetine in diabetic peripheral neuropathic pain. Neurology 67, 1411-1420.