The effects of pregabalin on sleep disturbance symptoms among individuals with fibromyalgia syndrome

Sleep Medicine

Volumn 10, Issue 6, 2009, Pages 604-610

  Russell, I Jon ^a   Crofford, Leslie J ^b   Leon, Teresa ^c   Cappelleri, Joseph C ^c   Bushmakin, Andrew G ^c   Whalen, Ed ^c   Barrett, Jeannette A ^c   Sadosky, Alesia ^c  

^a UNIVERSITY OF TEXAS HEALTH SCIENCE CENTER AT SAN ANTONIO   (United States)

^b UNIVERSITY OF KENTUCKY   (United States)

^c PFIZER INC   (United States)

Author keywords

Clinically important difference; Fibromyalgia syndrome; Insomnia; Mediation analysis; MOS Sleep Scale; Pain; Pregabalin; Sleep disturbance

Indexed keywords

PLACEBO; PREGABALIN;

ADULT; ANALGESIA; ARTICLE; CAUCASIAN; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DISEASE SEVERITY; DOUBLE BLIND PROCEDURE; DRUG DOSE COMPARISON; DRUG EFFICACY; FEMALE; FIBROMYALGIA; HUMAN; INSOMNIA; MAJOR CLINICAL STUDY; MALE; PAIN; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; RATING SCALE; SCORING SYSTEM; SLEEP DISORDER;

ANALGESICS; DOUBLE-BLIND METHOD; FEMALE; FIBROMYALGIA; GAMMA-AMINOBUTYRIC ACID; HUMANS; MALE; MEDICAL RECORDS; MIDDLE AGED; PAIN; PAIN MEASUREMENT; SEVERITY OF ILLNESS INDEX; SLEEP INITIATION AND MAINTENANCE DISORDERS; TREATMENT OUTCOME;

EID: 67349113140     PISSN: 13899457     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.sleep.2009.01.009     Document Type: Article

References (46)

1. Wolfe F., Smythe H.A., Yunus M.B., et al. The American College of Rheumatology 1990 Criteria for the classification of fibromyalgia. Report of the Multicenter Criteria Committee. Arthritis Rheum 33 (1990) 160-172
2. Wolfe F. The epidemiology of fibromyalgia. J Musculoskeletal Pain 1 (1993) 137-148
3. Wolfe F., Ross K., Anderson J., et al. The prevalence and characteristics of fibromyalgia in the general population. Arthritis Rheum 38 (1995) 19-28
4. Mease P.J., Arnold L.M., Crofford L.J., et al. Identifying the clinical domains of fibromyalgia: contributions from clinician and patient delphi exercises. Arthritis Rheum 59 (2008) 952-960
5. Abad V.C., Sarinas P.S.A., and Guilleminault C. Sleep and rheumatologic disorders. Sleep Med Rev 12 (2008) 211-228
6. Moldofsky H., and Alvarez-Horine S. Disordered sleep and sleep-related daytime functioning in fibromyalgia syndrome (FMS). Ann Rheum Dis 67 Suppl. II (2008) 256
7. Edwards R.R., Almeida D.M., Klick B., et al. Duration of sleep contributes to next-day pain report in the general population. Pain (2008) [Epub ahead of print]
8. Moldofsky H., and Scarisbrick P. Induction of neurasthenic musculoskeletal pain syndrome by selective sleep stage deprivation. Psychosom Med 38 (1976) 35-44
9. Moldofsky H., Scarisbrick P., England R., and Smythe H. Musculosketal symptoms and non-REM sleep disturbance in patients with "fibrositis syndrome" and healthy subjects. Psychosom Med 37 (1975) 341-351
10. Affleck G., Urrows S., Tennen H., et al. Sequential daily relations of sleep, pain intensity, and attention to pain among women with fibromyalgia. Pain 68 (1996) 363-368
11. McKracken L.M., and Iverson G.L. Disrupted sleep patterns and daily functioning in patients with chronic pain. Pain Res Manag 7 (2002) 75-79
12. Smith M.T., and Haythornthwaite J.A. How do sleep disturbance and chronic pain inter-relate? Insights from the longitudinal and cognitive-behavioral clinical trials literature. Sleep Med Rev 8 (2004) 119-132
13. Bigatti S.M., Hernandez A.M., Cronan T.A., and Rand K.L. Sleep disturbances in fibromyalgia syndrome: relationship to pain and depression. Arthritis Rheum 59 (2008) 961-967
14. Mease P.J., Russell I.J., Arnold L.M., et al. A randomized, double-blind, placebo-controlled, phase III trial of pregabalin in the treatment of patients with fibromyalgia. J Rheumatol 35 (2008) 502-514
15. Arnold L.M., Russell I.J., Diri E.W., et al. A 14-week, randomized, double-blind, placebo-controlled monotherapy trial of pregabalin in patients with fibromyalgia. J Pain (2008) [Epub ahead of print]
16. Melzack R. The short-form McGill Pain Questionnaire. Pain 30 (1987) 191-197
17. Max M.B. Neuropathic pain syndromes. In: Max M.B., Portenoy R., and Laska E. (Eds). Advances in pain research and management vol. 18 (1991), Raven Press Ltd., New York 193-219
18. Watson C.P.N. Neuropathic pain syndromes. In: Max M.B., Portenoy R., and Laska E. (Eds). Advances in pain research and management vol. 18 (1991), Raven Press Ltd., New York 221-231
19. Jensen M.P., and Karoly P. Self-report scales and procedures for assessing pain in adults. In: Turk D.C., and Melzack R. (Eds). Handbook of pain assessment (1992), The Guildford Press, New York 135-151
20. Hays R., and Stewart A. Sleep measures. In: Stewart A., and Ware J. (Eds). Measuring functioning and well-being: the medical outcomes study approach (1992), Duke University Press, Durham, NC 235-259
21. Hays R.D., Martin S.A., Sesti A.M., and Spritzer K.L. Psychometric properties of the Medical Outcomes Study Sleep measure. Sleep Med 6 (2005) 41-44
22. Cappelleri JC, Bushmakin AG, McDermott AM, et al. Measurement properties of the Medical Outcomes Sleep Scale in patients with fibromyalgia. Sleep Med, in press, doi:10.1016/j.sleep.2008.09.004.
23. Food and Drug Administration. Guidance for industry. Patient-reported outcome measures: use in medical product development to support labeling claims [Draft], ; 2006 [accessed 06.01.08].
24. SAS Institute. SAS/STAT User's Guide. Version 8. Cary, NC: SAS Institute; 2000.
25. Cohen J. Statistical power analysis for the behavioral sciences. 2nd ed. (1988), Lawrence Erlbaum Associates, Hillsdale, NJ
26. Hays R.D., Farivar S.S., and Liu H. Approaches and recommendations for estimating minimally important differences for health-related quality of life measures. COPD 2 (2005) 63-67
27. Fitzmaurice G., Laird N., and Ware J. Applied longitudinal analysis (2004), John Wiley & Sons, New York
28. Kline R. Principles and practice of structural equation modeling. 2nd ed. (2004), The Guilford Press, New York, NY
29. MacKinnon D.P. Introduction to statistical mediation analysis (2008), Taylor & Francis Group, New York, NY
30. Iacobucci D. Mediation analysis (2008), Sage Publications, Los Angeles, CA
31. Muthén L.K., and Muthén B.O. Mplus user's guide. 4th ed. (1998-2006), Muthén & Muthén, Los Angeles, CA
32. Bennett R.M., Jones J., Turk D.C., and Matallana L. An internet survey of 2,596 people with fibromyalgia. BMC Musculoskelet Disord 8 (2007) 27
33. Farrara J.T., Young J.P., LaMoreauxb L., et al. Clinical importance of changes in chronic pain intensity measured on an 11-point numeric rating scale. Pain 94 (2001) 149-158
34. Jaeschke R., Singer J., and Guyatt G.H. Measurement of health status. Ascertaining the minimal clinically important difference. Control Clin Trials 10 (1989) 407-415
35. Kubota T., Fang J., Meltzer L.T., and Krueger J.M. Pregabalin enhances nonrapid eye movement sleep. J Pharmacol Exp Ther 299 (2001) 1095-1105
36. Hindmarch I., Dawson J., and Stanley N. A double-blind study in healthy volunteers to assess the effects on sleep of pregabalin compared with alprazolam and placebo. Sleep 28 (2005) 187-193
37. de Haas S., Otte A., de Weerd A., et al. Exploratory polysomnographic evaluation of pregabalin on sleep disturbance in patients with epilepsy. J Clin Sleep Med 3 (2007) 473-478
38. Moldofsky H. The significance, assessment, and management of nonrestorative sleep in fibromyalgia syndrome. CNS Spectr 13 (2008) 22-26
39. Rizzi M., Sarzi-Puttini P., Atzeni F., et al. Cyclic alternating pattern: a new marker of sleep alteration in patients with fibromyalgia?. J Rheumatol 31 (2004) 1193-1199
40. Burns J.W., Crofford L.J., and Chervin R.D. Sleep stage dynamics in fibromyalgia patients and controls. Sleep Med 9 (2008) 689-696
41. Arnold L., Pritchett Y.L., D'Souza D.N., et al. A randomized, double-blind, placebo-controlled trial of duloxetine in the treatment of women with fibromyalgia with or without major depressive disorder. Pain 119 (2005) 5-15
42. Arnold L.M., Lu Y., Crofford L.J., et al. A double-blind, multicenter trial comparing duloxetine with placebo in the treatment of fibromyalgia patients with or without major depressive disorder. Arthritis Rheum 50 (2004) 2974-2984
43. Eichling P.S., and Sahni J. Menopause related sleep disorders. J Clin Sleep Med 1 (2005) 291-300
44. Annemans L., Wessely S., Spaepen E., et al. Health economic consequences related to the diagnosis of fibromyalgia syndrome. Arthritis Rheum 58 (2008) 895-902
45. Shah M.A., Feinberg S., and Krishnan E. Sleep-disordered breathing among women with fibromyalgia syndrome. J Clin Rheumatol 12 (2006) 277-281
46. Yunus M.B., and Aldag J.C. Restless legs syndrome and leg cramps in fibromyalgia syndrome: a controlled study. BMJ 312 (1996) 1339