Oxcarbazepine adjunctive therapy in infants and young children with partial seizures

Abstract

We appreciate that authors and researchers are challenged by significant methodologic difficulties in the implementation of clinical trials involving a pediatric population. However, we do not understand misleading or problematic interpretation and presentation of the clinical trial results. In the article by Pina-Garza et al., we believe the authors failed to straightforwardly report their findings in a number of significant ways.1 An initial concern is the objectivity of a group where only one of eight authors is not significantly financially linked to Novartis. In the abstract section, the authors state that the most frequent adverse events (less than or equal to 10%) were somnolence and pyrexia. However, table 4 demonstrates that the single most common adverse event in either treatment group was infections and infestations. Furthermore, the high dose oxcarbazepine group showed that 39.1% of the population had infections and infestations, a 2.8-fold increase over the comparison low dose group. Additionally, the most alarming percentage adverse event, suffered by 15.6% of the high dose group, one that represented a 9.8-fold increase over the comparison low dose group, was related to respiratory, thoracic, and mediastinal disorders. Finally, the …