Switching from long-term benzodiazepine therapy to pregabalin in patients with generalized anxiety disorder: a double-blind, placebo-controlled trial
Journal of Psychopharmacology, 06/28/2011
Clinical Article
Hadley SJ et al. – The results on the anxiety and withdrawal severity measures suggest that switching to pregabalin may be a safe and effective method for discontinuing long–term benzodiazepine therapy.
Methods- To evaluate the efficacy of pregabalin in facilitating taper off chronic benzodiazepines, outpatients (N = 106) with a lifetime diagnosis of generalized anxiety disorder (current diagnosis could be subthreshold) who had been treated with a benzodiazepine for 8–52 weeks were stabilized for 2–4 weeks on alprazolam in the range of 1–4 mg/day.
- Patients were then randomized to 12 weeks of double–blind treatment with either pregabalin 300–600 mg/day or placebo while undergoing a gradual benzodiazepine taper at a rate of 25% per week, followed by a 6–week benzodiazepine–free phase during which they continued double–blind study treatment.
- Outcome measures included ability to remain benzodiazepine–free (primary) as well as changes in Hamilton Anxiety Rating Scale (HAM)–A and Physician Withdrawal Checklist (PWC).
- At endpoint, a non–significant higher proportion of patients remained benzodiazepine–free receiving pregabalin compared with placebo (51.4% vs 37.0%).
- Treatment with pregabalin was associated with significantly greater endpoint reduction in the HAM–A total score versus placebo (–2.5 vs +1.3; p < 0.001), and lower endpoint mean PWC scores (6.5 vs 10.3; p = 0.012).
- Thirty patients (53%) in the pregabalin group and 19 patients (37%) in the placebo group completed the study, reducing the power to detect a significant difference on the primary outcome.
