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M9470090.TXT
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1994-07-02
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Document 0090
DOCN M9470090
TI Analysis of potential risk factors associated with the development of
pancreatitis in phase I patients with AIDS or AIDS-related complex
receiving didanosine.
DT 9409
AU Grasela TH; Walawander CA; Beltangady M; Knupp CA; Martin RR; Dunkle LM;
Barbhaiya RH; Pittman KA; Dolin R; Valentine FT; et al; Department of
Pharmacy and Social and Preventive Medicine, State; University of New
York at Buffalo, School of Pharmacy 14260.
SO J Infect Dis. 1994 Jun;169(6):1250-5. Unique Identifier : AIDSLINE
MED/94253582
AB Phase I dose-escalating trials of didanosine revealed dose-limiting
toxicities, including pancreatitis, and established a total daily dose
of 12.5 mg/kg/day as the maximum tolerated dose. Clinical and
pharmacokinetic data of 61 patients from two trials were analyzed to
further evaluate the risk of pancreatitis: 1 (6.3%) of 16 patients who
received < 500 mg/day didanosine, 2 (13.3%) of 15 who received 500-750
mg/day, and 15 (50%) of 30 who received > 750 mg/day developed
pancreatitis (P < .001). A relationship between risk of pancreatitis and
steady-state plasma concentrations of didanosine and age was also
observed, suggesting that knowledge of didanosine pharmacokinetics
provided additional information regarding risk of toxicity. Further
confirmation of these findings will be necessary to determine if the
risk factors for pancreatitis remain the same at lower doses currently
used.
DE Acquired Immunodeficiency Syndrome/COMPLICATIONS/*DRUG THERAPY Age
Factors AIDS-Related Complex/COMPLICATIONS/*DRUG THERAPY
Didanosine/*ADVERSE EFFECTS/PHARMACOKINETICS/THERAPEUTIC USE
Dose-Response Relationship, Drug Human Pancreatitis/*CHEMICALLY
INDUCED/COMPLICATIONS Risk Factors Support, Non-U.S. Gov't CLINICAL
TRIAL CLINICAL TRIAL, PHASE I JOURNAL ARTICLE
SOURCE: National Library of Medicine. NOTICE: This material may be
protected by Copyright Law (Title 17, U.S.Code).