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Objective: To assess the relationship between pancreatic enzyme therapy (PET) and the clinical outcomes of growth, abdominal pain, constipation, gassiness, and number of stools in cystic fibrosis (CF).Study design: Patients (n = 1215) >4 weeks of age from 33 Cystic Fibrosis Foundation accredited sites who had a sweat chloride >60 mmol/L or two CF-causing mutations were enrolled using a proportionate sampling strategy in a nonblinded study.Patients submitted a stool sample and completed a questionnaire.The study coordinator also completed a questionnaire for each patient.Enzyme dosing and growth, abdominal pain, gassiness, constipation, and number of stools were compared.Results: Of the 1215 enrolled patients, 1131 (93.1%) were prescribed PET.Only 14.9%had pancreatic function assessed before enrolling in this study.Stool elastase-1 analysis identified 1074 (89%) patients as pancreatic insufficient (PI).There was no association between PET and the outcomes: growth, abdominal pain, gassiness, constipation, and number of stools.Conclusion: PET dose is not correlated with growth or gastrointestinal symptoms.More sensitive outcome measures of the effectiveness of PET in patients with CF are needed to guide treatment of PI.
Objective: To assess the relationship between pancreatic enzyme therapy (PET) and the clinical outcomes of growth, abdominal pain, constipation, gassiness, and number of stools in cystic fibrosis (CF) .Study design: Patients (n = 1215) of age from 33 Cystic Fibrosis Foundation accredited sites who had a sweat chloride> 60 mmol / L or two CF-causing mutations were enrolled using a proportionate sampling strategy in a non-packed study. Pats submitted a stool sample and completed a questionnaire. The study coordinator also completed a questionnaire for each patient. Enzyme dosing and growth, abdominal pain, gassiness, constipation, and number of stools were compared. Results: Of the 1215 enrolled patients, 1131 (93.1%) were prescribed PET. assessed before enrolling in this study. Tolol elastase-1 analysis identified 1074 (89%) patients as pancreatic insufficiency (PI). There was no association between PET and the outcomes: growth, abdominal pain, gassin ess, constipation, and number of stools. Confc: PET dose is not correlated with growth or gastrointestinal symptoms. More sensitive outcome measures of the effectiveness of PET in patients with CF are needed to guide treatment of PI.