The efficacy and safety of pregabalin in the treatment of neuropathic pain associated with chronic lumbosacral radiculopathy

Baron, R; Freynhagen, R; Tölle, Tr; Cloutier, C; Leon, T; Murphy, Tk; Phillips, K; Hans GH, A0081007 I. n. v. e. s. t. i. g. a. t. o. r. s.; Morlion, Bj; Vissers, Kc; Maeyaert, J; Genge, Al; Morley Forster, P; Cloutier, C; Lasko, B; D'Ignazio, G; Borshch, Y; Ong Lam, M; Tölle, T; Mueller Schwefe, G; Freynhagen, R; Baron, R; Mueller, G; Ueberall, M; Schulz Meentzen, M; Grunert, S; Bonezzi, C; Marchettini, P; Serrati, C; Iolascon, Giovanni; Dalla Toffola, E; Bertolini, C; Calderon, Fm; Millan, Jm; Mateos, Rg; Hernandez, Cp; Samper, D; De Andres, J; Sigholm, G; Tuveson, B; Vasara, S; Ruthstrom, L; Runhall, B; Sorensen, J; Ergin, Es; Cakmak, A; Oncel, S; Lesser, Hd; Bajwa, Zh; Daiz Ramirez, M; Nicholson, Bd; Forde, Gi; Torres, Ml; Singer, Rp; Duerden, Me; Gimbel, Js; Kaplan, Ja; Charapata, S. G.

doi:10.1016/j.pain.2010.04.013

We evaluated the efficacy of pregabalin in patients with chronic lumbosacral radiculopathy. This randomized, controlled, withdrawal trial included five phases: screening (4-18 days); run-in (4-10 days) to screen out placebo responders; single-blind (28 days) to identify pregabalin responders; double-blind to randomize responders to pregabalin or placebo (35 days); and final study medication taper (7 days). The primary endpoint was time to loss of response (LOR) during the double-blind phase (≥1-point increase in pain, discontinuation, or rescue-medication use). In the single-blind phase, 58% of patients had ≥30% pain reduction. In the double-blind phase, pregabalin (n = 110) and placebo (n = 107) groups did not differ significantly in time to LOR. Adverse events caused the discontinuation of 9.9% and 5.6% of pregabalin-treated and placebo-treated patients, respectively. Most patients with chronic lumbosacral radiculopathy responded to pregabalin therapy; however, time to LOR did not significantly differ between pregabalin and placebo. Considering the results of all phases of the study, it is difficult to draw definitive conclusions from it, suggesting a need for further work to understand the clinical potential of pregabalin treatment for lumbosacral radiculopathy. © 2010 International Association for the Study of Pain. Published by Elsevier B.V. All rights reserved.

Titolo:	The efficacy and safety of pregabalin in the treatment of neuropathic pain associated with chronic lumbosacral radiculopathy
Autori:	Baron R Freynhagen R Tölle TR Cloutier C Leon T Murphy TK Phillips K A0081007 I.n.v.e.s.t.i.g.a.t.o.r.s. Hans GH Morlion BJ Vissers KC Maeyaert J Genge AL Morley Forster P Cloutier C Lasko B D'Ignazio G Borshch Y Ong Lam M Tölle T Mueller Schwefe G Freynhagen R Baron R Mueller G Ueberall M Schulz Meentzen M Grunert S Bonezzi C Marchettini P Serrati C IOLASCON, Giovanni Dalla Toffola E Bertolini C Calderon FM Millan JM Mateos RG Hernandez CP Samper D De Andres J Sigholm G Tuveson B Vasara S Ruthstrom L Runhall B Sorensen J Ergin ES Cakmak A Oncel S Lesser HD Bajwa ZH Daiz Ramirez M Nicholson BD Forde GI Torres ML Singer RP Duerden ME Gimbel JS Kaplan JA Charapata S.G. mostra contributor esterni nascondi contributor esterni
Data di pubblicazione:	2010
Rivista:	PAIN
Abstract:	We evaluated the efficacy of pregabalin in patients with chronic lumbosacral radiculopathy. This randomized, controlled, withdrawal trial included five phases: screening (4-18 days); run-in (4-10 days) to screen out placebo responders; single-blind (28 days) to identify pregabalin responders; double-blind to randomize responders to pregabalin or placebo (35 days); and final study medication taper (7 days). The primary endpoint was time to loss of response (LOR) during the double-blind phase (≥1-point increase in pain, discontinuation, or rescue-medication use). In the single-blind phase, 58% of patients had ≥30% pain reduction. In the double-blind phase, pregabalin (n = 110) and placebo (n = 107) groups did not differ significantly in time to LOR. Adverse events caused the discontinuation of 9.9% and 5.6% of pregabalin-treated and placebo-treated patients, respectively. Most patients with chronic lumbosacral radiculopathy responded to pregabalin therapy; however, time to LOR did not significantly differ between pregabalin and placebo. Considering the results of all phases of the study, it is difficult to draw definitive conclusions from it, suggesting a need for further work to understand the clinical potential of pregabalin treatment for lumbosacral radiculopathy. © 2010 International Association for the Study of Pain. Published by Elsevier B.V. All rights reserved.
Handle:	http://hdl.handle.net/11591/190126
Appare nelle tipologie:	1.1 Articolo in rivista

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