Pregabalin Safe, Effective in Generalized Anxiety Disorder

Laurie Barclay, MD

March 07, 2003

March 7, 2003 — Pregabalin was safe and effective in treating generalized anxiety disorder, according to the results of a placebo-controlled trial reported in the March issue of the American Journal of Psychiatry. This drug was almost as effective as benzodiazepines without withdrawal symptoms, making it a potentially good alternative. It may also be beneficial in a number of other neuropsychiatric disorders.

"Recent attempts to develop nonbenzodiazepine anxiolytic agents with novel mechanisms have been mostly unsuccessful," write Atul C. Pande, MD, FRCPC, from Pfizer Global Research and Development at Ann Arbor Laboratories in Michigan, and colleagues. "One novel agent, pregabalin, a structural analogue of gamma-aminobutyric acid (GABA), is currently in development as an anxiolytic on the basis of its profile of pharmacologic activity in animal behavioral models."

In this double-blind study, 276 patients meeting DSM-IV criteria for generalized anxiety disorder were randomized to treatment with pregabalin (150 mg/day or 600 mg/day), lorazepam (6 mg/day), or placebo. Some subjects had mild depressive symptoms, but patients with other comorbid psychiatric disorders were excluded. After a one-week placebo lead-in, subjects received four weeks of treatment followed by a one-week dose taper.

Mean decreases in total Hamilton anxiety scale score from baseline to endpoint for each group were –9.2 for pregabalin 150 mg/day, –10.3 for pregabalin 600 mg/day, and –12.0 for lorazepam, which were significantly greater than –6.8 for placebo. Pregabalin's effect on the total Hamilton anxiety scale score began as early as week 1.

Compared with the other groups, fewer patients in the lorazepam group completed the trial (59% vs. 73% for placebo, 71% for 600 mg/day pregabalin, and 90% for 150 mg/day pregabalin.) Somnolence and dizziness were the most frequent adverse events reported for pregabalin and lorazepam. No patients receiving pregabalin reported serious adverse events or had evidence of withdrawal syndrome.

"These results indicate that pregabalin is an effective, rapidly acting, and safe treatment for generalized anxiety disorder," the authors write. "In short-term treatment, pregabalin does not appear to have the withdrawal symptoms associated with the benzodiazepines.... Pregabalin is also currently under study for treatment of seizure disorders and neuropathic pain [and it] may have activity in several nervous system disorders other than anxiety."

Am J Psych. 2003;2160:533-540

Reviewed by Gary D. Vogin, MD


Comments on Medscape are moderated and should be professional in tone and on topic. You must declare any conflicts of interest related to your comments and responses. Please see our Commenting Guide for further information. We reserve the right to remove posts at our sole discretion.