Hostname: page-component-8448b6f56d-xtgtn Total loading time: 0 Render date: 2024-04-25T06:08:13.042Z Has data issue: false hasContentIssue false
  • English
  • Français

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 ,
G. Rubio ,
A. Terán ,
G. Cervera ,
V. López-Gómez ,
I. Vilardaga  and
M. Pérez
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: bobes@uniovi.es (J. Bobes).
Get access

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.

Keywords

PregabalinBenzodiazepine dependenceBenzodiazepine withdrawalBenzodiazepine discontinuation
Type
Original articles
Information
European Psychiatry , Volume 27 , Issue 4 , May 2012 , pp. 301 - 307
Copyright
Copyright © Elsevier Masson SAS 2012

Access options

Get access to the full version of this content by using one of the access options below. (Log in options will check for institutional or personal access. Content may require purchase if you do not have access.)

References

Ashton, C.H., Rawlins, M.D., Tyrer, S.P.A double-blind placebo-controlled study of buspirone in diazepam withdrawal in chronic benzodiazepine users. Br J Psychiatry. 1990; 157: 232–238.CrossRefGoogle ScholarPubMed
Ashton, H.The treatment of benzodiazepine dependence. Addiction. 1994; 89: 1535–1541.CrossRefGoogle ScholarPubMed
Ashton, H.The diagnosis and management of benzodiazepine dependence. Curr Opin Psychiatry. 2005; 18: 249–255.CrossRefGoogle ScholarPubMed
Biermann, T., Bleich, S., Kornhuber, J., Hillemacher, T.Pregabalin in benzodiazepine withdrawal. Pharmacopsychiatry. 2007; 40: 292–293.CrossRefGoogle ScholarPubMed
Bobes, J., Badía, X., Luque, A., García, M., González, M.P., Dal-Ré, R.Validation of the Spanish version of the Liebowitz social anxiety scale, social anxiety and distress scale and Sheehan disability inventory for the evaluation of social phobia. Med Clin (Barc). 1999; 112: 530–538.Google ScholarPubMed
Busch, J.A., Strand, J.A., Posvar, E.L., Bockbrader, H.N., Radulovic, L.L.Pregabalin (CI-1008) multiple-dose pharmacokinetics and safety/tolerance in healthy volunteers (abstract). Pharm Sci Suppl. 1999; 4: 2033.Google Scholar
Couvée, J.E., Zitman, F.G.The Benzodiazepine Withdrawal Symptom Questionnaire: psychometric evaluation during a discontinuation program in depressed chronic benzodiazepine users in general practice. Addiction. 2002; 97: 337–345.CrossRefGoogle ScholarPubMed
Crockford, D., White, W.D., Campbell, B.Gabapentin use in benzodiazepine dependence and detoxification. Can J Psychiatry. 2001; 46: 287.CrossRefGoogle ScholarPubMed
de Wet, C., Reed, L., Glasper, A., Moran, P., Bearn, J., Gossop, M.Benzodiazepine co-dependence exacerbates the opiate withdrawal syndrome. Drug Alcohol Depend. 2004; 76: 31–35.CrossRefGoogle ScholarPubMed
Denis C, Fatséas M, Lavie E, Auriacombe M. Pharmacological interventions for benzodiazepine mono-dependence management in outpatient settings. Cochrane Database Syst Rev 2006;3:CD005194.CrossRefGoogle Scholar
DHHS, Substance Abuse and Mental Health Services Administration. Results from the 2006 National Survey on Drug Use and Health: National Findings (Office of Applied Studies, NSDUH Series H-32, DHHS Publication No. SMA 07-4293). Rockville (MD); 2007.Google Scholar
Guy W. ECDEU Assessment Manual for Psychopharmacology – Revised (DHEW Publ No ADM 76–338). Rockville (MD, U.S.). Department of Health, Education, and Welfare, Public Health Service, Alcohol, Drug Abuse, and Mental Health Administration, NIMH Psychopharmacology Research Branch, Division of Extramural Research Programs; 1976. p. 218–22.Google Scholar
Hamilton, M.The assessment of anxiety states by rating. Br J Med Psychol. 1959; 32: 50–55.CrossRefGoogle ScholarPubMed
Hindmarch, I., Dawson, J., Stanley, N.A double-blind study in healthy volunteers to assess the effects on sleep of pregabalin compared with alprazolam and placebo. Sleep. 2005; 28: 187–193.CrossRefGoogle ScholarPubMed
Kazis, L.E., Anderson, J.J., Meenan, R.F.Effect sizes for interpreting changes in health status. Med Care. 1989; 27: 178–189.CrossRefGoogle ScholarPubMed
Lobo, A., Chamorro, L., Luque, A., Dal-Ré, R., Badia, X., Baró, E.Grupo de Validación en Español de Escalas Psicométricas (GVEEP). Validation of the Spanish versions of the Montgomery-Asberg depression and Hamilton anxiety rating scales. Med Clin (Barc). 2002; 118: 493–499.CrossRefGoogle ScholarPubMed
Martínez-Raga, J., Sabater, A., Perez-Galvez, B., Castellano, M., Cervera, G.Add-on gabapentin in the treatment of opiate withdrawal. Prog Neuropsychopharmacol Biol Psychiatry. 2004; 28: 599–601.CrossRefGoogle ScholarPubMed
Martinotti, G., Di Nicola, M., Tedeschi, D., Andreoli, S., Reina, D., Pomponi, M.et al.Pregabalin versus naltrexone in alcohol dependence: results from a multicenter, randomized, double-blind, comparison trial. Eur Neuropsychopharmacol. 18 suppl. 4: 2008 S523 [abstract].CrossRefGoogle Scholar
Montgomery, S.A.Pregabalin for the treatment of generalised anxiety disorder. Expert Opin Pharmacother. 2006; 7: 2139–2154.CrossRefGoogle ScholarPubMed
Murphy, S.M., Tyrer, P.A double-blind comparison of the effects of gradual withdrawal of lorazepam, diazepam and bromazepam in benzodiazepine dependence. Br J Psychiatry. 1991; 158: 511–516.CrossRefGoogle ScholarPubMed
Myrick, H., Malcolm, R., Randall, P.K., Boyle, E., Anton, R.F., Becker, H.C.et al.A Double-Blind Trial of Gabapentin Versus Lorazepam in the Treatment of Alcohol Withdrawal. Alcohol Clin Exp Res. 2009; 33: 1582–1588.CrossRefGoogle ScholarPubMed
Ohayon, M.M., Lader, M.H.Use of psychotropic medication in the general population of France, Germany, Italy, and the United Kingdom. J Clin Psychiatry. 2002; 63: 817–825.CrossRefGoogle ScholarPubMed
Oulis, P., Konstantakopoulos, G., Kouzoupis, A.V., Masdrakis, V.G., Karakatsanis, N.A., Karapoulios, E.et al.Pregabalin in the discontinuation of long-term benzodiazepines’ use. Hum Psychopharmacol. 2008; 23: 337–340.CrossRefGoogle Scholar
Owen, R.T.Pregabalin: its efficacy, safety and tolerability profile in generalized anxiety. Drugs Today (Barc). 2007; 43: 601–610.CrossRefGoogle ScholarPubMed
Paulose-Ram, R., Jonas, B.S., Orwig, D., Safran, M.A.Prescription psychotropic medication use among the U.S. adult population: results from the third National Health and Nutrition Examination Survey, 1988–1994. J Clin Epidemiol. 2004; 57: 309–317.CrossRefGoogle ScholarPubMed
Pfizer Inc. Lyrica. Full prescribing information. Available at: http://www.pfizer.com/files/products/uspi_lyrica.pdf; 2009 [accessed 4.01.10].Google Scholar
Prince, V., Turpin, K.R.Treatment of alcohol withdrawal syndrome with carbamazepine, gabapentin, and nitrous oxide. Am J Health Syst Pharm. 2008; 65: 1039–1047.CrossRefGoogle ScholarPubMed
Rickels, K., DeMartinis, N., García-España, F., Greenblatt, D.J., Mandos, L.A., Rynn, M.Imipramine and buspirone in treatment of patients with generalized anxiety disorder who are discontinuing long-term benzodiazepine therapy. Am J Psychiatry. 2000; 157: 1973–1979.CrossRefGoogle ScholarPubMed
Rickels, K., Schweizer, E., Garcia España, F., Case, G., DeMartinis, N., Greenblatt, D.Trazodone and valproate in patients discontinuing long-term benzodiazepine therapy: effects on withdrawal symptoms and taper outcome. Psychopharmacology (Berl). 1999; 141: 1–5.CrossRefGoogle ScholarPubMed
Rosenbaum, J.F.Attitudes toward benzodiazepines over the years. J Clin Psychiatry. 66 suppl. 2: 2005 4–8.Google ScholarPubMed
Schweizer, E., Rickels, K., Case, W.G., Greenblatt, D.J.Carbamazepine treatment in patients discontinuing long-term benzodiazepine therapy. Effects on withdrawal severity and outcome. Arch Gen Psychiatry. 1991; 48: 448–452.CrossRefGoogle ScholarPubMed
Sheehan, D.V., Harnett-Sheehan, K., Raj, B.A.The measurement of disability. Int Clin Psychopharmacol. 11 Suppl. 1996 S89–S95.CrossRefGoogle ScholarPubMed
Stein, D.J., Baldwin, D.S., Baldinetti, F., Mandel, F.Efficacy of pregabalin in depressive symptoms associated with generalized anxiety disorder: a pooled analysis of 6 studies. Eur Neuropsychopharmacol. 2008; 18: 422–430.CrossRefGoogle ScholarPubMed
Tassone, D.M., Boyce, E., Guyer, J., Nuzum, D.Pregabalin: a novel gamma-aminobutyric acid analogue in the treatment of neuropathic pain, partial-onset seizures, and anxiety disorders. Clin Ther. 2007; 29: 26–48.CrossRefGoogle ScholarPubMed
Tyrer, P., Murphy, S., Riley, P.The Benzodiazepine Withdrawal Symptom Questionnaire. J Affect Disord. 1990; 19: 53–61.CrossRefGoogle ScholarPubMed
Vorma, H., Naukkarinen, H., Sarna, S., Kuoppasalmi, K.Treatment of out-patients with complicated benzodiazepine dependence: comparison of two approaches. Addiction. 2002; 97: 851–859.CrossRefGoogle ScholarPubMed
Voshaar, R.C., Couvée, J.E., van Balkom, A.J., Mulder, P.G., Zitman, F.G.Strategies for discontinuing long-term benzodiazepine use: meta-analysis. Br J Psychiatry. 2006; 189: 213–220.CrossRefGoogle ScholarPubMed
Submit a response

Comments

No Comments have been published for this article.