Abstract | BACKGROUND AND PURPOSE: METHODS: Prospective analysis of subgroup of patients randomized into the ENOS trial within 6 hours of stroke onset. Safety and efficacy of GTN versus no GTN were assessed using data on early and late outcomes. RESULTS: Two hundred seventy-three patients were randomized within 6 hours of ictus: mean (SD) age, 69.9 (12.7) years; men, 154 (56.4%); ischemic stroke, 208 (76.2%); Scandinavian Stroke Scale, 32.1 (11.9); and total anterior circulation syndrome, 86 (31.5%). When compared with no GTN, the first dose of GTN lowered blood pressure by 9.4/3.3 mm Hg (P<0.01, P=0.064) and shifted the modified Rankin Scale to a better outcome by day 90, adjusted common odds ratio, 0.51 (95% confidence interval, 0.32-0.80). Significant beneficial effects were also seen with GTN for disability (Barthel Index), quality of life (EuroQol-Visual Analogue Scale), cognition (telephone Mini-Mental State Examination), and mood (Zung Depression Scale). GTN was safe to administer with less serious adverse events by day 90 (GTN 18.8% versus no GTN 34.1%) and death (hazard ratio, 0.44; 95% confidence interval, 0.20-0.99; P=0.047). CONCLUSIONS: In a subgroup analysis of the large ENOS trial, transdermal GTN was safe to administer and associated with improved functional outcome and fewer deaths when administered within 6 hours of stroke onset. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT00989716.
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Authors | Lisa Woodhouse, Polly Scutt, Kailash Krishnan, Eivind Berge, John Gommans, George Ntaios, Joanna Wardlaw, Nikola Sprigg, Philip M Bath, ENOS Investigators |
Journal | Stroke
(Stroke)
Vol. 46
Issue 11
Pg. 3194-201
(Nov 2015)
ISSN: 1524-4628 [Electronic] United States |
PMID | 26463698
(Publication Type: Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Copyright | © 2015 American Heart Association, Inc. |
Chemical References |
- Nitric Oxide Donors
- Vasodilator Agents
- Nitroglycerin
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Topics |
- Administration, Cutaneous
- Aged
- Aged, 80 and over
- Female
- Humans
- Male
- Middle Aged
- Nitric Oxide Donors
(administration & dosage, therapeutic use)
- Nitroglycerin
(administration & dosage, therapeutic use)
- Single-Blind Method
- Stroke
(drug therapy)
- Time-to-Treatment
- Treatment Outcome
- Vasodilator Agents
(administration & dosage, therapeutic use)
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