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Drug Class Review: Drugs for Fibromyalgia

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By Beth Smith, DO, et al. • www.ProHealth.com • March 16, 2014


Note: You can read the entire review by clicking on the links in the Contents section HERE.

Editor's comment: This is the final report on a review of drugs used for the treatment of fibromyalgia conducted in 2011 as part of the Drug Effectiveness Review Project (DERP). DERP is a collaboration of public entities (Medicaid pharmacy programs, the Center for Evidence-based Policy and the Pacific Northwest Evidence-based Practice Center) who have joined together to produce systematic, evidence-based products of the comparative effectiveness and safety of drugs in many widely used drug classes, and to apply the findings to inform public policy and related activities in local settings.

Final Original Report

Structured Abstract:

Purpose: We compared the effectiveness and harms of tricyclic antidepressants, serotonin norepinephrine reuptake inhibitors, selective serotonin reuptake inhibitors, selective serotonin and norepinephrine reuptake inhibitors, noradrenergic and specific serotonergic reuptake inhibitor, norepinephrine and dopamine reuptake inhibitor, serotonin receptor antagonist, antiepileptic drugs, and skeletal muscle relaxants in adults with fibromyalgia.
 
Data Sources: We searched Ovid MEDLINE®, the Cochrane Database of Systematic Reviews®, and the Cochrane Central Register of Controlled Trials® and Database of Abstracts of Reviews of Effects through October 2010. For additional data we also hand searched reference lists, US Food and Drug Administration medical and statistical reviews and dossiers submitted by pharmaceutical companies.

Review Methods: Study selection, data abstraction, validity assessment, grading the strength of the evidence, and data synthesis were all carried out according to standard Drug Effectiveness Review Project review methods.

Results and Conclusions: We found eligible studies of treatment for fibromyalgia with amitriptyline, nortriptyline, citalopram, fluoxetine, paroxetine, cyclobenzaprine, pregabalin, gabapentin, milnacipran, and duloxetine. We found no eligible studies with the other included drugs and no eligible studies of included interventions when used as adjunctive therapy.
  • Head-to-head trials were few, and provided low-strength evidence that short-term treatment with immediate-release paroxetine is superior to amitriptyline in reducing pain and sleep disturbance

  • and provided low-strength evidence there are no significant differences between amitriptyline as compared with cyclobenzaprine and nortriptyline.

  • Although there were some significant differences between drugs in overall adverse events, they did not produce any differences in withdrawals due to adverse events.

  • Additionally, based on indirect comparison meta-analysis, we found low evidence that duloxetine was superior to milnacipran on outcomes of pain, sleep disturbance, depressed mood, and health-related quality of life.

  • We found low evidence that both duloxetine and milnacipran were superior to pregabalin on improvement in depressed mood, whereas pregabalin was superior to milnacipran on improvement in sleep disturbance.

  • Amitriptyline was similar to duloxetine, milnacipran, and pregabalin on outcomes of pain and fatigue, with insufficient data on the other outcomes.

  • Although there were some significant differences between duloxetine, milnacipran, and pregabalin in specific adverse events, they did not produce any differences in overall withdrawals, overall adverse events, and withdrawals due to adverse events.

  • For the remaining drugs, there was only evidence of significant improvements in pain over placebo in 1 trial for gabapentin, in 1 of 3 trials for cyclobenzaprine, and in 1 trial of fluoxetine.

  • But, no conclusions can be drawn about comparative effectiveness or harms among these drugs because the numbers of trials/patients in placebo-controlled trials were too few to provide meaningful results in indirect comparisons.

  • Duloxetine was not effective on pain reduction in male, nonwhite, and older patients based on a small sample size that was underpowered to detect a difference.

  • Compared with placebo, duloxetine, fluoxetine, controlled-release paroxetine, and pregabalin significantly improved fibromyalgia symptoms regardless of baseline depression but milnacipran was only effective in nondepressed patients.

  • Controlled -release paroxetine and pregabalin significantly improved fibromyalgia symptoms regardless of baseline anxiety.

Source: Drug Effectiveness Review Project, April 2011. By Beth Smith, DO, Kim Peterson, MS, Rochelle Fu, PhD, Marian McDonagh, PharmD, and Sujata Thakurta, MPA:HA. Portland (OR): Oregon Health & Science University.





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