CLINICAL STUDY HIGHLIGHTS Intrathecal Baclofen Therapy with Lioresal® Intrathecal (baclofen injection)
ITB Therapy with Lioresal® Intrathecal (baclofen injection) has been proven through clinical studies to demonstrate safety and efficacy of screening and during long-term therapy.
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
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,7 and improvements in comfort, function, and/or ease of care7,8 during ITB Therapy.
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.
Penn RD. Intrathecal baclofen for spasticity of spinal origin: seven years experience. J Neurosurg. 1992;77:236-240.
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.
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.
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.
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.
Campbell, WM, et al. Long-term safety and efficacy of continuous intrathecal baclofen. Dev Med Child Neurol. 2002;44:660-665.
Middel B, et al. Effect of intrathecal baclofen delivered by an implanted programmable pump on health related quality of life in patients with severe spasticity. J Neurol Neurosurg Psychiatry. 1997;63:204-209.
Common Adverse Reactions
Serious Adverse Reactions
For more information, including BOX WARNING, refer to Lioresal® Intrathecal (baclofen injection) prescribing information, located at www.lioresal.com/prescribinginformation