Intravenous XXXX in clinical practice - Results from an independent registry.

@entity1 @entity4677 @entity410 @entity159
PURPOSE: Most common clinical studies with antiepileptic drugs do not reflect medical everyday practice due to their strict in- and exclusion criteria and specifications of treatment regimens. Here we present a large non-interventional registry with the intention to evaluate the spectrum of applications in daily use and the efficacy and tolerability of intravenously given @entity4677 (LEV-iv). METHODS: In a prospective approach of 17 neurological and neuropediatric centres in Germany LEV-iv treated @entity1 of all ages were included over a period of 10 months. The observational period was 10 days with daily documentation of LEV-iv administration, type and frequency of @entity410 , currently used drugs and doses, and adverse events (AEs). In addition, treatment efficacy and tolerability were assessed by @entity1 and physicians at study end as well as practicability of LEV-iv using a five-step scale. RESULTS: In 95 @entity1 LEV-iv was administered, 93 were included into the analysis. The median LEV-iv dose was 1500mg (range 110-6000mg) per day. Median age was 66 years (range 0.7-90.3 years). The majority of @entity1 (n=70, 75%) suffered from @entity159 ( @entity159 , n=55, 59%) and acute @entity410 clusters (n=15, 16%). Of those with @entity159 , 41 @entity1 (75%) had @entity159 for the first time. Acute @entity410 clusters and @entity159 terminated in 83% after LEV-iv administration. A total of 29 adverse events were reported in 17 of the 95 @entity1 from the safety set. Ten of these were at least possibly related to LEV-iv treatment. Slight decrease of blood pressure during the infusion (3 @entity1 each) was captured most frequently. No serious side effect was observed. Physicians rated the efficacy and tolerability of LEV-iv treatment as good or very good in 78% and 82% of the cases, respectively. CONCLUSION: In this large observational study of everyday practise the use of LEV-iv exhibited a remarkable good response and tolerability in @entity1 with acute onset @entity410 (mostly @entity159 ). Further randomized controlled studies, like the established @entity159 trial (ESET) are needed to confirm these findings.
