PMID- 24407102
OWN - NLM
STAT- MEDLINE
DCOM- 20140711
LR  - 20140527
IS  - 1532-821X (Electronic)
IS  - 0003-9993 (Linking)
VI  - 95
IP  - 6
DP  - 2014 Jun
TI  - Occurrence of adverse events in long-term intrathecal baclofen infusion: a 1-year 
      follow-up study of 158 adults.
PG  - 1032-8
LID - S0003-9993(14)00003-3 [pii]
LID - 10.1016/j.apmr.2013.12.019 [doi]
AB  - 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.
CI  - Copyright (c) 2014 American Congress of Rehabilitation Medicine. Published by 
      Elsevier Inc. All rights reserved.
FAU - Borrini, Leo
AU  - Borrini L
AD  - Department of Physical Medicine and Rehabilitation, Raymond Poincare Hospital, 
      Garches, France; Department of Physical Medicine and Rehabilitation, Percy 
      Military Hospital, Clamart, France. Electronic address: leoborrini@yahoo.fr.
FAU - Bensmail, Djamel
AU  - Bensmail D
AD  - Department of Physical Medicine and Rehabilitation, Raymond Poincare Hospital, 
      Garches, France; Versailles Saint Quentin en Yvelines University, Versailles, 
      France.
FAU - Thiebaut, Jean-Baptiste
AU  - Thiebaut JB
AD  - Department of Neurosurgery, Fondation Rothschild Hospital, Paris, France.
FAU - Hugeron, Caroline
AU  - Hugeron C
AD  - Department of Physical Medicine and Rehabilitation, Raymond Poincare Hospital, 
      Garches, France.
FAU - Rech, Celia
AU  - Rech C
AD  - Department of Physical Medicine and Rehabilitation, Raymond Poincare Hospital, 
      Garches, France.
FAU - Jourdan, Claire
AU  - Jourdan C
AD  - Department of Physical Medicine and Rehabilitation, Raymond Poincare Hospital, 
      Garches, France; Versailles Saint Quentin en Yvelines University, Versailles, 
      France.
LA  - eng
PT  - Comparative Study
PT  - Journal Article
PT  - Observational Study
DEP - 20140106
PL  - United States
TA  - Arch Phys Med Rehabil
JT  - Archives of physical medicine and rehabilitation
JID - 2985158R
RN  - 0 (Muscle Relaxants, Central)
RN  - H789N3FKE8 (Baclofen)
SB  - IM
MH  - Adolescent
MH  - Adult
MH  - Age Distribution
MH  - Aged
MH  - Baclofen/*adverse effects/therapeutic use
MH  - Cerebral Palsy/complications/diagnosis/drug therapy
MH  - Dose-Response Relationship, Drug
MH  - Drug Administration Schedule
MH  - Drug-Related Side Effects and Adverse Reactions/*epidemiology/etiology
MH  - Female
MH  - Follow-Up Studies
MH  - Humans
MH  - Incidence
MH  - Infusion Pumps, Implantable
MH  - Injections, Spinal/adverse effects
MH  - Long-Term Care
MH  - Male
MH  - Middle Aged
MH  - Multiple Sclerosis/complications/diagnosis/drug therapy
MH  - Muscle Relaxants, Central/*adverse effects/therapeutic use
MH  - Muscle Spasticity/*drug therapy/*etiology/physiopathology
MH  - Prospective Studies
MH  - Severity of Illness Index
MH  - Sex Distribution
MH  - Spinal Cord Injuries/complications/diagnosis/drug therapy
MH  - Statistics, Nonparametric
MH  - Time Factors
MH  - Treatment Outcome
MH  - Young Adult
OTO - NOTNLM
OT  - Adverse drug event
OT  - Baclofen
OT  - Infusion pumps, implantable
OT  - Muscle spasticity
OT  - Rehabilitation
EDAT- 2014/01/11 06:00
MHDA- 2014/07/12 06:00
CRDT- 2014/01/11 06:00
PHST- 2013/12/10 00:00 [received]
PHST- 2013/12/18 00:00 [revised]
PHST- 2013/12/22 00:00 [accepted]
PHST- 2014/01/11 06:00 [entrez]
PHST- 2014/01/11 06:00 [pubmed]
PHST- 2014/07/12 06:00 [medline]
AID - S0003-9993(14)00003-3 [pii]
AID - 10.1016/j.apmr.2013.12.019 [doi]
PST - ppublish
SO  - Arch Phys Med Rehabil. 2014 Jun;95(6):1032-8. doi: 10.1016/j.apmr.2013.12.019. 
      Epub 2014 Jan 6.