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A Double-Blind Placebo-Controlled Trial of a Pancreatic Enzyme Formulation (Panzytrat® 25 000) in the Treatment of Impaired Lipid Digestion in Patients with Cystic Fibrosis

Drug Investigation, ISSN: 1179-1918, Vol: 5, Issue: 5, Page: 274-280
1993
  • 8
    Citations
  • 0
    Usage
  • 2
    Captures
  • 0
    Mentions
  • 0
    Social Media
Metric Options:   Counts1 Year3 Year

Metrics Details

  • Citations
    8
    • Citation Indexes
      6
    • Policy Citations
      2
      • Policy Citation
        2
  • Captures
    2

Article Description

In 15 children (mean age 12 years) with proven cystic fibrosis and a lipid absorption coefficient (LAC) < 90%, the efficacy of a pancreatic enzyme formulation (Panzytrat® 25 000) was compared with placebo in a randomised double-blind parallel group study. The 14 patients evaluated for efficacy received Panzytrat® 25 000 (n = 7) or placebo (n = 7) orally during meals, in an age-adjusted dosage of 2 (< 18 months), 4 (18 months to puberty) or 6 (postpubertal) capsules daily for 8 days. Baseline values were established after treatment with a conventional powdered pancreatin preparation and an age-adjusted diet. After treatment, the mean LAC was 80.5% in the Panzytrat® 25 000 group compared with 55.6% in the placebo group. In the Panzytrat® 25 000 group there was an improvement in LAC (+25%), stool weight (−46%), and in nondigested (−38%) and nonabsorbed (−47%) faecal fat. In contrast, in the placebo group there was a worsening of all 4 of these parameters with changes of −10% for LAC, +32% for stool weight, +36% for non-digested fat, and +46% for nonabsorbed fat. The difference between the Panzytrat® 25 000 and the placebo groups was statistically significant (p < 0.01) for all 4 parameters. Subjective assessment of efficacy by the clinician was rated as ‘good’ or ‘excellent’ for 86% of patients in the Panzytrat® 25 000 group compared with 14% of those in the placebo group (p = 0.015). Tolerability was ‘good’ or ‘excellent’ in all patients except one placebo recipient who complained of digestive upset. © 1993, Adis International Limited. All rights reserved.

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