To define predictive or contributory risk factors for pancreatitis in human immunodeficiency virus-infected children receiving dideoxyinosine (ddI), the authors evaluated 95 children, 3 months to 18 years of age, who had received ddI at 60 to 540 mg/m2 per day for a mean of 56 weeks. Pancreatitis developed in 7 patients (7%) but resolved in all upon withdrawal of ddI. Neither age, sex, nor CD4 count at study entry was predictive of pancreatitis, but pancreatitis appeared more likely to develop in hemophiliacs than in other patients (4 of 23 vs 3 of 72). Pancreatitis developed only in patients who received ddI at the highest dose levels (7 of 60 patients who received ddI at a dose ≥ 360 mg/m2 per day vs 0 of 35 patients who received <270 mg/m2 per day). Patients in whom pancreatitis developed had received a higher mean daily dose of ddI than patients with normal amylase and lipase levels throughout the study (348 mg/m2 vs 282 mg/m2), but no relationship with the cumulative dose or the duration of ddI therapy was observed. Although a statistically significant relationship between ddI plasma concentration (area under the curve) and pancreatitis was not conclusively demonstrated, as the number of patients in whom pancreatitis actually developed was small, such a relationship may have been obscured. The mean interval from initiation of ddI to onset of symptoms of pancreatitis (25 weeks) was significantly shorter than the average duration of ddI therapy (56 weeks), and, consequently, patients in whom pancreatitis developed had been exposed to a lower cumulative dose of ddI than those with normal amylase and lipase levels (64.5 g/m2 vs 119.06 g/m2). Although baseline amylase values did not correlate with the later development of pancreatitis, elevation of baseline aspartate aminotransferase and alanine aminotransferase levels was significantly associated with the later development of pancreatitis.

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