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Intravenous minocycline in acute stroke: a randomized, controlled pilot study and meta-analysis.
- Source :
-
Stroke [Stroke] 2013 Sep; Vol. 44 (9), pp. 2493-9. Date of Electronic Publication: 2013 Jul 18. - Publication Year :
- 2013
-
Abstract
- Background and Purpose: Minocycline, in animal models and 2 small randomized controlled human trials, is a promising neuroprotective agent in acute stroke. We analyzed the efficacy and safety of intravenous minocycline in acute ischemic and hemorrhagic stroke.<br />Methods: A multicenter prospective randomized open-label blinded end point evaluation pilot study of minocycline 100 mg administered intravenously, commenced within 24 hours of onset of stroke, and continued 12 hourly for a total of 5 doses, versus no minocycline. All participants received routine stroke care. Primary end point was survival free of handicap (modified Rankin Scale, ≤2) at day 90.<br />Results: Ninety-five participants were randomized; 47 to minocycline and 48 to no minocycline. In the intention-to-treat population, 29 of 47 (65.9%) allocated minocycline survived free of handicap compared with 33 of 48 (70.2%) allocated no minocycline (rate ratio, 0.94; 95% confidence interval, 0.71-1.25 and odds ratio, 0.73; 95% CI, 0.31-1.71). A meta-analysis of the 3 human trials suggests minocycline may increase the odds of handicap-free survival by 3-fold (odds ratio, 2.99; 95% CI, 1.74-5.16) but there was substantial heterogeneity among the trials.<br />Conclusions: In this pilot study of a small sample of acute stroke patients, intravenous minocycline was safe but not efficacious. The study was not powered to identify reliably or exclude a modest but clinically important treatment effect of minocycline. Larger trials would improve the precision of the estimates of any treatment effect of minocycline.<br />Clinical Trial Registration Url: http://www.anzctr.org.au. Unique identifier: ACTRN12612000237886.
- Subjects :
- Administration, Intravenous
Aged
Aged, 80 and over
Anti-Bacterial Agents administration & dosage
Anti-Bacterial Agents adverse effects
Cerebral Hemorrhage drug therapy
Female
Humans
Male
Middle Aged
Minocycline administration & dosage
Minocycline adverse effects
Pilot Projects
Severity of Illness Index
Treatment Outcome
Anti-Bacterial Agents therapeutic use
Brain Ischemia drug therapy
Minocycline therapeutic use
Stroke drug therapy
Subjects
Details
- Language :
- English
- ISSN :
- 1524-4628
- Volume :
- 44
- Issue :
- 9
- Database :
- MEDLINE
- Journal :
- Stroke
- Publication Type :
- Academic Journal
- Accession number :
- 23868273
- Full Text :
- https://doi.org/10.1161/STROKEAHA.113.000780