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M9460270.TXT
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1994-06-12
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Document 0270
DOCN M9460270
TI Pharmacologic evaluation of megestrol acetate oral suspension in
cachectic AIDS patients.
DT 9408
AU Graham KK; Mikolich DJ; Fisher AE; Posner MR; Dudley MN; Antiinfective
Pharmacology Research Unit, University of Rhode; Island College of
Pharmacy, Miriam Hospital, Providence 02908.
SO J Acquir Immune Defic Syndr. 1994 Jun;7(6):580-6. Unique Identifier :
AIDSLINE MED/94231462
AB The objective of our study was to define the pharmacokinetics and
pharmacodynamics of megestrol acetate in patients with human
immunodeficiency virus (HIV) infection. A new suspension formulation of
megestrol acetate (40 mg/ml) was administered as a single oral dose of
800 mg per day in an open label pharmacokinetic study for 21 days. On
day 21 of therapy, patients were evaluated for changes in body weight
and plasma samples were obtained for steady-state pharmacokinetic
analysis. Ten HIV-infected men with an involuntary weight loss of > 10%
baseline were evaluated. A high degree of interpatient variability in
megestrol acetate pharmacokinetics was observed, with an 8- and 5-fold
range in the rate and extent of absorption, respectively. All patients
reported an increase in appetite, and 8 of 10 patients gained weight by
3 weeks; the median change in weight in all patients at 3 weeks was
1.8-kg gain (range: 2.3-kg loss to 6.4-kg gain). The two patients who
did not gain weight had the lowest area under the curve (AUC), Cmax, and
Cmin values. A statistically significant correlation between the ratio
of body weight at 3 weeks/initial weight (weight index) and the
percentage of the 24-h dosing interval that megestrol acetate
concentrations exceeded a 300-ng/ml threshold was observed. These data
indicate variable levels of systemic exposure to drug following a fixed
dose of a suspension formulation of megestrol acetate. Increase in
weight during the early stages of megestrol acetate therapy is related
to the extent of in vivo drug exposure above a threshold
concentration.(ABSTRACT TRUNCATED AT 250 WORDS)
DE Acquired Immunodeficiency Syndrome/*COMPLICATIONS/METABOLISM
Administration, Oral Adult Appetite/DRUG EFFECTS Body Weight/DRUG
EFFECTS Cachexia/*DRUG THERAPY/ETIOLOGY/METABOLISM Human Male
Megestrol/*ANALOGS & DERIVATIVES/ADMINISTRATION & DOSAGE/
PHARMACOLOGY/PHARMACOKINETICS/THERAPEUTIC USE Middle Age Support,
Non-U.S. Gov't Suspensions JOURNAL ARTICLE
SOURCE: National Library of Medicine. NOTICE: This material may be
protected by Copyright Law (Title 17, U.S.Code).