Pregabalin [Lyrica®] in fibromyalgia – Responder analysis from individual patient data – Source: BMC Musculoskeletal Disorders, Jul 5, 2010

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[Note: to read the full text of this article free click here. “Number needed to treat” represents the number of subjects who would need to be treated for one to achieve a greater benefit (e.g., 50% greater, considered significantly greater in this analysis) than those taking placebo in a clinical trial.]

Background: Population mean [average] changes are difficult to use in clinical practice. Responder analysis may be better, but needs validating for level of response and treatment duration. A consensus group has defined what constitutes minimal, moderate, and substantial benefit based on pain intensity and Patient Global Impression of Change scores.

Methods: We obtained individual patient data from four randomized double blind trials of pregabalin [Lyrica] in fibromyalgia lasting 8 to 14 weeks.

We calculated response for all efficacy outcomes using:

•  Any improvement ([greater than or equal to] 0%),

•  Minimal improvement ([greater than or equal to]15%),

•  Moderate improvement ([greater than or equal to] 30%),

•  Substantial improvement ([greater than or equal to] 50%), and

•  Extensive improvement ([greater than or equal to]70%)…

with numbers needed to treat (NNT) for pregabalin 300 mg, 450 mg, and 600 mg daily compared with placebo.

Results: Information from 2,757 patients was available.

Pain intensity and sleep interference showed reductions with increasing level of response, a significant difference between pregabalin and placebo, and a trend towards lower (better) NNTs at higher doses.

Maximum response rates occurred at 4-6 weeks for higher levels of response, and were constant thereafter.

Numbers needed to treat (with 95% confidence intervals) for [greater than or equal to]50% improvement in pain intensity compared with placebo after 12 weeks were:

•  22 (11 to 870) for pregabalin 300 mg, [that is, one in 22 patients taking this dose would achieve a “substantial improvement” in pain of 50% or more above those taking fake dose/placebo]

•  16 (9.3 to 59) for pregabalin 450 mg, and

•  13 (8.1 to 31) for pregabalin 600 mg daily.

Numbers needed to treat for [greater than or equal to]50% improvement in sleep interference compared with placebo after 12 weeks were:

•  13 (8.2 to 30) for pregabalin 300 mg,[that is one in 13 patients taking this dose would achieve a “substantial” 50% or more improvement in sleep above those taking fake dose/placebo]

•  8.4 (6.0 to 14) for pregabalin 450 mg, and

•  8.4 (6.1 to 14) for pregabalin 600 mg.

Other outcomes had fewer respondents at higher response levels, but generally did not discriminate between pregabalin and placebo, or show any dose response.

Shorter duration and use of ‘any improvement’ over-estimated treatment effect compared with longer duration and higher levels of response.

Conclusions: Responder analysis is useful in fibromyalgia, particularly for pain and sleep outcomes. Some fibromyalgia patients treated with pregabalin experience a moderate or substantial pain response that is consistent over time.

Short trials using ‘any improvement’ as an outcome overestimate treatment effects.

Source: BMC [BioMedCentral] Musculoskeletal Disorders, Jul 5, 2010;11:150. DOI:10.1186/1471-2474-11-150, by Straube S, Derry S, Moore RA, Paine J, McQuay HJ. Department of Occupational and Social Medicine, University of Göttingen, Germany and Pain Research and Nuffield Department of Anesthetics, University of Oxford, John Radcliffe Hospital, Oxford, UK. [Email sebastian.straube@googlemail.com]

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5 thoughts on “Pregabalin [Lyrica®] in fibromyalgia – Responder analysis from individual patient data – Source: BMC Musculoskeletal Disorders, Jul 5, 2010”

  1. smeyers says:

    I’m sorry but I don’t understand this article at all. It seems to me it just says how many people were needed/used in the study – not what their results were.

    I tried Lyrica and it didn’t work at all for me. In fact, I had to quit because it was making me really depressed. I couldn’t tell from your article how many people had a good outcome from trying this medication.

    Susan

    1. harboreen says:

      I’m not sure I get this article either but I wanted to respond to your comment smeyer. I too had to stop taking Lyrica due to depression which I did not have prior to using this med. It got rapidly worse as the days passed so after two months I went off Lyrica.
      It’s strange because I went back to using neurontin/gabapentin which does help my fibromyalgia pain although I do not use this soley for pain.

    2. amiller1914 says:

      Side effects not worth the limited results. It increased my swelling and inflammation. Weight can has led to plantafacitis.

  2. JulieL says:

    I agree with the previous lady. I don’t understand what the outcomes where for the people taking Lyrica.

    I started taking Lyrica about 2 1/2 months ago and I felt good for about 2 weeks. It has been down hill since. I am taking the lowest amt so I will need to speak to my doctor next month on my visit to see what she says.

  3. FMoldtimer says:

    The point of the article–depending on the effect you’re looking at, only roughly 1 in 13, 1 in 8.4 etc. people will see a significant result. On the whole, that means Lyrica may help some folks with FM, but not all, or even very many. That’s what “number needed to treat” is all about.

    That said, I’ve had modest success with the lowest possible dose, 75 mg, used primarily as a sleep aid. I’m combining that with 75 mg of nortriptyline. I won’t say my sleep is always great, but it’s better than with just the nortriptyline. When I took higher doses of that, I was just hung over the next day. I don’t think the Lyrica is helping with pain per se, but better sleep generally leads to less pain, at least for me.

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