Evaluation of the Effectiveness of In-line Immobilized Lipase Cartridge in Enterally Fed Patients With Cystic Fibrosis.

BACKGROUND

Pancreatic insufficiency occurs in most patients with cystic fibrosis (CF) contributing to malnutrition. In the United States, 3600 patients with CF require enteral feeding (EF). Oral pancreatic enzymes are commonly used with EF, despite not being designed or approved for this use. An immobilized lipase cartridge (ILC) for extracorporeal digestion of enteral feedings was developed. The sponsor provided it to patients via a structured program, which we evaluated to assess the effectiveness of the ILC on nutritional status.

METHODS

The program provided the ILC to patients prescribed the device while reimbursement efforts were ongoing. Baseline anthropometric data were obtained and subsequent measurements of height, weight, and body mass index (BMI) were collected at 6 and 12 months.

RESULTS

Inclusion criteria were met by 100 patients (age = 0--45 years). Over 12 months of use in patients >2 years of age (n = 93), there were significant improvements seen in height and weight z-scores with improvement trend seen in BMI. The frequency of achieving the 50th percentile increased steadily for weight and BMI from baseline to 12 months but not for height.

CONCLUSIONS

This evaluation of a program to assist patient access to ILC demonstrates that better growth is possible over standard of care. The association of ILC use with significant improvements in anthropometric parameters over a 12-month period in people with CF demonstrates the effectiveness of ILC as rational enzyme therapy during enteral feedings.