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A double-blind, long-term study of tizanidine ('Sirdalud') in spasticity due to cerebrovascular lesions.
Curr Med Res Opin. 1989; 11(6):398-407.CM

Abstract

A double-blind study was carried out in 30 patients suffering from spasticity due to cerebrovascular lesions to compare the long-term efficacy and tolerability of tizanidine hydrochloride with that of baclofen. A 2-week titration phase identified the optimum dose of tizanidine (max. 20 mg/day) or baclofen (max. 50 mg/day) in each patient. Patients were then treated with this dose for a 50-week maintenance phase. Efficacy and tolerability parameters were evaluated first on a monthly and then on a bimonthly basis. Both tizanidine and baclofen caused an improvement in the symptoms associated with spasticity. In end-point analysis, 87% of patients showed an improvement (p less than 0.01) in excessive muscle tone - the major efficacy parameter in this study - in the tizanidine group, while 79% improved (p less than 0.01) in the baclofen group. Side-effects in the tizanidine group were mild and transient and no patients discontinued the study; in the baclofen group, 3 patients discontinued the study due to severe side-effects. However, both drugs were assessed as effective and fairly well tolerated in the long-term. Although there were no statistically significant differences between the two drugs, the global assessment of antispastic efficacy revealed a nearly significant difference (p = 0.057) in favour of tizanidine and the global assessment of tolerability was also in favour of tizanidine.

Authors+Show Affiliations

Hospital de Clinicas, Instituto de Neurologica, Montevideo, Uruguay.No affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial
Comparative Study
Controlled Clinical Trial
Journal Article
Randomized Controlled Trial

Language

eng

PubMed ID

2651016

Citation

Medici, M, et al. "A Double-blind, Long-term Study of Tizanidine ('Sirdalud') in Spasticity Due to Cerebrovascular Lesions." Current Medical Research and Opinion, vol. 11, no. 6, 1989, pp. 398-407.
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(6):398-407.
Medici, M., Pebet, M., & Ciblis, D. (1989). A double-blind, long-term study of tizanidine ('Sirdalud') in spasticity due to cerebrovascular lesions. Current Medical Research and Opinion, 11(6), 398-407.
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(6):398-407. PubMed PMID: 2651016.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - A double-blind, long-term study of tizanidine ('Sirdalud') in spasticity due to cerebrovascular lesions. AU - Medici,M, AU - Pebet,M, AU - Ciblis,D, PY - 1989/1/1/pubmed PY - 1989/1/1/medline PY - 1989/1/1/entrez SP - 398 EP - 407 JF - Current medical research and opinion JO - Curr Med Res Opin VL - 11 IS - 6 N2 - A double-blind study was carried out in 30 patients suffering from spasticity due to cerebrovascular lesions to compare the long-term efficacy and tolerability of tizanidine hydrochloride with that of baclofen. A 2-week titration phase identified the optimum dose of tizanidine (max. 20 mg/day) or baclofen (max. 50 mg/day) in each patient. Patients were then treated with this dose for a 50-week maintenance phase. Efficacy and tolerability parameters were evaluated first on a monthly and then on a bimonthly basis. Both tizanidine and baclofen caused an improvement in the symptoms associated with spasticity. In end-point analysis, 87% of patients showed an improvement (p less than 0.01) in excessive muscle tone - the major efficacy parameter in this study - in the tizanidine group, while 79% improved (p less than 0.01) in the baclofen group. Side-effects in the tizanidine group were mild and transient and no patients discontinued the study; in the baclofen group, 3 patients discontinued the study due to severe side-effects. However, both drugs were assessed as effective and fairly well tolerated in the long-term. Although there were no statistically significant differences between the two drugs, the global assessment of antispastic efficacy revealed a nearly significant difference (p = 0.057) in favour of tizanidine and the global assessment of tolerability was also in favour of tizanidine. SN - 0300-7995 UR - https://www.unboundmedicine.com/medline/citation/2651016/A_double_blind_long_term_study_of_tizanidine__'Sirdalud'__in_spasticity_due_to_cerebrovascular_lesions_ L2 - https://www.tandfonline.com/doi/full/10.1185/03007998909110141 DB - PRIME DP - Unbound Medicine ER -