Arthritis & Rheumatism, Volume 60,
October 2009 Abstract Supplement
The 2009 ACR/ARHP Annual Scientific Meeting
Philadelphia October 16-21, 2009.
Pregabalin-Long-Term Follow-up in Treatment of Fibromyalgia Syndrome (FMS)
Abeles1, Micha, Abeles2, Aryeh M.
Long-term studies regarding the usefulness of pharmacological therapy in FMS are lacking. We compared pregabalin to conventional treatment in fibromyalgia patients and found that although response rate was somewhat better with pregabalin, when accounting for patient dropout due to side effects, there appeared to be no advantage to pregabalin over a 12 week period. The purpose of this study was to monitor the responders to treatment in the original study over an extended period of time to evaluate for persistence of response.
Randomization in the original cohort was done by placing every other patient who presented with FMS on pregabalin or routine therapy (defined as medication chosen by treating physician preference). Evaluation was done utilizing the Fibromyalgia Impact Questionnaire (FIQ), Hospital Anxiety and Depression Scale, and visual analogue scale (VAS). The primary endpoint was a comparison of the FIQ global score and the VAS. In the long- term follow-up, the FIQ global score and VAS were the primary endpoints. Response was considered to be clinically meaningful if there was a 30% or greater improvement from baseline. This was a prospective non-blinded and unfunded study.
18 of the original 68 pregabalin responders patients and 16 of 66 of the original comparator responders patients entered the long term observational phase of the study. All patients were female. Other characteristics of the subgroup included average age of 53 in the pregabalin and 51 in the comparator groups, average fibromyalgia duration of 6 and 7.2 years duration respectively and predominance of white (80%) and the remainder Hispanic (20%). Therapy in the comparator group included duloxetene (3), gabapentin (2), tricyclics (nortriptyline or amitriptyline), (5) tramadol (5), and hydrocodone (2). At the end of one year, 16 of 18 pregabalin but only 6 of 16 comparator patients were still on the same medication.
Although pregabalin appeared to be equivalent to standard of care therapy in a short-term observational study, when responders are followed for a prolonged period of greater than one year, pregabalin's efficacy appears to persist whereas there is loss of efficacy in standard treatment therapy. Despite this is being an observational uncontrolled and unblinded study, our observations suggest that pregabalin may offer an advantage over standard therapy when prolonged use is indicated; further study comparing the long-term efficacy of individual drugs (or combinations of drugs) in a blinded fashion is warranted.
To cite this abstract, please use the following information:
Abeles, Micha, Abeles, Aryeh M.; Pregabalin-Long-Term Follow-up in Treatment of Fibromyalgia Syndrome (FMS) [abstract]. Arthritis Rheum 2009;60 Suppl 10 :1426