Analysis of Potential Risk Factors Associated with the Development of Pancreatitis in Phase I Patients with AIDS or AIDS-Related Complex Receiving Didanosine
- 1 June 1994
- journal article
- clinical trial
- Published by Oxford University Press (OUP) in The Journal of Infectious Diseases
- Vol. 169 (6) , 1250-1255
- https://doi.org/10.1093/infdis/169.6.1250
Abstract
Phase I dose-escalating trials of didanosine revealeddose-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 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.Keywords
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