Local view for "https://dbmi-icode-01.dbmi.pitt.edu/dikb/resource/Evidence/1167"
| Predicate | Value (sorted: default) |
|---|---|
| rdfs:label |
"evidence_1233"
|
| rdf:type | |
| ?:Evidence_enzyme_system | |
| ?:Evidence_numb_subjects | |
| ?:Evidence_object_dose | |
| ?:Evidence_precip_dose | |
| ?:Evidence_type | |
| ?:Evidence_value | |
| ?:content |
"NOTE: This is entered as "for" but the evidence board suggests that the AUC value might not be significant.
route of administration: oral
study duration: 21 days
population: 17 healthy subjects (96% male), 64% white
tested for known CYP450 polymorphisms?
NO
ages: 19-44
description:
Studies 1 and 2 enrolled healthy male and female subjects aged 18-45 years with a body mass index (BMI) of 18-33 kg/m2 between August and September 2006 (Study 1) or August and November 2006 (Study 2). Excluded were women who were pregnant, breastfeeding or of childbearing potential without an acceptable contraceptive method; subjects with any significant acute or chronic medical or psychiatric illness or history of neuroleptic malignant syndrome, serotonin syndrome or acute dystonic reactions and subjects with a history of allergy to the study treatments or related compounds, or exposure to monoamine oxidase inhibitors, or CYP2D6 or CYP3A4 inhibitors or inducers in the 4 weeks before the study.
The majority of subjects in Study 2 were male (96%), and 64% were white. The mean +/- SD age was 29 +/- 8 years (range 19-44 years), the mean +/- SD weight was 79.5 +/- 8.7 kg (range 60.2-98.6 kg) and the mean +/- SD BMI was 25.3 +/- 2.6 kg/m2 (range 21.6-32.0 kg/m2). Of the subjects who received concomitant medications while taking aripiprazole and venlafaxine, eight received lorazepam for akathisia and five received benztropine for EPS-related AEs.
Of the 25 subjects who received treatment (safety sample), 23 completed treatment with escitalopram monotherapy and received adjunctive aripiprazole. Two subjects discontinued escitalopram monotherapy (investigator’s decision, n = 1; consent withdrawn, n = 1). Six subjects discontinued during adjunctive aripiprazole treatment (AEs, n = 3; consent withdrawn, n = 3) and 17 subjects completed the study (pharmacokinetic sample).
The design of Study 2 was similar, except that subjects received escitalopram 10 mg/day for 7 days (Day -7 to Day -1) before the addition of once-daily aripiprazole 10 mg/day on Study Day 1 for a further 14 days (Day +1 to Day +14).
Mean steady-state plasma concentration–time profiles for escitalopram administered alone or in combination with aripiprazole were similar (Figure 1C) with a small effect of aripiprazole 10 mg/day on AUC_TAU (7% increase; Table 2). Based on the escitalopram C_min on Day 14 (at t = 0 h and t = 24 h), escitalopram plasma concentration appeared to be at steady state (Table 2)."
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| dc:creator | |
| dc:date |
"09/23/2010 14:03:24"
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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:
{ aripiprazole_increases_auc_escitalopram, <http://purl.org/swan/1.2/swan-commons#citesAsSupportingEvidence>, evidence_1233 }