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Title: Transdermal rivastigmine for HIV-associated cognitive impairment: A randomized pilot study
Author: Muñoz-Moreno, Jose A.
Prats, Anna
Moltó, José
Garolera Freixa, Maite
Pérez Álvarez, Núria
Díez Quevedo, Crisanto
Miranda, Cristina
Fumaz, Carmina R.
Ferrer, Maria J.
Clotet, Bonaventura
Others: Universitat Oberta de Catalunya. Estudis de Psicologia i Ciències de l'Educació
Keywords: cognitive impairment
combination antiretroviral therapy
Issue Date: 30-Aug-2017
Publisher: Plos One
Citation: Muñoz-Moreno,J., Prats, A., Moltó, J., Garolera, M., Pérez-Álvarez N, Díez-Quevedo C, et al. (2017). Transdermal rivastigmine for HIVassociated cognitive impairment: A randomized pilot study. PLoS ONE 12(8), e0182547. doi: 10.1371/journal.pone.0182547
Project identifier: info:eu-repo/grantAgreement/EC10-320
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Abstract: 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. 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 (mean NPZ-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.
Language: English
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