Local view for "https://dbmi-icode-01.dbmi.pitt.edu/dikb/resource/Evidence/826"
| Predicate | Value (sorted: default) |
|---|---|
| rdfs:label | |
| rdf:type | |
| ?:Evidence_enzyme_system | |
| ?:Evidence_numb_subjects | |
| ?:Evidence_object_dose | |
| ?:Evidence_precip_dose | |
| ?:Evidence_type | |
| ?:Evidence_value | |
| ?:content |
"NOTE: The object dose given is the dose starting the 9th day of the study. The AUC_i/AUC is the comparison between study days 19 and 15.
route of administration: oral
study duration: 19 days
population: 7 subjects with selected psychotic disorders (all male)
tested for known CYP450 polymorphisms?
NO
ages: 21-59
description:
SUBJECTS: Thirteen men entered the study (eight were white, four black, and one mixed ethnicity). The mean (range) age, weight, and height of the patients were 37.5 (21–59) years, 86.7 (49–140) kg, and 177.8 (160–193) cm, respectively. Nine men (69.2%) had schizoaffective disorder, three (23.1%) had bipolar disorder, and one (7.7%) had paranoid schizophrenia. Six patients were withdrawn because of lack of efficacy (N = 2), adverse events (N = 2), and refusal to continue (N = 2). All 13 patients were included in the safety analysis, but only the seven patients who completed the entire study were entered into the pharmacokinetic analysis.
METHODS: Thirteen men (aged 18–60 years) with selected psychotic disorders were entered into this open-label, non-randomized, escalating-dose, pharmacokinetic trial conducted at a single center. Psychotropic medications were withdrawn on day, 1 and patients underwent a 2-day washout period. On days 3 to 8, patients received quetiapine in escalating doses from 25 to 150 mg three times daily, at approximately 7 a.m., 3 p.m., and 11 p.m. Quetiapine 150 mg three times daily was then administered on days 9 to 18. The final dose was given on the morning of day 19. Cimetidine 400 mg was initiated on the afternoon of day 15 and was administered three times daily with each dose of quetiapine thereafter.
RESULTS: The mean plasma concentration versus time profiles for quetiapine determined on days 11, 15, and 19 were similar with a slight increase in the mean plasma concentration during coadministration with cimetidine. Using day 15 as baseline, geometric mean steady-state AUC_0–8h and C_max increased by 24% and 19%, respectively, after coadministration with cimetidine (day 19). Using day 11 as baseline, however, increases of only 10% and 4% were detected. In addition, differences between the 2 baseline days (11 and 15) in mean steady-state AUC_0–8h and C_max were 13% and 14%, respectively (intrasubject variability).
The geometric mean quetiapine AUC_0–8h,ss was significantly higher with cimetidine than without compared with day 15 (p=0.002) but not on day 11 (p=0.09). However, variability between the days without cimetidine coadministration (i.e., days 11 and 15) was also significant (p=0.04), with a change of 13% (p=0.04)."
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| dc:creator | |
| dc:date |
"09/16/2010 12:29:46"
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| rdfs:seeAlso |
All properties reside in the graph file:///home/swish/src/ClioPatria/guidelines/dikb.ttl
The resource appears as object in one triple:
{ cimetidine_increases_auc_quetiapine, <http://purl.org/swan/1.2/swan-commons#citesAsSupportingEvidence>, evidence_1222 }