New Study Shows BOTOX(R) Injections For Treatment Of Spastic

Final results from a large, open-label study(1) demonstrate that repeated treatment with botulinum toxin type A (or BoNTA, marketed as BOTOX(R) by Allergan, Inc.) safely reduces upper limb (wrist, finger and/or arm) spasticity following stroke, and is associated with significant improvements in patients' ability to function in their daily lives. Significant improvements were also noted in the amount of assistance required by caregivers. A reduction was noted in both hours of care provided each week as well as the number of days that caregivers missed work to care for the patient. Results of the study were presented this week at the American College of Rehabilitation Medicine/American Society for Neurorehabilitation (ACRM-ASNR) Joint Annual Meeting in Boston and also have been published in abstract form in the October 2006 issue of Archives of Physical Medicine and Rehabilitation.

Spasticity occurs when muscles in some areas of the body are overactive, making them tight, sometimes painful, difficult to relax and often less functional. It is estimated that 19-38 percent of stroke patients develop spasticity, often affecting the hands and wrists.(2,3) This type of spasticity is especially disruptive because it can interfere with patient mobility, positioning, care, comfort,(4) as well as dressing, hygiene, washing, and other activities of daily living.(5) The effect of post-stroke disability on caregivers can be profound, requiring substantial time away from work and other activities(6) as well as causing significant emotional, financial and physical stress.(7)

"In this study, treatment with BoNTA benefited patients on several fronts. It significantly reduced spasticity in the wrist, fingers and elbow; and improved patients' ability to perform activities related to work as well as daily living, such as bathing, dressing, and mobility," noted Elie Elovic, M.D., Director of Traumatic Brain Injury Research at Kessler Medical Rehabilitation Research and Education Corporation in West Orange, New Jersey and the study's lead investigator. "The improvements also were associated with statistically significant decreases in the number of hours per week patients required assistance, improving the quality of life not only for patients but also for caregivers."

About the Study

The study involved 35 centers and included 279 stroke patients with wrist, hand or elbow spasticity six months or more after their stroke. BoNTA injections were given to block overactive nerves that trigger excessive muscle contractions or "tone." Treatment effects were measured using standard, validated scales and questionnaires completed by patients, physicians and caregivers.

Researchers found that at week six of the study, muscle tone in the wrist, fingers, thumb, and elbow was markedly decreased from baseline, and the improvement was sustained throughout the one-year study. The study also measured functional disability in four areas: hygiene, dressing, limb posture and pain. Before the first treatment, patients selected an area that was most important to them. On a four-point scale that ranged from "no disability" to "severe disability," at least 50 percent of patients achieved a 1-point or greater improvement in the area they selected.

Prior to treatment with BoNTA, 57% of patients had reported being either moderately, quite a bit, or extremely limited in their mobility and walking ability because of their impaired arm function. After treatment, 46%-49% of these patients reported improvements in their ability to walk and in overall mobility. Patients also reported improvements in their work activities. Prior to treatment, 79% of patients had experienced significant impairment in performing their work due to impaired arm function. After treatment, 44%-51% of these patients reported improvements in their work activities, and 37%-47% reported improvements in their abilities to accomplish adequate amounts of work.

Patients also required less assistance from caregivers. Prior to treatment the patients in this study had required an average of 26.2 hours per week of assistance by a friend or family member, and friends/family members took an average of 2.5 days per month off from work to provide care.(6) After treatment the average number of hours per week of assistance provided was reduced and productive work time lost was reduced by an average of 1.5 days.

Treatment-related adverse events, including transient, mild to moderate muscle weakness or pain in the extremities, were reported in 6.5 percent of patients. No serious treatment-related adverse events were reported.

"The low incidence of adverse events associated with BoNTA treatment in this year-long study suggests that BoNTA may represent a clear advantage over many oral anti-spasticity medications, which are associated with a high incidence of systemic side effects such as sedation, dizziness and muscle weakness, all of which can impair stroke rehabilitation," said Dr. Elovic.

Every year, about 700,000 Americans suffer a new or recurring stroke. Stroke is a leading cause of serious, long-term disability in the United States, and it is estimated that the costs associated with lost productivity due to stroke-related disability totaled $21.8 billion in 2005.(8)

This study was supported by a grant from Allergan Inc.

About Kessler Medical Rehabilitation Research and Education Corporation

Kessler Medical Rehabilitation Research and Education Corporation is a leading national and international rehabilitation research and education organization that conducts state-of-the-art research and, as a recognized center of excellence for rehabilitation education, communicates the results of its research to a broad audience of scientists, professionals, and consumers. The primary objective is to enhance the quality of patient care and optimize quality of life for persons with physical disabilities, as well as musculoskeletal, neurological, and chronic health conditions that may lead to impairment, disability, and/or handicap.

References

(1) Elovic E, Brashear A, Kaelin D, et al. Safety and efficacy of repeated botulinum toxin type a treatments for focal upper limb poststroke spasticity: results of a 12-month multicenter, open-label trial. Presented at the ACRM-ASNR Annual Meeting, September 28- October 1, 2006.

(2) Watkins CL, Leathley MJ, Gregson JM, Moore AP, Smith TL, Sharma AK. Prevalence of spasticity post stroke. Clin Rehabil. 2002;16(5):515-522.

(3) Sommerfeld DK, Eek EUB, Svensson AK, Holmqvist LW; von Arbin MH. Spasticity after stroke: its occurrence and association with motor impairments and activity limitations. Stroke. 2004;35:134-140.

(4) Gormley, O'Brien, and Yablon, chapter 2, pg 11 of WE Move reference, Sept 2002

(5) Brashear A, Gordon MF, Elovic E, Kassicieh D, Marciniak C, Do M, et al. Intramuscular injection of botulinum toxin for the treatment of wrist and finger spasticity after a stroke. N Engl J Med 2002;347(6):395-400.

(6) Mayer N, Barron RL, Liu J, Turkel CC. The burden of illness associated with loss of function after stroke in patients with arm spasticity enrolled in a multi-center open-label study. . Presented at the ACRM-ASNR Annual Meeting, September 28-October 1, 2006.

(7) Bates B, Choi J, Duncan PW, et al. Veteran's Affairs/Department of Defense clinical practice guideline for the management of adult stroke rehabilitation care: executive summary. Stroke. 2005;36:2049-2056.

(8) American Heart Association. Heart Disease and Stroke Statistics - 2005 Update. Dallas, Tex.: American Heart Association; 2004.

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New Study Shows BOTOX(R) Injections For Treatment Of Spastic