Major Trial Concludes Pregabalin (Lyrica®) Promising FM Pain Therapy

Research presented at the 2006 American College of Rheumatology Scientific Meeting points to significant, extended pain relief for many FM patients with the drug pregabalin (Lyrica®).

A series of large clinical trials at the University of Kentucky, Lexington, indicates the drug pregabalin (Lyrica®) – already approved in the U.S. to treat nerve pain and seizures – is also an effective pain relief therapy for many Fibromyalgia patients, with generally mild to moderate side-effects.

Further, the researchers report, their latest 6-1/2 month placebo controlled, double blinded study indicated that for a significant proportion of the FM patients the drug's therapeutic benefit endured for an extended period of time.

As Crofford, et al. explained in presenting their findings* to the annual American College of Rheumatology meeting in Washington, DC, November 10-15, 2006:

In Phase One, 1,051 Fibromyalgia patients received daily does of Pregabalin for 6 weeks. These patients had been diagnosed with FM for an average of 7.8 years, all had "washed out" other forbidden medications from their systems, and measured their baseline pain severity at an average of 78 on the 100-point Visual Analog Scale (VAS). This overall study cohort was 93 percent female and 88 percent white, with an average age of 50 years.

The patients received daily doses of either 300, 450, or 600 mg, depending on which proved best given tracking of the individual's pain control/medication tolerance.

At the end of the six-week program, 63 percent (663 of the 1,051) reported a reduction in pain severity of more than 50 percent – and assessed their pain as either "much improved" or "very much improved." But how much of this was owing to a common phenomenon – the "placebo effect," reflecting patients' belief that the therapy is working? And would the drug's pain relieving effect endure for an extended period? A second phase was designed to help answer these questions.

In Phase Two, which lasted 6-1/2 months (26 weeks), 556 of the patients who had reported pain reduction of more than 50 percent were randomly assigned to receive either the optimal dose of pregabalin they'd received in Phase One, or a daily placebo (fake) dose. The assignment was "double-blinded," which means neither the patients nor the researchers who worked with them knew during Phase Two which patients were taking pregabalin and which the fake dose.

Then the researchers conducted ongoing VAS pain severity scoring, to determine the extent to which patients in the pregabalin and placebo groups maintained their initial pain improvement over time. They defined "loss of therapeutic response" as an increase of 30 percent vs. the patient's final Phase One VAS score – "or subjective worsening of FM symptoms" – for two consecutive weekly visits.

Overall, at the end of Phase Two, the group receiving pregabalin was much more likely than the group receiving fake doses (68 percent versus 39 percent) to retain a significant positive improvement in FM pain compared with the pre-Phase One baseline.

The most common "adverse effects" noted among the 1,051 patients who received pregabalin during Phase One were somnolence/sleepiness (22 percent of participants) and dizziness (35 percent) – both "mostly mild to moderate in intensity." And during the 6-1/2 month double blinded trial, the only adverse effects that were more common among the patients receiving pregabalin than those receiving placebo doses were sinusitis (5 percent of the pregabalin patients, 3 percent of the placebo patients) and arthralgia/joint pain and anxiety (5 percent of the pregabalin patients, 2 percent of the placebo patients). Although two of the 1,501 participants died during the study, their deaths were not considered associated with the treatment.


* See an abstract of the presentation – "A Six-month, Double-blind, Placebo-controlled, Durability of Effect Study of Pregabalin for Pain Associated with Fibromyalgia," by L.J. Crofford, et al., at

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8 thoughts on “Major Trial Concludes Pregabalin (Lyrica®) Promising FM Pain Therapy”

  1. music14 says:

    I was diagnosed with FM in 2001. My doctor has tried many different drug therapies. Some have worked a little, but nothing has given me significant relief. I became desperate. I heard an ad for a FM study and decided to call. It was the best thing I ever did for my FM.

    I participated in one of the studies for Lyrica. They told us we could either be on the drug or on plecebo. After one week, I knew I was on the drug. As they increaesed the dosage, the relief became more significant. I found Lyrica to be very helpful in relieving my pain, helping me sleep and giving me more energy. I have remained on the drug for over a year. There are a few side effects the worse one being weight gain. I decided this past June I would try to go off of it because I didn’t like the wieght gain. I went completely off the drug and all of my FM symptoms returned with a vengence. I wasn’t pain free on the drug, but the pain has been unbearable since being off the drug. We tried a coup0le of other thereapies, but nothing seenmed to work. I just went back on a lower dose of Lyrica and will work up the dosage. I am already feeling relief.

  2. baytalon says:

    I’m only 2 weeks into my treatment on lyrica and I can tell a difference. Initially I was “loopy” but that passed and I can tell my muscles feel better. Joint pain is still there, but that may my arthritis.

    1. music14 says:

      Yes, it does make you feel a little lightheaded at first and also as you increase the dosage. It does go away and was amazing how much better it made me feel. It may not be for everyone, but I know it worked the first time for me and it seems to be working as I am going back on it.

    2. LNevada says:

      I just started taking Lyrica two weeks ago and it has really been a help with the pain. I have severe pain, with taking Lyrica, I have been able to quit taking so many pain meds. It is such a releif. Yes, when I started taking Lyrica I was dizzy, light headed and loopy. They have now passed and I would much rather live with a few side effects, rather then the chronic pain I was in all the time. I am finally getting relief for the first time in a very long time. For me, I will keep taking Lyrica. I take Lyrica three times a day and it is so helpful. For this ME/FMS sufferer I am a believer in Lyrica. It has been so helpful. It also, helped immensley with the depression that I was having from having chronic pain constantly. When I received help from the constant pain the depression lifted. I can tell when the Lyrica is wearing off and I need to take another one. Lyrica started helping me immediately. I had instant relief from the first one I took. I was hooked then. It was such a pleasure not to wake up in the morning with such horrendous pain, for once. Yes, the pain is still there, but Lyrica has made my life more liveable!

    3. rfscala says:

      I started Lyrica Oct. 2007, after having read many articles and plenty of personal experiences. I knew there was a possibility of side effects before I made the decision.

      My doctor gave me a bottle of 75mg Lyrica with instructions to take one at night, then work up to two, etc.

      I went even slower. Since Lyrica is a capsule, I dumped the contents of a 75mg capsule and took 1/3 of it every few hours during the day. Then I did the same with two capsules, taking 1/3 every few hours in the morning, then splitting another capsule into thirds for the afternoon. I have had no side effects of any kind working up this way. Finally I added one whole capsule at bedtime.

      Now I am at 225mg daily with no side-effects of any kind. I am feeling better and will stay at this dosage unless and until I feel the need to very slowly take more.

      Just because the “recommended” dosage is higher, or your doctor gave you a higher dosage and told you to take 3 per day from the beginning, doesn’t mean that is the best way to do it.

      If a high dosage makes you stop taking the pills because you feel more tired or wierd or fat or dizzy, you could be missing out on a med that would actually help you if taken in a different way.

      Every person is different and their tolerance for any specific drug is also different. If you get relief from Lyrica at 200mg but your friend needs 600mg, that’s normal.

      Don’t give up, keep trying to find relief, and best wishes to all.

    4. WINNIEHA says:

      Hello. I was in a clinical trial for Lyrica and thought it was the answer to my prayers. I felt a bit drowsy, but kept using it because it kept the pain away and helped with sleep and depression. Now I realize that it’s affecting my short term memory a lot and my supervisors have been documenting my errors and are about to fire me after 15 years. My doctor is going to put me on short term disability until I can be tested to rule out Alzheimers or anything else, but let’s face it fellow Fibro sufferers, we know my symptoms are being caused by FM and Lyrica. Please someone come up with a drug that works without these awful side effects.

      1. Loon13 says:

        Hi there,
        I am so sorry to hear that Lyrica is causing you so many problems. I had problems with it too. I had tried it many years ago through a pain clinic. It actually made me really extremely anxious. I wanted it to work so badly, nothing in the past had helped at all besides narcotic pain medication, which the pain clinic was really against. I bought some empty capsules so that I could divide it up into smaller doses. One of the pain clinic doctors wasn’t happy about that at all and didn’t want me to continue doing that. I had to quite using it. The doctor incorrectly recorded in the progress notes that I reported that it was making me “extremely sleepy”. In the first place I don’t use the word “sleepy”, and in the second place, I don’t know how a doctor that probably sees 20 patients a day can remember at the end of the day, accurately what all of them said. I know that this is what that particular doctor did-record all of his progress notes at the end of the day, because I had temped there many times before I actually became a patient. Beware. Hopefully there will be another drug that comes along soon for all of us that are soooo sensitive to many, many meds!!

      2. marthajb says:

        Memory loss has been a big problem for me too. I was starting to wonder if I was getting Alzheimer’s! Did you completely quit taking Lyrica or did you simply reduce the dosage? Right now I am reducing the dosage and hoping that helps. Do you know if this is a common problem?
        If so, it is quite scary. I do hope you are doing better now. Thank you for leaving your message!

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