Safety and efficacy of rivastigmine in adolescents with Down syndrome: long-term follow-up.
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Following the completion of a 20-week, open-label study of the safety and efficacy of liquid rivastigmine for adolescents with Down syndrome, 5 of the 10 adolescents in the clinical trial continued long-term rivastigmine therapy and 5 did not. After an average period of 38 months, all 10 subjects returned for a follow-up assessment to determine the safety and efficacy of long-term rivastigmine use. Rivastigmine was well tolerated and overall health appeared to be unaffected by long-term rivastigmine use. Performance change on cognitive and language measures administered at the termination of the open-label clinical trial was compared between the two groups. No between-group difference in median performance change across the long-term period was found, suggesting that the long-term use of rivastigmine does not improve cognitive and language performance. However, two subjects demonstrated remarkable improvement in adaptive function over the long-term period. Both subjects had received long-term rivastigmine therapy. The discussion addresses the challenge of assessing cognitive change in clinical trials using adolescents with Down syndrome as subjects and the use of group versus individual data to evaluate the relevance of medication effects.
Published Version (Please cite this version)10.1089/cap.2009.0099
Publication InfoHeller, James H; Spiridigliozzi, Gail A; Crissman, Blythe G; McKillop, Jane Anne; Yamamoto, Haru; & Kishnani, Priya S (2010). Safety and efficacy of rivastigmine in adolescents with Down syndrome: long-term follow-up. J Child Adolesc Psychopharmacol, 20(6). pp. 517-520. 10.1089/cap.2009.0099. Retrieved from https://hdl.handle.net/10161/3343.
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Chen Family Distinguished Professor of Pediatrics
RESEARCH INTERESTS A multidisciplinary approach to care of individuals with genetic disorders in conjunction with clinical and bench research that contributes to: 1) An understanding of the natural history and delineation of long term complications of genetic disorders with a special focus on liver Glycogen storage disorders, lysosomal disorders witha special focus on Pompe disease, Down syndrome and hypophosphatasia2) The development of new therapies for genetic d
Associate Professor in Psychiatry and Behavioral Sciences
Cholinergic therapy in children and adolescents with Down syndrome; premutation carriers of fragile X syndrome; cognitive development of children with infantile-onset Pompe disease who are being treated with enzyme replacement therapy.
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