Safety Profile and Tolerability of Up to 1 Year of Pregabalin Treatment in 3 Open-Label Extension Studies in Patients With Fibromyalgia

Clinical Therapeutics

Volumn 34, Issue 5, 2012, Pages 1092-1102

  Arnold, Lesley M ^a   Emir, Birol ^b   Murphy, Kevin T ^b   Zeiher, Bernhardt G ^c   Pauer, Lynne ^d   Scott, Gayle ^e   Petersel, Danielle ^b  

^a UNIVERSITY OF CINCINNATI COLLEGE OF MEDICINE   (United States)

^b Pfizer Global Pharmaceuticals   (United States)

^c ASTELLAS PHARMA GLOBAL DEVELOPMENT   (United States)

^d PFIZER GLOBAL RESEARCH AND DEVELOPMENT   (United States)

^e UBC Scientific Solutions   (United States)

Author keywords

Fibromyalgia; Pain; Pregabalin; Safety profile

Indexed keywords

ACETYLSALICYLIC ACID; ANTICONVULSIVE AGENT; ANTIDEPRESSANT AGENT; CORTICOSTEROID; IBUPROFEN; LIDOCAINE; MUSCLE RELAXANT AGENT; NONSTEROID ANTIINFLAMMATORY AGENT; OPIATE; PARACETAMOL; PREGABALIN; TRAMADOL;

ADULT; ARTICLE; CONFUSION; DAYTIME SOMNOLENCE; DIPLOPIA; DISEASE SEVERITY; DIZZINESS; DRUG INDUCED HEADACHE; DRUG SAFETY; DRUG TOLERABILITY; DRUG WITHDRAWAL; FATIGUE; FEMALE; FIBROMYALGIA; HUMAN; MAJOR CLINICAL STUDY; MALE; MIGRAINE; MULTICENTER STUDY; MYOCLONUS; NAUSEA; OPEN STUDY; OUTCOME ASSESSMENT; PAIN ASSESSMENT; PERIPHERAL EDEMA; SCORING SYSTEM; SIDE EFFECT; SOMNOLENCE; TREATMENT DURATION; VISUAL ANALOG SCALE; VOMITING; WEIGHT GAIN; XEROSTOMIA;

ADULT; ANALGESICS; DOSE-RESPONSE RELATIONSHIP, DRUG; DOUBLE-BLIND METHOD; FEMALE; FIBROMYALGIA; GAMMA-AMINOBUTYRIC ACID; HUMANS; INCIDENCE; MALE; MIDDLE AGED; PAIN MEASUREMENT; RANDOMIZED CONTROLLED TRIALS AS TOPIC; SEVERITY OF ILLNESS INDEX; TIME FACTORS;

EID: 84860767037     PISSN: 01492918     EISSN: 1879114X     Source Type: Journal    
DOI: 10.1016/j.clinthera.2012.03.003     Document Type: Article

References (17)

1. Goldenberg D.L. Office management of fibromyalgia. Rheum Dis Clin North Am 2002, 28:437-446. xi.
2. Rao S.G., Bennett R.M. Pharmacological therapies in fibromyalgia. Best Pract Res Clin Rheumatol 2003, 17:611-627.
3. 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 1990, 33:160-172.
4. Mease P.J., Clauw D.J., Arnold L.M., et al. Fibromyalgia syndrome. J Rheumatol 2005, 32:2270-2277.
5. Clauw D.J., Crofford L.J. Chronic widespread pain and fibromyalgia: what we know, and what we need to know. Best Pract Res Clin Rheumatol 2003, 17:685-701.
6. Bennett R.M. Emerging concepts in the neurobiology of chronic pain: evidence of abnormal sensory processing in fibromyalgia. Mayo Clin Proc 1999, 74:385-398.
7. Russell I.J., Orr M.D., Littman B., et al. Elevated cerebrospinal fluid levels of substance P in patients with the fibromyalgia syndrome. Arthritis Rheum 1994, 37:1593-1601.
8. Russell I.J., Vaeroy H., Javors M., et al. Cerebrospinal fluid biogenic amine metabolites in fibromyalgia/fibrositis syndrome and rheumatoid arthritis. Arthritis Rheum 1992, 35:550-556.
9. Yunus M.B. Towards a model of pathophysiology of fibromyalgia: aberrant central pain mechanisms with peripheral modulation. J Rheumatol 1992, 19:846-850.
10. 2+ channel α2δ ligands: novel modulators of neurotransmission. Trends Pharmacol Sci. 2007, 28:75-82.
11. 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 2008, 35:502-514.
12. Arnold L.M., Russell I.J., Diri E.W., et al. A 14-week, randomized, double-blinded, placebo-controlled monotherapy trial of pregabalin in patients with fibromyalgia. J Pain 2008, 9:792-805.
13. Pauer L., Winkelmann A., Arsenault P., et al. An international, randomized, double-blind, placebo-controlled, phase III trial of pregabalin monotherapy in treatment of patients with fibromyalgia. J Rheumatol 2011, 38:2643-2652.
14. Crofford L.J., Mease P.J., Simpson S.L., et al. Fibromyalgia relapse evaluation and efficacy for durability of meaningful relief (FREEDOM): a 6-month, double-blind, placebo-controlled trial with pregabalin. Pain 2008, 136:419-431.
15. Jensen M.P., Karoly P. Self-report scales and procedures for assessing pain in adults. Handbook of Pain Assessment 1992, Vol 135:51. The Guildford Press, New York, NY. D.C. Turk, R. Melzack (Eds.).
16. Zaccara G., Gangemi P., Perucca P., et al. The adverse event profile of pregabalin: a systematic review and meta-analysis of randomized controlled trials. Epilepsia 2011, 52:826-836.
17. Lyrica prescribing information Pfizer Inc, Accessed October 3, 2011. http://www.pfizer.com/files/products/uspi_lyrica.pdf.