PANCREATITIS AND PANCREATIC DYSFUNCTION IN PATIENTS TAKING DIDEOXYINOSINE

Objective: To describe the incidence, clinical characteristics and dose relationship of dideoxyinosine (ddl)-associated pancreatitis. Design: Patients enrolled in a Phase I dose escalation trial of ddl [AIDS Clinical Trials Group (ACTG) 064] were evaluated for signs and symptoms of pancreatic dysfunction. Setting: Two ACTG sites. Patients: Forty-four patients with AIDS or AIDS-related complex (ARC) and a CD4 cell count less-than-or-equal-to 400 x 10(6)/l. Main outcome measures: Seven patients developed pancreatitis that lasted from 1 to 7 weeks and varied in severity from mild to life-threatening. Seven other patients had evidence of hyperamylasemia or hypertriglyceridemia. Six patients who developed pancreatitis were able to tolerate rechallenge with lower doses of ddl. Results: Development of pancreatitis correlated with cumulative dose of ddl but not with stage of disease or concomitant medications. Cumulative dose was not significantly associated with development of hyperamylasemia or hypertriglyceridemia in patients without clinical pancreatitis. Conclusions: The development of pancreatitis in AIDS or ARC patients receiving ddl varies in severity and time course and is associated with cumulative dose. Patients who develop pancreatitis may be able to tolerate therapy with a lower dose after resolution of their symptoms. Patients receiving ddl require careful monitoring for the development of this complication.