PURPOSE: To evaluate the tolerability and safety of @entity2682 (GBP) as add-on therapy for @entity410 control. METHODS: Conducted in an outpatient setting and reflecting usual practice, this study compared tolerability of GBP dosages < or = 1,800 versus >1,800 mg/day, when these doses were required to achieve the most effective @entity410 control. Two analyses of adverse events are presented: tolerability and safety. In the tolerability analysis, each @entity1 served as his or her own control to compare the occurrence of adverse events at GBP < or =1,800 versus >1,800 mg/day. The safety analysis required @entity1 to receive at least one dose of GBP and have a follow-up contact. RESULTS: A total of 2,216 @entity1 enrolled in this open-label, 16-week study and were evaluable for safety. Of these, 74.0% completed the 16-week study, and 281 met the tolerability criteria. Within these 281 @entity1 , two mutually exclusive groups were compared (a) those reporting adverse events at only < or =1,800 mg/day (low dose); and (b) those reporting adverse events at only >1,800 mg/day (high dose). Three adverse events ( @entity1395 , @entity10 , and dizziness) were observed in a statistically significantly larger number of @entity1 at only the low dose than in the group reporting these same adverse events at only the high dose, suggesting that @entity1 who tolerated GBP at < or = 1,800 mg/day did not experience a significant increase in adverse events with dosages >1,800 mg/day. Overall, 10.6% of the 2,216 @entity1 in the safety population prematurely withdrew because of adverse events, and 3.5% discontinued because of lack of efficacy. Safety and tolerability of GBP was rated as excellent or good for 78.5% of all @entity1 . CONCLUSIONS: @entity2682 doses >1,800 mg/day were as well tolerated as doses < or =1,800 mg/day and were not associated with more adverse events.

Safety and tolerability of XXXX as adjunctive therapy in a large, multicenter study.

@entity1 :: ('9606', 'Species') :: ['patients', 'patient'] @entity410 :: ('MESH:D012640', 'Disease') :: ['seizure'] @entity2682 :: ('MESH:C040029', 'Chemical') :: ['Gabapentin', 'gabapentin'] @entity1395 :: ('MESH:D001247', 'Disease') :: ['asthenia'] @entity10 :: ('MESH:D006261', 'Disease') :: ['headache']
@entity2682 :: (MESH:C040029,Chemical) :: ['gabapentin']
