Notice the discrepancy between results and conclusion.
http://stroke.ahajournals.org/content/44/9/2493.abstract.html?etoc
A Randomized, Controlled Pilot Study and Meta-analysis
- Edith Kohler, MD, FRACP;
- David A. Prentice, FRACP;
- Timothy R. Bates, FRACP;
- Graeme J. Hankey, MD, FRACP;
- Anne Claxton, BSc;
- Jolandi van Heerden, FRANZCR;
- David Blacker, FRACP
+ Author Affiliations
- Correspondence to Edith Kohler, MD, Stroke Unit, Royal Perth Hospital, Perth, Western Australia, Australia. E-mail Edith_Kohler@hotmail.com
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.
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.
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.
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.
Clinical Trial Registration—URL: http://www.anzctr.org.au. Unique identifier: ACTRN12612000237886.
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