PMID- 19480610
OWN - NLM
STAT- MEDLINE
DCOM- 20091130
LR  - 20151119
IS  - 1473-4877 (Electronic)
IS  - 0300-7995 (Linking)
VI  - 25
IP  - 7
DP  - 2009 Jul
TI  - Efficacy and safety of combination therapy with 5% lidocaine medicated plaster 
      and pregabalin in post-herpetic neuralgia and diabetic polyneuropathy.
PG  - 1677-87
LID - 10.1185/03007990903048078 [doi]
AB  - OBJECTIVE: Neuropathic pain is often difficult to treat due to a complex 
      pathophysiology. This study evaluated the efficacy, tolerability and safety of 
      combination therapy with 5% lidocaine medicated plaster and pregabalin for 
      neuropathic pain in patients with post-herpetic neuralgia (PHN) or painful 
      diabetic polyneuropathy (DPN). METHODS: Patients completing 4-week monotherapy 
      with 5% lidocaine medicated plaster or pregabalin were enrolled in an 8-week 
      combination phase. Patients with adequate response to monotherapy (recalled 
      average pain intensity of 4 or less on 11-point numeric rating scale in the 
      previous 3 days [NRS-3 score]) continued their previous therapy, whereas those 
      with insufficient response received combination therapy. Efficacy endpoints 
      included change in NRS-3 from combination phase baseline, Patient and Clinical 
      Global Impression of Change (PGIC/CGIC), and patient's satisfaction with 
      treatment. Safety evaluation included adverse events (AEs), drug-related AEs 
      (DRAEs), and withdrawal due to AEs. CLINICAL TRIAL REGISTRATION: EudraCT No. 
      2006-003132-29. RESULTS: Of 229 patients in the per-protocol set (PPS: 68 PHN and 
      161 DPN), 71 received 5% lidocaine medicated plaster monotherapy, 57 had 
      pregabalin added to 5% lidocaine medicated plaster, 57 pregabalin monotherapy and 
      44 received 5% lidocaine medicated plaster in addition to continued pregabalin 
      treatment. There were no meaningful differences in demographic data between the 
      treatment groups. Patients continuing on monotherapy demonstrated additional 
      decreases in NRS-3 scores. Patients receiving combination therapy achieved 
      clinically relevant reduction in NRS-3 values in addition to improvement achieved 
      during the 4 weeks of monotherapy. Improvement was similar between the two 
      combination therapy groups. Considerable improvements in patients' treatment 
      satisfaction were reported. Incidences of AEs were in line with previous reports 
      for the two treatments and combination therapy was generally well tolerated. 
      CONCLUSIONS: In patients with PHN and painful DPN failing to respond to 
      monotherapy, combination therapy with 5% lidocaine medicated plaster and 
      pregabalin provides additional clinically relevant pain relief and is safe and 
      well-tolerated.
FAU - Baron, Ralf
AU  - Baron R
AD  - Division of Neurological Pain Research and Therapy, Department of Neurology, 
      Universitatsklinikum Schleswig-Holstein, Campus Kiel, Kiel, Germany. 
      r.baron@neurologie.uni-kiel.de
FAU - Mayoral, Victor
AU  - Mayoral V
FAU - Leijon, Goran
AU  - Leijon G
FAU - Binder, Andreas
AU  - Binder A
FAU - Steigerwald, Ilona
AU  - Steigerwald I
FAU - Serpell, Michael
AU  - Serpell M
LA  - eng
PT  - Clinical Trial, Phase III
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
PL  - England
TA  - Curr Med Res Opin
JT  - Current medical research and opinion
JID - 0351014
RN  - 0 (Analgesics)
RN  - 0 (Drug Combinations)
RN  - 55JG375S6M (Pregabalin)
RN  - 56-12-2 (gamma-Aminobutyric Acid)
RN  - 98PI200987 (Lidocaine)
SB  - IM
MH  - Aged
MH  - Algorithms
MH  - Analgesics/administration & dosage/adverse effects
MH  - *Casts, Surgical/adverse effects
MH  - Diabetic Neuropathies/complications/*drug therapy
MH  - Drug Combinations
MH  - Female
MH  - Humans
MH  - Lidocaine/*administration & dosage/adverse effects
MH  - Male
MH  - Middle Aged
MH  - Neuralgia, Postherpetic/complications/*drug therapy
MH  - Osmolar Concentration
MH  - Pain/drug therapy/etiology
MH  - Patient Satisfaction
MH  - Pregabalin
MH  - Treatment Outcome
MH  - gamma-Aminobutyric Acid/administration & dosage/adverse effects/*analogs & 
      derivatives
EDAT- 2009/06/02 09:00
MHDA- 2009/12/16 06:00
CRDT- 2009/06/02 09:00
PHST- 2009/06/02 09:00 [entrez]
PHST- 2009/06/02 09:00 [pubmed]
PHST- 2009/12/16 06:00 [medline]
AID - 10.1185/03007990903048078 [doi]
PST - ppublish
SO  - Curr Med Res Opin. 2009 Jul;25(7):1677-87. doi: 10.1185/03007990903048078.