Efficacy and safety of the α 4β 2 neuronal nicotinic receptor agonist ABT-894 in patients with diabetic peripheral neuropathic pain

Pain

Volumn 153, Issue 4, 2012, Pages 862-868

  Rowbotham, Michael C ^a   Arslanian, Armen ^b   Nothaft, Wolfram ^c   Duan, W Rachel ^c   Best, Andrea E ^c   Pritchett, Yili ^c   Zhou, Qian ^c   Stacey, Brett R ^d  

^a CALIFORNIA PACIFIC MEDICAL CENTER   (United States)

^b Beacon Clinical Research   (United States)

^c ABBOTT LABORATORIES   (United States)

^d OREGON HEALTH AND SCIENCE UNIVERSITY   (United States)

Author keywords

ABT 894; Neuronal nicotinic receptor; Neuropathic pain; Randomized clinical trial

Indexed keywords

DULOXETINE; NICOTINIC RECEPTOR ALPHA4BETA2; PLACEBO; SOFINICLINE;

ADULT; AGED; ANALGESIC ACTIVITY; ARTICLE; CONTROLLED STUDY; DIABETIC NEPHROPATHY; DIABETIC NEUROPATHY; DIZZINESS; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; DRUG SAFETY; DRUG TOLERABILITY; FATIGUE; FEMALE; HEADACHE; HUMAN; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; NAUSEA; NEUROPATHIC PAIN; OUTCOME ASSESSMENT; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; RATING SCALE; STATISTICAL SIGNIFICANCE;

AGED; DIABETIC NEUROPATHIES; DOUBLE-BLIND METHOD; FEMALE; HUMANS; MALE; MIDDLE AGED; NEURALGIA; NICOTINIC AGONISTS; PAIN MEASUREMENT; RECEPTORS, NICOTINIC; THIOPHENES; TREATMENT OUTCOME;

EID: 84858698916     PISSN: 03043959     EISSN: 18726623     Source Type: Journal    
DOI: 10.1016/j.pain.2012.01.009     Document Type: Article

References (24)

1. D.G. Armstrong, A.S. Chappell, T.K. Le, D.K. Kajdasz, M. Backonja, D.N. D'Souza, and J.M. Russell Duloxetine for the management of diabetic peripheral neuropathic pain: evaluation of functional outcomes Pain Med 8 2007 410 418 (Pubitemid 47163278)
2. M.W. Decker, L.E. Rueter, and R.S. Bitner Nicotinic acetylcholine receptor agonists: a potential new class of analgesics Curr Top Med Chem 4 2004 369 384 (Pubitemid 38842575)
3. D.L. Donnelly-Roberts, P.S. Puttfarcken, T.A. Kuntzweiler, C.A. Briggs, D.J. Anderson, J.E. Campbell, M. Piattoni-Kaplan, D.G. McKenna, J.T. Wasicak, M.W. Holladay, M. Williams, and S.P. Arneric ABT-594 [(R)-5-(2- azetidinylmethoxy)-2-chloropyridine]: a novel, orally effective analgesic acting via neuronal nicotinic acetylcholine receptors. I. In vitro characterization J Pharmacol Exp Ther 285 1998 777 786 (Pubitemid 28237461)
4. R.H. Dworkin, A.B. O'Connor, M. Backonja, J.T. Farrar, N.B. Finnerup, T.S. Jensen, E.A. Kalso, J.D. Loeser, C. Miaskowski, T.J. Nurmikko, R.K. Portenoy, A.S. Rice, B.R. Stacey, R.D. Treede, D.C. Turk, and M.S. Wallace Pharmacologic management of neuropathic pain: evidence-based recommendations Pain 132 2007 237 251 (Pubitemid 350051570)
5. R.H. Dworkin, D.C. Turk, D.A. Revicki, G. Harding, K.S. Coyne, S. Peirce-Sandner, D. Bhagwat, D. Everton, L.B. Burke, P. Cowan, J.T. Farrar, S. Hertz, M.B. Max, B.A. Rappaport, and R. Melzack Development and initial validation of an expanded and revised version of the Short-Form McGill Pain Questionnaire (SF-MPQ-2) Pain 144 2009 35 42
6. N.B. Finnerup, S.H. Sindrup, and T.S. Jensen The evidence for pharmacological treatment of neuropathic pain Pain 150 2010 573 581
7. D.J. Goldstein, Y. Lu, M.J. Detke, T.C. Lee, and S. Iyengar Duloxetine vs. placebo in patients with painful diabetic neuropathy Pain 116 2005 109 118 (Pubitemid 40828506)
8. D.L. Hoffman, A. Sadosky, E.M. Dukes, and J. Alvir How do changes in pain severity levels correspond to changes in health status and function in patients with painful diabetic peripheral neuropathy? Pain 149 2010 194 201
9. IN-STEP Phase IIb study results - V3381 misses primary endpoint in neuropathic pain. Vernalis press release, March 24, 2010. < http://www.vernalis.com/media-centre/latest-releases/567-in-step-phase-iib- study-results- > (accessed 19.8.2011).
10. 2 nicotinic acetylcholine receptor selective agonists J Med Chem 50 2007 5493 5508 (Pubitemid 350057859)
11. A.B. O'Connor, and R.H. Dworkin Treatment of neuropathic pain: an overview of recent guidelines Am J Med 122 2009 S22 32
12. Pfizer suspends chronic pain studies in tanezumab clinical trial program; some studies continue in areas of unmet medical need. Pfizer press release, July 19, 2010. < http://pfizer.mediaroom.com/index.php?s=5149&item=11206 > (accessed 19.8.2011).
13. A.N. Poncelet Diabetic polyneuropathy. Risk factors, patterns of presentation, diagnosis, and treatment Geriatrics 58 2003 16 18 24-5, 30
14. J. Raskin, F. Wang, Y.L. Pritchett, and D.J. Goldstein Duloxetine for patients with diabetic peripheral neuropathic pain: a 6-month open-label safety study Pain Med 7 2006 373 385 (Pubitemid 44463498)
15. M.C. Rowbotham, W.R. Duan, J. Thomas, W. Nothaft, and M.M. Backonja A randomized, double-blind, placebo-controlled trial evaluating the efficacy and safety of ABT-594 in patients with diabetic peripheral neuropathic pain Pain 146 2009 245 252
16. A. Shaibani, S. Fares, J.-L. Selam, A. Arslanian, J. Simpson, D. Sen, and S. Bongardt Lacosamide in painful diabetic neuropathy: an 18-week double-blind placebo-controlled trial J Pain 10 2009 818 828
17. A. Shaibani, S. Fares, J.L. Selam, A. Arslanian, J. Simpson, D. Sen, and S. Bongardt Lacosamide in painful diabetic neuropathy: an 18-week double-blind placebo-controlled trial J Pain 10 2009 818 828
18. S.H. Sindrup, M. Otto, N.B. Finnerup, and T.S. Jensen Antidepressants in the treatment of neuropathic pain Basic Clin Pharmacol Toxicol 96 2005 399 409 (Pubitemid 40835693)
19. V. Skljarevski, D. Desaiah, H. Liu-Seifert, Q. Zhang, A.S. Chappell, M.J. Detke, S. Iyengar, J.H. Atkinson, and M. Backonja Efficacy and safety of duloxetine in patients with chronic low back pain Spine 35 2010 E578 E585
20. N. Wang, A. Orr-Urtreger, and A.D. Korczyn The role of neuronal nicotinic acetylcholine receptor subunits in autonomic ganglia: lessons from knockout mice Prog Neurobiol 68 2002 341 360 (Pubitemid 36071511)
21. J.E. Ware Jr, K.K. Snow, M. Kosinski, and B. Gandek SF-36 health survey: manual and interpretation guide 1993 The Health Institute, New England Medical Center Boston, MA
22. J.F. Wernicke, Y.L. Pritchett, D.N. D'Souza, A. Waninger, P. Tran, S. Iyengar, and J. Raskin A randomized controlled trial of duloxetine in diabetic peripheral neuropathic pain Neurology 67 2006 1411 1420 (Pubitemid 44632065)
23. J.P. Wymer, J. Simpson, D. Sen, and S. Bongardt Efficacy and safety of lacosamide in diabetic neuropathic pain: an 18-week double-blind placebo-controlled trial of fixed-dose regimens Clin J Pain 25 2009 376 385
24. D. Ziegler, T. Hidvegi, I. Gurieva, S. Bongardt, R. Freynhagen, D. Sen, and K. Sommerville Efficacy and safety of lacosamide in painful diabetic neuropathy Diabetes Care 33 2010 839 841