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Minocycline in Acute Cerebral Hemorrhage: An Early Phase Randomized Trial.
Fouda, Abdelrahman Y; Newsome, Andrea S; Spellicy, Samantha; Waller, Jennifer L; Zhi, Wenbo; Hess, David C; Ergul, Adviye; Edwards, David J; Fagan, Susan C; Switzer, Jeffrey A.
Afiliação
  • Fouda AY; From the Department of Neurology, Medical College of Georgia, Augusta (S.S., J.L.W., W.Z., D.C.H., A.E., J.A.S.); University of Georgia College of Pharmacy, Athens (A.Y.F., A.S.N., S.C.F.); and University of Waterloo, Ontario, Canada (D.J.E.).
  • Newsome AS; From the Department of Neurology, Medical College of Georgia, Augusta (S.S., J.L.W., W.Z., D.C.H., A.E., J.A.S.); University of Georgia College of Pharmacy, Athens (A.Y.F., A.S.N., S.C.F.); and University of Waterloo, Ontario, Canada (D.J.E.).
  • Spellicy S; From the Department of Neurology, Medical College of Georgia, Augusta (S.S., J.L.W., W.Z., D.C.H., A.E., J.A.S.); University of Georgia College of Pharmacy, Athens (A.Y.F., A.S.N., S.C.F.); and University of Waterloo, Ontario, Canada (D.J.E.).
  • Waller JL; From the Department of Neurology, Medical College of Georgia, Augusta (S.S., J.L.W., W.Z., D.C.H., A.E., J.A.S.); University of Georgia College of Pharmacy, Athens (A.Y.F., A.S.N., S.C.F.); and University of Waterloo, Ontario, Canada (D.J.E.).
  • Zhi W; From the Department of Neurology, Medical College of Georgia, Augusta (S.S., J.L.W., W.Z., D.C.H., A.E., J.A.S.); University of Georgia College of Pharmacy, Athens (A.Y.F., A.S.N., S.C.F.); and University of Waterloo, Ontario, Canada (D.J.E.).
  • Hess DC; From the Department of Neurology, Medical College of Georgia, Augusta (S.S., J.L.W., W.Z., D.C.H., A.E., J.A.S.); University of Georgia College of Pharmacy, Athens (A.Y.F., A.S.N., S.C.F.); and University of Waterloo, Ontario, Canada (D.J.E.).
  • Ergul A; From the Department of Neurology, Medical College of Georgia, Augusta (S.S., J.L.W., W.Z., D.C.H., A.E., J.A.S.); University of Georgia College of Pharmacy, Athens (A.Y.F., A.S.N., S.C.F.); and University of Waterloo, Ontario, Canada (D.J.E.).
  • Edwards DJ; From the Department of Neurology, Medical College of Georgia, Augusta (S.S., J.L.W., W.Z., D.C.H., A.E., J.A.S.); University of Georgia College of Pharmacy, Athens (A.Y.F., A.S.N., S.C.F.); and University of Waterloo, Ontario, Canada (D.J.E.).
  • Fagan SC; From the Department of Neurology, Medical College of Georgia, Augusta (S.S., J.L.W., W.Z., D.C.H., A.E., J.A.S.); University of Georgia College of Pharmacy, Athens (A.Y.F., A.S.N., S.C.F.); and University of Waterloo, Ontario, Canada (D.J.E.).
  • Switzer JA; From the Department of Neurology, Medical College of Georgia, Augusta (S.S., J.L.W., W.Z., D.C.H., A.E., J.A.S.); University of Georgia College of Pharmacy, Athens (A.Y.F., A.S.N., S.C.F.); and University of Waterloo, Ontario, Canada (D.J.E.). jswitzer@augusta.edu.
Stroke ; 48(10): 2885-2887, 2017 10.
Article em En | MEDLINE | ID: mdl-28887388
ABSTRACT
BACKGROUND AND

PURPOSE:

Minocycline is under investigation as a neurovascular protective agent for stroke. This study evaluated the pharmacokinetic, anti-inflammatory, and safety profile of minocycline after intracerebral hemorrhage.

METHODS:

This study was a single-site, randomized controlled trial of minocycline conducted from 2013 to 2016. Adults ≥18 years with primary intracerebral hemorrhage who could have study drug administered within 24 hours of onset were included. Patients received 400 mg of intravenous minocycline, followed by 400 mg minocycline oral daily for 4 days. Serum concentrations of minocycline after the last oral dose and biomarkers were sampled to determine the peak concentration, half-life, and anti-inflammatory profile.

RESULTS:

A total of 16 consecutive eligible patients were enrolled, with 8 randomized to minocycline. Although the literature supports a time to peak concentration (Tmax) of 1 hour for oral minocycline, the Tmax was estimated to be at least 6 hours in this cohort. The elimination half-life (available on 7 patients) was 17.5 hours (SD±3.5). No differences were observed in inflammatory biomarkers, hematoma volume, or perihematomal edema. Concentrations remained at neuroprotective levels (>3 mg/L) throughout the dosing interval in 5 of 7 patients.

CONCLUSIONS:

In intracerebral hemorrhage, a 400 mg dose of minocycline was safe and achieved neuroprotective serum concentrations. However, oral administration led to delayed absorption in these critically ill patients and should not be used when rapid, high concentrations are desired. Given the safety and pharmacokinetic profile of minocycline in intracerebral hemorrhage and promising data in the treatment of ischemic stroke, intravenous minocycline is an excellent candidate for a prehospital treatment trial. CLINICAL TRIAL REGISTRATION URL http//www.clinicaltrials.gov. Unique identifier NCT01805895.
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Texto completo: 1 Base de dados: MEDLINE Assunto principal: Hemorragia Cerebral / Fármacos Neuroprotetores / Minociclina Tipo de estudo: Clinical_trials / Diagnostic_studies / Prognostic_studies Limite: Female / Humans / Male Idioma: En Ano de publicação: 2017 Tipo de documento: Article
Texto completo
Imprimir
XML
PubMed Links
Buscar no Google

Texto completo: 1 Base de dados: MEDLINE Assunto principal: Hemorragia Cerebral / Fármacos Neuroprotetores / Minociclina Tipo de estudo: Clinical_trials / Diagnostic_studies / Prognostic_studies Limite: Female / Humans / Male Idioma: En Ano de publicação: 2017 Tipo de documento: Article