Treatment of Gunshot Fractures of Limbs
Authors: S. S. Yudin
Journal: BMJ (1943)

<h3>Objective:</h3> To assess real-world effectiveness, safety and tolerability of perampanel (PER) when used as monotherapy in everyday clinical practice. <h3>Background:</h3> PER is indicated in the US for treatment of focal-onset seizures (patients aged ≥4 years) and as adjunctive therapy for generalized-onset tonic-clonic seizures (patients aged ≥12 years). Information on using PER monotherapy in clinical practice is currently limited. <h3>Design/Methods:</h3> Patients treated with PER monotherapy for focal and/or generalized seizures were identified from interim pooled analysis of data from 18 clinical practice studies/work groups. Retention was assessed after 3, 6 and 12 months of PER treatment. Effectiveness was assessed by seizure type at last visit. Effectiveness assessments included seizure freedom rate (no seizures since at least prior visit) and responder rate (≥50% seizure frequency reduction). Safety and tolerability were assessed by evaluating adverse events (AEs). <h3>Results:</h3> A total of 111 patients treated with PER monotherapy at baseline were identified (51.4% male; mean age, 32.1 years; mean epilepsy duration, 14.3 years). Seizure types at baseline were focal only (54.7%), generalized only (42.2%), and focal and generalized (3.1%). At last visit, 54.2% of patients were being treated with concomitant antiseizure medications. Effectiveness was assessed for 31 patients; safety and tolerability were assessed for 38 patients. At 3, 6 and 12 months, retention rates were 94.4%, 88.9% and 55.6%, respectively. Mean time under PER treatment was 9.5 months. At last visit, seizure freedom rates in patients with focal and generalized seizures were 20.0% and 47.6%, respectively; corresponding 50% responder rates were 50.0% and 100.0%, respectively. AEs were reported for 60.5% of patients; most common AEs were behavioral AEs (aggression/anger/irritability; 26.3%) and dizziness/vertigo (21.1%). Overall, 11.1% of patients discontinued due to AEs. <h3>Conclusions:</h3> PER monotherapy was effective and generally well tolerated in patients with focal and/or generalized seizures treated in clinical practice. <b>Disclosure:</b> Dr. Alsaadi has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Eli Lilli. Dr. Alsaadi has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Novartis. Dr. Alsaadi has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for NewBridge. Dr. Alsaadi has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Eli Lilli. Dr. Alsaadi has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Novartis. Dr. Alsaadi has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for NewBridge. Dr. Alsaadi has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Hikma. Dr. Alsaadi has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Lundbeck. Dr. Alsaadi has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Sanofi. Manuel Toledo has received personal compensation in the range of $0-$499 for serving on a Scientific Advisory or Data Safety Monitoring board for EISAI INC. Manuel Toledo has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for UCB Pharma. Manuel Toledo has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Arvelle Therapeutics. Manuel Toledo has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for EISAI INC. Fernando Ayuga Loro has nothing to disclose. Eugen Trinka has received personal compensation in the range of $500-$4,999 for serving as a Consultant for UCB. Eugen Trinka has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Eisai. Eugen Trinka has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Bial. Eugen Trinka has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Böhringer Ingelheim. Eugen Trinka has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Medtronic. Eugen Trinka has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Everpharma. Eugen Trinka has received personal compensation in the range of $500-$4,999 for serving as a Consultant for GSK. Eugen Trinka has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Biogen. Eugen Trinka has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Takeda. Eugen Trinka has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Liva-Nova. Eugen Trinka has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Newbridge. Eugen Trinka has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Novartis. Eugen Trinka has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Sanofi. Eugen Trinka has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Sandoz. Eugen Trinka has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Sunovion. Eugen Trinka has received personal compensation in the range of $500-$4,999 for serving as a Consultant for GW Pharmaceuticals. Eugen Trinka has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Marinus. The institution of Eugen Trinka has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Arvelle. Eugen Trinka has received research support from Austrian Science Fund (FWF). Eugen Trinka has received research support from Österreichische Nationalbank. Eugen Trinka has received research support from European Union. Eugen Trinka has received research support from GSK. Eugen Trinka has received research support from Biogen. Eugen Trinka has received research support from Eisai. Eugen Trinka has received research support from Novartis. Eugen Trinka has received research support from Red Bull. Eugen Trinka has received research support from Bayer. Eugen Trinka has received research support from UCB. Eugen Trinka has received personal compensation in the range of $500-$4,999 for serving as a other with Neuroconsult Ges.m.b.H.. Dr. Wu has nothing to disclose. Dr. Malhotra has received personal compensation for serving as an employee of Eisai. Dr. Ngo has received personal compensation for serving as an employee of Eisai Inc.. Vicente Villanueva has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for UCB. Vicente Villanueva has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for EISAI. Vicente Villanueva has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for BIAL. Vicente Villanueva has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for GW pharmaceutical. Vicente Villanueva has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Arvelle. Vicente Villanueva has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for UCB. Vicente Villanueva has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for EISAI. Vicente Villanueva has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for BIAL. Vicente Villanueva has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for GW pharma. Vicente Villanueva has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Arvelle.