Rufinamide as an adjunctive therapy for Lennox–Gastaut syndrome: A randomized double-blind placebo-controlled trial in Japan

Abstract

The present results showed a favorable risk-benefit profile for rufinamide as an adjunctive therapy for patients with LGS.

Rufinamide (Inovelon) in the Treatment of Lennox–gastaut Syndrome (A Review of Literature and Clinical Case)

“…Все побочные эффекты были легкими или умеренными по степени тяжести. Таким образом, по мнению авторов исследования, руфинамид проде-монстрировал благоприятное соотношение польза-риск в дополнительной терапии пациентов с СЛГ [28].…”

Rufinamide in patients with Lennox-Gastaut syndrome

“…29 Similarly, in a double-blind Japanese study of children and adults with LGS, body weight and age were not found to affect the circulating rufinamide concentration. 40 Rufinamide clearance appears to be 6%-14% lower in females than in males. 29 Race and renal function also do not seem to affect the pharmacokinetics of rufinamide; 31 however, the drug is not recommended for patients with severe hepatic impairment.…”

“…Clinical global impressions of the patients' conditions were significantly better in the rufinamide group than in the placebo group (P=0.007). 40 …”

“…40 A similar weight-dependent dosing scheme was employed in this study (1,000 mg per day for those weighing 15-30 kg, 1,800 mg per day for those weighing 30.1-50 kg, 2,400 mg per day for those weighing 50.1-70 kg, and 3,200 mg per day for those weighing ≥70.1 kg), and the same periods of drug titration and maintenance were used. In this study, rufinamide was associated with a median total seizure frequency reduction of 32.9% (vs 3.1% for placebo) and a median tonic-atonic seizure frequency reduction of 24.4% (vs 3.3% for placebo).…”

“…31 In another study, rufinamide did not affect the serum levels of valproic acid, lamotrigine, or clobazam. 40 A LGS, Lennox-Gastaut syndrome. The oral suspension has also been used with endoscopic gastrostomy or nasogastric tube.…”