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Add-on perampanel safe, effective in patients with secondarily generalized seizures

23 Apr 2018

Long‐term treatment with perampanel in the adjunctive setting appears to provide improved seizure control without raising new safety/tolerability signals in patients with epilepsy, particularly those with secondarily generalized seizures (SGS) at baseline, according to the results of an open-label extension of phase III trials.

The open-label extension included 1,218 patients, of which 838 were previously randomized to perampanel and the remaining 380 to placebo. Safety/tolerability (median percent reduction in seizure frequency per 28 days) and seizure (50 percent responder and seizure freedom rates) outcomes were evaluated for all focal seizures and SGS.

Majority of patients (65.4–80.9 percent) received a last daily dose of perampanel 12 mg and completed long‐term assessment on the same, or one fewer, concomitant antiepileptic drug.

Long-term safety/tolerability profile of perampanel was consistent with previous reports. Treatment‐emergent adverse events (TEAEs) resulted in treatment discontinuation in >1 percent of patients. Commonly reported TEAEs included dizziness, irritability and fatigue, with TEAEs of clinical interest being stable for 4 years.

Improvements in seizure outcome improvements were sustained over time. Median percent seizure reductions per 28 days reached 62.0 percent in patients with ≥3 years of perampanel exposure (n=436) and 70.6 percent in patients with ≥4 years of exposure (n=78). The respective 50-percent responder rates were 59.6 percent and 67.9 percent.

The largest median percent seizure reduction per 28 days was seen in SGS, specifically in patients with SGS at baseline: 88.0 percent with ≥3 years of perampanel exposure (n=190) and 100.0 percent with ≥4 years of exposure (n=28). Freedom from SGS occurred in 40.0 percent and 53.6 percent of patients in the ≥3- and ≥4-year exposure groups.

Median percent seizure reductions per 28 days did not significantly differ when early dropouts were accounted for.

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Most Read Articles
Pearl Toh, 3 days ago
The combination therapy comprising carfilzomib, cyclophosphamide and dexamethasone (KCd) is effective, with a tolerable safety profile, in an Asian cohort with high-risk multiple myeloma (MM) — thus providing a more economical alternative as a potential upfront regimen in resource-limited settings, according to leading experts during a myeloma education webinar.
Audrey Abella, 5 days ago
Extremes of sleep duration (≤5 or ≥10 hours/day), which is a known mortality risk factor in the general population, may increase absolute mortality in adults with type 2 diabetes (T2D), a prospective study has shown.
Pearl Toh, 21 Sep 2020
Early and sustained treatments with simplified regimen are the key to achieving good asthma control, said experts during a presentation at the ERS 2020 Congress.
Roshini Claire Anthony, 12 Oct 2020

Insulin icodec, an in-development basal insulin analogue administered once weekly, was as effective as once-daily insulin glargine in patients with type 2 diabetes (T2D) insufficiently controlled with metformin with or without a DPP-4* inhibitor, according to a phase II trial presented at EASD 2020.