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Summary   Objective  Perampanel, a selective, noncompetitive α‐amino‐3‐hydroxy‐5‐methyl‐4‐isoxazolepropionic acid (AMPA) glutamate receptor antagonist, is indicated for adjunctive treatment of partial seizures in patients ≥12 years based on three phase  III  clinical studies. The perampanel  U.S.  Prescribing Information includes a boxed warning for serious psychiatric and behavioral adverse reactions. To provide context for this warning, detail on psychiatric and behavioral safety data from perampanel clinical studies is presented.    Methods  An analysis of pooled safety data from three phase  III  studies in patients with partial seizures is presented. Data from phase I and phase  II  studies in patients with and without epilepsy were also analyzed. Psychiatric and behavioral treatment‐emergent adverse events ( TEAE s) were evaluated according to Medical Dictionary for Regulatory Activities (Med DRA ) terms, using “narrow” and “narrow‐and‐broad” standardized Med DRA  queries ( SMQ s) for  TEAE s suggestive of hostility/aggression.    Results  From the three phase  III  partial‐seizure studies, the overall rate of psychiatric  TEAE s was higher in the 8 mg (17.2%) and 12 mg (22.4%) perampanel groups versus placebo (12.4%). In the “narrow”  SMQ , hostility/aggression  TEAE s were observed in 2.8% for 8 mg and 6.3% for 12 mg perampanel groups, versus 0.7% of placebo patients. “Narrow‐and‐broad”  SMQ s for hostility/aggression  TEAE  rates were 12.3% for 8 mg and 20.4% for 12 mg perampanel groups, versus 5.7% for placebo; rates for events resulting in discontinuation were perampanel = 1.6% versus placebo = 0.7%. For events reported as serious  AE s ( SAE s), rates were perampanel = 0.7% versus placebo = 0.2%. In nonepilepsy patients, psychiatric  TEAE s were similar between patients receiving perampanel and placebo. In phase I subjects/volunteers, all psychiatric  TEAE s were mild or moderate. These analyses suggest that psychiatric adverse effects are associated with use of perampanel.    Significance  Patients and caregivers should be counseled regarding the potential risk of psychiatric and behavioral events with perampanel in patients with partial seizures; patients should be monitored for these events during treatment, especially during titration and at higher doses.

Psychiatric and behavioral adverse events in randomized clinical studies of the noncompetitive AMPA receptor antagonist perampanel