Clinical use of sustained release of
alprazolam: A naturalistic
study
by
De La Gandara Martin JJ, Sanz Granado O,
Varona Martinez A, Such P
Servicio de Psiquiatria,
Hospitales General Yague y Divino Valles,
Burgos,
Espana.
Actas Esp Psiquiatr 1999 May-Jun; 27(3):191-7
ABSTRACT
OBJECTIVES: Alprazolam extended release
formulation (Alprazolam XR) is a new formulation with useful features in
the treatment of pathological anxiety, when compared both to the original
formulation of alprazolam or to other benzodiazepines, as it adds to the
well known properties of alprazolam a sustained clinical effect. The available
investigational clinical trials show good efficacy for this new formulation.
There is the need, however, of observational studies in the clinical setting
that confirm its usefulness. METHODS: We present an observational prospective
naturalistic study of all the pathological anxiety cases that followed treatment
with Alprazolam XR in two psychiatry outpatient centres. Sixty-eight (68)
patients were included in the study. The treatment period was 21 weeks.
In each of the 4 control visits, efficacy (HAMA, GCI, GCI improvement) and
tolerability (adverse events) were assessed, as well as the dose, dosage
pattern and need of change of the medication. RESULTS: Global anxiety (HAMA,
GCI and CGI improvement) showed a significant reduction throughout the study.
There was a reduction in the number of panic
attacks> and in the severity of agoraphobia. Global clinical impression
(efficacy and tolerability) was good or very good in 75% of the patients,
both assessed by the investigator and by the patient. Fifty percent (50%)
of the patients had an adverse event (mainly sedation), most cases being
mild and transient. Fifty-eight percent (58%) of the patients needed a change
in the dosage regimen (dose, number of daily doses), mostly due to clinical
dose adjustment. Some patients needed a change in the dosage due to adverse
events. Sixteen patients that had been treated with the conventional formulation
of alprazolam and started treatment with Alprazolam XR needed a slightly
higher dose of the extended release formulation. In these cases the change
of medication was easy. CONCLUSION: The clinical use of Alprazolam XR in
the treatment of pathological anxiety was useful in most of the patients
(75%). The dose regime was usually 2-3 mg in two daily doses, with a trend
to lower the dose (1-2 mg in a single dose) in the third or fourth control.
The change from the conventional formulation to the extended release was
not difficult in most of the patients.
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