Preliminary Efficacy of the Dopamine Agonist, Pramipexole, for Fibromyalgia: The First, Open Label, Multicenter Experience

Abstract

Objective: Recognition of autonomic dysregulation in fibromyalgia [FMS] suggests new treatment options such as dopamine 3 specific agonists already used for Parkinson's disease and restless leg syndrome [RLS].

Methods: For 22 patients with the American College of Rheumatology criteria FMS [age 39–60, FMS 11.3 yrs., 6.32 medications used from 3.3 medical doctors], pramipexole at bedtime was added to their best medical regimen to date, increasing weekly by 0.25 mg. At baseline, at one month [1 mg] and at two months [2 mg], sleep scale, RLS scale, pain score, and Multidimensional Health Assessment Questionnaire were obtained at three referral based rheumatology clinics, while monitoring intolerance.

Results: After two months, pain score decreased from 20.6 to 11.5 [P <.004] and all Multidimensional Health Assessment Questionnaire parameters significantly improved at month two [mean 46.2 percent] and for most by month one [mean 28.6 percent]. By intent to treat, sleep quality rating improved for 64 percent, and RLS symptoms resolved for two of five affected patients. Eight of 22 patients discontinued pramipexole for mild intolerances, including nausea and insomnia. There were no serious adverse events or ‘sleep attacks’ as described with pramipexole used for Parkinson's disease.

Conclusion: These observations justify further formal study of dopamine agonists for FMS.

KEYWORDS:

• Fibromyalgia
• pramipexole
• dopamine agonist
• autonomic nervous system