Efficacy and safety of combination therapy with 5% lidocaine medicated plaster and pregabalin in post-herpetic neuralgia and diabetic polyneuropathy.
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.


BACKGROUND
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.
Baron
Ralf
R
Division of Neurological Pain Research and Therapy, Department of Neurology, Universitätsklinikum Schleswig-Holstein, Campus Kiel, Kiel, Germany. r.baron@neurologie.uni-kiel.de
Mayoral
Victor
V
Leijon
Göran
G
Binder
Andreas
A
Steigerwald
Ilona
I
Serpell
Michael
M
D000368:Aged; D000465:Algorithms; D000700:Analgesics / Q000008:administration & dosage / Q000009:adverse effects; D002370:Casts, Surgical / Q000009:adverse effects; D003929:Diabetic Neuropathies / Q000150:complications / Q000188:drug therapy*; D004338:Drug Combinations; D005260:Female; D006801:Humans; D008012:Lidocaine / Q000008:administration & dosage* / Q000009:adverse effects; D008297:Male; D008875:Middle Aged; D051474:Neuralgia, Postherpetic / Q000150:complications / Q000188:drug therapy*; D009994:Osmolar Concentration; D010146:Pain / Q000188:drug therapy / Q000209:etiology; D017060:Patient Satisfaction; D000069583:Pregabalin; D016896:Treatment Outcome; D005680:gamma-Aminobutyric Acid / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*
D000700:Analgesics; D004338:Drug Combinations; D000069583:Pregabalin; D005680:gamma-Aminobutyric Acid; D008012:Lidocaine