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Occurrence of adverse events in long-term intrathecal baclofen infusion: a 1-year follow-up study of 158 adults.
Arch Phys Med Rehabil 2014; 95(6):1032-8AP

Abstract

OBJECTIVE

To assess the frequency and types of adverse events (AEs) related to intrathecal baclofen (ITB) therapy in adults, and associated risk factors.

DESIGN

A prospective, observational cohort study of adults followed up from January 1 to December 31, 2010.

SETTING

A neurologic rehabilitation department in a university hospital.

PARTICIPANTS

All consecutive adult subjects (N=158) receiving ITB via a pump, either implanted or followed up during the study period.

INTERVENTION

Not applicable.

MAIN OUTCOME MEASURES

Frequency and type of AEs.

RESULTS

In 2010, 158 subjects were followed up for ITB therapy, of whom 128 were implanted before 2010 (nonsurgical subjects), and 30 underwent implantation in 2010 (surgical subjects). Of these 30 subjects, 20 were "newly implanted" and 10 were "replacements." The most frequent pathologic disorders were spinal cord injury (42%) and multiple sclerosis (28%). Twenty-eight subjects (18%) experienced a total of 38 AEs. The rate of AEs was .023 per month of ITB treatment. AEs were related to the surgical procedure in 53% of cases, to the device in 29% (predominantly catheter dysfunctions), and to adverse effects of baclofen in 18%. AEs related to the surgical incision (scar complications and collections) were more frequent in replacement than newly implanted subjects (P=.009). No significant association between occurrence of an AE and subject characteristics (age, gait capacity, spinal vs cerebral spasticity, duration of ITB therapy follow-up) was found. Nearly half of the AEs were serious, extending admission time by a mean of 16 days. No AE induced long-term morbidity or death.

CONCLUSIONS

The AE rate was relatively low in this cohort. This has to be balanced against the clinical, functional, and quality-of-life improvements, which are expected from ITB therapy.

Authors+Show Affiliations

Department of Physical Medicine and Rehabilitation, Raymond Poincaré Hospital, Garches, France; Department of Physical Medicine and Rehabilitation, Percy Military Hospital, Clamart, France. Electronic address: leoborrini@yahoo.fr.Department of Physical Medicine and Rehabilitation, Raymond Poincaré Hospital, Garches, France; Versailles Saint Quentin en Yvelines University, Versailles, France.Department of Neurosurgery, Fondation Rothschild Hospital, Paris, France.Department of Physical Medicine and Rehabilitation, Raymond Poincaré Hospital, Garches, France.Department of Physical Medicine and Rehabilitation, Raymond Poincaré Hospital, Garches, France.Department of Physical Medicine and Rehabilitation, Raymond Poincaré Hospital, Garches, France; Versailles Saint Quentin en Yvelines University, Versailles, France.

Pub Type(s)

Comparative Study
Journal Article
Observational Study

Language

eng

PubMed ID

24407102

Citation

Borrini, Léo, et al. "Occurrence of Adverse Events in Long-term Intrathecal Baclofen Infusion: a 1-year Follow-up Study of 158 Adults." Archives of Physical Medicine and Rehabilitation, vol. 95, no. 6, 2014, pp. 1032-8.
Borrini L, Bensmail D, Thiebaut JB, et al. Occurrence of adverse events in long-term intrathecal baclofen infusion: a 1-year follow-up study of 158 adults. Arch Phys Med Rehabil. 2014;95(6):1032-8.
Borrini, L., Bensmail, D., Thiebaut, J. B., Hugeron, C., Rech, C., & Jourdan, C. (2014). Occurrence of adverse events in long-term intrathecal baclofen infusion: a 1-year follow-up study of 158 adults. Archives of Physical Medicine and Rehabilitation, 95(6), pp. 1032-8. doi:10.1016/j.apmr.2013.12.019.
Borrini L, et al. Occurrence of Adverse Events in Long-term Intrathecal Baclofen Infusion: a 1-year Follow-up Study of 158 Adults. Arch Phys Med Rehabil. 2014;95(6):1032-8. PubMed PMID: 24407102.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Occurrence of adverse events in long-term intrathecal baclofen infusion: a 1-year follow-up study of 158 adults. AU - Borrini,Léo, AU - Bensmail,Djamel, AU - Thiebaut,Jean-Baptiste, AU - Hugeron,Caroline, AU - Rech,Célia, AU - Jourdan,Claire, Y1 - 2014/01/06/ PY - 2013/12/10/received PY - 2013/12/18/revised PY - 2013/12/22/accepted PY - 2014/1/11/entrez PY - 2014/1/11/pubmed PY - 2014/7/12/medline KW - Adverse drug event KW - Baclofen KW - Infusion pumps, implantable KW - Muscle spasticity KW - Rehabilitation SP - 1032 EP - 8 JF - Archives of physical medicine and rehabilitation JO - Arch Phys Med Rehabil VL - 95 IS - 6 N2 - OBJECTIVE: To assess the frequency and types of adverse events (AEs) related to intrathecal baclofen (ITB) therapy in adults, and associated risk factors. DESIGN: A prospective, observational cohort study of adults followed up from January 1 to December 31, 2010. SETTING: A neurologic rehabilitation department in a university hospital. PARTICIPANTS: All consecutive adult subjects (N=158) receiving ITB via a pump, either implanted or followed up during the study period. INTERVENTION: Not applicable. MAIN OUTCOME MEASURES: Frequency and type of AEs. RESULTS: In 2010, 158 subjects were followed up for ITB therapy, of whom 128 were implanted before 2010 (nonsurgical subjects), and 30 underwent implantation in 2010 (surgical subjects). Of these 30 subjects, 20 were "newly implanted" and 10 were "replacements." The most frequent pathologic disorders were spinal cord injury (42%) and multiple sclerosis (28%). Twenty-eight subjects (18%) experienced a total of 38 AEs. The rate of AEs was .023 per month of ITB treatment. AEs were related to the surgical procedure in 53% of cases, to the device in 29% (predominantly catheter dysfunctions), and to adverse effects of baclofen in 18%. AEs related to the surgical incision (scar complications and collections) were more frequent in replacement than newly implanted subjects (P=.009). No significant association between occurrence of an AE and subject characteristics (age, gait capacity, spinal vs cerebral spasticity, duration of ITB therapy follow-up) was found. Nearly half of the AEs were serious, extending admission time by a mean of 16 days. No AE induced long-term morbidity or death. CONCLUSIONS: The AE rate was relatively low in this cohort. This has to be balanced against the clinical, functional, and quality-of-life improvements, which are expected from ITB therapy. SN - 1532-821X UR - https://www.unboundmedicine.com/medline/citation/24407102/Occurrence_of_adverse_events_in_long_term_intrathecal_baclofen_infusion:_a_1_year_follow_up_study_of_158_adults_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0003-9993(14)00003-3 DB - PRIME DP - Unbound Medicine ER -