The safety and tolerability of botulinum toxins for the treatment of cervical dystonia

Expert Opinion on Drug Safety

Volumn 4, Issue 2, 2005, Pages 241-249

  Brashear, Allison ^a  

^a INDIANA UNIVERSITY MEDICAL CENTER   (United States)

Author keywords

Botulinum toxins; Cervical dystonia; Clinical trials

Indexed keywords

BACLOFEN; BOTULINUM TOXIN A; BOTULINUM TOXIN B; PLACEBO; TRIHEXYPHENIDYL;

ANTIBODY PRODUCTION; BACKACHE; BLEPHAROSPASM; BRAIN DEPTH STIMULATION; CERVICAL DYSTONIA; CLINICAL TRIAL; DISEASE SEVERITY; DOSE RESPONSE; DRUG APPROVAL; DRUG EFFICACY; DRUG EXPOSURE; DRUG FORMULATION; DRUG LABELING; DRUG RESPONSE; DRUG SAFETY; DRUG TOLERABILITY; DYSPHAGIA; DYSTONIA; ELECTROMYOGRAPHY; FOOD AND DRUG ADMINISTRATION; HUMAN; IMMUNITY; IMMUNOASSAY; NECK MUSCLE; NECK PAIN; NONHUMAN; PAIN ASSESSMENT; PHYSICAL DISABILITY; POSTMARKETING SURVEILLANCE; PROTEIN CONTENT; QUALITY OF LIFE; RATING SCALE; REVIEW; RHINITIS; SEROTYPE; TORTICOLLIS; TREATMENT OUTCOME; UPPER RESPIRATORY TRACT INFECTION; XEROSTOMIA;

ANTIBODY FORMATION; BOTULINUM TOXIN TYPE A; BOTULINUM TOXINS; HUMANS; SEROTYPING; TORTICOLLIS; TREATMENT OUTCOME;

EID: 20944450705     PISSN: 14740338     EISSN: None     Source Type: Journal    
DOI: 10.1517/14740338.4.2.241     Document Type: Review

References (79)

1. JANKOVIC J, BRIN MF: Therapeutic uses of botulinum toxin. N. Engl. J. Med. (1991) 324:1186-1194.
2. BRASHEAR A, AMBROSIUS WT, ECKERT GJ, SIEMERS ER: Comparison of treatment of tardive dystonia and idiopathic cervical dystonia with botulinum toxin type A. Mov. Disord. (1998) 13:158-161.
3. BRESSMAN SB, GREENE PE: Dystonia. Curr. Treat. Options Neurol. (2000) 2:275-285.
4. JANKOVIC J, NUTT JG: Blepharospasm and cranial-cervical dystonia (Meige's syndrome): Familial occurrence. Adv. Neurol. (1988) 49:117-123.
5. ADLER CH, KUMAR R: Pharmacological and surgical options for the treatment of cervical dystonia. Neurology. (2000) 55:S9-S14.
6. BRASHEAR A, GORDON MF, ELOVIC E et al.: Intramuscular injection of botulinum toxin for the treatment of wrist and finger spasticity after a stroke. N. Engl. J. Med. (2002) 347:395-400.
7. BORG-STEIN J, PINE ZM, MILLER JR, BRIN MF: Botulinum toxin for the treatment of spasticity in multiple sclerosis. New observations. Am. J. Phys. Med. Rehabil. (1993) 72:364-368.
8. KOMAN LA, MOONEY JF 3RD, SMITH BP, WALKER F, LEON JM: Botulinum toxin type a neuromuscular blockade in the treatment of lower extremity spasticity in cerebral palsy: A randomized, double-blind, placebo-controlled trial. Botox study group. J. Pediatr. Orthop. (2000) 20:108-115.
9. DODICK DW: Botulinum neurotoxin for the treatment of migraine and other primary headache disorders: From bench to bedside. Headache (2003) 43(Suppl. 1):25-33
10. MATHEW NT, KAUP AO: The use of botulinum toxin type a in headache treatment. Curr. Treat. Options. Neurol. (2002) 4:365-373
11. MARIA G, CASSETTA E, GUI D, BRISINDA G, BENTIVOGLIO AR, ALBANESE A: A comparison of botulinum toxin and saline for the treatment of chronic anal fissure. N. Engl. J. Med. (1998) 338:217-220.
12. BONI R, KREYDEN OP, BURG G: Revival of the use of botulinum toxin: Application in dermatology. Dermatology. (2000) 200:287-291
13. ACQUADRO MA, BORODIC GE: Treatment of myofascial pain with botulinum a toxin. Anesthesiology. (1994) 80:705-706.
14. AOKI KR: Evidence for antinociceptive activity of botulinum toxin type a in pain management. Headache. (2003) 43(Suppl.1):9-15
15. SCOTT AB: Botulinum toxin injection of eye muscles to correct strabismus. Trans. Am. Ophthalmol. Soc. (1981) 79:734-770
16. BRASHEAR A, LEW MF, DYKSTRA DD et al.: Safety and efficacy of neurobloc (botulinum toxin type b) in type a-responsive cervical dystonia. Neurology. (1999) 53:1439-1446.
17. BRIN MF, LEW MF, ADLER CH et al.: Safety and efficacy of neurobloc (botulinum toxin type b) in type a- resistant cervical dystonia. Neurology. (1999) 53:1431-1438.
18. GREENE PE, FAHN S: Response to botulinum toxin f in seronegative botulinum toxin a- resistant patients. Mov. Disord (1996) 11:181-184.
19. GREENE PE, FAHN S: Use of botulinum toxin type f injections to treat torticollis in patients with immunity to botulinum toxin type a. Mov. Disord. (1993) 8:479-483.
20. HATHEWAY CL: Botulism The present status of the disease. Curr. Top Microbiol. Immunol. (1995) 195:55-75.
21. LEW MF, BRASHEAR A, FACTOR S. The safety and efficacy of botulinum toxin type b in the treatment of patients with cervical dystonia: Summary of three controlled clinical trials. Neurology. (2000) 55:S29-S35.
22. SCHIAVO G, SHONE CC, ROSSETTO O, ALEXANDER FC, MONTECUCCO C: Botulinum neurotoxin serotype f is a zinc endopeptidase specific for vamp/synaptobrevin. J. Biol. Chem. (1993) 268:11516-11519.
23. CHEN R, KARP BI, HALLETT M: Botulinum toxin type f for treatment of dystonia: Long-term experience. Neurology. (1998) 51:1494-1496.
24. DE PAIVA A, ASHTON AC, FORAN P, SCHIAVO G, MONTECUCCO C, DOLLY JO: Botulinum a like type b and tetanus toxins fulfils criteria for being a zinc-dependent protease. J. Neurochem. (1993) 61:2338-2341.
25. BRIN MF, AOKI KR: Botulinum toixn type a: Pharmacology. In: Mayer N, Simpson DM (Eds). Spasticity: Etiology, evaluation, management and the role of botulinum toxin. New York: WeMove; (2002).
26. DE PAIVA A, POULAIN B, LAWRENCE GW, SHONE CC, TAUC L, DOLLY JO: A role for the interchain disulfide or its participating thiols in the internalization of botulinum neurotoxin a revealed by a toxin derivative that binds to ecto-acceptors and inhibits transmitter release intracellularly. J. Biol. Chem. (1993) 268:20838-20844.
27. SIMPSON LL: Pharmacological studies on the subcellular site of action of botulinum toxin type a. J. Pharmacol Exp. Ther. (1978) 206:661-669.
28. DE PAIVA A, MEUNIER FA, MOLGO J, AOKI KR, DOLLY JO: Functional repair of motor endplates after botulinum neurotoxin type a poisoning: Biphasic switch of synaptic activity between nerve sprouts and their parent terminals. Proc. Natl. Acad. Sci. U.S.A. (1999) 96:3200-3205.
29. FAHN S, BRESSMAN SB, MARSDEN CD: Classification of dystonia. Adv. Neurol. (1998) 78:1-10.
30. ALBANESE A, BENTIVOGLIO AR, COLOSIMO C, GALARDI G, MADERNA L, TONALI P: Pretarsal injections of botulinum toxin improve blepharospasm in previously unresponsive patients. J. Neurol. Neurosurg. Psychiatry. (1996) 60:693-694.
31. BLITZER A, BRIN MF, GREENE PE, FAHN S: Botulinum toxin injection for the treatment of oromandibular dystonia. Ann. Otol. Rhinol. Laryngol. (1989) 98:93-97.
32. BLITZER A, BRIN MF, STEWART CF: Botulinum toxin management of spasmodic dysphonia (laryngeal dystonia): A 12-year experience in more than 900 patients. Laryngoscope. (1998) 108:1435-1441.
33. RIVEST J, LEES AJ, MARSDEN CD: Writer's cramp: Treatment with botulinum toxin injections. Mov. Disord. (1991) 6:55-59.
34. BRASHEAR A: The botulinum toxins in the treatment of cervical dystonia. Semin. Neurol. (2001) 21:85-90.
35. FORD B, GREENE PE, LOUIS ED et al.: Intrathecal baclofen in the treatment of dystonia. Adv. Neurol. (1998) 78:199-210.
36. BERTRAND CM: Selective peripheral denervation for spasmodic torticollis: Surgical technique, results, and observations in 260 cases. Surg. Neurol. (1993) 40:96-103.
37. ANDALUZ N, TAHA JM, DALVI A: Bilateral pallidal deep brain stimulation for cervical and truncal dystonia. Neurology (2001) 57:557-558.
38. BRONTE-STEWART H: Surgical therapy for dystonia. Curr. Neurol. Neurosci. Rep. (2003) 3:296-305.
39. BRASHEAR A: Botulinum toxin type b: A new injectable treatment for cervical dystonia. Expert. Opin. Investig. Drugs (2001) 10:2191-2199.
40. JANKOVIC J: Blepharospasm and oromandibular-laryngeal-cervical dystonia: A controlled trial of botulinum a toxin therapy. Adv. Neurol. (1988) 50:583-591.
41. JANKOVIC J, ORMAN J: Botulinum a toxin for cranial-cervical dystonia: A double-blind, placebo-controlled study. Neurology (1987) 37:616-623.
42. LEW MF, ADORNATO BT, DUANE DD et al.: Botulinum toxin type b: A double-blind, placebo-controlled, safety and efficacy study in cervical dystonia. Neurology (1997) 49:701-707.
43. SILBERSTEIN SD: Review of botulinum toxin type a and its clinical applications in migraine headache. Expert Opin. Pharmacother. (2001) 2:1649-1654.
44. FOSTER L, CLAPP L, ERICKSON M, JABBARI B: Botulinum toxin a and chronic low back pain: A randomized, double-blind study. Neurology (2001) 56:1290-1293.
45. ASSESSMENT: The clinical usefulness of botulinum toxin-a in treating neurologic disorders. Report of the Therapeutics and Technology Assessment Subcommittee of the American Academy of Neurology. Neurology (1990) 40:1332-1336.
46. ALLERGAN I. PACKAGE INSERT: botox (botulinum toxin type a purified neurotoxin complex). (2000)
47. ELAN PHARMACEUTICALS I. PACKAGE INSERT: myobloc botulinum toxin type b injectable solution. (2000)
48. CONSKY E, LANG A: Clinical assessments of patients with cervical dystonia. In: Jankovic J, Hallett M (Eds.) Therapy with botulinum toxin. New York: Marcel Dekker, (1994):211-237.
49. O'BRIEN C, BRASHEAR A, CULLIS P et al.: Cervical dystonia severity scale reliability study. Mov. Disord. (2001) 16:1086-1090.
50. COMELLA CL, JANKOVIC J, LEURGANS S, FAN W, CHMURA TA, GROUP DS: Botulinum toxin serotype a compared to b in cervical dystonia: Randomizd, double-blind, parallel study (abstract). Ann. Neurol. (2004) 56:S25.
51. CEBALLOS-BAUMANN AO: Evidence-based medicine in botulinum toxin therapy for cervical dystonia. J. Neurol. (2001) 248(Suppl. 1):14-20.
52. GREENE P, KANG U, FAHN S, BRIN M, MOSKOWITZ C, FLASTER E. Double-blind, placebo-controlled trial of botulinum toxin injections for the treatment of spasmodic torticollis. Neurology (1990) 40:1213-1218.
53. BORODIC GE, MILLS L, JOSEPH M: Botulinum a toxin for the treatment of adult-onset spasmodic torticollis. Plast. Reconstr. Surg. (1991) 87:285-289.
54. JANKOVIC J, SCHWARTZ KS: Longitudinal experience with botulinum toxin injections for treatment of blepharospasm and cervical dystonia. Neurology. (1993) 43:834-836.
55. Botulinum toxin a (allergan). Agn 191622, botox. Drugs R D. (1999) 2:381-382.
56. JANKOVIC J, SCHWARTZ K: Botulinum toxin injections for cervical dystonia. Neurology. (1990) 40:277-280.
57. GELB DJ, LOWENSTEIN DH, AMINOFF MJ: Controlled trial of botulinum toxin injections in the treatment of spasmodic torticollis. Neurology (1989) 39:80-84.
58. BLACKIE JD, LEES AJ: Botulinum toxin treatment in spasmodic torticollis. J. Neurol. Neurosurg. Psychiatry (1990) 53:640-643.
59. COMELLA CL, BUCHMAN AS, TANNER CM, BROWN-TOMS NC, GOETZ CG: Botulinum toxin injection for spasmodic torticollis: Increased magnitude of benefit with electromyographic assistance. Neurology (1992) 42:878-882.
60. BHAUMIK S, BEHARI M: Botulinum toxin a-injection for cervical dystonia. J. Assoc. Physicians India (1999) 47:267-270.
61. HAUSSERMANN P, MARCZOCH S, KLINGER C, LANDGREBE M, CONRAD B, CEBALLOS-BAUMANN A: Long-term follow-up of cervical dystonia patients treated with botulinum toxin a. Mov. Disord. (2004) 19:303-308
62. WISSEL J, KANOVSKY P, RUZICKA E et al.: Efficacy and safety of a standardised 500 unit dose of dysport (clostridium botulinum toxin type a haemaglutinin complex) in a heterogeneous cervical dystonia population: Results of a prospective, multicentre, randomised, double-blind, placebo-controlled, parallel group study. J. Neurol. (2001) 248:1073-1078.
63. BRANS JW, LINDEBOOM R, SNOEK JW et al.: Botulinum toxin versus trihexyphenidyl in cervical dystonia: A prospective, randomized, double-blind controlled trial. Neurology (1996) 46:1066-1072.
64. ODERGREN T, HJALTASON H, KAAKKOLA S et al.: A double blind, randomised, parallel group study to investigate the dose equivalence of dysport and botox in the treatment of cervical dystonia. J. Neurol. Neurosurg. Psychiatry (1998) 64:6-12.
65. SAMPAIO C, FERREIRA JJ, SIMOES F et al.: Dysbot: A single-blind, randomized parallel study to determine whether any differences can be detected in the efficacy and tolerability of two formulations of botulinum toxin type a-dysport and botox-assuming a ratio of 4:1. Mov. Disord. (1997) 12:1013-1018.
66. POEWE W, DEUSCHL G, NEBE A et al.: What is the optimal dose of botulinum toxin a in the treatment of cervical dystonia? Results of a double blind, placebo controlled, dose ranging study using dysport. German dystonia study group. J. Neurol. Neurosurg. Psychiatry (1998) 64:13-17.
67. CULLIS PA, O'BRIEN CF, TRUONG DD, KOLLER M, VILLEGAS TP, WALLACE JD: Botulinum toxin type b: An open-label, dose-escalation, safety and preliminary efficacy study in cervical dystonia patients. Adv. Neurol. (1998) 78:227-230.
68. JANKOVIC J, SCHWARTZ K: Response and immunoresistance to botulinum toxin injections. Neurology (1995) 45:1743-1746.
69. GREENE P, FAHN S, DIAMOND B: Development of resistance to botulinum toxin type a in patients with torticollis. Mov. Disord. (1994) 9:213-217.
70. ZUBER M, SEBALD M, BATHIEN N, DE RECONDO J, RONDOT P: Botulinum antibodies in dystonic patients treated with type a botulinum toxin: Frequency and significance. Neurology (1993) 43:1715-1718.
71. BORODIC GE, DUANE D, PEARCE B, JOHNSON E: Antibodies to botulinum toxin. Neurology (1995) 45:204.
72. HANNA PA, JANKOVIC J: Mouse bioassay versus western blot assay for botulinum toxin antibodies: Correlation with clinical response. Neurology (1998) 50:1624-1629.
73. HANNA PA, JANKOVIC J, VINCENT A: Comparison of mouse bioassay and immunoprecipitation assay for botulinum toxin antibodies. J. Neurol. Neurosurg. Psychiatry (1999) 66:612-616.
74. HAMJIAN JA, WALKER FO: Serial neurophysiological studies of intramuscular botulinum-a toxin in humans. Muscle Nerve (1994) 17:1385-1392.
75. KESSLER KR, BENECKE R: The ebd test-a clinical test for the detection of antibodies to botulinum toxin type a. Mov. Disord. (1997) 12:95-99.
76. JANKOVIC J, VUONG KD, AHSAN J: Comparison of efficacy and immunogenicity of original versus current botulinum toxin in cervical dystonia. Neurology (2003) 60:1186-1188.
77. KESSLER KR, SKUTTA M, BENECKE R: Long-term treatment of cervical dystonia with botulinum toxin a: Efficacy, safety, and antibody frequency. German dystonia study group. J. Neurol. (1999) 246:265-274.
78. FACTOR SA, MOLHO E, EVANS S, FEUSTEL PJ: Efficacy and safety of repeated doses of botulinum toxin type b in type a resistant and responsive cervical dystonia patients (abstract). Mov. Disord. (2004) 19:1124.
79. RANOUX D, GURY C, FONDARAI J, MAS JL, ZUBER M: Respective potencies of botox and dysport: A double blind, randomised, crossover study in cervical dystonia. J. Neurol. Neurosurg. Psychiatry (2002) 72:459-462.