A practical overview of tizanidine use for spasticity secondary to multiple sclerosis, stroke, and spinal cord injury

References

• WE MOVE: Spasticity – Overview. Available at http://www.wemove.org/spa/spa_overview.html [accessed 10 September 2007]
   Google Scholar
• Young RR. Spasticity: a review. Neurology 1994;44:S12–20
   PubMed Web of Science ®Google Scholar
• Adams MM, Hicks AL. Spasticity and spinal cord injury. Spinal Cord 2005;43,577–86
   PubMed Web of Science ®Google Scholar
• Rizzo MA, Hadjimichael OC, Preiningerva J, Vollmer TL. Prevalence and treatment of spasticity reported by multiple sclerosis patients. Mult Scler 2004;10:589–95
   PubMed Web of Science ®Google Scholar
• WE MOVE™: Spasticity. Available at http://www.mdvu.org/library/disease/spasticity/ [accessed 2 May 2007]
   Google Scholar
• Inman RP. The economic consequences of a debilitating illness: the case of multiple sclerosis. Rev Econ Stat 1987;69: 651–60
   Web of Science ®Google Scholar
• Bourdette DN, Prochazka AV, Mitchell W, et al. VA Multiple Sclerosis Study Group. Health care costs of veterans with multiple sclerosis: implications for the rehabilitation of MS. Arch Phys Med Rehabil 1993;74:26–31
   PubMed Web of Science ®Google Scholar
• Catanzaro M, Weinert C. Economic status of families living with multiple sclerosis. Int J Rehabil Res 1992;15:209–18
   PubMedGoogle Scholar
• Whetten-Goldstein K, Sloan FA, Goldstein LB, Kulas ED. A comprehensive assessment of the cost of multiple sclerosis in the United States. Mult Scler 1998:4;419–25
   PubMed Web of Science ®Google Scholar
• Kobelt G, Berg J, Atherly D, Hadjimichael O. Costs and quality of life in multiple sclerosis: a cross sectional study in the United States. Neurology 2006:66;1696–702
   PubMed Web of Science ®Google Scholar
• Kobelt G, Berg J, Lindgren P, et al. Costs and quality of life of patients with multiple sclerosis in Europe. J Neurol Neurosurg Psychiatry 2006;77:918–26
   PubMed Web of Science ®Google Scholar
• Haselkorn JK, Balsdon Richer C, Fry Welch D, et al. Overview of spasticity management in multiple sclerosis. Evidence-based management strategies for spasticity treatment in multiple sclerosis. J Spinal Cord Med 2005;28:167–99
   Google Scholar
• Nance PW, Shears AH, Nance DM. Clonidine in spinal cord injury. Can Med Assoc J 1985;133:41–2
   PubMed Web of Science ®Google Scholar
• Nance PW, Shears AH, Nance DM. Reflex changes induced by clonidine in spinal cord injured patients. Paraplegia 1989;27:296–301
   Google Scholar
• Dall JT, Harmon RL, Quinn CM. Use of clonidine for treatment of spasticity arising from various forms of brain injury: a case series. Brain Inj 1996;10:453–8
   Google Scholar
• Coward DM. Tizanidine: neuropharmacology and mechanism of action. Neurology 1994;44:S6–11
   PubMed Web of Science ®Google Scholar
• Donovan WH, Carter RE, Rossi CD, Wilkerson MA. Clonidine effect on spasticity: a clinical trial. Arch Phys Med Rehabil 1988;69:193–4
   PubMed Web of Science ®Google Scholar
• Wagstaff AJ, Bryson HM. Tizanidine. A review of its pharmacology, clinical efficacy and tolerability in the management of spasticity associated with cerebral and spinal disorders. Drugs 1997;53:435–52
   Google Scholar
• Sayers AC, Burki HR, Eichenberger E. The pharmacology of 5-chloro-4-(2-imidazolin-2-yl-amino)-2,1,3-benzothiadiazole (DS 103–282), a novel myotonolytic agent. Arzneimittelforschung 1980;30: 793–803
   Google Scholar
• Mathias CJ, Luckitt J, Desai P, et al. Pharmacodynamics and pharmacokinetics of the oral antispastic agent tizanidine in patients with spinal cord injury. J Rehabil Res Dev 1989;26:9–16
   PubMedGoogle Scholar
• Davies J. Selective depression of synaptic transmission of spinal neurones in the cat by a new centrally acting muscle relaxant, 5-chloro-4-(2-imidazolin-2-yl-amino)-2, 1, 3-benzothiodazole (DS103–282). Br J Pharmacol 1982;76:473–81
   PubMed Web of Science ®Google Scholar
• Curtis DR, Leah JD, Peet MJ. Spinal interneurone depression by DS103–282. Br J Pharmacol 1983;79: 9–11
   Google Scholar
• Newman PM, Nogues M, Newman PK, et al. Tizanidine in the treatment of spasticity. Eur J Clin Pharmacol 1982;23:31–5
   PubMed Web of Science ®Google Scholar
• Tanabe M, Kaneko T, Tonohiro T, Iwata N. The pharmacological properties of CS-722, a newly synthesized centrally acting muscle relaxant. Neuropharmacology 1992;31:1059–66
   PubMed Web of Science ®Google Scholar
• Emre M, Leslie GC, Muir C, et al. Correlations between dose, plasma concentrations, and antispastic action of tizanidine (Sirdalud®). J Neurol Neurosurg Psychiatry 1994;57:1355–9
   PubMed Web of Science ®Google Scholar
• Knutsson E, Martensson A, Gransberg L. Antiparetic and antispastic effects induced by tizanidine in patients with spastic paresis. J Neurol Sci 1982;53:187–204
   Google Scholar
• Hassan N, McLellan DL. Double-blind comparison of single doses of DS103–282, baclofen and placebo for suppression of spasticity. J Neurol Neurosurg Psychiatry 1980;43:1132–6
   PubMed Web of Science ®Google Scholar
• Wallace JD. Summary of combined clinical analysis of controlled clinical trials with tizanidine. Neurology 1994;44:S60–8
   PubMed Web of Science ®Google Scholar
• Nomura M, Kusaba-Suzuki M, Kimura T, et al. Cardiovascular effects of tizanidine, a new centrally acting muscle relaxant, in rats and dogs. Pharmacometrics 1985;29:477–91
   Google Scholar
• Skoog B. A comparison of the effects of two antispastic drugs, tizanidine and baclofen, on synaptic transmission from muscle spindle afferents to spinal interneurones in cats. Acta Physiol Scand 1996;156:81–90
   PubMedGoogle Scholar
• Nance PW, Sheremata WA, Lynch SG, et al. Relationship of the antispasticity effect of tizanidine to plasma concentration in patients with multiple sclerosis. Arch Neurol 1997;54:731–6
   PubMed Web of Science ®Google Scholar
• Taittonen M, Raty H, Kirvela O, et al. The metabolic effects of oral tizanidine in healthy volunteers. Acta Anaesthesiol Scand 1995;39:628–32
   PubMed Web of Science ®Google Scholar
• Davies J, Johnston SE. Selective antinociceptive effects of tizanidine (DS 103–282), a centrally acting muscle relaxant, on dorsal horn neurones in the feline spinal cord. Br J Pharmacol 1984;82:409–21
   PubMed Web of Science ®Google Scholar
• Kameyama T, Nabeshima T, Matsuno K, Sugimoto A. Comparison of alpha-adrenoceptor involvement in the antinociceptive action of tizanidine and clonidine in the mouse. Eur J Pharmacol 1986;125:257–64
   PubMed Web of Science ®Google Scholar
• Kameyama T, Nabeshima T, Sugimoto A, et al. Antinociceptive action of tizanidine in mice and rats. Naunyn Schmiedebergs Arch Pharmacol 1985;330:93–6
   PubMed Web of Science ®Google Scholar
• Ali BH, Bashir AA. The effect of some alpha 2-adrenoceptor agonists and antagonists on gastrointestinal transit in mice: influence of morphine, castor oil and glucose. Clin Exp Pharmacol Physiol 1993;20:1–6
   PubMed Web of Science ®Google Scholar
• Ramabadran K, Bansinath M, Turndorf H, Puig MM. Streptozotocin-diabetes attenuates alpha 2-adrenoceptor agonist-induced delay in small intestinal transit in mice. J Auton Pharmacol 1990;10:163–71
   PubMedGoogle Scholar
• Maeda-Hagiwara M, Watanabe H, Kanaoka R, Watanabe K. Reduction of centrally-stimulated gastric acid secretion by tizanidine, a new imidazoline derivative, in anesthetized rats. Arch Int Pharmacodyn Ther 1985;277:321–7
   Google Scholar
• Heazlewood V, Symoniw P, Maruff P, Eadie MJ. Tizanidine – initial pharmacokinetic studies in patients with spasticity. Eur J Clin Pharmacol 1983;25:65–7
   PubMed Web of Science ®Google Scholar
• Koch P, Hirst DR, von Wartburg BR. Biological fate of Sirdalud in animals and man. Xenobiotica 1989;19:1255–65
   PubMed Web of Science ®Google Scholar
• Shellenberger MK, Groves L, Shah J, Novack GD. A controlled pharmacokinetic evaluation of tizanidine and baclofen at steady state. Drug Metab Dispos 1999;27:201–4
   PubMed Web of Science ®Google Scholar
• Tse FL, Jaffe JM, Bhuta S. Pharmacokinetics of orally administered tizanidine in healthy volunteers. Fundam Clin Pharmacol 1987;1:479–88
   Google Scholar
• Henney.3rd HR, Shah J. Relative bioavailability of tizanidine tablet and capsule formulations after a standard high-fat meal: a single-dose, open-label, randomized, crossover study in healthy subjects. Clin Ther 2007;29: 661–9
   Google Scholar
• Roberts RC, Part NJ, Pokorny R, et al. Pharmacokinetics and pharmacodynamics of tizanidine. Neurology 1994;44:S29–31
   PubMed Web of Science ®Google Scholar
• Zanaflex Capsules™ and Zanaflex® tablets [package insert]. Hawthorne, NY: Acorda Therapeutics; 2006
   Google Scholar
• Groves L, Shellenberger MK, Davis CS. Tizanidine treatment of spasticity: a meta-analysis of controlled, double-blind, comparative studies with baclofen and diazepam. Adv Ther 1998;15:241–51
   Google Scholar
• Granfors MT, Backman JT, Laitila J, Neuvonen PJ. Tizanidine is mainly metabolized by cytochrome p450 1A2 in vitro. Br J Clin Pharmacol 2004;57:349–53
   PubMed Web of Science ®Google Scholar
• Granfors MT, Backman JT, Laitila J, Neuvonen PJ. Oral contraceptives containing ethinyl estradiol and gestodene markedly increase plasma concentrations and effects of tizanidine by inhibiting cytochrome P450 1A2. Clin Pharmacol Ther 2005;78:400–11
   PubMed Web of Science ®Google Scholar
• Granfors MT, Backman JT, Neuvonen M, et al. Fluvoxamine drastically increases concentrations and effects of tizanidine: a potentially hazardous interaction. Clin Pharmacol Ther 2004;75:331–41
   PubMed Web of Science ®Google Scholar
• Granfors MT, Backman JT, Neuvonen M, Neuvonen PJ. Ciprofloxacin greatly increases concentrations and hypotensive effect of tizanidine by inhibiting its cytochrome P450 1A2-mediated presystemic metabolism. Clin Pharmacol Ther 2004;76:598–606
   PubMed Web of Science ®Google Scholar
• Backman JT, Karjalainen MJ, Neuvonen M, et al. Rofecoxib is a potent inhibitor of cytochrome P450 1A2: studies with tizanidine and caffeine in healthy subjects. Br J Clin Pharmacol 2006;62:345–57
   PubMed Web of Science ®Google Scholar
• Ueno K, Miyai K, Mitsuzane K. Phenytoin–tizanidine interaction. Ann Pharmacother 1991;25:1273
   Google Scholar
• Guidance for Industry. Statistical Approaches to Establishing Bioequivalence. Washington, DC: US Food and Drug Administration, Center for Drug Evaluation and Research; 2001
   Google Scholar
• Shah J, Wesnes KA, Kovelesky RA, Henney HR, 3rd. Effects of food on the single-dose pharmacokinetics/pharmacodynamics of tizanidine capsules and tablets in healthy volunteers. Clin Ther 2006;28: 1308–17
   Google Scholar
• Wesnes KA, Meulenberg O, Vermeij B, et al. The acute cognitive effects of amitriptyline, hydroxyzine and lorazepam in volunteers. J Psychopharmacol 1996;10(Suppl):A51
   Google Scholar
• Wesnes KA, Walker MB, Walker LG, et al. Cognitive performance and mood after a weekend on call in a surgical unit. Br J Surg 1997;84:493–5
   PubMed Web of Science ®Google Scholar
• Wesnes KA, Garratt C, Wickens M, et al. Effects of sibutramine alone and with alcohol on cognitive function in healthy volunteers. Br J Clin Pharmacol 2000;49:110–17
   PubMed Web of Science ®Google Scholar
• Wesnes KA, Ward T, McGinty A, Petrini O. The memory enhancing effects of a Ginkgo biloba/Panax ginseng combination in healthy middle-aged volunteers. Psychopharmacology (Berl) 2000;152:353–61
   PubMed Web of Science ®Google Scholar
• Wesnes KA, McKeith IG, Ferrara R, et al. Effects of rivastigmine on cognitive function in dementia with lewy bodies: a randomised placebo-controlled international study using the cognitive drug research computerised assessment system. Dement Geriatr Cogn Disord 2002;13:183–92
   PubMed Web of Science ®Google Scholar
• Kennedy DO, Scholey AB, Wesnes KA. The dose-dependent cognitive effects of acute administration of Ginkgo biloba to healthy young volunteers. Psychopharmacology (Berl) 2000;151:416–23
   PubMed Web of Science ®Google Scholar
• Kennedy DO, Scholey AB, Wesnes KA. Differential, dose dependent changes in cognitive performance following acute administration of a Ginkgo biloba/Panax ginseng combination to healthy young volunteers. Nutr Neurosci 2001;4: 399–412
   Google Scholar
• Kennedy DO, Scholey AB, Wesnes KA. Dose dependent changes in cognitive performance and mood following acute administration of Ginseng to healthy young volunteers. Nutr Neurosci 2001;4:295–310
   Google Scholar
• Nance PW, Bugaresti J, Shellenberger K, et al. Efficacy and safety of tizanidine in the treatment of spasticity in patients with spinal cord injury. North American Tizanidine Study Group. Neurology 1994;44:S44–51
   Google Scholar
• Ashworth B. Preliminary trial of carisoprodal in multiple sclerosis. Practitioner 1964;192:540–2
   PubMedGoogle Scholar
• Wartenburg R. Pendulousness of the legs as a diagnostic test. Neurology 1951;1:18–24
   PubMed Web of Science ®Google Scholar
• Coward DM, Davies J, Herrling P, Rudeberg C. Pharmacological Properties of Tizanidine (DS103–282). New York, NY: Springer-Verlag NY Inc.; 1984:61–71
   Google Scholar
• Emre M. Review of clinical trials with Sirdalud in spasticity. In: Emre M, Benecke R, eds. Spasticity. Pearl River, NY: Parthenon Publishing, 1989
   Google Scholar
• Nance PW. A comparison of clonidine, cyproheptadine and baclofen in spastic spinal cord injured patients. J Am Paraplegia Soc 1994;17:151–7
   Google Scholar
• Smith C, Birnbaum G, Carter JL, et al. Tizanidine treatment of spasticity caused by multiple sclerosis: results of a double-blind, placebo-controlled trial. US Tizanidine Study Group. Neurology 1994;44:S34–42
   PubMed Web of Science ®Google Scholar
• The United Kingdom Tizanidine Trial Group. A double-blind, placebo-controlled trial of tizanidine in the treatment of spasticity caused by multiple sclerosis. Neurology 1994;44:S70–8
   PubMed Web of Science ®Google Scholar
• Gelber DA, Good DC, Dromerick A, et al. Open-label dosetitration safety and efficacy study of tizanidine hydrochloride in the treatment of spasticity associated with chronic stroke. Stroke 2001;32:1841–6
   PubMed Web of Science ®Google Scholar
• Meythaler JM, Guin-Renfroe S, Johnson A, et al. Prospective assessment of tizanidine for spasticity due to acquired brain injury. Arch Phys Med Rehabil 2001;82:1155–63
   PubMed Web of Science ®Google Scholar
• Kita M, Goodkin DE. Drugs used to treat spasticity. Drug 2000;59:487–95
   PubMed Web of Science ®Google Scholar
• Gracies JM, Nance P, Elovic E, et al. Traditional pharmacological treatments for spasticity part II: General and regional treatments. Muscle Nerve 1997;(Suppl 6) S92–120
   Google Scholar
• Anonymous: Central Nervous System Agents. In: Kastrup E, Wickersham R, Novak K, et al., eds. Drug Facts and Comparisons. St. Louis, MO: Wolters Kluwer Health. 2007:1021–582
   Google Scholar
• Eyssette M, Rohmer F, Serratrice G, et al. Multi-centre, double-blind trial of a novel antispastic agent, tizanidine, in spasticity associated with multiple sclerosis. Curr Med Res Opin 1988;10:699–708
   PubMed Web of Science ®Google Scholar
• Bass B, Weinshenker B, Rice GP, et al. Tizanidine versus baclofen in the treatment of spasticity in patients with multiple sclerosis. Can J Neurol Sci 1988;15:15–19
   PubMed Web of Science ®Google Scholar
• Medici M, Pebet M, Ciblis D. A double-blind, long-term study of tizanidine (‘Sirdalud’) in spasticity due to cerebrovascular lesions. Curr Med Res Opin 1989;11:398–407
   Google Scholar
• Stien R, Nordal HJ, Oftedal SI, Slettebo M. The treatment of spasticity in multiple sclerosis: a double-blind clinical trial of a new anti-spastic drug tizanidine compared with baclofen. Acta Neurol Scand 1987;75:190–4
   PubMed Web of Science ®Google Scholar
• Hoogstraten MC, van der Ploeg RJ, vd Burg W, et al. Tizanidine versus baclofen in the treatment of spasticity in multiple sclerosis patients. Acta Neurol Scand 1988;77:224–30
   PubMed Web of Science ®Google Scholar
• Pagano M, Ferreiro M, Herskovis E. Comparative study of tizanidine and baclofen in patients with chronic spasticity. Rev Neurol Argent 1988;14:268–76
   Google Scholar
• Rinne U. Tizanidine treatment of spasticity in multiple sclerosis and chronic myelopathy. Curr Ther Res 1980;28: 827–36
   Web of Science ®Google Scholar
• Smolenski C, Muff S, Smolenski-Kautz S. A double-blind comparative trial of new muscle relaxant, tizanidine (DS 103–282), and baclofen in the treatment of chronic spasticity in multiple sclerosis. Curr Med Res Opin 1981;7: 374–83
   Google Scholar
• Bes A, Eyssette M, Pierrot-Deseilligny E, et al. A multi-centre, double-blind trial of tizanidine, a new antispastic agent, in spasticity associated with hemiplegia. Curr Med Res Opin 1988;10:709–18
   Google Scholar
• Chou R, Peterson K, Helfand M. Comparative efficacy and safety of skeletal muscle relaxants for spasticity and musculoskeletal conditions: a systematic review. J Pain Symptom Manage 2004;28:140–75
   Google Scholar
• Ferrendelli, JA. Relating pharmacology to clinical practice: the pharmacologic basis of rational polypharmacy. Neurology 1995;45(3 Suppl 2):S12–16
   Google Scholar
• Kinsbury SJ, Yi D, Simpson GM. Rational and irrational poly-pharmacy. Psychiatr Serv 2001;52:1033–6
   Google Scholar
• Lataste X, Emre M, Davis C, Groves L. Comparative profile of tizanidine in the management of spasticity. Neurology 1994;44:S53–9
   PubMed Web of Science ®Google Scholar
• Rustemovic N, Huic M, Opacic M. Tizanidine-induced acute toxic hepatitis: case report. Pharmaca 1994;32:457–61
   Google Scholar
• de Graaf EM, Oosterveld M, Tjabbes T, Stricker BH. A case of tizanidine-induced hepatic injury. J Hepatol 1996;25: 772–3
   PubMed Web of Science ®Google Scholar
• Spiller HA, Bosse GM, Adamson LA. Retrospective review of tizanidine (Zanaflex®) overdose. J Toxicol 2004;42:593–6
   PubMed Web of Science ®Google Scholar
• Data on file. Acorda Therapeutics, Inc. Clinical Trial Report for Study AN021–101. September 2001
   Google Scholar