PROVEN SAFETY AND EFFICACY PROFILE
ITB Therapy with Intrathecal (baclofen injection) has been proven through clinical studies to demonstrate safety and efficacy of screening and during long-term therapy.1-6
SCREENING TEST RESULTS
- At least 90% of patients with spasticity of cerebral origin demonstrated a positive response to the screening test for ITB therapy in two studies.1,6
- At least 94% of patients with spasticity of spinal origin demonstrated a positive response to the screening test for ITB therapy in two studies.2,4
- 87% of physicians rated their overall satisfaction for each patient's outcomes as good or very good in one clinical study, despite the occurrence of complications.3
LONG-TERM EFFECTIVENESS
Two clinical studies have demonstrated that severe spasticity of spinal origin responds to long-term ITB Therapy.2,4 Long-term control of severe spasticity was achieved in most patients in the studies. Complications and side effects were reported in both studies. The most common device-related complications were catheter kinks, dislodgments, and disconnections. The most common drug-related side effects were drowsiness, dizziness, blurred vision, slurred speech, hypotension, depression, and seizures.
Long-term effectiveness in spasticity of cerebral origin has been demonstrated (median of 67 months) with ITB Therapy; adverse effects experienced in the study were usually managed by dose adjustments. The most commonly reported drug-related adverse effects were hypotonia (25%), somnolence (19%), seizures (13%), and headache (2%).5 The majority of complications considered related to the system occurred within the first 60 days, the most common of which were pump pocket seroma (16.2%) and CSF leak (14.7%).5
A statistically significant improvement was demonstrated with ITB Therapy in muscle tone, function, and quality of life among stroke survivors. Adverse events in this study included accidental injury (11%), somnolence (10%), dizziness (10%), hypotonia (8%), headache (5%), constipation (5%), pain (5%), urinary tract infection (5%), and hypertonia (5%).6
Subjective reports from caregivers indicate a reduction in use of oral medication for spasticity, and improvements in comfort, function, and/or ease of care during ITB Therapy.7
1
Gilmartin R, Bruce D, Storrs BB, et al. Intrathecal baclofen for management of spastic cerebral palsy: multicenter trial. J Child Neurol. 2000;15:71-77.
2
Penn RD. Intrathecal baclofen for spasticity of spinal origin: seven years experience. J Neurosurg. 1992;77:236-240.
3
Guillaume D, Van Havenbergh A, Vloeberghs M, Vidal J, Roeste G. A clinical study of intrathecal baclofen using a programmable pump for intractable spasticity. Arch Phys Med Rehabil. 2005;86:2165-2171.
4
Coffey RJ, Cahill D, Steers W, et al. Intrathecal baclofen for intractable spasticity of spinal origin: results of a long-term multi-center study. J Neurosurg. 1993;78:226-232.
5
Albright AL, Gilmartin R, Swift D, et al. Long-term intrathecal baclofen therapy for severe spasticity of cerebral origin. J Neurosurg. 2003;98:291-295.
6
Ivanhoe CB, Francisco GE, McGuire JR, Subramanian T, Grissom SP. Intrathecal baclofen management of poststroke spastic hypertonia: implications for function and quality of life. Arch Phys Med Rehabil. 2006;87:1509-1515.
7
Campbell, WM, et al. Long-term safety and efficacy of continuous intrathecal baclofen. Dev Med Child Neurol. 2002;44:660-665.