In addition to the lack of objective evidence for effectiveness, antispasticity agents are associated with significant side effects. The common side effects of baclofen include drowsiness, vertigo, psychiatric disturbances, insomnia, slurred speech, ataxia, hypotonia, and weakness. These side effects are dose related, and elderly patients are at higher risk, particularly for side effects affecting the central nervous system. The common side effects of dantrolene include drowsiness, dizziness, lightheadedness, fatigue, rash, diarrhea, nausea, vomiting, and muscle weakness.
More than 80 complex continuing care patients were taking one or both of the targeted drugs at the time the proposal for this study was submitted (June 2002). The main indications were spasticity and contractures due to a variety of causes, including multiple sclerosis, cerebral palsy, spinal cord injury, ankylosing spondyli- tis, brain injury, and cerebral bleeding. The stage and severity of the conditions varied widely, and treatment of the spasticity and contractures was indicated for a variety of reasons: to reduce pain, to reduce spasms, to facilitate nursing care, to enable seating and to maintain or improve mobility. cialis soft tabs
At the time, approximately $25 000 was spent annually on baclofen and dantrolene at the SCO Health Service. Under the direction of the Drug Utilization Task Force and the Medical Advisory Committee, the Pharmacy and Therapeutics Committee was charged with attempting to limit use of these medications while maintaining quality of care for patients.
Through discussion with physicians and pharmacists working in the Complex Continuing Care Program, it was determined that attempts were not routinely made to discontinue baclofen or dantrolene, even when their efficacy was unclear. This might have been due to the need for gradual withdrawal and individualized monitoring to prevent medication withdrawal reactions, anticipated worsening of symptoms on withdrawal, or increased care requirements because of changes in the patient’s condition. To find out more about this hesitancy to withdraw medications in the face of limited evidence of usefulness, a short oral survey was administered to physicians and patients (or their substitute decision makers) to ask why they might or might not want to participate in a withdrawal protocol for these medications. The specific objectives of this study were
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• to evaluate the effects of planned withdrawal of baclofen and dantrolene in consenting complex continuing care patients
• to determine the proportion of patients for whom it was possible to taper or withdraw baclofen or dantrolene without negative effects
• to determine whether any symptoms potentially caused by baclofen or dantrolene improved or resolved with tapering or discontinuation of the medication
• to determine if any demographic variables were predictive of successful withdrawal
• to describe changes in other spasticity-related therapy during medication withdrawal
• to describe the factors considered by physicians and patients (including substitute decision makers) when deciding whether or not to participate in the withdrawal program.