Core evidence.
Outcome measure | Evidence | Implications |
---|---|---|
Disease-oriented evidence | Randomized, double-blind, placebocontrolled trials showed that pancreatic enzyme replacement therapy with pancrelipase even for short periods of a few weeks improved steatorrhea and the coefficient of fat absorption and of nitrogen absorption along with increase in body weight, in both pediatric and adult patients with chronic pancreatitis and cystic fibrosis | Pancrelipase improves maldigestion and malnutrition, which leads to restoration of nutritional conditions, irrespective of age |
Patient-oriented evidence | ||
Clinical symptoms | Stool frequency, stool consistency, and abdominal pain were improved after PERT with pancrelipase | PERT with pancrelipase ameliorates clinical symptoms effectively, with good tolerability and without serious adverse events |
Gastrointestinal adverse events | Some gastrointestinal adverse events such as nausea, diarrhea, and abdominal pain, were observed No serious adverse events were observed in clinical trials with pancrelipase approved by the US FDA |
|
Economic evidence | Not available |
Abbreviations: FDA, Food and Drug Administration; PERT, pancreatic enzyme replacement therapy.