The Role of Pregabalin in Fibromyalgia

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1 The Role of Pregabalin in Fibromyalgia Sofia Exarchou Resident at Internal Medicine and Rheumatology at the University Hospital of Skåne, Malmö-Lund Metsovo Greece 2011

2 History Gowers 1904 Hench 1976 Smythe & Moldofsky 1979 American College of Rheumatology 1990

3 ACR criteria 1990 Classification criteria Not diagnostic!!!!! Widespread pain in all four quadrants of the body for 3 months Tenderness on pressure in at least 11 of 18 scecified sites

4 Realities about ACR criteria 1990 The clinical diagnosis in primary care does not ordinarily involve a tender point count or an adequately executed tender point count when performed The case definition of FM has changed somewhat with increasing recognition of the importance of cognitive problems and somatic symptoms Diagnostic criteria ACR 2010 Wolf F. Et al. Atrhritis Care & Research. May ;5:

5

6

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8 Mechanism of action of Pregabalin Excessive neurotransmitter release in hyperexcited neuron Pregabalin reduces excessive neurotransmitter release

9 Indications of Pregabalin Neuropathic pain from diabetic neuropathy or post-herpetic neuralgia Adjunctive therapy in adults with partial seizures with or without secondary generalization. Generalized anxiety disorder (EU) Fibromyalgia (FDA 21 June 2007)

10

11 RCTs Trial 105 Pregabalin for the treatment of fibromyalgia syndrome: results of a RCT. Crofford LJ et al. Arthritis Rheum 2005;52: Trial 1056 A RCT phase III of pregabalin in the treatment of patients with fibromyalgia. Mease PJ et al. J Rheumatol 2008;35: Trial 1077 A 14-week, RCT monotherapy of pregabalin in patients with fibromyalgia. Arnold LM et al. J Pain 2008;9: Trial 1100 Pregabalin for the management of fibromyalgia: a 14-week RCT Pauer L et al. Ann Rheum Dis 2008;67(suppl 2):256 Trial 1059 FREEDOM Fibromyalgia relapse evaluation and efficacy for durability of meaningful relief: a 6-month RCT Crofford LJ et al. Pain 2008;136:419-31

12 Trial characteristics

13 Inclusion Exclusion criteria Patients 18 yrs Women - neither pregnant nor lactating - postmenopausal, surgically sterilized, using contraception. ACR criteria for FM. VAS-pain scores 40/100mm after stopping any relevant pain or sleep medication. Important exclusion criteria: - severe pain due to other conditions - rheumatic diseases other than FM - active infections - untreated endocrine disorders - severe depression - active malignancy - immunocompromised - other severe acute or chronic medical or psycgiatric conditions or laboratory abnormalities.

14 Trial characteristics

15 Outcomes chosen for meta-analysis of the four classical design RCTs Mean weekly pain scores 30% - 50% responders ( pat achieving at least 30% or 50% pain relief) PGIC Patient Global Impression of Change ( much or very much improvement) FIQ Fibromyalgia Impact Questionnaire MOS-sleep: mean sleep quality score SF-36: HRQOL MAF global index: Multidimentional Assessment of Fatigue global index HADS Hospital Anxiety and Depression Scale Additional analgesic consumption Adverse events Discontinuations Weight gain

16 Trial characteristics

17 Trial characteristics

18 Pooled weekly mean pain scores for the 4 classical RCTs

19 Efficacy Outcomes Pooled Analysis of the 4 classical design RCTs

20 Efficacy Outcomes Pooled Analysis of the 4 classical design RCTs

21 Efficacy Outcomes Pooled Analysis of the 4 classical design RCTs

22 Efficacy Outcomes Pooled Analysis of the 4 classical design RCTs

23 Efficacy Outcomes Pooled Analysis of the 4 classical design RCTs

24 Efficacy Outcomes Pooled Analysis of the 4 classical design RCTs

25 Efficacy Outcomes Pooled Analysis of the 4 classical design RCTs

26 FREEDOM Study Open label phase 50% του VAS-πόνου PGIC: much or very much Double-blind phase 54%

27 FREEDOM Study

28 FREEDOM Study

29

30 FREEDOM Study Open label phase: - 82% experienced at least one adverse event - most common: dissiness and somnolence - 19% withdrew because of AEs - 0,8% serious ΑΕs Double-blind phase: - 45% placebo - 59% taking 300mg - 63% taking 450mg - 62% taking 600mg Experienced an AE

31 Conclusions - efficacy PGB significantly improved pain and other symptoms of FM. A dose-response relationship could only be shown for 50% responders, a measurement constituting substantial improvement. At least 50% pain relief was obtained by only 24% of the people taking PGB at the higher doses mg/d. While applicable only to a minority, this is an important outcome to those people who achieve it. A 6-week trial of PGB was sufficient to identify responders, enabling an early decision about lack of response and choice of alternative therapy Sustained benefit over 26 weeks, with loss of therapeutic response occurring soon after randomization, and being uncommon after 14 weeks.

32 Effect of trial design on efficacy estimates

33 Conclusions - AEs Most people in PGB and placebo groups experienced AEs This is not surprising considering the range of symptoms associated with FM, some of which may be reported as AEs in a clinical trial The rate of serious AEs was roughly similar, and low with PGB and placebo Some AEs such as weight gain, somnolence and dizziness are typical of PGB and occurred most commonly with PGB. For dizziness, clear dose dependence was apparent over the range mg/d

34 How to interpret these data in terms of the individual patient? To make trial data more relevant would require individual patient analysis showing that patients who benefited on one outcome, like pain, showed relevant clinical improvements in all or many of the major outcomes.

35 Non-pharmacologic therapy Heated pool treatment with or without exercise Individually tailored exercise programmes, including aerobic exercise and strength training Cognitive behavioural therapy Relaxation, rehabilitation, physiotherapy and psychological support Pharmacotherapy Tramadol Simple analgesics such as paracetamol and other weak opioids Antidepressants: amitriptyline, fluoxetine, duloxetine, milnacipran, moclobemide and pirlindole Tropisetron, pramipexole and pregabalin

36 Comparison of PGB with other treatments for FM There is no clear evidence of superiority of one drug over another in FM at present, because thhe drug we have produce a substantial benefit in only a minority of patients We do not know whether patients who respond to one would also respond to another. On average a number of drugs seen to be roughly equally effective, but individual patients may respond to one drug better than another. Various treatment options should be made available to patients.

37 Clinical challenge in FM lies in finding the right combination of treatments, pharmacological and/or non-pharmacological, best suited to individual patients. This will in part be empirical, at least until sub/types of FM with distinct pathophysiology can be differentiated, and drug choice informed by mechanistic or genetic determinants. Both then and now, there will be a need for tailored treatment for individual patients

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