Local view for "https://dbmi-icode-01.dbmi.pitt.edu/dikb/resource/Evidence/338"
Predicate | Value (sorted: default) |
rdfs:label |
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rdf:type |
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?:Evidence_assump_list_id |
"61"
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?:Evidence_enzyme_system |
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?:Evidence_type |
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?:claim_assumed_valid_for_evidence_application_evidence_1906 |
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?:content |
"Route of administration: oral
polymorphic enzyme: NO
study duration: 7 days
population: 12 male
ages:21-41
description:
Potential for inhibition of CYP3A activity by simvastatin, an HMG-CoA reductase inhibitor, was evaluated in 12 healthy male subjects who received placebo or 80 mg of simvastatin, the maximal recommended dose, once daily for 7 consecutive days. On day 7, an intravenous injection of 3 microCi [14C N-methyl]erythromycin for the erythromycin breath test (EBT) was coadministered with a 2 mg oral solution of midazolam. The values for percent 14C exhaled during the first hour (for EBT) and the pharmacokinetic parameters of midazolam (AUC, Cmax, t1/2) were not affected following multiple once-daily oral doses of simvastatin 80 mg. The 95% confidence interval was 0.97 to 1.18 for EBT and 0.99 to 1.23 for midazolam AUC. In addition, the total urinary recoveries of midazolam and its 1'-hydroxy metabolites (free plus conjugate) obtained from both treatments were not statistically different (p > 0.200). These data demonstrate that multiple dosing of simvastatin, at the highest recommended clinical dose, does not significantly alter the in vivo hepatic or intestinal CYP3A4/5 activity as measured by the commonly used EBT and oral midazolam probes."
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dc:creator |
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dc:date |
"11/13/2007 13:22:40"
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rdfs:seeAlso |
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All properties reside in the graph file:///home/swish/src/ClioPatria/guidelines/dikb.ttl
The resource appears as object in one triple:
{ beta-hydroxy-simvastatin_inhibits_cyp3a4, <http://purl.org/swan/1.2/swan-commons#citesAsRefutingEvidence>, evidence_1906 }
Context graph