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Pertzye

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Pertzye

CLINICAL PHARMACOLOGY

Mechanism of Action

The pancreatic enzymes in PERTZYE catalyze the hydrolysis of fats to monoglyceride, glycerol and free fatty acids, proteins into peptides and amino acids, and starches into dextrins and short chain sugars such as maltose and maltotriose in the duodenum and proximal small intestine, thereby acting like digestive enzymes physiologically secreted by the pancreas.

Pharmacokinetics

The pancreatic enzymes in PERTYZE are enteric-coated to minimize destruction or inactivation in gastric acid. PERTZYE is expected to release most of the enzymes in vivo at pH greater than 5.5. Pancreatic enzymes are not absorbed from the gastrointestinal tract in appreciable amounts.

Clinical Studies

The short-term safety and efficacy of PERTZYE were evaluated in a randomized, doubleblind, placebo-controlled, crossover study conducted in 24 patients ages 8 to 43 years (mean age = 20 years) with exocrine pancreatic insufficiency due to cystic fibrosis.6 The efficacy analysis population included 21 patients who completed both double-blind treatment periods. Patients were randomized to receive PERTZYE at individually titrated doses (not to exceed 2,500 lipase units per kilogram per meal) or matching placebo for 6 to 8 days of treatment, followed by crossover to the alternate treatment for an additional 6 to 8 days.

The primary efficacy endpoint was the mean difference in coefficient of fat absorption (CFA) between PERTZYE and placebo treatment. The CFA was determined by a 72-hour stool collection during both treatments, when both fat ingestion and excretion were measured.

Mean CFA was 83% with PERTZYE treatment compared to 46% with placebo treatment. The mean difference in CFA was 36 percentage points in favor of PERTZYE treatment with 95% CI: (28, 45) and p < 0.001.

The coefficient of nitrogen absorption (CNA) was determined by a 72-hour stool collection during both treatments, when nitrogen excretion was measured and nitrogen ingestion from a controlled diet was estimated (based on the assumption that proteins contain 16% nitrogen). Each patient's CNA during placebo treatment was used as their no-treatment CNA value. Mean CNA was 79% with PERTZYE treatment compared to 47% with placebo treatment. The mean difference in CNA was 32 percentage points in favor of PERTZYE treatment and this was a statistically significant change.

There were no differences between children and adults in the severity of pancreatic insufficiency (placebo response) or in the magnitude of the response to PERTZYE.

REFERENCES

6. Konstan MW, et al. A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Cross-Over Study to Evaluate the Effectiveness and Safety of a Novel Pancrelipase (PANCRECARB® MS-16) in Reducing Steatorrhea in Children and Adults with Cystic Fibrosis. 2008 North American Cystic Fibrosis Conference. Abstract #618.

Last reviewed on RxList: 5/24/2012
This monograph has been modified to include the generic and brand name in many instances.

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