Transdermal rivastigmine for HIV-associated cognitive impairment: A randomized pilot study
Muñoz-Moreno, Jose A. (Institut Germans Trias i Pujol. Institut de Recerca de la Sida IrsiCaixa)
Prats, Anna (Universitat Autònoma de Barcelona. Departament de Psiquiatria i de Medicina Legal)
Moltó, José (Institut Germans Trias i Pujol. Fundació de Lluita Contra la Sida)
Garolera, Maite (Consorci Sanitari Hospital de Terrassa)
Pérez-Álvarez, Núria (Institut Germans Trias i Pujol. Fundació de Lluita Contra la Sida)
Diez-Quevedo, Crisanto (Universitat Autònoma de Barcelona. Departament de Psiquiatria i de Medicina Legal)
Miranda, Cristina (Institut Germans Trias i Pujol. Fundació de Lluita Contra la Sida)
Fumaz, Carmina R. (Institut Germans Trias i Pujol. Fundació de Lluita Contra la Sida)
Ferrer, Maria Jose (Institut Germans Trias i Pujol. Fundació de Lluita Contra la Sida)
Clotet Sala, Bonaventura (Institut Germans Trias i Pujol. Fundació de Lluita Contra la Sida)
TRIANT-TE Study Group

Date:	2017
Abstract:	Objective. To assess the efficacy and safety of transdermal rivastigmine for the treatment of HIV-associated cognitive impairment. Methods. We recruited HIV-infected patients with cognitive impairment on stable antiretroviral therapy in a randomized controlled pilot trial with a 48-week follow-up. An additional assessment was held at 12 weeks. Participants received transdermal rivastigmine (9. 5 mg daily), lithium (400 mg twice daily, titrated progressively), or remained in a control group (no new medication). The primary efficacy endpoint was change in a global cognitive score (NPZ-7). Secondary endpoints included change in specific cognitive measures, domains, and functional parameters. Safety covered the frequency of adverse events and changes in laboratory results. Results. Seventy-six subjects were screened, and 29 were finally enrolled. Better cognitive outcomes were observed in all groups, although there were no significant differences between the arms (mean NPZ-7 change [SD]): rivastigmine, 0. 35 (0. 14); lithium, 0. 25 (0. 40); control, 0. 20 (0. 44) (p = 0. 78). The rivastigmine group showed the highest positive trend (meanNPZ-7 [SD], baseline vs week 48): rivastigmine, ±0. 47 (0. 22) vs ±0. 11 (0. 29), p = 0. 06; lithium, ±0. 50 (0. 40) vs ±0. 26 (0. 21), p = 0. 22; control, ±0. 52 (0. 34) vs ±0. 32 (0. 52), p = 0. 44. The cognitive domains with the highest positive trends were information processing speed at week 12 and executive function at week 48 (rivastigmine vs control): information processing speed, 0. 35 (0. 64) vs ±0. 13 (0. 25), p = 0. 17, d = 0. 96; and executive functioning, 0. 73 (0. 33) vs 0. 03 (0. 74), p = 0. 09, d = 1. 18. No relevant changes were observed regarding functional outcomes. A total of 12 (41%) individuals dropped out of the study: 2 (20%) were due to medication-related effects in the rivastigmine group and 4 (36%) in the lithium group. No severe adverse events were reported. Conclusions. The results from this small randomized trial indicate that transdermal rivastigmine did not provide significant cognitive benefits in people with HAND on stable antiretroviral therapy, even though positive trends were found in specific cognitive domains. Relevant tolerability issues were not observed.
Note:	Altres ajuts: MSSSI/PICI/EC10-320
Rights:	Aquest document està subjecte a una llicència d'ús Creative Commons. Es permet la reproducció total o parcial, la distribució, la comunicació pública de l'obra i la creació d'obres derivades, fins i tot amb finalitats comercials, sempre i quan es reconegui l'autoria de l'obra original.
Language:	Anglès
Document:	Article ; recerca ; Versió publicada
Published in:	PloS one, Vol. 12 Núm. 8 (august 2017) , ISSN 1932-6203

DOI: 10.1371/journal.pone.0182547
PMID: 28854283

14 p, 1.8 MB

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Research literature > UAB research groups literature > Research Centres and Groups (research output) > Health sciences and biosciences > Institut d'Investigació en Ciencies de la Salut Germans Trias i Pujol (IGTP)
Articles > Research articles
Articles > Published articles