alexa 5\% lidocaine medicated plaster versus pregabalin in post-herpetic neuralgia and diabetic polyneuropathy: an open-label, non-inferiority two-stage RCT study.


Journal of Anesthesia & Clinical Research

Author(s): Baron R, Mayoral V, Leijon G, Binder A, Steigerwald I,

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Abstract 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. This article was published in Curr Med Res Opin and referenced in Journal of Anesthesia & Clinical Research

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