Pharmacotherapeutic group: Digestives, including enzymes, multienzyme preparations (lipase, protease, etc.)
ATC code: A09AA02
Mechanism of action
Kreon contains porcine pancreatin in the form of gastro-resistant (acid-resistant) minimicrospheres in gelatin capsules.
The capsules dissolve rapidly in the stomach and release numerous minimicrospheres. This multi-unit delivery system allows thorough mixing with chyme, passage from the stomach along with chyme, and upon release, effective penetration of enzymes into the intestinal contents.
Once the minimicrospheres reach the small intestine, the enteric coating dissolves rapidly (at pH > 5.5) and releases enzymes with lipolytic, amylolytic, and proteolytic activity, thereby enabling the digestion of fats, starches, and proteins. The products of pancreatic digestion are then absorbed either directly or after further hydrolysis by intestinal enzymes.
Clinical efficacy
A total of 30 studies were conducted in patients with pancreatic exocrine insufficiency (PEI) evaluating the efficacy of Kreon (10,000 or 25,000 Ph.Eur. units of lipase). Ten of these were placebo-controlled studies conducted in patients with cystic fibrosis, chronic pancreatitis, or patients following surgical procedures.
In all randomised, placebo-controlled efficacy studies, the predefined primary objective was to demonstrate the superiority of Kreon over placebo on the primary efficacy parameter — the coefficient of fat absorption (CFA).
The coefficient of fat absorption determines the percentage of fat absorbed by the body when fat intake and faecal fat output are assessed. In PEI placebo-controlled studies, the mean CFA (%) was higher during treatment with Kreon (83.0%) compared with placebo (62.6%). In all studies, regardless of design, the mean CFA (%) at the end of the Kreon treatment period was similar to the mean CFA values for Kreon in placebo-controlled studies.
Treatment with Kreon improves the symptoms of pancreatic exocrine insufficiency, including stool consistency, abdominal pain, flatulence, and stool frequency, regardless of the underlying disease.
Paediatric population
The efficacy of Kreon 10,000/25,000 in cystic fibrosis was demonstrated in 288 paediatric patients, ranging in age from neonates to adolescents. In all studies, the mean CFA values at the end of treatment with Kreon exceeded 80%, comparably across all paediatric age groups.
⚠️ Warnings
Fibrosing colonopathy
The development of strictures in the large intestine and ileocaecal region with subsequent obstruction (fibrosing colonopathy) has been reported in patients with cystic fibrosis receiving high-dose pancreatin preparations. As a precautionary measure, unusual abdominal symptoms or changes in symptoms should be medically evaluated to exclude the possibility of fibrosing colonopathy, especially if the patient is taking more than 10,000 units of lipase/kg/day. Pancreatin treatment should be discontinued until complete resolution of symptoms.
Anaphylactic reaction
Anaphylactic reactions have been rarely reported with the use of pancreatic enzyme-containing products. Patients must be instructed to discontinue treatment immediately and seek emergency medical attention if such a reaction occurs.
Caution is required in patients with allergy to porcine protein to reduce the risk of adverse effects caused by hypersensitivity.
Oral mucosal irritation
If the capsules are chewed or held in the mouth for a prolonged period, pain, irritation (stomatitis), bleeding, or ulceration of the mouth may occur. Rinsing the mouth and drinking a glass of water may help alleviate early signs of oral irritation.
This medicinal product contains less than 1 mmol (23 mg) of sodium per dosage unit, i.e. it is essentially "sodium-free".
Traceability
In order to improve the traceability of biological medicinal products, the name of the administered product and the batch number should be clearly recorded.
