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Viokace

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Viokace

Viokace

CLINICAL PHARMACOLOGY

Mechanism of Action

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

Pharmacokinetics

Pancreatic enzymes are not absorbed from the gastrointestinal tract in appreciable amounts.

Clinical Studies

The short-term safety and efficacy of VIOKACE were evaluated in a randomized, double-blind, placebo-controlled, parallel group study comparing VIOKACE Tablets (20,880 USP units of lipase per tablet) to placebo in 50 patients, ages 24 to 70, with exocrine pancreatic insufficiency (EPI) due to chronic pancreatitis (CP) or pancreatectomy. Eighteen patients had a history of pancreatectomy (11 were treated with VIOKACE). All patients were maintained on a controlled high fat diet of 100 grams of fat per day. After a wash-out period (6 to 7 days), patients were randomized to a fixed dose of VIOKACE (22 tablets per day; 6 tablets per meal and 2 tablets with 2 of 3 snacks) or placebo, in combination with a proton pump inhibitor. Forty-nine patients completed the double-blind treatment period (6 to 7 days); 29 patients received VIOKACE, and 20 patients received placebo.

The coefficient of fat absorption (CFA) was determined by a 72-hour stool collection during both treatments, when both fat excretion and fat ingestion were measured.

The wash-out period mean CFA was 48% in the VIOKACE treatment group and was 57% in the placebo group. At the end of the double-blind treatment period, the mean CFA was 86% with VIOKACE treatment compared to 58% with placebo. The mean difference in CFA at the end of the double-blind treatment period was 28 percentage points in favor of VIOKACE treatment with 95% Confidence Interval of (21, 37) and p ≤ 0.0001.

Subgroup analyses of the CFA results showed that mean change in CFA with VIOKACE treatment (from the washout period to the end of the double-blind period) was greater in patients with lower wash-out period CFA values than in patients with higher wash-out period CFA values.

Only 2 of the patients with a history of total pancreatectomy were treated with VIOKACE. One of these patients had a CFA of 12% during the wash-out period and a CFA of 90% at the end of the double-blind period; the other patient had a CFA of 38% during the wash-out period and a CFA of 77% at the end of the double-blind period. The remaining 9 patients with a history of partial pancreatectomy treated with VIOKACE had a mean CFA of 56% during the wash-out period and a mean CFA of 86% at the end of the double-blind period.

Last reviewed on RxList: 3/12/2012
This monograph has been modified to include the generic and brand name in many instances.

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