Local view for "https://dbmi-icode-01.dbmi.pitt.edu/dikb/resource/Evidence/527"
| Predicate | Value (sorted: default) |
|---|---|
| rdfs:label | |
| rdf:type | |
| ?:Evidence_enzyme_system | |
| ?:Evidence_numb_subjects | |
| ?:Evidence_object_dose |
"0.1975"
|
| ?:Evidence_precip_dose | |
| ?:Evidence_type | |
| ?:Evidence_value | |
| ?:content |
"NOTE: The AUC_i/AUC is from the combined male and female study results. The object dose was given intravenously as a 250 mg dose of aminophylline over 30 minutes.
route of administration: oral (duloxetine)/IV (theophylline)
study duration: 5 days
population: 28 healthy non-smokers (10 male, 18 female)
tested for known CYP450 polymorphisms? No
ages: 18-55
description:
In the nonsmoking men-only study, 10 of 11 subjects completed the study. One subject was withdrawn because of reports of several adverse events (cause not documented) before receiving the study drug. The mean (+/-SD) age of the subjects was 33 +/- 9 years, the mean height was 174.2 +/- 7.2 cm, the mean bodyweight was 73.9 +/- 9.3 kg and the mean BMI was 24.3 +/- 2.0 kg/m2. All subjects were Caucasian. In the nonsmoking women-only study, 18 of 20 subjects completed the study. Two subjects were withdrawn; one had mild to moderate adverse events related to duloxetine administration, and the other, who received only placebo, had poor venous access. The mean (+/-SD) age of the subjects was 38.2 +/- 9.8 years, the mean height was 166.5 +/- 7 cm, the mean bodyweight was 75.3 +/- 10 kg and the mean BMI was 27.1 +/- 2.8 kg/m2. Sixty percent of the subjects were Caucasian and the rest were African American.
METHODS:
The separate studies in women and men were designed identically as single-centre, subject-blind, randomized, two-way, two-period, balanced crossover studies. Duloxetine was administered in a subject-blind manner, but the infusion of aminophylline was open-label. In each period, duloxetine 60 mg and placebo were given orally twice daily on days 1–4 and once on the morning of day 5. On day 5, theophylline 197.5 mg was given as a 30-minute intravenous infusion of aminophylline 250 mg. Each aminophylline dose was separated by at least 17 days.
RESULTS:
In men, the presence of duloxetine was associated with a small, statistically insignificant increase of 7% in the theophylline C_max and the AUC_inf (table IV). However, in women, there was a statistically significant increase in the theophylline C_max (9%) and the AUC_inf (20%). When the results from both men and women were combined, there was a statistically significant increase in the theophylline AUC_inf (13%) but not in the C_max (7%). Nonetheless, the change in the theophylline AUC_inf in the presence of duloxetine was small, and the 90% CI was within the 0.8–1.25 equivalence range for men, and for men and women combined, but narrowly missed the upper boundary of the equivalence range in women (0.8–1.27)."
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| dc:creator | |
| dc:date |
"08/23/2010 14:30:03"
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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:
{ duloxetine_increases_auc_theophylline, <http://purl.org/swan/1.2/swan-commons#citesAsSupportingEvidence>, evidence_1750 }