Cognitive effects of pregabalin in healthy volunteers: A double-blind, placebo-controlled trial — Salinsky et al. 74 (9): 755 — Neurology

March 2, 2010 at 9:43 pm Leave a comment

Cognitive effects of pregabalin in healthy volunteers: A double-blind, placebo-controlled trial — Salinsky et al. 74 (9): 755 — Neurology.

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NEUROLOGY 2010;74:755-761
© 2010 American Academy of Neurology

Cognitive effects of pregabalin in healthy volunteers

A double-blind, placebo-controlled trial Martin Salinsky, MD, Daniel Storzbach, PhD andSonia Munoz, MD

From the Oregon Health & Science University, Portland.

Address correspondence and reprint requests to Dr. Martin Salinsky, 3181 SW Sam Jackson Park Road, CR-120, Portland, OR 97239 Salinsky@ohsu.edu.

Background: Antiepileptic drugs (AEDs) can be associated with neurotoxic side effects including cognitive dysfunction, a problem of considerable importance given the usual long-term course of treatment. Pregabalin is a relatively new AED widely used for the treatment of seizures and some types of chronic pain including fibromyalgia. We measured the cognitive effects of 12 weeks of pregabalin in healthy volunteers.

Methods: Thirty-two healthy volunteers were randomized in a double-blind parallel study to receive pregabalin or placebo (1:1). Pregabalin was titrated over 8 weeks to 600 mg/d. At baseline, and after 12 weeks of treatment, all subjects underwent cognitive testing. Test-retest changes in all cognitive and subjective measures were Zscored against test-retest regressions previously developed from 90 healthy volunteers. Z scores from the placebo and pregabalin groups were compared using Wilcoxon tests.

Results: Thirty subjects completed the study (94%). Three of 6 target cognitive measures (Digit Symbol, Stroop, Controlled Oral Word Association) revealed significant test-retest differences between the pregabalin and placebo groups, all showing negative effects with pregabalin (p < 0.05). These cognitive effects were paralleled by complaints on the Portland Neurotoxicity Scale, a subjective measure of neurotoxicity (p < 0.01).

Conclusion: At conventional doses and titration, pregabalin induced mild negative cognitive effects and neurotoxicity complaints in healthy volunteers. These effects are one factor to be considered in the selection and monitoring of chronic AED therapy.

Class of Evidence: This study provides Class I evidence that pregabalin 300 mg BID negatively impacts cognition on some tasks in healthy volunteers.

Abbreviations: AED = antiepileptic drug; CI = confidence interval; CLTR = Consistent Long-Term Retrieval; COWAT = Controlled Oral Word Association; GBP = gabapentin; OHSU = Oregon Health & Science University; PGB = pregabalin; PNS = Portland Neurotoxicity Scale; POMS = Profile of Mood States; RT = reaction time; TLTS = Total Long-Term Storage; TREC = Total Recall; WAIS-R = Wechsler Adult Intelligence Scale–Revised.

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Entry filed under: Allodynia, Amalgams, Analgesia, Anesthesia, Asymptomatic, C-Fibers, Chief Complaint, Complaints, Daubert Test, Drugs, False Diagnosis, Family, Laws, Media, Medical, Mercury, Nerve, Nocioception, Pain, Pain Fibers, Peer-Review, Police, Proprioception, Racism, Repeated Mistakes, Scientific, Sensory, Signs, Slander, Symptoms, Toxicology, Vibration. Tags: , , , , , , , , , , , , , , , , .

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