The effect of a combination of gabapentin and donepezil in an experimental pain model in healthy volunteers: Results of a randomized controlled trial

Pain

Volumn 155, Issue 12, 2014, Pages 2510-2516

  Boyle, Yvonne ^a   Fernando, Disala ^a   Kurz, Hazel ^b   Miller, Sam R ^b   Zucchetto, Mauro ^c   Storey, James ^b  

^a ADDENBROOKE S HOSPITAL   (United Kingdom)

^b GLAXOSMITHKLINE   (United Kingdom)

^c GSK   (Italy)

Author keywords

Biological; Donepezil; Electric stimulation; Gabapentin; Humans; Hyperalgesia; Models; Randomized controlled trial

Indexed keywords

DONEPEZIL; GABAPENTIN; PLACEBO; 4 AMINOBUTYRIC ACID; AMINE; ANALGESIC AGENT; CYCLOHEXANECARBOXYLIC ACID DERIVATIVE; INDAN DERIVATIVE; NOOTROPIC AGENT; PIPERIDINE DERIVATIVE;

ADULT; ALLODYNIA; ARTICLE; CLINICAL ARTICLE; CONTROLLED STUDY; CROSSOVER PROCEDURE; DOUBLE BLIND PROCEDURE; DRUG BLOOD LEVEL; DRUG HALF LIFE; DRUG SAFETY; ELECTROSTIMULATION; EVENING DOSAGE; EXPERIMENTAL MODEL; EXPERIMENTAL PAIN; FATIGUE; HUMAN; HYPERALGESIA; MALE; MONOTHERAPY; MORNING DOSAGE; MULTIPLE CYCLE TREATMENT; NERVE STIMULATION; NORMAL HUMAN; PINPRICK TEST; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; SAMPLE SIZE; STEADY STATE; SURAL NERVE; TREATMENT DURATION; TREATMENT RESPONSE; UNSPECIFIED SIDE EFFECT; ADOLESCENT; ADVERSE EFFECTS; DRUG COMBINATION; FEMALE; FOLLOW UP; INNERVATION; MIDDLE AGED; PAIN; PAIN MEASUREMENT; PHYSIOLOGY; PSYCHOLOGY; SKIN; YOUNG ADULT;

ADOLESCENT; ADULT; AMINES; ANALGESICS, NON-NARCOTIC; CROSS-OVER STUDIES; CYCLOHEXANECARBOXYLIC ACIDS; DOUBLE-BLIND METHOD; DRUG THERAPY, COMBINATION; ELECTRIC STIMULATION; FEMALE; FOLLOW-UP STUDIES; GAMMA-AMINOBUTYRIC ACID; HEALTHY VOLUNTEERS; HUMANS; INDANS; MALE; MIDDLE AGED; NOOTROPIC AGENTS; PAIN; PAIN MEASUREMENT; PIPERIDINES; SKIN; SURAL NERVE; YOUNG ADULT;

EID: 84922739963     PISSN: 03043959     EISSN: 18726623     Source Type: Journal    
DOI: 10.1016/j.pain.2014.09.003     Document Type: Article

References (25)

1. Arendt-Nielsen L, Brennum J, Sindrup S, Bak P. Electrophysiological and psychophysical quantification of temporal summation in the human nociceptive system. Eur J Appl Physiol Occup Physiol 1994;68:266-73.
2. Attal N, Cruccu G, Baron R, Haanpää M, Hansson P, Jensen TS, Nurmikko T, European Federation of Neurological Societies. EFNS guidelines on the pharmacological treatment of neuropathic pain, 2010 revision. Eur J Neurol 2010;2010. 1113-e88.
3. Basnet A, Butler S, Honoré PH, Butler M, Gordh TE, Kristensen K, Bjerrum OJ. Donepezil provides positive effects to patients treated with gabapentin for neuropathic pain: an exploratory study. Acta Anaesthesiol Scand 2014;58:61-73.
4. Bockbrader HN, Wesche D, Miller R, Chapel S, Janiczek N, Burger P. A comparison of the pharmacokinetics and pharmacodynamics of pregabalin and gabapentin. Clin Pharmacokinet 2010;49:661-9.
5. Bruera E, Strasser F, Shen L, Palmer JL, Willey J, Driver LC, Burton AW. The effect of donepezil on sedation and other symptoms in patients receiving opioids for cancer pain: a pilot study. J Pain Symptom Manage 2003;26:1049-54.
6. Cheewakriengkrai L, Gauthier S. A 10-year perspective on donepezil. Expert Opin Pharmacother 2013;14:331-8.
7. Chizh BA, Göhring M, Tröster A, Quartey GK, Schmelz M, Koppert W. Effects of oral pregabalin and aprepitant on pain and central sensitization in the electrical hyperalgesia model in human volunteers. Br J Anaesth 2007;98:246-54.
8. Clayton BA, Hayashida K, Childers SR, Xiao R, Eisenach JC. Oral donepezil reduces hypersensitivity after nerve injury by a spinal muscarinic receptor mechanism. Anesthesiology 2007;106:1019-25.
9. Dworkin RH, O'Connor AB, Audette J, Baron R, Gourlay GK, Haanpää ML, Kent JL, Krane EJ, Lebel AA, Levy RM, Mackey SC, Mayer J, Miaskowski C, Raja SN, Rice AS, Schmader KE, Stacey B, Stanos S, Treede RD, Turk DC, Walco GA, Wells CD. Recommendations for the pharmacological management of neuropathic pain: an overview and literature update. Mayo Clin Proc 2010;85:S3-S14.
10. Enggaard TP, Mikkelsen SS, Zwisler ST, Klitgaard NA, Sindrup SH. The effects of gabapentin in human experimental pain models. Scand J Pain 2010;1:143-8.
11. Folkesson A, Honoré PH, Andersen LM, Kristensen P, Bjerrum OJ. Low dose of donepezil improves gabapentin analgesia in the rat spared nerve injury model of neuropathic pain: single and multiple dosing studies. J Neural Transm 2010;117:1377-85.
12. Geber C, Fondel R, Krämer HH, Rolke R, Treede RD, Sommer C, Birklein F. Psychophysics, flare, and neurosecretory function in human pain models: capsaicin versus electrically evoked pain. J Pain 2007;8:503-14.
13. Gilron I. Gabapentin and pregabalin for chronic neuropathic and early postsurgical pain: current evidence and future directions. Curr Opin Anaesthesiol 2007;20:456-72.
14. Hayashida K, Obata H, Nakajima K, Eisenach JC. Gabapentin acts within the locus coeruleus to alleviate neuropathic pain. Anesthesiology 2008;109:1077-84.
15. Hayashida K, Parker R, Eisenach JC. Oral gabapentin activates spinal cholinergic circuits to reduce hypersensitivity after peripheral nerve injury and interacts synergistically with oral donepezil. Anesthesiology 2007;106:1213-9.
16. Kenward MG, Roger JH. The use of baseline covariates in crossover studies. Biostatistics 2010;11:1-17.
17. Kimura M, Hayashida K, Eisenach JC, Saito S, Obata H. Relief of hypersensitivity after nerve injury from systemic donepezil involves spinal cholinergic and caminobutyric acid mechanisms. Anesthesiology 2013;118:173-80.
18. Klede M, Handwerker HO, Schmelz M. Central origin of secondary mechanical hyperalgesia. J Neurophysiol 2003;90:353-9.
19. Koppert W, Dern SK, Sittl R, Albrecht S, Schüttler J, Schmelz M. A new model of electrically evoked pain and hyperalgesia in human skin: the effects of intravenous alfentanil, S (+)-ketamine, and lidocaine. Anesthesiology 2001;95:395-402.
20. Kukkar A, Bali A, Singh N, Jaggi AS. Implications and mechanism of action of gabapentin in neuropathic pain. Arch Pharm Res 2013;36:237-51.
21. Mehta CR, Pocock SJ. Adaptive increase in sample size when interim results are promising: a practical guide with examples. Stat Med 2011;30:3267-84.
22. Nicolodi M, Galeotti N, Ghelardini C, Bartolini A, Sicuteri F. Central cholinergic challenging of migraine by testing second-generation anticholinesterase drugs. Headache 2002;42:596-602.
23. Proschan MA. Sample size re-estimation in clinical trials. Biom J 2009;51:348-57.
24. Tanabe M, Takasu K, Takeuchi Y, Ono H. Pain relief by gabapentin and pregabalin via supraspinal mechanisms after peripheral nerve injury. J Neurosci Res 2008;86:3258-64.
25. Wilkinson DG. The pharmacology of donepezil: a new treatment of Alzheimer's disease. Expert Opin Pharmacother 1999;1:121-35.