REDUCTIONS IN FREQUENCY AND INTENSITY OF PAIN WITH BOTULINUM TOXIN TYPE A FOR THE TREATMENT OF CERVICAL DYSTONIA
Author(s)
Manasee V Shah, MPH, Senior Research Associate1, Rashad Carlton, PharmD, Analyst2, Thomas Bramley, PhD, Senior Director31Allergan, Inc, Irvine, CA, USA; 2 Xcenda, Palm Harbor, FL, USA; 3 Xcenda, Salt Lake City, UT, USA
Objective: The objective of this study was to assess reductions in pain frequency and intensity in cervical dystonia patients treated with botulinium toxin (BoNT-A). Methods: A total of 170 patients were randomized to receive (BoNT-A) or placebo as part of a 10-week, double-blind study. Patients assessed their pain frequency on a scale from 0 (never) to 4 (constant) and their pain intensity on a scale from 0 (none) to 4 (very severe). Pain frequency and intensity were measured at follow-up visits at weeks 2, 4, 6, 8, and 10. Results: The mean baseline pain frequency scores were 1.79 for the BoNT-A group and 1.91 for the placebo group. The reduction in mean change of pain frequency ranged from -0.19 to -0.37 in the BoNT-A group and from -0.01 to -0.20 in the placebo group. A greater reduction in the mean change in pain frequency was seen at all timepoints in the botulinium toxin group; the difference was statistically significant at week 6 (-0.31 vs -0.01; P=0.018). The mean baseline pain intensity scores were 1.78 in the BoNT-A group and 1.80 in the placebo group. The reduction in the mean change of pain intensity ranged from -0.20 to -0.47 in the BoNT-A group, while the placebo group had an increase in pain intensity at week 6, no change from baseline at week 10, and reductions ranging from -0.06 to -0.18 at other timepoints. The mean change in pain intensity showed a greater reduction at all timepoints in the BoNT-A group compared to placebo, with the difference being statistically significant at week 2 (-0.39 vs -0.07; P=0.026) and week 6 (-0.36 vs 0.06; P=0.001). Adverse events rates were nearly equivalent between groups (59.1% BoNT-A vs. 58.5% placebo group). Conclusion: Treatment with BoNT-A lowered frequency and intensity of patient-assessed pain as compared to placebo.
Conference/Value in Health Info
2008-05, ISPOR 2008, Toronto, Ontario, Canada
Value in Health, Vol. 11, No. 3 (May/June 2008)
Code
PND37
Topic
Methodological & Statistical Research
Topic Subcategory
PRO & Related Methods
Disease
Neurological Disorders