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Four participants in the leflunomide group reported three grade 2 events (headache, elevated lipase, and neutropenia) and nine grade 1 events (headache, fatigue, rash, dry mouth, taste alteration, abdominal cramping, increased amylase, increased lipase and hyperbilirubinemia) that were at least possibly related to leflunomide or placebo.
Elevated lipase levels are common in NE and may reflect a more severe form of NE.
The most common reasons for dose reduction were anemia (n=5) and elevated lipase levels (n=4).
Elevated lipase levels were common in our patient cohort and might reflect a more severe form of NE.
Furthermore, almost 40% of patients under 3 years of age with a diagnosis of acute pancreatitis were reported to have normal amylase but elevated lipase levels [ 19].
Haematological and biochemical grade 3/4 toxicities were rare with lymphopenia, hypophosphataemia and elevated lipase marginally more common in the treatment arm.
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In our patient cohort, 15%% of the patients had elevated serum lipase levels at time of diagnosis and 7 patients had a threefold increased serum lipase above the normal range.
LFT's were not elevated and lipase level was normal at 30 U/L.
The most common toxicities included hyperglycemia secondary to dexamethasone, and elevated serum lipase, both of which were asymptomatic and reversible.
Neonates also have elevated gastric lipase activity (Hamosh 1990), which may enhance their ability to convert DEHP to MEHP.
At screening, more subjects in the type 2 diabetic group had elevated (>ULN) lipase (13%) or elevated pancreatic amylase (6%) concentrations than did subjects in the obese nondiabetic group (4% and 2%, respectively).
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