| Title: |
Transdermal rivastigmine for HIV-associated cognitive impairment: A randomized pilot study |
| Authors: |
Muñoz-Moreno, Jose A.; Prats, Anna; Moltó, José; Garolera, Maite; Pérez-Álvarez, Núria; Diez-Quevedo, Crisanto; Miranda, Cristina; Fumaz, Carmina R.; Ferrer, Maria Jose; Clotet Sala, Bonaventura; TRIANT-TE Study Group |
| Publication Year: |
2017 |
| Collection: |
Universitat Autònoma de Barcelona: Dipòsit Digital de Documents de la UAB |
| Description: |
Altres ajuts: MSSSI/PICI/EC10-320 ; 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 ... |
| Document Type: |
article in journal/newspaper |
| File Description: |
application/pdf |
| Language: |
English |
| ISSN: |
19326203 |
| Relation: |
PloS one; Vol. 12 Núm. 8 (august 2017); https://ddd.uab.cat/record/196957; urn:10.1371/journal.pone.0182547; urn:oai:ddd.uab.cat:196957; urn:articleid:19326203v12n8; urn:pmid:28854283; urn:scopus_id:85029077054; urn:wos_id:000408693600011; urn:altmetric_id:24536246; urn:pmcid:PMC5576750; urn:oai:pubmedcentral.nih.gov:5576750 |
| Availability: |
https://ddd.uab.cat/record/196957 |
| Rights: |
open access ; 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. ; https://creativecommons.org/licenses/by/4.0/ |
| Accession Number: |
edsbas.8299CC93 |
| Database: |
BASE |