A Multicentre Double-Blind Placebo-Controlled Study of the Effect of a Pancreatic Enzyme Formulation (Panzytrat® 25 000) on Impaired Lipid Digestion in Adults with Chronic Pancreatitis
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In this multicentre double-blind placebo-controlled trial, the efficacy and tolerability of Panzytrat® 25 000, a pancreatic enzyme formulation, were examined in 72 patients with chronic alcoholic pancreatitis and steatorrhoea of ⩽ 10g per 24 hours. Patients received either Panzytrat® 25 000 or placebo as 2 capsules 3 times daily for 7 days. Of 41 patients who were in strict compliance with the study protocol, 24 received Panzytrat® 25 000 and 17 received placebo. Panzytrat® 25 000 produced a 50% reduction in mean steatorrhoea and decreases in mean creatorrhoea and stool weight of about 40%. These parameters increased slightly in the placebo group. Treatment efficacy, calculated as relative changes from baseline (i.e. the difference between preand post-treatment values divided by the baseline value for each patient), showed that Panzytrat® 25 000 reduced steatorrhoea (−40.9%), creatorrhoea (−29.3%), and stool weight (31.9%) compared with respective increases of 7.2, 11.1 and 8.8% in the placebo group (p = 0.001).
In the 60 patients in whom there were no major protocol deviations, 32 received Panzytrat® 25 000 and 28 received placebo (12 patients were excluded because of protocol violation). Panzytrat® 25 000 reduced mean steatorrhoea (≈ −50%), creatorrhoea (≈ −40%) and mean stool weight (≈ −30%) compared with slight increases in these parameters in the placebo group. Treatment efficacy, calculated as relative changes from baseline in each patient, showed decreases in steatorrhoea, creatorrhoea and stool weight of 35.6, 26.9 and 23.9%, respectively, with Panzytrat® 25 000, compared with increases of 1.9, 7.5 and 5.2%, respectively, in the placebo group (p = 0.001, 0.001 and 0.01, respectively).
In both analyses, Panzytrat® 25 000 appeared to be more effective in patients who had not undergone prior surgery compared with those who had received surgery considered likely to hamper treatment; however, differences between these subgroups were not statistically significant. Global efficacy of Panzytrat® 25 000 was considered ‘good or excellent’ by approximately 80% of patients and clinicians. Panzytrat® 25 000 was well tolerated, with 97% of patients and clinicians considering the drug to have ‘good or excellent’ tolerability.
KeywordsLipase Chronic Pancreatitis Drug Invest Pancreatic Enzyme Strict Compliance
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