A reanalysis of pain crises data from the pivotal l-glutamine in sickle cell disease trial.
Annual crisis rate
Endari
Pain crises
Sickle cell disease
l-glutamine
Journal
Contemporary clinical trials
ISSN: 1559-2030
Titre abrégé: Contemp Clin Trials
Pays: United States
ID NLM: 101242342
Informations de publication
Date de publication:
11 2021
11 2021
Historique:
received:
10
05
2021
revised:
23
08
2021
accepted:
24
08
2021
pubmed:
13
9
2021
medline:
25
11
2021
entrez:
12
9
2021
Statut:
ppublish
Résumé
The pivotal Endari trial in sickle cell disease showed a reduction in pain crises events. This reanalysis of the l-glutamine phase 3 trial using annual rates of pain crises, consistent with other SCD studies, supported the statistically significant outcomes of the original analysis. The observed 45% difference in the VOC rate is comparable to what was reported in other sickle cell therapeutics used to reduce the incidence of pain. The results presented in this communication are informative for clinicians evaluating treatment effects across available SCD therapeutic options based on studies that utilized VOC as the primary endpoint.
Identifiants
pubmed: 34509600
pii: S1551-7144(21)00282-2
doi: 10.1016/j.cct.2021.106546
pii:
doi:
Substances chimiques
Glutamine
0RH81L854J
Types de publication
Journal Article
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
106546Informations de copyright
Copyright © 2021 The Authors. Published by Elsevier Inc. All rights reserved.