Safety profile and tolerability of up to 1 year of pregabalin treatment in 3
open-label extension studies in patients with fibromyalgia.
Author(s): Arnold LM, Emir B, Murphy TK, Zeiher BG, Pauer L, Scott G, Petersel D.
Affiliation(s): Women's Health Research Program, Department of Psychiatry and Behavioral
Neuroscience, University of Cincinnati College of Medicine, Ohio, USA.
Publication date & source: 2012, Clin Ther. , 34(5):1092-102
BACKGROUND: Pain relief and an acceptable safety profile have been reported in
randomized controlled trials (RCTs) of pregabalin in the treatment of
fibromyalgia (FM) for up to 14 weeks.
OBJECTIVE: To evaluate the safety profile and tolerability of pregabalin (75-300
mg BID) treatment for up to 1 year in patients with FM.
METHODS: Twelve-week data were pooled from 3 open-label extension studies of
pivotal RCTs. Study 1 was a 1-year extension of a 13-week RCT, and studies 2 and
3 were 12-week extensions of 14-week RCTs. The 1-year data were separately
evaluated. The open-label data are summarized using descriptive statistics.
RESULTS: Overall, 1206 patients (92.4% female) with a mean (SD) age of 48.8
(10.7) years received open-label extended pregabalin treatment. A total of 119 of
1206 patients (9.9%) permanently discontinued study participation due to
treatment-emergent adverse events (all causality) at 12 weeks (pooled data) and
53 of 429 (12.4%) within 1 year. Consistent with previous RCTs, the most commonly
reported treatment-emergent adverse events with open-label pregabalin treatment
were dizziness, somnolence, headache, peripheral edema, and increased weight. The
highest incidence rates in the pooled 12-week data were for dizziness (214 of
1206; 17.7%) and somnolence (96 of 1206; 8.0%). In ratings of severity (mild,
moderate, severe), most were reported as mild to moderate. The mean (SD) change
in patient-reported visual analog scale pain scores (0-100) from the open-label
baseline to the end of treatment was -21 (30.5) in study 1 (1 year), -26.7 (28.8)
in study 2 (12 weeks), and -20.1 (26.8) in study 3 (12 weeks).
CONCLUSIONS: The data from these extension studies suggest that the adverse event
safety profile and tolerability of patients with FM treated with open-label
pregabalin (75-300 mg BID) for up to 1 year were stable and were consistent with
those of previous studies. ClinicalTrials.gov identifiers: NCT00151528 (A0081057
[study 1]), NCT00282997 (A0081078 [study 2]), and NCT00346034 (A0081101 [study