PMID- 17286624
OWN - NLM
STAT- MEDLINE
DCOM- 20070605
LR  - 20181201
IS  - 0001-6314 (Print)
IS  - 0001-6314 (Linking)
VI  - 115
IP  - 4
DP  - 2007 Apr
TI  - Long-term safety and tolerability of oxcarbazepine in painful diabetic 
      neuropathy.
PG  - 284-8
AB  - BACKGROUND: Painful diabetic neuropathy is a common complication of diabetes and 
      often resistant to treatment with standard analgesics. Treatment of diabetic 
      neuropathy with antiepileptic drugs may provide pain relief. AIM: To evaluate the 
      long-term safety and tolerability of oxcarbazepine in two studies investigating 
      the treatment of diabetic neuropathy. OBJECTIVES: Patients with diabetes and a 
      history of neuropathic pain were included. Study 1 was a multicenter, open-label 
      study comprising a screening and 12-month treatment phase. Study 2 was a 
      multicenter, open-label extension to a double-blind, randomized study. 
      Oxcarbazepine was initiated at 300 mg/day and titrated over 4 weeks to 
      tolerability or a maximum dose of 900 mg b.i.d. Safety was assessed by monitoring 
      adverse events (AEs), serious AEs (SAEs), hematology, blood chemistry, urinalysis 
      values, and vital signs. RESULTS: Adverse events were most frequently reported in 
      the nervous and gastrointestinal systems; 20.5% and 21.6% of patients withdrew 
      because of AEs in study 1 and study 2, respectively. SAEs were reported in 13.7% 
      and 14.4% of patients in study 1 and study 2, respectively. CONCLUSIONS: 
      Long-term treatment with oxcarbazepine is generally well tolerated in patients 
      with painful diabetic neuropathy. Rapid titration of oxcarbazepine may be 
      responsible for discontinuations resulting from AEs during early stages of 
      treatment.
FAU - Beydoun, S
AU  - Beydoun S
AD  - Department of Neurology, Keck USC School of Medicine, Los Angeles, CA 90033, USA. 
      sbeydoun@usc.edu
FAU - Alarcon, F
AU  - Alarcon F
FAU - Mangat, S
AU  - Mangat S
FAU - Wan, Y
AU  - Wan Y
LA  - eng
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PL  - Denmark
TA  - Acta Neurol Scand
JT  - Acta neurologica Scandinavica
JID - 0370336
RN  - 0 (Anticonvulsants)
RN  - 33CM23913M (Carbamazepine)
RN  - VZI5B1W380 (Oxcarbazepine)
SB  - IM
MH  - Adult
MH  - Aged
MH  - Anticonvulsants/*administration & dosage/adverse effects
MH  - Carbamazepine/administration & dosage/adverse effects/*analogs & derivatives
MH  - Diabetic Neuropathies/*drug therapy
MH  - Double-Blind Method
MH  - Drug Administration Schedule
MH  - Female
MH  - Follow-Up Studies
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Oxcarbazepine
MH  - Pain Measurement
MH  - Treatment Outcome
EDAT- 2007/02/09 09:00
MHDA- 2007/06/06 09:00
CRDT- 2007/02/09 09:00
PHST- 2007/02/09 09:00 [pubmed]
PHST- 2007/06/06 09:00 [medline]
PHST- 2007/02/09 09:00 [entrez]
AID - ANE710 [pii]
AID - 10.1111/j.1600-0404.2006.00710.x [doi]
PST - ppublish
SO  - Acta Neurol Scand. 2007 Apr;115(4):284-8. doi: 10.1111/j.1600-0404.2006.00710.x.