Long-term efficacy of botulinum toxin A for treatment of blepharospasm, hemifacial spasm, and spastic entropion: a multicentre study using two drug-dose escalation indexes.

Abstract

PURPOSE:

To investigate the long-term effectiveness and safety of botulinum neurotoxin A (BoNT-A) treatment in patients with blepharospasm (BEB), hemifacial spasm (HFS), and entropion (EN) and to use for the first time two modified indexes, 'botulin toxin escalation index-U' (BEI-U) and 'botulin toxin escalation index percentage' (BEI-%), in the dose-escalation evaluation.

METHODS:

All patients in this multicentre study were followed for at least 10 years and main outcomes were clinical efficacy, duration of relief, BEI-U and BEI-%, and frequency of adverse events.

RESULTS:

BEB, HFS, and EN patients received a mean BoNT-A dose with a significant inter-group difference (P<0.0005, respectively). The mean (+/-SD) effect duration was statistically different (P=0.009) among three patient groups. Regarding the BoNT-A escalation indexes, the mean (+/-SD) values of BEI-U and BEI-% were statistically different (P=0.035 and 0.047, respectively) among the three groups. In BEB patients, the BEI-% was significantly increased in younger compared with older patients (P=0.008). The most frequent adverse events were upper lid ptosis, diplopia, ecchymosis, and localized bruising.

CONCLUSIONS:

This long-term multicentre study supports a high efficacy and good safety profile of BoNT-A for treatment of BEB, HFS, and EN. The BEI indexes indicate a significantly greater BoNT-A-dose escalation for BEB patients compared with HFS or EN patients and a significantly greater BEI-% in younger vsolder BEB patients. These results confirm a greater efficacy in the elderly and provide a framework for long-term studies with a more flexible and reliable evaluation of drug-dose escalation.

• Authors: S Cillino, G Raimondi, N Guépratte, S Damiani, M Cillino, F Di Pace, A Casuccio
• Journal: Eye (London, England) (Eye (Lond)) Vol. 24 Issue 4 Pg. 600-7 (Apr 2010) ISSN: 1476-5454 [Electronic] England
• PMID: 19648904 (Publication Type: Journal Article, Multicenter Study)

Chemical References

• Drug Combinations
• Neuromuscular Agents
• Botulinum Toxins, Type A

Topics

• Aged
• Aged, 80 and over
• Blepharospasm (drug therapy)
• Botulinum Toxins, Type A (administration & dosage, therapeutic use)
• Dose-Response Relationship, Drug
• Drug Combinations
• Entropion (drug therapy)
• Female
• Follow-Up Studies
• Hemifacial Spasm (drug therapy)
• Humans
• Longitudinal Studies
• Male
• Middle Aged
• Muscle Spasticity (drug therapy)
• Neuromuscular Agents (administration & dosage, therapeutic use)