DI-094 Botulinum toxin type a for the treatment of neurological diseases: drug utilisation review

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Abstract

Background

Neurology is one of the medical specialities in which botulinum toxin (BT) provides greater therapeutic benefits due to its ability to produce muscle paralysis, which can be used to treat certain neurological diseases involving muscle hyperactivity.

Purpose

To analyse the prescription profile of BT type A in neurological diseases and prescription suitability based on the data sheet, comparing the frequency of administration between the different approved indications.

Material and methods

A retrospective observational study of the prescription profile and frequency of administration of BT was conducted in the neurology department of a third level hospital. All patients with at least two administrations of BT were included during the period January and September 2016. Prescription suitability was determined based on the approved indications in the drug data sheet of the three BT type A available in the hospital: Botox, Dysport and Xeomin. Data were collected from clinical histories and outpatient dispensing software Farmatools. ANOVA test (SPSS) was used to compare differences between the frequency of administration of each approved indication.

Results

83 patients were included. 79% received BT for one approved indication. Hemifacial spasm was the most common authorised diagnosis (31%), followed by blepharospasm (13%), different types of spasticity (13%), migraine (12%) and cervical dystonia (10%). The average frequency of administration in patients with hemifacial spasm, cervical dystonia, spasticity (stroke or cerebral palsy origin) and blepharospasm were 6.1 months (95% CI 5.1–7.0); 5.0 months (95% CI 4.1–5.9); 4.6 months (95% CI 3.5–5.7); and 4.6 months (95% CI 3.9–5.7), respectively (p=0.332). The frequency of injection in patients with migraine was 3.8 months (95% CI 2.9–3.9), existing differences that were statistically significant with the hemifacial spasm indication (p=0.009). In 17 patients, BT was used in off-label indications: dystonia (generalised, cranial and oropharyngeal) (n=9); writer’s cramp (n=5); bruxism (n=2); and facial pain (n=1).

Conclusion

BT was used in a high percentage for approved indications (79%), hemifacial spasm being the most prevalent. Significant differences in the frequency of administration between migraine and hemifacial spasm were observed. The more common off-label indications were dystonia and writer’s cramp.

References and/or acknowledgements

Botox, XeominandDysport data sheet (available at https://www.aemps.gob.es/cima).

References and/or acknowledgements

No conflict of interest

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