Linked Life Data

15885050

Source:http://linkedlifedata.com/resource/pubmed/id/15885050

Statements in which the resource exists as a subject.
PredicateObject
rdf:type
lifeskim:mentions
pubmed:issue
6
pubmed:dateCreated
2005-5-11
pubmed:abstractText
To study the efficacy and safety of tolperisone - a centrally acting muscle relaxant with membrane stabilizing activity - in the treatment of stroke-related spasticity. This was a randomized, double-blind, placebo-controlled, multicenter study with parallel groups. Treatment lasted 12 weeks and was started with a titration period of variable length (dose range 300-900 mg tolperisone daily). The degree of spasticity determined on the Ashworth Scale in the most severely affected joint area was defined as primary target parameter. Hundred and twenty patients (43 females, 77 males) in a mean age of 63.3 +/- 10.6 years were recruited and received treatment. In the majority of patients both limbs of each side (right: n = 59; left: n = 56) were affected by the spasticity which on average had been present for 3.3 +/- 4.4 years. A 62% of the patients were treated with a daily dose >/=600 mg tolperisone. Tolperisone reduced the mean Ashworth Score by a mean of 1.03 +/- 0.71 compared with a mean reduction of 0.47 +/- 0.54 in the placebo group (P < 0.0001). A 78.3% of the patients on tolperisone versus 45% of the placebo patients experienced a reduction by at least 1 point on the Ashworth Scale (P < 0.0001). Functional and overall assessments of efficacy confirmed superior efficacy of tolperisone. Adverse events occurred less often on active treatment (n = 19) than on placebo (n = 26) and were mostly of mild-to-moderate intensity. No withdrawals caused by adverse events were reported in the tolperisone group. The findings of the present study demonstrate the efficacy and excellent tolerance of tolperisone in the treatment of spastic hypertonia following cerebral stroke. Study data further suggest that an individual dose titration which may exceed the recommended maximum dose of 450 mg daily results in optimized therapeutic benefit.
pubmed:language
eng
pubmed:journal
pubmed:citationSubset
IM
pubmed:chemical
pubmed:status
MEDLINE
pubmed:month
Jun
pubmed:issn
1351-5101
pubmed:author
pubmed:issnType
Print
pubmed:volume
12
pubmed:owner
NLM
pubmed:authorsComplete
Y
pubmed:pagination
453-61
pubmed:dateRevised
2007-11-15
pubmed:meshHeading
pubmed:year
2005
pubmed:articleTitle
A randomized, double-blind, placebo-controlled study of the efficacy and safety of tolperisone in spasticity following cerebral stroke.
pubmed:affiliation
University Hospital Queen Giovanna, Sofia, Bulgaria.
pubmed:publicationType
Journal Article, Clinical Trial, Comparative Study, Randomized Controlled Trial, Multicenter Study