A systematic review of duloxetine for osteoarthritic pain: What is the number needed to treat, number needed to harm, and likelihood to be helped or harmed?

Postgraduate Medicine

Volumn 124, Issue 1, 2012, Pages 83-93

  Citrome, Leslie ^a,b   Weiss Citrome, Amy ^b  

^a NEW YORK MEDICAL COLLEGE   (United States)

^b NONE

Author keywords

Adverse events; Duloxetine; Efficacy; Number needed to harm; Number needed to treat; Osteoarthritis; Pain; Safety; Tolerability

Indexed keywords

DICLOFENAC; DULOXETINE; NONSTEROID ANTIINFLAMMATORY AGENT; PLACEBO;

ABDOMINAL PAIN; ARTICLE; ASTHENIA; CHRONIC PAIN; CONSTIPATION; CONVULSION; DECREASED APPETITE; DIARRHEA; DIASTOLIC BLOOD PRESSURE; DRUG DOSE REDUCTION; DRUG EFFICACY; DRUG INDUCED HEADACHE; DRUG SAFETY; DRUG TOLERABILITY; DRUG WITHDRAWAL; EJACULATION DISORDER; ERECTILE DYSFUNCTION; FATIGUE; FIBROMYALGIA; FLATULENCE; GENERALIZED ANXIETY DISORDER; HUMAN; HYPERHIDROSIS; HYPOMANIA; JAUNDICE; KNEE OSTEOARTHRITIS; KNEE PAIN; LIBIDO DISORDER; LIVER DYSFUNCTION; MAJOR DEPRESSION; MANIA; MUSCULOSKELETAL PAIN; NAUSEA; NEUROLEPTIC MALIGNANT SYNDROME; ORTHOSTATIC HYPOTENSION; OSTEOARTHRITIS; PAIN; RANDOMIZED CONTROLLED TRIAL (TOPIC); SEIZURE; SEROTONIN SYNDROME; SIDE EFFECT; SOMNOLENCE; SYNCOPE; SYSTEMATIC REVIEW; SYSTOLIC BLOOD PRESSURE; XEROSTOMIA;

CHRONIC PAIN; HUMANS; MUSCULOSKELETAL PAIN; OSTEOARTHRITIS; RANDOMIZED CONTROLLED TRIALS AS TOPIC; SEROTONIN UPTAKE INHIBITORS; THIOPHENES;

EID: 84856893689     PISSN: 00325481     EISSN: 19419260     Source Type: Journal    
DOI: 10.3810/pgm.2012.01.2521     Document Type: Article

References (31)

1. Woolf AD, Pfleger B. Burden of major musculoskeletal conditions. Bull World Health Organ. 2003;81(9):646-656.
2. McKenzie S, Torkington A. Osteoarthritis-management options in general practice. Aust Fam Physician. 2010;39(9):622-625.
3. Cymbalta (duloxetine hydrochloride) Delayed-Release Capsules for Oral Use [package insert]. Revised May 2011. Indianapolis, IN: Eli Lilly and Co; 2011. http://pi.lilly.com/us/cymbalta-pi.pdf. Accessed August 30, 2011.
4. Chappell AS, Ossanna MJ, Liu-Seifert H, et al. Duloxetine, a centrally acting analgesic, in the treatment of patients with osteoarthritis knee pain: a 13-week, randomized, placebo-controlled trial. Pain. 2009;146(3):253-260.
5. Chappell AS, Desaiah D, Liu-Seifert H, et al. 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. 2011;11(1):33-41.
6. ClinicalTrials.gov. Duloxetine Versus Placebo for Osteoarthritis Knee Pain. Eli Lilly and Co. Updated July 7, 2009. http://clinicaltrials.gov/ct2/show/NCT00408421. Accessed August 30, 2011.
7. ClinicalTrials.gov. Duloxetine vs. Placebo in the Treatment of Osteoarthritis Knee Pain. Eli Lilly and Co. Updated August 26, 2009. http://clinicaltrials.gov/ct2/show/NCT00433290. Accessed August 30, 2011.
8. ClinicalTrials.gov. A Study of Duloxetine in Patients With Osteoarthritis Knee Pain. Eli Lilly and Co. Updated February 11, 2011. http://clinicaltrials.gov/ct2/show/NCT00945945. Accessed August 30, 2011.
9. ClinicalTrials.gov. A Study Comparing Duloxetine Versus Placebo in Patients Taking a Nonsteroidal Anti-inflammatory Drug (NSAID) for Knee Pain Due to Osteoarthritis. Eli Lilly and Co Updated April 28, 2011. http://clinicaltrials.gov/ct2/show/NCT01018680. Accessed August 30, 2011.
10. ClinicalTrials.gov. A Clinical Trial for Pain Related to Knee Osteoarthritis. University of Michigan. http://clinicaltrials.gov/ct2/show/NCT01377038. Accessed August 30, 2011.
11. Eli Lilly and Company. Clinical Study Summary: Study F1 J-MCHMEP; Duloxetine 60 to 120 mg versus Placebo in the Treatment of Patients with Osteoarthritis Knee Pain. August 4, 2008. http://www.clinicalstudyresults.org/documents/company-study_4528_0.pdf. Accessed August 30, 2011.
12. US Food and Drug Administration. Anesthetic Life Support Drugs Advisory Committee Meeting; Cymbalta (Duloxetine)/Eli Lilly and Company. August 19, 2010. http://www.fda.gov/downloads/AdvisoryCommittees/ CommitteesMeetingMaterials/Drugs/AnestheticAndLifeSupportDrugsAdvisoryCommittee/UCM233737.pdf. Accessed August 30, 2011.
13. Eli Lilly and Company. Anesthetic Life Support Drugs Advisory Committee Briefing Document; Cymbalta (duloxetine) Chronic Pain. August 19, 2010. http://www.fda.gov/downloads/AdvisoryCommittees/ CommitteesMeetingMaterials/Drugs/AnestheticAndLifeSupportDrugsAdvisoryCommittee/UCM222702.pdf. Accessed August 30, 2011.
14. US Food and Drug Administration. Summary Review for Regulatory Action; Cymbalta (Duloxetine HCl) for the management of chronic pain. November 4, 2010. http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022516Orig1s000SumR.pdf. Accessed August 30, 2011.
15. US Food and Drug Administration. NDA approval: Cymbalta (duloxetine hydrochloride), chronic musculoskeletal pain. November 4, 2010. http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022516s000ltr.pdf. Accessed August 30, 2011.
16. Citrome L. Compelling or irrelevant? Using number needed to treat can help decide. Acta Psychiatr Scand. 2008;117(6):412-419.
17. Citrome L. Quantifying risk: the role of absolute and relative measures in interpreting risk of adverse reactions from product labels of antipsychotic medications. Curr Drug Saf. 2009;4(3):229-237.
18. Citrome L, Kantrowitz J. Antipsychotics for the treatment of schizophrenia: likelihood to be helped or harmed, understanding proximal and distal benefits and risks. Expert Rev Neurother. 2008;8(7):1079-1091.
19. Straus SE. Individualizing treatment decisions. The likelihood of being helped or harmed. Eval Health Prof. 2002;25(2):210-224.
20. Kidd BL. Osteoarthritis and joint pain. Pain. 2006;123(1-2):6-9.
21. Mease PJ, Hanna S, Frakes EP, Altman RD. Pain mechanisms in osteoarthritis: understanding the role of central pain and current approaches to its treatment. J Rheumatol. 2011;38(8):1546-1551.
22. Fishbain D. Evidence-based data on pain relief with antidepressants. Ann Med. 2000;32(5):305-316.
23. Wohlreich MM, Sullivan MD, Mallinckrodt CH, et al. Duloxetine for the treatment of recurrent major depressive disorder in elderly patients: treatment outcomes in patients with comorbid arthritis. Psychosomatics. 2009;50(4):402-412.
24. Osiri M, Suarez-Almazor ME, Wells GA, Robinson V, Tugwell P. Number needed to treat (NNT): implication in rheumatology clinical practice. Ann Rheum Dis. 2003;62(4):316-321.
25. Caldwell JR, Rapoport RJ, Davis JC, et al. Efficacy and safety of a once-daily morphine formulation in chronic, moderate-to-severe osteoarthritis pain: results from a randomized, placebo-controlled, double-blind trial and an open-label extension trial. J Pain Symptom Manage. 2002;23(4):278-291.
26. Kraemer HC, Kupfer DJ. Size of treatment effects and their importance to clinical research and practice. Biol Psychiatry. 2006;59(11): 990-996.
27. Citrome L. Relative vs. absolute measures of benefit and risk: what's the difference? Acta Psychiatr Scand. 2010;121(2):94-102.
28. Richmond J, Hunter D, Irrgang J, et al; American Academy of Orthopaedic Surgeons. American Academy of Orthopaedic Surgeons clinical practice guideline on the treatment of osteoarthritis (OA) of the knee. J Bone Joint Surg Am. 2010;92(4):990-993.
29. Cochrane Library. http://www2.cochrane.org/reviews/. Accessed August 30, 2011.
30. Citrome L. Evidence-based medicine: it's not just about the evidence. Int J Clin Pract. 2011;65(6):634-635.
31. Sackett DL, Rosenberg WM, Gray JA, Haynes RB, Richardson WS. Evidence based medicine: what it is and what it isn't. BMJ. 1996;312 (7023):71-72.