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      Patients Should Be Monitored for Aggression During Perampanel Treatment

      By Brian Hoyle

      Washington, DC -- December 9, 2013 -- Treatment of epilepsy with perampanel may cause serious and severe hostility- and aggression-related adverse reactions, according to a study presented here at the 67th Annual Meeting of the American Epilepsy Society (AES).

      The latest findings do not detract from the drug’s efficacy as an adjunctive treatment for partial-onset seizures. However, they do highlight risks that may come with perampanel use and add to the knowledge of those at risk, particularly adolescents.

      Antonia LoPresti, MD, Eisai Inc., Woodcliff Lake, New Jersey, presented the post hoc analysis on December 8.

      The data came from 3 phase 3 trials that formed the basis of the regulatory approvals of perampanel in the United States, Canada, and Europe in the adjunctive treatment of partial-onset seizures in adolescent and adult patients with epilepsy.

      In these trials, after a 6-week baseline period, patients were randomised in a double-blind fashion to once-daily treatment with placebo or perampanel 2, 4, 8, or 12 mg. The drug was titrated to the target dosage during a 6-week period and used thereafter for 13 weeks.

      The pooled results involved a safety population of 1,480 patients; 1,038 received perampanel and 442 received placebo. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported with narrow and broad Medical Dictionary for Regulatory Activities (MedDRA) search terms and standard MedDRA queries (SMQs) for hostility- and aggression-related events. Narrow SMQ identified cases likely to represent the condition of interest, such as anger or physical assault. Broad SMQ identified all possible cases, including some that could be of little or no interest on closer inspection (eg, skin laceration).

      A subgroup analysis for aggression-related events included 84 adolescents aged <16 years and 1,368 adults aged 16 to <65 years.

      Hostility/aggression-related TEAEs occurred more often in patients receiving perampanel (3.0% of treated patients) than in those receiving placebo (0.7% of placebo patients). Of the perampanel patients, aggression and anger were documented in 1.6% and 1.2% patients, respectively, versus 0.5% and 0.2% in placebo patients. Hostility and aggression increased at perampanel 8 and 12 mg.

      One aggression-related SAE occurred in patients receiving perampanel 2 mg, and 3 occurred in patients receiving 12 mg (2 aggression related, 1 belligerence related). No SAEs occurred in patients who received placebo. No anger-related SAEs were seen. TEAEs that prompted discontinuation of treatment did not occur for placebo but did occur in 10 patients receiving perampanel (1 aggression-related at 8 mg; 9 at 12 mg, including 4 aggression-related events, 4 anger-related events, and 1 belligerence-related event). There was no SAE-related mortality.

      The narrow and broad SMQ terms for hostility/aggression revealed 25 TEAEs in the placebo group (6%), versus 53 with perampanel 8 mg (n = 431; 12%) and 52 with perampanel 12 mg (n = 255; 20%). The most common TEAE was irritability, at 7.0% with the drug and 2.9% with placebo. No patient had irritability-related SAEs, although irritability led to discontinuation in 0.4% of patients who received perampanel and 0.2% of patients who received placebo.

      In the subgroup analysis, adolescents were more prone to aggression. TEAEs occurred in a larger percentage of adolescents than adults treated with perampanel, at 7.8% versus 1.3%, respectively, versus 0% and 0.5% of placebo patients.

      “Patients, caregivers, and families should be aware of potential hostility/aggression-related adverse reactions associated with taking perampanel,” concluded the researchers. “Patients should be monitored for hostility/aggression-related adverse reactions during perampanel treatment, particularly during dose titration and at higher doses.”

      <i>[Presentation title: Analysis of Aggression in Perampanel Phase III Epilepsy Clinical Trials. Abstract 2.050]
      </i>



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