PMID- 19485723
OWN - NLM
STAT- MEDLINE
DCOM- 20091130
LR  - 20151119
IS  - 1473-4877 (Electronic)
IS  - 0300-7995 (Linking)
VI  - 25
IP  - 7
DP  - 2009 Jul
TI  - 5% lidocaine medicated plaster versus pregabalin in post-herpetic neuralgia and 
      diabetic polyneuropathy: an open-label, non-inferiority two-stage RCT study.
PG  - 1663-76
LID - 10.1185/03007990903047880 [doi]
AB  - OBJECTIVE: To compare efficacy and safety of 5% lidocaine medicated plaster with 
      pregabalin in patients with post-herpetic neuralgia (PHN) or painful diabetic 
      polyneuropathy (DPN). STUDY DESIGN AND METHODS: This was a two-stage adaptive, 
      randomized, open-label, multicentre, non-inferiority study. Data are reported 
      from the initial 4-week comparative phase, in which adults with PHN or painful 
      DPN received either topical 5% lidocaine medicated plaster applied to the most 
      painful skin area or twice-daily pregabalin capsules titrated to effect according 
      to the Summary of Product Characteristics. The primary endpoint was response rate 
      at 4 weeks, defined as reduction averaged over the last three days from baseline 
      of > or = 2 points or an absolute value of < or = 4 points on the 11-point 
      Numerical Rating Scale (NRS-3). Secondary endpoints included 30% and 50% 
      reductions in NRS-3 scores; change in allodynia severity rating; quality of life 
      (QoL) parameters EQ-5D, CGIC, and PGIC; patient satisfaction with treatment; and 
      evaluation of safety (laboratory parameters, vital signs, physical examinations, 
      adverse events [AEs], drug-related AEs [DRAEs], and withdrawal due to AEs). 
      RESULTS: Ninety-six patients with PHN and 204 with painful DPN were analysed 
      (full analysis set, FAS). Overall, 66.4% of patients treated with the 5% 
      lidocaine medicated plaster and 61.5% receiving pregabalin were considered 
      responders (corresponding numbers for the per protocol set, PPS: 65.3% vs. 
      62.0%). In PHN more patients responded to 5% lidocaine medicated plaster 
      treatment than to pregabalin (PPS: 62.2% vs. 46.5%), while response was 
      comparable for patients with painful DPN (PPS: 66.7% vs 69.1%). 30% and 50% 
      reductions in NRS-3 scores were greater with 5% lidocaine medicated plaster than 
      with pregabalin. Both treatments reduced allodynia severity. 5% lidocaine 
      medicated plaster showed greater improvements in QoL based on EQ-5D in both PHN 
      and DPN. PGIC and CGIC scores indicated greater improvement for 5% lidocaine 
      medicated plaster treated patients with PHN. Improvements were comparable between 
      treatments in painful DPN. Fewer patients administering 5% lidocaine medicated 
      plaster experienced AEs (safety set, SAF: 18.7% vs. 46.4%), DRAEs (5.8% vs. 
      41.2%) and related discontinuations compared to patients taking pregabalin. 
      CONCLUSION: 5% lidocaine medicated plaster showed better efficacy compared with 
      pregabalin in patients with PHN. Within DPN, efficacy was comparable for both 
      treatments. 5% lidocaine medicated plaster showed a favourable efficacy/safety 
      profile with greater improvements in patient satisfaction and QoL compared with 
      pregabalin for both indications, supporting its first line position in the 
      treatment of localized neuropathic pain.
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  - 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  - 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  - Female
MH  - Humans
MH  - Lidocaine/*administration & dosage/adverse effects/chemistry
MH  - Male
MH  - Middle Aged
MH  - Neuralgia, Postherpetic/complications/*drug therapy
MH  - Osmolar Concentration
MH  - Pain/drug therapy/etiology
MH  - Pregabalin
MH  - Treatment Outcome
MH  - gamma-Aminobutyric Acid/administration & dosage/adverse effects/*analogs & 
      derivatives
EDAT- 2009/06/03 09:00
MHDA- 2009/12/16 06:00
CRDT- 2009/06/03 09:00
PHST- 2009/06/03 09:00 [entrez]
PHST- 2009/06/03 09:00 [pubmed]
PHST- 2009/12/16 06:00 [medline]
AID - 10.1185/03007990903047880 [doi]
PST - ppublish
SO  - Curr Med Res Opin. 2009 Jul;25(7):1663-76. doi: 10.1185/03007990903047880.