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Pregabalin for the discontinuation of long-term benzodiazepines use: An assessment of its effectiveness in daily clinical practice

Published online by Cambridge University Press:  15 April 2020

J. Bobes*
Affiliation:
School of Medicine, Psychiatry Department, University of Oviedo, Centro de Investigación Biomédica en Red de Salud Mental, CIBERSAM. Julián Clavería, 6 33006Oviedo, Spain
G. Rubio
Affiliation:
Department of Psychiatry, Hospital 12 de Octubre. Avda de Córdoba s/n28041Madrid, Spain
A. Terán
Affiliation:
Center for Drug Dependence Treatment San Juan de Dios. Paseo Padre Faustino Calvo s/n, apartado 66, 34005Palencia, Spain
G. Cervera
Affiliation:
Department of Psychiatry, Hospital Clínico Universitario, Avda. Blasco Ibañez, 17 46010Valencia, Spain
V. López-Gómez
Affiliation:
Medical Unit, Pfizer España. Avda. Europa, 20B, Parque Empresarial La Moraleja 28108 Alcobendas, Madrid, Spain
I. Vilardaga
Affiliation:
European Biometrics Institute. C/ Diputación, 284 4ª 08009 Barcelona, Spain
M. Pérez
Affiliation:
Medical Unit, Pfizer España. Avda. Europa, 20B, Parque Empresarial La Moraleja 28108 Alcobendas Madrid, Spain
*
*Corresponding author. Tel.: +34 985 10 35 53; fax: +34 985 10 35 53. E-mail address: [email protected] (J. Bobes).
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Abstract

Purpose

To evaluate the effectiveness and tolerability of pregabalin in the management of the discontinuation of benzodiazepines in long-term users.

Subjects and methods

We performed a 12-week, prospective, uncontrolled, non-interventional, and observational study in patients aged 18 years old or above, who met DSM-IV-TR criteria for benzodiazepine dependence without other major psychiatry disorder. Evaluations included the Benzodiazepine Withdrawal Symptom Questionnaire, the Hamilton Anxiety Rating Scale, the Clinical Global Impression Scale, and the Sheehan Disability Scale. A urine drug screen for benzodiazepines was performed at baseline and every 4 weeks thereafter. The primary effectiveness variable was success rate, defined as achievement of benzodiazepine-free status at week 12 according to the urine drug screen.

Results and discussion

The mean dose at week 12 was 315 (±166) mg/day. The success rate of the benzodiazepine taper in the primary efficacy population (n = 282) was 52% (95% confidence interval [CI], 46–58). Success rates for women and men were 58% (95% CI, 49–67) and 46% (95% CI, 38–55), respectively. The success rates did not differ according to either the benzodiazepine of abuse or the presence of other substance use disorders. Significant and clinically relevant improvements were observed in withdrawal and anxiety symptoms, as well as in patients’ functioning. At week 12, tolerability was rated as good or excellent by 90% and 83% of the clinicians and patients, respectively.

Conclusion

Our results suggest that pregabalin is an efficacious and well-tolerated adjunctive treatment for benzodiazepine withdrawal.

Type
Original articles
Copyright
Copyright © Elsevier Masson SAS 2012

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