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Pregabalin fares poorly for Fibromyalgia outside of US

Monday 10 October 2011

About.com's Adrienne Dellwo reports:

 

LyricaPregabalin Fares Poorly for Fibromyalgia Outside of U.S.

By Adrienne Dellwo, About.com Guide
October 6, 2011

I recently came across a fibromyalgia drug study that raises some interesting questions in my mind, including whether the first FDA-approved fibromyalgia drug is as effective as previously thought.

The Study

Researchers looked at the effectiveness of pregabalin - the drug in Lyrica - outside of the U.S. They enrolled 747 fibromyalgia patients from medical facilities in multiple countries and tested 3 different dosages -- 300, 450 and 600 mg a day for 14 weeks. They were looking for changes in pain, sleep and function.

Initially, pain went down in all the treatment groups, and sleep appeared to improve across the board. However, by the end of the study researchers concluded that 300 and 600-mg doses didn't provide consistent benefits. The 450-mg dose showed only a modest effect in pain and function.

Questions Raised

To me, this study raises a couple of questions, especially since typical Lyrica dosages in the U.S. are 300 and 450:

  1. Is this drug as effective as other studies have indicated?
  2. And are we seeing vast differences in subgroups in different regions of the world?

At this moment, there's no way to answer either of these questions - we simply don't have enough information. However, I think these are both valid questions for researchers to pursue.

The Importance of Subgrouping

Many top fibromyalgia researchers have talked about the need for accurate subgrouping, but so far we haven't seen a lot of research into it. Some experts believe this condition can be broken down into several subgroups that actually represent different illnesses that need to be researched and treated differently from each other.

If they're right, current studies are significantly flawed, which could be why they haven't uncovered treatments that are effective for large percentages of us - one treatment, for example, might only be effective for 2 or 3 subgroups, but 6 subgroups could be represented in the study.

If subgroups vary geographically, as the pregabalin study may suggest, it could help reveal some of the causal factors. Differences in diet, pollutants, common infectious agents and more could be better identified if we could tie subgroups to regions.

I believe that we won't make a lot of progress on treatment or causation until researchers clearly identify subgroups and start studying them independently. Until then, we'll be left with the current process of guessing, experimenting and hoping.

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The above, with comments, originally appeared here.

 


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