More threads by David Baxter PhD

David Baxter PhD

Late Founder
Pramipexole May Decrease Fibromyalgia Symptoms
July 28, 2005
by Laurie Barclay, MD

Pramipexole, a dopamine 3 receptor agonist, may decrease symptoms of fibromyalgia, according to the results of a randomized, double-blind trial reported in the August issue of Arthritis and Rheumatism.

"Blinded, placebo-controlled studies have demonstrated [pramipexole's] efficacy in the treatment of Parkinson's disease and restless legs syndrome," write Andrew J. Holman, MD, and Robin R. Myers, MS, ARNP, from Pacific Rheumatology Associates in Renton, Washington. "The cause of restless legs syndrome is unknown, but this arousal is more commonly found in patients with fibromyalgia than in healthy controls."

In this 14-week, parallel-group, escalating-dose trial, 60 patients with fibromyalgia were randomized 2:1 (pramipexole:placebo) to receive either 4.5 mg of pramipexole or placebo orally every evening. Patients with comorbid conditions and disability were not excluded, and stable dosages of analgesics and other concomitant medications were permitted.

The main endpoint was improvement in the pain score (10-cm visual analog scale [VAS]) at 14 weeks, and secondary outcomes were scores on the Fibromyalgia Impact Questionnaire (FIQ), the Multidimensional Health Assessment Questionnaire (MDHAQ), the pain improvement scale, the tender point score, the 17-question Hamilton Depression Inventory (HAM-d), and the Beck Anxiety Index (BAI).

Compared with patients receiving placebo, those receiving pramipexole had gradual and more significant improvements in pain, fatigue, function, and global status. At 14 weeks, the VAS pain score decreased by 36% in the pramipexole group and by 9% in the placebo group (treatment difference, -1.77 cm). Decrease in pain by at least 50% occurred in 42% of patients receiving pramipexole and in 14% of those receiving placebo.

The pramipexole group also fared better than the placebo group in the total FIQ score (treatment difference, -9.57) and the percentages of improvement in function (22% vs 0%), fatigue (29% vs 7%), and global (38% vs 3%) scores on the MDHAQ. Compared with baseline, some outcomes showed a better trend with pramipexole than with placebo but did not reach statistical significance, including improvement in the tender point score (51% vs 36%) and decreases in the MDHAQ psychiatric score (37% vs 28%), the BAI score (39% vs 27%), and the HAM-d score (29% vs 9%).

Transient anxiety and weight loss were the most common adverse events reported with pramipexole. No patient withdrew from the study because of lack of efficacy or a pramipexole-related adverse event.

"In a subset of patients with fibromyalgia, [about] 50% of whom required narcotic analgesia and/or were disabled, treatment with pramipexole improved scores on assessments of pain, fatigue, function, and global status, and was safe and well-tolerated," the authors write.

Study limitations include use of concomitant medications; inability to interpret why or how pramipexole may improve pain, fatigue, and function scores; insufficient power to predict which combination of concomitant medications might yield a positive response; short duration; inability to determine optimal dosage; and exclusion of patients with positional cervical myelopathy and untreated obstructive sleep apnea.

"In summary, a new treatment approach using a D3 [dopamine 3] receptor agonist offers hope to patients with fibromyalgia," the authors conclude. "Further investigation of this pramipexole treatment paradigm is warranted to determine its mechanism of action in patients with fibromyalgia, its long-term risks and benefits, and to confirm these findings in patients not taking concomitant medications."

Dr. Holman holds patents for the use of dopamine 2 and D3 receptor agonists in the treatment of fibromyalgia.

Arthritis Rheum. 2005;52:2495-2505

So is Pramipexole approved or is it still in the trial stage? Just wondering if there is any additional information on it and if it would be something to ask the doctor to try.
I deal with the pain on a daily basis and am always looking for something to help without some of the horrible side effects like those of other meds I've tried. Anxiety and weight loss doesn't seem too intense, though the added anxiety could cause more panic attacks I guess, Wondering too if you can take Pramipesole along with antianxiety meds. And isn't dopamine classified as antipsychotic?

David Baxter PhD

Late Founder
I'll see what i can find out. However, when it receives approval will depend on what part of the world you live in, since each country has their own procedures and standards for drug testing.

In terms of drug interactions, if it's released there should be some info on that but the best person to talk to about that would be your own doctor.

Finally, re: your question about dopamine -- dopamine is, along with serotonin and norepinephrine, one of the three major neurotransmitters, necessary for normal brain functioning and emotional regulation.

David Baxter PhD

Late Founder
It apparently has been released, at least in the US:

Apparently, it was originally developed to treat Parkinson's disease, so this article is about using the drug to treat something other than what it was developed for (which by the way is far from unusual or uncommon), rather than announcing a new drug.

It does not appear that there are any adverse interactions with tranquilizers, although there are some side-effects that may occur, notably postural hyptension (dizziness, lightheadedness caused by a drop in blood pressure when suddenly standing up from a sitting or prone position).
Thanks for the follow up. I actually have the onset of Parkinsons so maybe if I can take this, I'll get a two for one :) I will definitely be asking my doctor about giving it a try. Have a good night.
Ps...I thought the article was referring to dopamine as a drug :-0
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