File Download

There are no files associated with this item.

  Links for fulltext
     (May Require Subscription)
Supplementary

Article: The value of patient selection in demonstrating treatment effect in stroke recovery trials: Lessons from the CHIMES study of MLC601 (NeuroAiD)

TitleThe value of patient selection in demonstrating treatment effect in stroke recovery trials: Lessons from the CHIMES study of MLC601 (NeuroAiD)
Authors
KeywordsNumber-needed-to-treat
NeuroAiD
Clinical trial
Acute stroke
Stroke recovery
Issue Date2015
Citation
Journal of Evidence-Based Medicine, 2015, v. 8, n. 3, p. 149-153 How to Cite?
Abstract© 2015 Chinese Cochrane Center, West China Hospital of Sichuan University and Wiley Publishing Asia Pty Ltd. Objective: The CHIMES Study compared MLC601 to placebo in patients with ischemic stroke of intermediate severity in the preceding 72 hours. We aimed to verify if patient selection based on two prognostic factors (ie, stroke severity and time to treatment) improves detection of a treatment effect with MLC601. Methods: Analyses were performed using data from the CHIMES Study, an international, randomized, placebo-controlled, double-blind trial comparing MLC601 to placebo in patients with ischemic stroke of intermediate severity in the preceding 72 hours. Three subgroups, that is, onset to treatment time (OTT) ≥48 hours; baseline National Institute of Health Stroke Scale (NIHSS) ≥10; both OTT ≥48 hours and baseline NIHSS ≥10, were analyzed using modified Rankin Scale (mRS) ≤1 and a composite endpoint of mRS ≤1, Barthel Index ≥95, and NIHSS ≤1 at month 3. Results: Placebo response rates were lower (ie, worse natural outcome) among subgroups with prognostic factors. Conversely, MLC601 treatment effects were significantly higher in the subgroups with prognostic factors than for the entire cohort, being highest among patients with both OTT ≥48 hours and baseline NIHSS of 10 to 14: odds ratios of 2.18 (95% CI 1.02 to 4.65) for month 3 mRS ≤1 and 3.88 (95% CI 1.03 to 14.71) for the composite endpoint. Conclusions: : Patients who have moderately severe strokes and longer OTT demonstrate better treatment effects with MLC601. These factors can guide patient selection in future trials.
Persistent Identifierhttp://hdl.handle.net/10722/220873
ISSN
2015 SCImago Journal Rankings: 0.337

 

DC FieldValueLanguage
dc.contributor.authorVenketasubramanian, Narayanaswamy-
dc.contributor.authorLee, Chun Fan-
dc.contributor.authorWong, K. S Lawrence-
dc.contributor.authorChen, Christopher L H-
dc.date.accessioned2015-10-22T09:04:40Z-
dc.date.available2015-10-22T09:04:40Z-
dc.date.issued2015-
dc.identifier.citationJournal of Evidence-Based Medicine, 2015, v. 8, n. 3, p. 149-153-
dc.identifier.issn1756-5383-
dc.identifier.urihttp://hdl.handle.net/10722/220873-
dc.description.abstract© 2015 Chinese Cochrane Center, West China Hospital of Sichuan University and Wiley Publishing Asia Pty Ltd. Objective: The CHIMES Study compared MLC601 to placebo in patients with ischemic stroke of intermediate severity in the preceding 72 hours. We aimed to verify if patient selection based on two prognostic factors (ie, stroke severity and time to treatment) improves detection of a treatment effect with MLC601. Methods: Analyses were performed using data from the CHIMES Study, an international, randomized, placebo-controlled, double-blind trial comparing MLC601 to placebo in patients with ischemic stroke of intermediate severity in the preceding 72 hours. Three subgroups, that is, onset to treatment time (OTT) ≥48 hours; baseline National Institute of Health Stroke Scale (NIHSS) ≥10; both OTT ≥48 hours and baseline NIHSS ≥10, were analyzed using modified Rankin Scale (mRS) ≤1 and a composite endpoint of mRS ≤1, Barthel Index ≥95, and NIHSS ≤1 at month 3. Results: Placebo response rates were lower (ie, worse natural outcome) among subgroups with prognostic factors. Conversely, MLC601 treatment effects were significantly higher in the subgroups with prognostic factors than for the entire cohort, being highest among patients with both OTT ≥48 hours and baseline NIHSS of 10 to 14: odds ratios of 2.18 (95% CI 1.02 to 4.65) for month 3 mRS ≤1 and 3.88 (95% CI 1.03 to 14.71) for the composite endpoint. Conclusions: : Patients who have moderately severe strokes and longer OTT demonstrate better treatment effects with MLC601. These factors can guide patient selection in future trials.-
dc.languageeng-
dc.relation.ispartofJournal of Evidence-Based Medicine-
dc.subjectNumber-needed-to-treat-
dc.subjectNeuroAiD-
dc.subjectClinical trial-
dc.subjectAcute stroke-
dc.subjectStroke recovery-
dc.titleThe value of patient selection in demonstrating treatment effect in stroke recovery trials: Lessons from the CHIMES study of MLC601 (NeuroAiD)-
dc.typeArticle-
dc.description.natureLink_to_subscribed_fulltext-
dc.identifier.doi10.1111/jebm.12170-
dc.identifier.scopuseid_2-s2.0-84941909139-
dc.identifier.volume8-
dc.identifier.issue3-
dc.identifier.spage149-
dc.identifier.epage153-
dc.identifier.eissn1756-5391-

Export via OAI-PMH Interface in XML Formats


OR


Export to Other Non-XML Formats