CREON Clinical Efficacy

Clinical Trial Endpoints

CFA: In normal, healthy subjects,
CFA is approximately 90%2

CNA: In normal, healthy subjects,
CNA is approximately 88%6

Trapnell Study:
Children and adults with EPI due to CF1,8

TREATMENT PERIOD OF 5 DAYS

Treatment-Related Improvement in Fat Absorption

49%

89%

Mean CFA (%)

100

80

60

40

20

0

Placebo

CREON

n=29

Mean difference in CFA was 41% (P<0.001)

  • Significant improvement in CFA in patients with EPI due to cystic fibrosis aged 12 to 43 years
  • Patients received CREON at a dose of 4,000 lipase units per gram of fat per day or placebo and had a dietary fat intake ≥90 g per day
  • The most common adverse reactions reported in this study were gastrointestinal-related, dizziness, and cough
Randomized, double-blind, multicenter, placebo-controlled, 2-period crossover study of CREON in 32 patients aged 12 to 43 with confirmed diagnosis of EPI and CF. Patients were randomized to receive CREON 24,000 lipase unit capsules, at a dose of 4,000 lipase units per gram of fat per day, or matching placebo for 5 to 6 days, followed by crossover to the alternate treatment for 5 to 6 days. Patients consumed ≥90 grams of fat per day during treatment periods. A washout period of 3 to 14 days was included between crossover periods to return patients to baseline conditions. The primary endpoint was the coefficient of fat absorption (CFA) and the secondary endpoint was coefficient of nitrogen absorption (CNA). The final analysis population was limited to 29 patients; 3 patients were excluded due to protocol deviations.

Graff Study:
Children with EPI due to CF1,7

TREATMENT PERIOD OF 5 DAYS

Treatment-Related Improvement in Fat Absorption

47%

83%

Mean CFA (%)

100

80

60

40

20

0

Placebo

CREON

n=16

Mean difference in CFA was 35% (P<0.001)

  • Significant improvement in CFA in pediatric patients aged 7 to 11 with EPI due to cystic fibrosis (CF)
  • Patients received CREON at a dose of 4,000 lipase units per gram of fat per day or placebo and had a dietary fat intake ≥90 g per day
  • The most common adverse reactions reported in this study were vomiting and headache
Randomized, double-blind, multicenter, placebo-controlled, 2-period crossover study of CREON in children aged 7 to 11 with confirmed EPI and CF. A total of 17 patients were randomized to receive CREON 12,000 lipase unit capsules, at a dose of 4,000 lipase units per gram of fat per day, or matching placebo for 5 to 6 days, followed by crossover to the alternate treatment for 5 to 6 days. Patients consumed ≥90 grams of fat per day during treatment periods. A washout period of 3 to 14 days was included between crossover periods to return patients to baseline conditions. The primary endpoint was the coefficient of fat absorption (CFA) and the secondary endpoint was coefficient of nitrogen absorption (CNA). One patient in the pancrelipase/placebo treatment sequence withdrew and was not included in the efficacy analysis.

Whitcomb Study: Adults with EPI due
to CP or pancreatectomy1,9

TREATMENT PERIOD OF 7 DAYS

Treatment-Related Improvement in Fat Absorption

66%

86%

Mean CFA (%)

100

80

60

40

20

0

Placebo

CREON

n=16

Mean difference in CFA was 35% (P<0.001)

Placebo

n=28

CREON

n=24

Mean difference in CFA was 21% (P<0.0001)

  • Significant improvement in CFA in adult patients aged 32 to 75 with EPI due to chronic pancreatitis (CP) and pancreatectomy
  • Patients received CREON at a dose of 72,000 lipase units per meal (3 meals) and 36,000 lipase units per snack (2 snacks) or placebo and had a dietary fat intake ≥100 g per day
  • The most common adverse reactions reported in this study were related to glycemic control and were reported more commonly during CREON treatment than during placebo treatment
Randomized, double-blind, multicenter, placebo-controlled, parallel-group study of CREON in patients aged 32 to 75 years with EPI due to chronic pancreatitis or pancreatectomy. Patients entered a 5-day placebo run-in period, followed by pancreatic enzyme replacement therapy as directed by the investigator for 16 days. Only patients with a coefficient of fat absorption (CFA) <80% in the run-in period were randomized to the double-blind period. A total of 54 patients were randomized to receive CREON 12,000 lipase unit capsules, at 72,000 lipase units per main meal (3 main meals) and 36,000 lipase units per snack (2 snacks), or matching placebo for 7 days. Patients consumed ≥100 grams of fat per day during the treatment period. The primary endpoint was CFA and the secondary endpoint was the coefficient of nitrogen absorption (CNA). The final analysis population was limited to 52 patients; 2 patients were excluded due to protocol violations.

Trapnell Study:
Children and adults with EPI due to CF1,8

TREATMENT PERIOD OF 5 DAYS

Treatment-Related Improvement in Protein Absorption

49%

86%

Mean CNA (%)

100

80

60

40

20

0

Placebo

CREON

n=29

Mean difference in CNA was 37% (P<0.001)

  • Significant improvement in CNA in patients with EPI due to cystic fibrosis aged 12 to 43 years
  • The primary efficacy measurement was CFA. The secondary efficacy measurement was CNA
  • Patients received CREON at a dose of 4,000 lipase units per gram of fat per day or placebo and had a dietary fat intake ≥90 g per day
  • The most common adverse reactions reported in this study were gastrointestinal-related, dizziness, and cough
Randomized, double-blind, multicenter, placebo-controlled, 2-period crossover study of CREON in 32 patients aged 12 to 43 with confirmed diagnosis of EPI and CF. Patients were randomized to receive CREON 24,000 lipase unit capsules, at a dose of 4,000 lipase units per gram of fat per day, or matching placebo for 5 to 6 days, followed by crossover to the alternate treatment for 5 to 6 days. Patients consumed ≥90 grams of fat per day during treatment periods. A washout period of 3 to 14 days was included between crossover periods to return patients to baseline conditions. The primary endpoint was the coefficient of fat absorption (CFA) and the secondary endpoint was coefficient of nitrogen absorption (CNA). The final analysis population was limited to 29 patients; 3 patients were excluded due to protocol deviations.

Graff Study:
Children with EPI due to CF1,7

TREATMENT PERIOD OF 5 DAYS

Treatment-Related Improvement in Protein Absorption

45%

80%

Mean CNA (%)

100

80

60

40

20

0

Placebo

CREON

n=16

Mean difference in CNA was 35% (P<0.001)

  • Significant improvement in CNA in pediatric patients aged 7 to 11 with EPI due to cystic fibrosis (CF)
  • The primary efficacy measurement was CFA. The secondary efficacy measurement was CNA
  • Patients received CREON at a dose of 4,000 lipase units per gram of fat per day or placebo and had a dietary fat intake ≥90 g per day
  • The most common adverse reactions reported in this study were vomiting and headache
Randomized, double-blind, multicenter, placebo-controlled, 2-period crossover study of CREON in children aged 7 to 11 with confirmed EPI and CF. A total of 17 patients were randomized to receive CREON 12,000 lipase unit capsules, at a dose of 4,000 lipase units per gram of fat per day, or matching placebo for 5 to 6 days, followed by crossover to the alternate treatment for 5 to 6 days. Patients consumed ≥90 grams of fat per day during treatment periods. A washout period of 3 to 14 days was included between crossover periods to return patients to baseline conditions. The primary endpoint was the coefficient of fat absorption (CFA) and the secondary endpoint was coefficient of nitrogen absorption (CNA). One patient in the pancrelipase/placebo treatment sequence withdrew and was not included in the efficacy analysis.
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