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Journal of Pain and Symptom Management Apr 2020Therapeutic Reviews aim to provide essential independent information for health professionals about drugs used in palliative and hospice care. Additional content is...
Therapeutic Reviews aim to provide essential independent information for health professionals about drugs used in palliative and hospice care. Additional content is available via www.palliativedrugs.com. The series editors welcome feedback on the articles.
Topics: Hospice Care; Humans; Palliative Care; Pancrelipase
PubMed: 31760143
DOI: 10.1016/j.jpainsymman.2019.11.008 -
Pancreas 2016The aim of this study was to perform exploratory analyses of the efficacy and safety of pancrelipase delayed-release capsules (Creon) in patients with exocrine... (Randomized Controlled Trial)
Randomized Controlled Trial
OBJECTIVES
The aim of this study was to perform exploratory analyses of the efficacy and safety of pancrelipase delayed-release capsules (Creon) in patients with exocrine pancreatic insufficiency (EPI) with (n = 36) and without (n = 18) concurrent diabetes mellitus (DM).
METHODS
This was a retrospective, post hoc, subgroup (±DM) analysis of a double-blind, randomized, placebo-controlled trial of pancrelipase in patients with EPI due to chronic pancreatitis or pancreatectomy (total or partial). After a 5-day placebo run-in period (baseline), patients were randomized to pancrelipase (72,000 lipase units/meal, 36,000/snack) or placebo for 7 days. Outcomes included changes in coefficients of fat absorption (CFA) and nitrogen absorption (CNA) from baseline to the end of the double-blind period.
RESULTS
Mean changes in nutrient absorption were greater with pancrelipase versus placebo in patients with DM (CFA, 36.0% vs 7.5%, P < 0.0001; CNA, 33.4% vs 3.7%, P = 0.0002) and without DM (CFA, 25.2% vs 12.3%, P = 0.0326; CNA, 39.1% vs 17.6%, P = 0.1187). Diabetes mellitus was not significantly associated with outcomes for CFA (P = 0.0802) and CNA (P = 0.2934). Incidences of adverse events, including hypoglycemia and hyperglycemia, were similar in the pancrelipase and placebo arms.
CONCLUSIONS
Pancrelipase improved fat and protein absorption in patients with EPI due to chronic pancreatitis or pancreatectomy, with or without DM, and matched the safety profile previously reported.
Topics: Abdominal Pain; Adult; Diabetes Mellitus; Double-Blind Method; Drug Administration Schedule; Enzyme Replacement Therapy; Exocrine Pancreatic Insufficiency; Female; Humans; Male; Middle Aged; Pancreatectomy; Pancreatin; Pancreatitis, Chronic; Pancrelipase; Retrospective Studies; Treatment Outcome
PubMed: 26495784
DOI: 10.1097/MPA.0000000000000514 -
Gastroenterology Clinics of North... Mar 2019Celiac disease (CD) is an autoimmune enteropathy triggered by gluten. Gluten-free diets can be challenging because of their restrictive nature, inadvertent... (Review)
Review
Celiac disease (CD) is an autoimmune enteropathy triggered by gluten. Gluten-free diets can be challenging because of their restrictive nature, inadvertent cross-contaminations, and the high cost of gluten-free food. Novel nondietary therapies are at the preclinical stage, clinical trial phase, or have already been developed for other indications and are now being applied to CD. These therapies include enzymatic gluten degradation, binding and sequestration of gluten, restoration of epithelial tight junction barrier function, inhibition of tissue transglutaminase-mediated potentiation of gliadin oligopeptide immunogenicity or of human leukocyte antigen-mediated gliadin presentation, induction of tolerance to gluten, and antiinflammatory interventions.
Topics: Autoimmunity; Bifidobacterium longum subspecies infantis; Celiac Disease; Combined Modality Therapy; Diet, Gluten-Free; HLA-DQ Antigens; Humans; Immunologic Factors; Lactococcus lactis; Molecular Targeted Therapy; Oligopeptides; Pancrelipase; Peptide Hydrolases; Probiotics; Sulfonamides
PubMed: 30711207
DOI: 10.1016/j.gtc.2018.09.011 -
Pancreas Feb 2021The aim of this study was to evaluate whether improvement in coefficient of fat absorption (CFA) with pancreatic enzyme replacement therapy correlates with clinical...
OBJECTIVE
The aim of this study was to evaluate whether improvement in coefficient of fat absorption (CFA) with pancreatic enzyme replacement therapy correlates with clinical symptoms in patients with chronic pancreatitis with moderate to severe exocrine pancreatic insufficiency.
METHODS
Data were pooled from 2 randomized double-blind trials of the effects of 1 week of pancrelipase (n = 59) versus placebo (n = 57) on CFA and stool frequency, stool consistency, abdominal pain, and flatulence; 1 trial included a 51-week open-label pancrelipase treatment period (n = 34).
RESULTS
Compared with placebo, significantly more patients receiving pancrelipase reported decreased stool frequency at week 1 (72% vs 38%; P < 0.001). Although 30% of patients receiving pancrelipase and 20% receiving placebo reported improved stool consistency, changes in stool consistency, abdominal pain, and flatulence were not different between groups. Mean CFA absolute change from baseline was significantly greater with pancrelipase versus placebo (24.7% vs 6.4%; P < 0.001). Improvements in stool consistency and frequency correlated with CFA improvement. Symptom improvements persisted or further improved through 52 weeks of treatment.
CONCLUSIONS
Pancrelipase significantly improved exocrine pancreatic insufficiency maldigestive symptoms. Improvements in objective stool symptoms with pancreatic enzyme replacement therapy correlated with CFA improvement at 1 week.
Topics: Abdominal Pain; Adolescent; Adult; Aged; Defecation; Exocrine Pancreatic Insufficiency; Feces; Female; Flatulence; Gastrointestinal Agents; Humans; Intestinal Absorption; Lipid Metabolism; Male; Middle Aged; Pancreatitis, Chronic; Pancrelipase; Randomized Controlled Trials as Topic; Time Factors; Treatment Outcome; Young Adult
PubMed: 33560089
DOI: 10.1097/MPA.0000000000001733 -
JOP : Journal of the Pancreas Sep 2018Drug-induced exanthems are commonly associated with NSAIDs, antibiotics, and anti-epileptics. Pancrelipase is frequently used for conditions resulting in pancreatic...
INTRODUCTION
Drug-induced exanthems are commonly associated with NSAIDs, antibiotics, and anti-epileptics. Pancrelipase is frequently used for conditions resulting in pancreatic exocrine insufficiency. Published case reports of pancrelipase hypersensitivity focus on the respiratory manifestations.
CASE REPORT
Here we report a case of skin hypersensitivity resulting from pancrelipase use. To further assess this association, we used a Naranjo nomogram, which determines the likelihood that an adverse drug reaction is the result of the drug itself. Our patient had a score of seven, suggesting our patient had a probably adverse drug reaction.
DISCUSSION
As pancrelipase is a commonly prescribed drug, clinicians should be aware of the potential hypersensitivity skin reactions associated with pancrelipase.
PubMed: 30405325
DOI: No ID Found -
Digestion 2019The aims of the study are to clarify the pathophysiological differences among early chronic pancreatitis (ECP), functional dyspepsia with pancreatic (FD-P) enzyme...
Camostat Mesilate, Pancrelipase, and Rabeprazole Combination Therapy Improves Epigastric Pain in Early Chronic Pancreatitis and Functional Dyspepsia with Pancreatic Enzyme Abnormalities.
BACKGROUND/AIMS
The aims of the study are to clarify the pathophysiological differences among early chronic pancreatitis (ECP), functional dyspepsia with pancreatic (FD-P) enzyme abnormalities and FD patients and to determine whether camostat mesilate, pancrelipase, and rabeprazole triple therapy improve FD symptoms in the ECP patients and FD-P patients in cross-over way.
METHODS
We enrolled 84 consecutive patients presenting with typical symptoms of FD patients (n = 42), ECP patients (n = 15), and FD-P patients (n = 27). Gastric emptying was assessed by the 13C-acetate breath test. ECP was diagnosed based on the criteria recommended by the Japan Pancreatic Association.
RESULTS
The proportions of female in ECP patients and FD-P were significantly higher compared to that in FD patients. The early phase of gastric emptying in ECP and FD-P patients was significantly disturbed compared to that in FD patients. The primary outcome of this study is that 4 weeks of camostat mesilate, pancrelipase, and rabeprazole triple therapy significantly ameliorated epigastric pain in ECP patients compared to acotiamide and rabeprazole combination therapy.
CONCLUSION
Although there were no significant differences in pathophysiology between ECP patients and FD-P patients, triple therapy can significantly ameliorate epigastric pain in ECP patients. Further studies will be needed to clarify why triple therapy can improve epigastric pain in ECP patients.
Topics: Abdominal Pain; Aged; Benzamides; Drug Therapy, Combination; Dyspepsia; Esters; Female; Gabexate; Gastrointestinal Agents; Guanidines; Humans; Male; Middle Aged; Pancreatitis, Chronic; Pancrelipase; Rabeprazole; Thiazoles; Treatment Outcome
PubMed: 30391941
DOI: 10.1159/000492813 -
PloS One 2023The coefficient of fat absorption (CFA) quantifies fat that remains in stool after digestion and is not a direct measure of lipolysis. CFA has been used to assess...
INTRODUCTION
The coefficient of fat absorption (CFA) quantifies fat that remains in stool after digestion and is not a direct measure of lipolysis. CFA has been used to assess treatment of pancreatic insufficiency but does not correlate with pancreatic enzyme replacement therapy dose. We explored use of an omega-3 substrate absorption challenge test as a sensitive test of lipolysis and absorption.
METHODS
We studied a novel microbially-derived lipase (SNSP003) employing an established surgical model commonly used to study the uptake of macronutrients, the exocrine pancreatic insufficient pig. Pigs were fed a high-fat diet and given a standardized omega-3 substrate challenge to test the effect of lipolysis on its absorption. Blood was drawn at 0, 1, 2, 4, 6, 8, 12, and 24 hours following the substrate challenge and was analyzed for omega-3 and total fat levels (c14:c24). SNSP003 was also compard to porcine pancrelipase.
RESULTS
The absorption of omega-3 fats was significantly increased following administration of 40, 80 and 120 mg SNSP003 lipase by 51% (p = 0.02), 89%, (p = 0.001) and 64% (p = 0.01), respectively, compared to that observed when no lipase was administered to the pigs, with Tmax at 4 hours. The two highest SNSP003 doses were compared to porcine pancrelipase and no significant differences were observed. Both doses increased plasma total fatty acids (141% for the 80 mg dose (p = 0.001) and 133% for the 120 mg dose (p = 0.006), compared to no lipase) and no significant differences were observed between the SNSP003 lipase doses and porcine pancrelipase.
CONCLUSION
The omega-3 substrate absorption challenge test differentiates among different doses of a novel microbially-derived lipase and correlates with global fat lipolysis and absorption in exocrine pancreatic insufficient pigs. No significant differences were observed between the two highest novel lipase doses and porcine pancrelipase. Studies in humans should be designed to support the evidence presented here that suggests the omega-3 substrate absorption challenge test has advantages over the coefficient of fat absorption test to study lipase activity.
Topics: Humans; Swine; Animals; Pancrelipase; Lipolysis; Intestinal Absorption; Lipase; Exocrine Pancreatic Insufficiency; Fatty Acids, Omega-3
PubMed: 37155649
DOI: 10.1371/journal.pone.0284651