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).