The effect of methylprednisolone, naloxone, and spinal cord trauma on four liver enzymes: observations from NASCIS 2

Shepard, Mary Jo; Bracken, Michael B.

doi:10.1038/sc.1994.43

Cited by 17 publications

(9 citation statements)

References 3 publications

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“…Enzyme elevations were transient and bilirubin levels were normal on the last day of riluzole administration. Mild and moderate elevation of ALT and AST in SCI patients, as reported by Shepard and Bracken, 23 was confirmed to occur within the first day of injury before administration of riluzole.…”

Section: Safety: Effects On Liver Enzymessupporting

confidence: 63%

“…Elevation of liver enzymes has been reported in patients with ALS undergoing treatment with riluzole. 17 Elevation of liver enzymes has been reported to occur acutely in patients with SCI 23 and in animal models of SCI, possibly resulting from impairment of blood flow to the liver. 24,25 In the present study, riluzole administration in SCI patients was associated with a mild to moderate elevation of blood levels of ALT, AST, GGT, ALP, and bilirubin, to a varying degree for each of these markers of liver function.…”

Section: Safety: Effects On Liver Enzymesmentioning

confidence: 99%

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A Prospective, Multicenter, Phase I Matched-Comparison Group Trial of Safety, Pharmacokinetics, and Preliminary Efficacy of Riluzole in Patients with Traumatic Spinal Cord Injury

Grossman

Fehlings

Frankowski³

et al. 2014

Journal of Neurotrauma

179

126

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A prospective, multicenter phase I trial was undertaken by the North American Clinical Trials Network (NACTN) to investigate the pharmacokinetics and safety of, as well as obtain pilot data on, the effects of riluzole on neurological outcome in acute spinal cord injury (SCI). Thirty-six patients, with ASIA impairment grades A-C (28 cervical and 8 thoracic) were enrolled at 6 NACTN sites between April 2010 and June 2011. Patients received 50 mg of riluzole PO/NG twice-daily, within 12 h of SCI, for 14 days. Peak and trough plasma concentrations were quantified on days 3 and 14. Peak plasma concentration (Cmax) and systemic exposure to riluzole varied significantly between patients. On the same dose basis, Cmax did not reach levels comparable to those in patients with amyotrophic lateral sclerosis. Riluzole plasma levels were significantly higher on day 3 than on day 14, resulting from a lower clearance and a smaller volume of distribution on day 3. Rates of medical complications, adverse events, and progression of neurological status were evaluated by comparison with matched patients in the NACTN SCI Registry. Medical complications in riluzole-treated patients occurred with incidences similar to those in patients in the comparison group. Mild-to-moderate increase in liver enzyme and bilirubin levels were found in 14-70% of patients for different enzymes. Three patients had borderline severe elevations of enzymes. No patient had elevated bilirubin on day 14 of administration of riluzole. There were no serious adverse events related to riluzole and no deaths. The mean motor score of 24 cervical injury riluzole-treated patients gained 31.2 points from admission to 90 days, compared to 15.7 points for 26 registry patients, a 15.5-point difference (p=0.021). Patients with cervical injuries treated with riluzole had more-robust conversions of impairment grades to higher grades than the comparison group.

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Section: Safety: Effects On Liver Enzymessupporting

confidence: 63%

Section: Safety: Effects On Liver Enzymesmentioning

confidence: 99%

A Prospective, Multicenter, Phase I Matched-Comparison Group Trial of Safety, Pharmacokinetics, and Preliminary Efficacy of Riluzole in Patients with Traumatic Spinal Cord Injury

Grossman

Fehlings

Frankowski³

et al. 2014

Journal of Neurotrauma

179

126

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“…In order to determine the impact of extremely large doses of methyl prednisolone, naloxone, or of spinal cord injury itself on liver enzymes, the results of SGOT, SGPT, alkaline phosphatase and total bilirubin tests were obtained 24 hours, 3 and 10 days after the end of the study drug infusions in spinal cord injured patients entered in the NASCIS. The variations in enzyme levels appeared to be the result of the spinal cord injury, not the study drugs (21). In another study, the mean and median days of elevations of liver enzymes after trauma were 22 and 18, respectively.…”

Section: Discussionmentioning

confidence: 90%

Ultrastructural changes in liver after experimental spinal cord injury in rats: effects of methylprednisolone, immunoglobulin-g and albumin

Erel¹,

Gok²,

Kısmet³

et al. 2009

Turkish Neurosurgery

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SCI resulted in neutrophil infiltration and changes in ultrastructure of liver. It was revealed that MPSS has no detrimental effects on liver. Although all treatments preserved liver tissue structure, Although all treatments preserved liver tissue structure, Ig G and albumin treatments also prevented neutrophil infiltration. To provide protection from secondary liver injury after SCI, use of albumin and Ig G treatments may be beneficial.

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“…However, the trend to a higher incidence of sepsis and hyperglycemia cannot be ignored in the absence of Level I evidence of benefit for this treatment. [21][22][23][24] Physicians should not feel intimidated into prescribing high-dose methylprednisolone for acute spinal cord injuries. The utility of high-dose methylprednisolone infusion within 8 h following acute spinal cord injury has not been adequately tested.…”

Section: Review Of Evidencementioning

confidence: 99%

Steroids in acute spinal cord injury

2003

CJEM

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Confusion persists about the utility of high-dose methylprednisolone infusion for acute spinal cord injury. This treatment was widely adopted following the report of the Second National Acute Spinal Cord Injury Study (NASCIS II) in 1990 and became an implied standard of care. 1 Despite the fact that subsequent clinical studies and critical reviews have challenged the validity of the recommendations that followed the NASCIS studies, failure to administer steroids in acute spinal cord injury has been cited in litigation against physicians. 2-10 A survey of attendees at the First Annual Canadian Spine Society Meeting in Mont Tremblant, Que., on Mar. 23, 2001, revealed that 75% of respondents were using methylprednisolone either "because everyone else does" or out of fear of litigation for failing to do so. A systematic review of this treatment (see Table 1 11-18) was conducted at the request of the Canadian Spine Society and the Canadian Neurosurgical Society in order to provide current, evidence-based recommendations about its utility for practising physicians. 19 A committee of neurosurgeons, orthopedic surgeons, emergency physicians and physiatrists, some with a Masters in Clinical Epidemiology reviewed the evidence and concluded the following.

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The effect of methylprednisolone, naloxone, and spinal cord trauma on four liver enzymes: observations from NASCIS 2

Cited by 17 publications

References 3 publications

A Prospective, Multicenter, Phase I Matched-Comparison Group Trial of Safety, Pharmacokinetics, and Preliminary Efficacy of Riluzole in Patients with Traumatic Spinal Cord Injury

A Prospective, Multicenter, Phase I Matched-Comparison Group Trial of Safety, Pharmacokinetics, and Preliminary Efficacy of Riluzole in Patients with Traumatic Spinal Cord Injury

Ultrastructural changes in liver after experimental spinal cord injury in rats: effects of methylprednisolone, immunoglobulin-g and albumin

Steroids in acute spinal cord injury

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