CREON(R) (pancrelipase) Delayed-Release Capsules Improves Digestive Outcomes In Adults With Chronic Pa...(CFA) as compared to the placebo group. ...),Health

Date:10/26/2009

CFA) as compared to the placebo group. CFA is calculated based on measures of fat ingestion and fat excretion; assessing the CFA of a patient is another way to measure the absorption of fat as a percentage of fat intake in patients being tested for EPI. The primary efficacy endpoint was the change in CFA from baseline to the end of the double-blind treatment period. The CFA improved by 32.1% in the CREON® group compared to 8.8% in the placebo group, representing a statistically significant difference between CREON® and placebo (P<0.0001).

"These data add to the growing body of evidence supporting the efficacy and safety profile of CREON® across multiple conditions while also providing clarity around the appropriate dosing of pancreatic enzyme replacement therapy in these patients," said Elizabeth M. Mutisya, M.D., Vice President of U.S. Medical Affairs and Chief Medical Officer at Solvay Pharmaceuticals, Inc. "These CREON® study results are encouraging as dosing of pancreatic enzymes for patients with EPI due to CP or pancreatic surgery has not previously been well defined."

Study Details

The double-blind, randomized, placebo-controlled, two-arm, parallel-group study conducted in the United States, Eastern and Central Europe, examined the efficacy and safety of CREON® 12,000-lipase unit capsules in 52 adults aged 18 years or older with EPI due to CP or pancreatic surgery. Patients were randomized to receive CREON® 12,000-lipase unit capsules at a dose of 72,000 lipase units per main meal and 36,000 lipase units per snack or matching placebo. EPI was confirmed in all subjects through direct pancreatic function testing such as, secretin tests or fecal elastase (< 100 micrograms/g), 72-hour fecal fat determination (> 15 g/day) or pancreatectomy more than 180 days prior to study enrollment.

Upon analysis of the primary efficacy results, the mean CFA increased by 32.1% in t
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SOURCE Solvay Pharmaceuticals, Inc. Copyright©2009 PR Newswire. All rights reserved

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