Efficacy and safety of lacosamide in painful diabetic neuropathy

Dan Ziegler, Tibor Hidvégi, Irina Gurieva, Sabine Bongardt, Rainer Freynhagen, David Sen, Kenneth Sommerville, Lacosamide SP743 Study Group, C Mathieu, L Van Gaal, F Duyck, A Verhaegen, B Vets, J Hovorka, R Mazanec, D Dolezil, P Valensi, C Le Devehat, L Geffray, J von Hubbenet, J Jansen, C Klein, T Drescher, A Herzner, R Bodenschatz, A Pfeiffer, R Nischik, B Bergtholdt, E Boenninghoff, H Stahl, A Holst, P Franz, R Lehmann, G Jermendy, G Winkler, V Spallone, G Comi, J Banga, A Mikolajczyk-Swatko, W Fryze, M Arciszewska, E Semetkowska-Jurkiewicz, M Polaszewska-Muszynska, J Skowron, D Cheta, N Hancu, C Ionescu-Tirgoviste, G Negriçsanu, N Verbovaya, A Zalevskaya, A Ametov, I Dedov, M Ansiferov, F J Salvador Rodriguez, A Baksi, D Price, K Simpson, G Rayman, Dan Ziegler, Tibor Hidvégi, Irina Gurieva, Sabine Bongardt, Rainer Freynhagen, David Sen, Kenneth Sommerville, Lacosamide SP743 Study Group, C Mathieu, L Van Gaal, F Duyck, A Verhaegen, B Vets, J Hovorka, R Mazanec, D Dolezil, P Valensi, C Le Devehat, L Geffray, J von Hubbenet, J Jansen, C Klein, T Drescher, A Herzner, R Bodenschatz, A Pfeiffer, R Nischik, B Bergtholdt, E Boenninghoff, H Stahl, A Holst, P Franz, R Lehmann, G Jermendy, G Winkler, V Spallone, G Comi, J Banga, A Mikolajczyk-Swatko, W Fryze, M Arciszewska, E Semetkowska-Jurkiewicz, M Polaszewska-Muszynska, J Skowron, D Cheta, N Hancu, C Ionescu-Tirgoviste, G Negriçsanu, N Verbovaya, A Zalevskaya, A Ametov, I Dedov, M Ansiferov, F J Salvador Rodriguez, A Baksi, D Price, K Simpson, G Rayman

Abstract

Objective: To evaluate efficacy and safety of lacosamide compared with placebo in painful diabetic polyneuropathy.

Research design and methods: Diabetic patients with at least moderate neuropathic pain were randomized to placebo or lacosamide 400 (in a slow or standard titration) or 600 mg/day over 6-week titration and 12-week maintenance periods. Primary efficacy criterion was intra-individual change in average daily Numeric Pain Rating Scale score from baseline to the last 4 weeks.

Results: For the primary end point, pain reduction was numerically but not statistically greater with lacosamide compared with placebo (400 mg/day, P = 0.12; 600 mg/day, P = 0.18). Both doses were significantly more effective compared with placebo over the titration (P = 0.03, P = 0.006), maintenance (P = 0.01, P = 0.005), and entire treatment periods (P = 0.03, P = 0.02). Safety profiles between titration schemes were similar.

Conclusions: Lacosamide reduced neuropathic pain and was well tolerated in diabetic patients, but the primary efficacy criterion was not met, possibly due to an increased placebo response over the last 4 weeks.

Figures

Figure 1
Figure 1
Mean change from baseline in average daily pain score at each trial visit (weeks 2, 4, 5, 6, 10, 14, and 18) for observed cases (OC: patients still in the trial at the time of the clinic visit or during that visit interval) and last observation carried forward (LOCF). BL, baseline; LCM, lacosamide; MP, maintenance period.

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Source: PubMed

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