Abstract
Objectives: We studied a novel pancreatic enzyme product, ALTU-135, a proprietary formulation of microbially derived lipase, protease, and amylase, to determine its efficacy and safety in treatment of pancreatic insufficiency (PI) in patients with cystic fibrosis (CF). Study design: Ambulatory subjects with CF-PI (n = 117) had baseline coefficient of fat and nitrogen absorption (CFA and CNA, respectively) determined in an inpatient setting while not receiving pancreatic enzyme replacement therapy. Subjects were then randomized to treatment with ALTU-135 containing 5000 (low), 25,000 (mid), or 100,000 (highest) units of lipase (1:1:0.15 of lipase:protease:amylase) for 28 days. After 14 days, CFA and CNA were re-measured. The primary outcomes were change from baseline in CFA and CNA between treatments. Results: Treatment CFA was significantly greater in the mid and highest dose groups compared with that in the low dose group (P = .0229 and P =.0041, respectively); findings were similar for CNA. Subjects with baseline CFA ≤ 40% and >40% in the 2 higher dose groups had a mean increase of 31 and 8 percentage points in CFA, respectively (P < .0001). Conclusion: ALTU-135 was efficacious during the 1-month study period at the dose of 25,000 units of lipase, 25,000 units of protease, and 3750 units of amylase.
| Original language | English |
|---|---|
| Journal | Journal of Pediatrics |
| Volume | 149 |
| Issue number | 5 |
| DOIs | |
| State | Published - Nov 1 2006 |
| Externally published | Yes |
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ASJC Scopus subject areas
- Pediatrics, Perinatology, and Child Health
Cite this
Study of a novel pancreatic enzyme replacement therapy in pancreatic insufficient subjects with cystic fibrosis. / Borowitz, Drucy; Goss, Christopher H.; Limauro, Stacey; Konstan, Michael W.; Blake, Kathryn; Casey, Susan; Quittner, Alexandra; Murray, Frederick T.
In: Journal of Pediatrics, Vol. 149, No. 5, 01.11.2006.Research output: Contribution to journal › Article
}
TY - JOUR
T1 - Study of a novel pancreatic enzyme replacement therapy in pancreatic insufficient subjects with cystic fibrosis
AU - Borowitz, Drucy
AU - Goss, Christopher H.
AU - Limauro, Stacey
AU - Konstan, Michael W.
AU - Blake, Kathryn
AU - Casey, Susan
AU - Quittner, Alexandra
AU - Murray, Frederick T.
PY - 2006/11/1
Y1 - 2006/11/1
N2 - Objectives: We studied a novel pancreatic enzyme product, ALTU-135, a proprietary formulation of microbially derived lipase, protease, and amylase, to determine its efficacy and safety in treatment of pancreatic insufficiency (PI) in patients with cystic fibrosis (CF). Study design: Ambulatory subjects with CF-PI (n = 117) had baseline coefficient of fat and nitrogen absorption (CFA and CNA, respectively) determined in an inpatient setting while not receiving pancreatic enzyme replacement therapy. Subjects were then randomized to treatment with ALTU-135 containing 5000 (low), 25,000 (mid), or 100,000 (highest) units of lipase (1:1:0.15 of lipase:protease:amylase) for 28 days. After 14 days, CFA and CNA were re-measured. The primary outcomes were change from baseline in CFA and CNA between treatments. Results: Treatment CFA was significantly greater in the mid and highest dose groups compared with that in the low dose group (P = .0229 and P =.0041, respectively); findings were similar for CNA. Subjects with baseline CFA ≤ 40% and >40% in the 2 higher dose groups had a mean increase of 31 and 8 percentage points in CFA, respectively (P < .0001). Conclusion: ALTU-135 was efficacious during the 1-month study period at the dose of 25,000 units of lipase, 25,000 units of protease, and 3750 units of amylase.
AB - Objectives: We studied a novel pancreatic enzyme product, ALTU-135, a proprietary formulation of microbially derived lipase, protease, and amylase, to determine its efficacy and safety in treatment of pancreatic insufficiency (PI) in patients with cystic fibrosis (CF). Study design: Ambulatory subjects with CF-PI (n = 117) had baseline coefficient of fat and nitrogen absorption (CFA and CNA, respectively) determined in an inpatient setting while not receiving pancreatic enzyme replacement therapy. Subjects were then randomized to treatment with ALTU-135 containing 5000 (low), 25,000 (mid), or 100,000 (highest) units of lipase (1:1:0.15 of lipase:protease:amylase) for 28 days. After 14 days, CFA and CNA were re-measured. The primary outcomes were change from baseline in CFA and CNA between treatments. Results: Treatment CFA was significantly greater in the mid and highest dose groups compared with that in the low dose group (P = .0229 and P =.0041, respectively); findings were similar for CNA. Subjects with baseline CFA ≤ 40% and >40% in the 2 higher dose groups had a mean increase of 31 and 8 percentage points in CFA, respectively (P < .0001). Conclusion: ALTU-135 was efficacious during the 1-month study period at the dose of 25,000 units of lipase, 25,000 units of protease, and 3750 units of amylase.
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UR - http://www.scopus.com/inward/citedby.url?scp=33751119814&partnerID=8YFLogxK
U2 - 10.1016/j.jpeds.2006.07.030
DO - 10.1016/j.jpeds.2006.07.030
M3 - Article
VL - 149
JO - Journal of Pediatrics
JF - Journal of Pediatrics
SN - 0022-3476
IS - 5
ER -