link.springer.com

Pregabalin: A Review of its Use in Adults with Generalized Anxiety Disorder - CNS Drugs

  • ️Frampton, James E.
  • ️Sat Aug 23 2014
  • Baldwin DS, Ajel K, Masdrakis VG, et al. Pregabalin for the treatment of generalized anxiety disorder: an update. Neuropsychiatr. 2013;9:883–92.

    CAS  Google Scholar 

  • Katzman MA. Current considerations in the treatment of generalized anxiety disorder. CNS Drugs. 2009;23(2):103–20.

    Article  CAS  PubMed  Google Scholar 

  • Both C, Kojda G, Lange-Asschenfeldt C. Pharmacotherapy of generalized anxiety disorder: focus and update on pregabalin. Expert Rev Neurother. 2014;14(1):29–38.

    Article  CAS  PubMed  Google Scholar 

  • Brown TA, O’Leary TA, Barlow DH. Chapter 4. Generalized anxiety disorder. In: Barlow DH, editor. Clinical handbook of psychological disorders. 3rd ed. New York: Guilford Press; 2001. p. 154–208. http://commonweb.unifr.ch/artsdean/pub/gestens/f/as/files/4660/21992_121827.pdf. Accessed 28 Apr 2014.

  • Hoffman DL, Dukes EM, Wittchen HU. Human and economic burden of generalized anxiety disorder. Depress Anxiety. 2008;25(1):72–90.

    Article  PubMed  Google Scholar 

  • Carter RM, Wittchen HU, Pfister H, et al. One-year prevalence of subthreshold and threshold DSM-IV generalized anxiety disorder in a nationally representative sample. Depress Anxiety. 2001;13:78–88.

    Article  CAS  PubMed  Google Scholar 

  • Hunt C, Slade T, Andrews G. Generalized anxiety disorder and major depressive disorder comorbidity in the National Survey of Mental Health and Well-Being. Depress Anxiety. 2004;20(1):23–31.

    Article  PubMed  Google Scholar 

  • Aina Y, Susman JL. Understanding comorbidity with depression and anxiety disorders. J Am Osteopath Assoc. 2006;106(5 Suppl 2):S9–14.

    PubMed  Google Scholar 

  • Kanwar A, Malik S, Prokop LJ, et al. The association between anxiety disorders and suicidal behaviours: a systematic review and meta-analysis. Depress Anxiety. 2013;30(10):917–29.

    PubMed  Google Scholar 

  • Dumais A, Lesage AD, Alda M, et al. Risk factors for suicide completion in major depression: a case–control study of impulsive and aggressive behaviors in men. Am J Psychiatry. 2005;162(11):2116–24.

    Article  CAS  PubMed  Google Scholar 

  • National Collaborating Centre for Mental Health. Generalized anxiety disorder in adults—the NICE guideline on management in primary, secondary and community care. 2011. http://www.nice.org.uk/nicemedia/live/13314/52667/52667.pdf. Accessed 7 May 2014.

  • Hoge EA, Ivkovic A, Fricchione GL. Generalized anxiety disorder: diagnosis and treatment. BMJ. 2012;345:e7500. doi:10.1136/bmj.e7500.

  • Bandelow B, Zohar J, Hollander E, et al. World Federation of Societies of Biological Psychiatry (WFSBP) guidelines for the pharmacological treatment of anxiety, obsessive–compulsive and post-traumatic stress disorders—first revision. World J Biol Psychiatry. 2008;9(4):248–312.

    Article  PubMed  Google Scholar 

  • Hoffman SG, Smits JAJ. Cognitive-behavioral therapy for adult anxiety disorders: a meta-analysis of randomized, placebo-controlled trials. J Clin Psychiatry. 2008;69(4):621–32.

    Article  Google Scholar 

  • Uptodate®. Psychotherapy for generalized anxiety disorder. 2013. http://www.uptodate.com/contents/psychotherapy-for-generalized-anxiety-disorder. Accessed 27 Feb 2014.

  • Bandelow B, Sher L, Bunevicius R, et al. Guidelines for the pharmacological treatment of anxiety disorders, obsessive–compulsive disorder and posttraumatic stress disorder in primary care. Int J Psychiatry Clin Pract. 2012;16(2):77–84.

    Article  CAS  PubMed  Google Scholar 

  • Pfizer Limited. Lyrica [25, 50, 75, 100, 200, 225 and 300 mg hard capsules; 20 mg/mL oral solution]: EU summary of product characteristics. 2013. http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/000546/WC500046602.pdf. Accessed 26 Feb 2014.

  • Frampton JE, Foster RH. Pregabalin: in the treatment of generalised anxiety disorder. [Erratum appears in CNS Drugs. 2007;21(6):481]. CNS Drugs. 2006;20(8):685–93 (discussion 94–5).

  • Ben-Menachem E. Pregabalin pharmacology and its relevance to clinical practice. Epilepsia. 2004;45(Suppl 6):13–8.

    Article  CAS  PubMed  Google Scholar 

  • Tassone DM, Boyce E, Guyer J, et al. Pregabalin: a novel γ-aminobutyric acid analogue in the treatment of neuropathic pain, partial-onset seizures, and anxiety disorders. Clin Ther. 2007;29(1):26–48.

    Article  CAS  PubMed  Google Scholar 

  • Micó JA, Prieto R. Elucidating the mechanism of action of pregabalin: α2δ as a therapeutic target in anxiety. CNS Drugs. 2012;26(8):637–48.

    Article  PubMed  Google Scholar 

  • Bockbrader HN, Wesche D, Miller R, et al. A comparison of the pharmacokinetics and pharmacodynamics of pregabalin and gabapentin. Clin Pharmacokinet. 2010;49(10):661–9.

    Article  CAS  PubMed  Google Scholar 

  • Bockbrader HN, Radulovic LL, Posvar EL, et al. Clinical pharmacokinetics of pregabalin in healthy volunteers. J Clin Pharmacol. 2010;50(8):941–50.

    Article  CAS  PubMed  Google Scholar 

  • Field MJ, Cox PJ, Stott E, et al. Identification of the alpha2-delta-1 subunit of voltage-dependent calcium channels as a molecular target for pain mediating the analgesic actions of pregabalin. Proc Natl Acad Sci USA. 2006;103(46):17537–42.

    Article  CAS  PubMed Central  PubMed  Google Scholar 

  • Taylor CP, Angelotti T, Fauman E. Pharmacology and mechanism of action of pregabalin: the calcium channel alpha2-delta (alpha2-delta) subunit as a target for antiepileptic drug discovery. Epilepsy Res. 2007;73(2):137–50.

    Article  CAS  PubMed  Google Scholar 

  • Bellioti TR, Capiris T, Ekhato IV, et al. Structure-activity relationships of pregabalin and analogues that target the alpha(2)-delta protein. J Med Chem. 2005;48(7):2294–307.

    Article  Google Scholar 

  • Lotarski SM, Donevan S, El-Kattan A, et al. Anxiolytic-like activity of pregabalin in the Vogel conflict test in alpha2-1 (R217A) and alpha2-2 (R279A) mouse mutants. J Pharmacol Exp Ther. 2011;338(2):615–21.

    Article  CAS  PubMed  Google Scholar 

  • Randinitis EJ, Posvar EL, Alvey CW, et al. Pharmacokinetics of pregabalin in subjects with various degrees of renal function. J Clin Pharmacol. 2003;43(3):277–83.

    Article  CAS  PubMed  Google Scholar 

  • Corrigan BW, Pool WF, Posvar EL. Metabolic disposition of pregabalin in healthy volunteers [abstract no. PI-68]. Clin Pharmacol Ther. 2001;69:P18.

    Google Scholar 

  • Pande AC, Crockatt JG, Feltner DE, et al. Pregabalin in generalized anxiety disorder: a placebo-controlled trial. Am J Psychiatry. 2003;160(3):533–40.

    Article  PubMed  Google Scholar 

  • Feltner DE, Crockatt JG, Dubovsky SJ, et al. A randomized, double-blind, placebo-controlled, fixed-dose, multicenter study of pregabalin in patients with generalized anxiety disorder. J Clin Psychopharmacol. 2003;23(3):240–9.

    CAS  PubMed  Google Scholar 

  • Rickels K, Pollack MH, Feltner DE, et al. Pregabalin for treatment of generalized anxiety disorder: a 4-week, multicenter, double-blind, placebo-controlled trial of pregabalin and alprazolam. Arch Gen Psychiatry. 2005;62(9):1022–30.

    Article  CAS  PubMed  Google Scholar 

  • Kasper S, Herman B, Nivoli G, et al. Efficacy of pregabalin and venlafaxine-XR in generalized anxiety disorder: results of a double-blind, placebo-controlled 8-week trial. Int Clin Psychopharmacol. 2009;24(2):87–96.

    Article  PubMed  Google Scholar 

  • Hadley SJ, Mandel FS, Schweizer E. Switching from long-term benzodiazepine therapy to pregabalin in patients with generalized anxiety disorder: a double-blind, placebo-controlled trial. J Psychopharmacol (Oxf). 2012;26(4):461–70.

    Article  CAS  Google Scholar 

  • Montgomery SA, Tobias K, Zornberg GL, et al. Efficacy and safety of pregabalin in the treatment of generalized anxiety disorder: a 6-week, multicenter, randomized, double-blind, placebo-controlled comparison of pregabalin and venlafaxine. J Clin Psychiatry. 2006;67(5):771–82.

    Article  CAS  PubMed  Google Scholar 

  • Rickels K, Shiovitz TM, Ramey TS, et al. Adjunctive therapy with pregabalin in generalized anxiety disorder patients with partial response to SSRI or SNRI treatment. Int Clin Psychopharmacol. 2012;27(3):142–50.

    Article  PubMed  Google Scholar 

  • Kasper S, Iglesias-Garcia C, Schweizer E, et al. Pregabalin long-term treatment and assessment of discontinuation in patients with generalized anxiety disorder. Int J Neuropsychopharmacol. 2014;17(5):685–95.

    Article  CAS  PubMed  Google Scholar 

  • Feltner D, Wittchen H-U, Kavoussi R, et al. Long-term efficacy of pregabalin in generalized anxiety disorder. Int Clin Psychopharmacol. 2008;23(1):18–28.

    Article  PubMed  Google Scholar 

  • Montgomery S, Chatamra K, Pauer L, et al. Efficacy and safety of pregabalin in elderly people with generalised anxiety disorder. Br J Psychiatry. 2008;193(5):389–94.

    Article  PubMed  Google Scholar 

  • Pohl RB, Feltner DE, Fieve RR, et al. Efficacy of pregabalin in the treatment of generalized anxiety disorder: double-blind, placebo-controlled comparison of BID versus TID dosing. J Clin Psychopharmacol. 2005;25(2):151–8.

    Article  CAS  PubMed  Google Scholar 

  • Pande AC, Crockatt JG, Janney C, et al. Three randomised, placebo-controlled double-blind trials of pregabalin treatment of generalised anxiety disorder (GAD) [abstract no. P.3.025]. Int J Neuropsychopharmacol. 2000;3(Suppl 1):S344.

    Google Scholar 

  • European Medicines Agency. Product name: LYRICA. Product no. EMEA/H/C00546/II0004. Scientific discussion. 2005. http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Scientific_Discussion_-_Variation/human/000546/WC500046605.pdf. Accessed 7 Mar 2014.

  • Stein DJ, Bruce Lydiard R, Herman BK, et al. Impact of gastrointestinal symptoms on response to pregabalin in generalized anxiety disorder: results of a six-study combined analysis. Int Clin Psychopharmacol. 2009;24(3):126–32.

    Article  PubMed  Google Scholar 

  • Montgomery SA, Herman BK, Schweizer E, et al. The efficacy of pregabalin and benzodiazepines in generalized anxiety disorder presenting with high levels of insomnia. Int Clin Psychopharmacol. 2009;24(4):214–22.

    Article  PubMed  Google Scholar 

  • Stein DJ, Baldwin DS, Baldinetti F, et al. Efficacy of pregabalin in depressive symptoms associated with generalized anxiety disorder: a pooled analysis of 6 studies. Eur Neuropsychopharmacol. 2008;18(6):422–30.

    Article  CAS  PubMed  Google Scholar 

  • Boschen MJ. Pregabalin: dose-response relationship in generalized anxiety disorder. Pharmacopsychiatry. 2012;45(2):51–6.

    Article  CAS  PubMed  Google Scholar 

  • Lydiard RB, Rickels K, Herman B, et al. Comparative efficacy of pregabalin and benzodiazepines in treating the psychic and somatic symptoms of generalized anxiety disorder. Int J Neuropsychopharmacol. 2010;13(2):229–41.

    Article  CAS  PubMed  Google Scholar 

  • Boschen MJ. A meta-analysis of the efficacy of pregabalin in the treatment of generalized anxiety disorder. Can J Psychiatry. 2011;56(9):558–66.

    PubMed  Google Scholar 

  • Bech P. Dose-response relationship of pregabalin in patients with generalized anxiety disorder. A pooled analysis of four placebo-controlled trials. Pharmacopsychiatry. 2007;40(4):163–8.

    Article  CAS  PubMed  Google Scholar 

  • Pollack MH, Walsh T, Cohn CK, et al. Pregabalin in GAD: efficacy in clinically-relevant subtypes [abstract no. NR224]. 157th Annual Meeting of the American Psychiatric Association; 1–6 May 2004; New York (NY).

  • Pollack M. Pregabalin in generalized anxiety disorder: influence of subsyndromic depression [abstract no. P.3.056]. Eur Neuropsychopharmacol. 2003;13(Suppl 4):377.

    Article  Google Scholar 

  • Montgomery SA, Rickels K, Bielski RJ. Pregabalin in GAD: speed of onset [abstract no. NR775]. 156th American Psychiatric Association Annual Meeting; 17–22 May 2003; San Francisco (CA).

  • Montgomery SA. Pregabalin in generalized anxiety disorder: speed of onset [abstract no. P.3.054]. Eur Neuropsychopharmacol. 2003;13(Suppl 4):376–7.

    Article  Google Scholar 

  • Montgomery SA. Pregabalin for the treatment of generalised anxiety disorder. Expert Opin Pharmacother. 2006;7(15):2139–54.

    Article  CAS  PubMed  Google Scholar 

  • Montgomery S, Emir B, Haswell H, et al. Long-term treatment of anxiety disorders with pregabalin: a 1 year open-label study of safety and tolerability. Curr Med Res Opin. 2013;29(10):1223–30.

    Article  CAS  PubMed  Google Scholar 

  • Montgomery S, Kasper S. Pharmacotherapy update: pregabalin in the treatment of generalized anxiety disorder. Clin Med Insights Ther. 2010;2:189–202.

    Article  CAS  Google Scholar 

  • Boehm G, Hughes ATD. NDA: 21-446, 21-273, 21-724; drug: pregabalin (Lyrica). Review and evaluation of clinical data: NDA safety review. 2004. http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/021724s000_MedR_P2.pdf and http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/021724s000_MedR_P3.pdf. Accessed 5 Apr 2014.

  • Zaccara G, Perucca P, Gangemi PF. The adverse event profile of pregabalin across different disorders: a meta-analysis. Eur J Clin Pharmacol. 2012;68(6):903–12.

    Article  CAS  PubMed  Google Scholar 

  • Zaccara G, Gangemi P, Perucca P, et al. The adverse event profile of pregabalin: a systematic review and meta-analysis of randomized controlled trials. Epilepsia. 2011;52(4):826–36.

    Article  CAS  PubMed  Google Scholar 

  • Hindmarch I, Dawson J, Stanley N. A double-blind, placebo- and positive-internal-controlled (alprazolam) investigation of the cognitive and psychomotor profile of pregabalin in healthy volunteers. Psychopharmacology (Berl). 2005;183:133–43.

    Article  CAS  Google Scholar 

  • Cabrera J, Emir B, Dills D, et al. Characterizing and understanding body weight patterns in patients treated with pregabalin. Curr Med Res Opin. 2012;28(6):1027–37.

    Article  CAS  PubMed  Google Scholar 

  • Schwan S, Sundstrom A, Stjernberg E, et al. A signal for an abuse liability for pregabalin-results from the Swedish spontaneous adverse drug reaction reporting system. Eur J Clin Pharmacol. 2010;66(9):947–53.

    Article  PubMed  Google Scholar 

  • Filipetto FA, Zipp CP, Coren JS. Potential for pregabalin abuse or diversion after past drug-seeking behavior. J Am Osteopath Assoc. 2010;110(10):605–7.

    PubMed  Google Scholar 

  • Chalabianloo F, Schjøtt J. Pregabalin and its potential for abuse [Article in Norwegian]. Tidsskr Nor Laegeforen. 2009;129(3):186–7.

    Article  PubMed  Google Scholar 

  • Miguel LS, Miguel NS, Inês M. A cost-utility analysis of pregabalin versus venlafaxine XR in the treatment of generalized anxiety disorder in Portugal. Cost Eff Resour Alloc. 2013;2013(11):8.

    Article  Google Scholar 

  • Vera-Llonch M, Dukes E, Rejas J, et al. Cost-effectiveness of pregabalin versus venlafaxine in the treatment of generalized anxiety disorder: findings from a Spanish perspective. Eur J Health Econ. 2010;11(1):35–44.

    Article  PubMed Central  PubMed  Google Scholar 

  • De Salas-Cansado M, Olivares JM, Álvarez E, et al. Pregabalin versus SSRIs and SNRIs in benzodiazepine-refractory outpatients with generalized anxiety disorder: a post hoc cost-effectiveness analysis in usual medical practice in Spain. Clinicoecon. 2012;4:157–68.

    Google Scholar 

  • De Salas-Cansado M, Álvarez E, Olivares JM, et al. Modelling the cost-effectiveness of pregabalin versus usual care in daily practice in the treatment of refractory generalised anxiety disorder in Spain. Soc Psychiatry Psychiatr Epidemiol. 2013;48(6):985–96.

    Article  PubMed  Google Scholar 

  • Carrasco JL, Olivares JM, Álvarez E, et al. Cost-effectiveness of pregabalin versus usual care in duloxetine-refractory out-patients with generalized anxiety disorder: an economic evaluation under medical usual practice in mental health centers [poster]. International Society for Pharmacoeconomics and Outcomes Research 12th Annual European Congress; 24–27 Oct 2009; Paris.

  • Carrasco JL, Olivares JM, Álvarez E, et al. Adjunctive therapy with pregabalin in generalized anxiety disorder patients with partial response to SSRI treatment: a cost-consequences analysis in medical practice in Spain [poster]. International Society for Pharmacoeconomics and Outcomes Research 16th Annual European Congress; 2–6 Nov 2013; Dublin.

  • Carrasco JL, Álvarez E, Olivares JM, et al. A comparative cost-analysis of initiating pregabalin or SSRI/SNRI therapy in benzodiazepine-resistant patients with generalized anxiety disorder in Spain. Actas Esp Psiquiatr. 2013;41(3):164–74.

    PubMed  Google Scholar 

  • Löfroth E, Myrén KJ, Sandelin R. Cost impact of initiating pregabalin treatment in Swedish patients with generalized anxiety disorder [poster]. International Society for Pharmacoeconomics and Outcomes Research 13th Annual European Congress; 6–9 Nov 2010; Prague.

  • Mavranezouli I, Meader N, Cape J, et al. The cost effectiveness of pharmacological treatments for generalized anxiety disorder. Pharmacoeconomics. 2013;31(4):317–33.

    Article  PubMed  Google Scholar 

  • Álvarez E, Carrasco JL, Olivares JM, et al. Broadening of generalized anxiety disorders definition does not affect the response to psychiatric care: findings from the observational ADAN study. Clin Pract Epidemiol Men Health. 2012;8:158–68.

    Article  Google Scholar 

  • Wensel TM, Powe KW, Cates ME. Pregabalin for the treatment of generalized anxiety disorder. Ann Pharmacother. 2012;46(3):424–9.

    Article  PubMed  Google Scholar 

  • Spina E, Santoro V, D’Arrigo C. Clinically relevant pharmacokinetic drug interactions with second-generation antidepressants: an update. Clin Ther. 2008;30(7):1206–27.

    Article  CAS  PubMed  Google Scholar 

  • Parke-Davis Div of Pfizer Inc. Lyrica (pregabalin) capsules, oral solution: US prescribing information. 2013. http://labeling.pfizer.com/ShowLabeling.aspx?id=561. Accessed 24 Jun 2014.

  • Kasper S, Brasser M, Schweizer E, et al. How well do randomized controlled trial data generalize to ‘real-world’ clinical practice settings? A comparison of two generalized anxiety disorder studies. Eur Neuropsychopharmacol. 2014;24(1):125–32.

    Article  CAS  PubMed  Google Scholar 

  • Holsboer-Trachsler E, Prieto R. Effects of pregabalin on sleep in generalized anxiety disorder. Int J Neuropsychopharmacol. 2013;16(4):925–36.

    Article  CAS  PubMed  Google Scholar 

  • Fricchione GL. Generalized anxiety disorder. N Engl J Med. 2004;351(7):675–82.

    Article  CAS  PubMed  Google Scholar 

  • Samuel M, Zimovetz EA, Gabriel Z, et al. Efficacy and safety of treatments for refractory generalized anxiety disorder: a systematic review. Int Clin Psychopharmacol. 2011;26(2):63–8.

    Article  PubMed  Google Scholar 

  • Bandelow B, Wedekind D, Leon T. Pregabalin for the treatment of generalized anxiety disorder: a novel pharmacologic intervention. Expert Rev Neurother. 2007;7(7):769-81.

  • Hidalgo RB, Tupler LA, Davidson JR. An effect size analysis of pharmacologic treatments for generalized anxiety disorder. J Psychopharmacol. 2007;21(8):864–72.

    Article  CAS  PubMed  Google Scholar 

  • Taylor TN, Feltner DE, Goodrich J. Pregabalin improves patient-reported work productivity in patients with GAD (abstract no. NR812). American Psychiatric Association 2003 Annual Meeting; 17–22 May 2003; San Francisco (CA).