RESUMEN
BACKGROUND: Baclofen is an effective treatment for spasticity. Abrupt cessation of intrathecal (IT) or oral baclofen risks the development of withdrawal symptoms; however, the magnitude of the problem is unknown. OBJECTIVES: The aims for this study were as follows: (1) using an administrative claims database, estimate the number of patients in the United States on baclofen, and (2) estimate the annual percent hospitalized pediatric and adult populations consequently at risk for interruption of chronic baclofen therapy. METHODS: Using 2011-2014 data representing commercially insured individuals, patients were selected based on insurance coverage; evidence of a baclofen claim; and hospitalization. All patients hospitalized while receiving chronic baclofen were assumed to be at risk for baclofen discontinuation. Yearly counts were determined and then extrapolated to national estimates using census data. RESULTS: Extrapolating from the claims database, oral or IT baclofen was prescribed annually to 33,061 or 1486 patients ≤ 18 years, and 654,294 or 7084 patients 19-64 years, respectively. The estimated national mean number of at-risk hospitalizations per year for patients aged 19-64 years on chronic oral or IT baclofen was 31,116 and 3774, respectively; patients ≤ 18 years numbered 4691 and 959, respectively. The mean percent of patients hospitalized per year was 42% in those ≤ 18 years receiving IT baclofen compared with 30% in adults, and 3-10% in the populations receiving oral baclofen. CONCLUSIONS: Extrapolation from an administrative claims database was used to estimate the national number and demographics of hospitalized chronic baclofen users. Patients ≤ 18 years receiving IT baclofen were at highest risk of withdrawal due to a high occurrence of hospitalization.
RESUMEN
OBJECTIVE: We studied physicians' opinions and experiences concerning clinical concerns, perceived severity, occurrence, and management of baclofen withdrawal due to abrupt discontinuation. METHODS: A nationwide 26-question electronic survey was distributed via e-mail to physicians (N = 952) representing varying specialties who manage spasticity with baclofen. A total of 110 physicians provided responses to the survey (response rate = 11.6%). Results were evaluated using descriptive statistics. RESULTS: Withdrawal from both oral and intrathecal (IT) baclofen was recognized as a significant concern and was observed by most respondents. However, approximately 75% and 35% of respondents or their clinic sites lack established management protocols for managing anticipated interruption of oral or IT baclofen, respectively. CONCLUSIONS: These findings highlight the need for further research on and the development of guidelines for the prevention and treatment of baclofen withdrawal. The results of this survey, along with a systematic literature review and multidisciplinary stakeholder input, may be helpful in establishing guidelines for the treatment and prevention of baclofen withdrawal.
