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Pregabalin and Gabapentin for GAD (Node 3A) David N. Osser, MD Associate Professor of Psychiatry Harvard Medical School Brockton Division of the VA Boston Healthcare System General Editor - Psychopharmacology Algorithm Project Harvard South Shore Residency Training Program

Pregabalin Not approved in U.S. for GAD Rejected twice Why? Not superior to placebo? Safety? Approved in Europe and South America for GAD 7 positive RCTs Bech, P. (2007). Dose-response relationship of pregabalin in patients with generalized anxiety disorder. A pooled analysis of four placebo-controlled trials. Pharmacopsychiatry, 40(04), 163-168. Wensel, T. M., Powe, K. W., & Cates, M. E. (2012). Pregabalin for the treatment of generalized anxiety disorder. Annals of Pharmacotherapy, 46(3), 424-429.

Pregabalin Compared to SSRIs: rapid onset, helps with insomnia Dose-dependent effect: > 300 mg/day more effective Caution in elderly: falls and somnolence Bech, P. (2007). Dose-response relationship of pregabalin in patients with generalized anxiety disorder. A pooled analysis of four placebo-controlled trials. Pharmacopsychiatry, 40(04), 163-168. Wensel, T. M., Powe, K. W., & Cates, M. E. (2012). Pregabalin for the treatment of generalized anxiety disorder. Annals of Pharmacotherapy, 46(3), 424-429.

Pregabalin vs. Gabapentin Gabapentin: lower cost Very similar compound & chemical structure Frequently used off-label use as anxiolytic Clarke, H., Kirkham, K. R., Orser, B. A., Katznelson, R., Mitsakakis, N., Ko, R., ... & Katz, J. (2013). Gabapentin reduces preoperative anxiety and pain catastrophizing in highly anxious patients prior to major surgery: a blinded randomized placebo-controlled trial. Canadian Journal of Anesthesia/Journal canadien d'anesthésie, 60(5), 432-443.

Pregabalin vs. Gabapentin Trial in 420 women with breast cancer Dose: 300mg and 900mg Superior to placebo for anxiety No studies in GAD Concerns for misuse Lavigne, J. E., Heckler, C., Mathews, J. L., Palesh, O., Kirshner, J. J., Lord, R., ... & Mustian, K. (2012). A randomized, controlled, double-blinded clinical trial of gabapentin 300 versus 900 mg versus placebo for anxiety symptoms in breast cancer survivors. Breast cancer research and treatment, 136(2), 479-486. Schifano, F., D’Offizi, S., Piccione, M., Corazza, O., Deluca, P., Davey, Z., ... & Mannonen, M. (2011). Is there a recreational misuse potential for pregabalin? Analysis of anecdotal online reports in comparison with related gabapentin and clonazepam data. Psychotherapy and psychosomatics, 80(2), 118-122. Smith, R. V., Lofwall, M. R., & Havens, J. R. (2015). Abuse and diversion of gabapentin among nonmedical prescription opioid users in Appalachian Kentucky. American Journal of Psychiatry, 172(5), 487-488.

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