Pancreatic enzyme addition to the list

Transcription

1 Pancreatic enzyme addition to the list Explanation for addition Ontario Public Drug Program (OPDP) data- financial year 2015/2016: the number of recipients was 3, and cumulative total number of claims was 13. Relevant medications on CLEAN Meds Essential Medication List none Literature review question Is the pancreatic enzyme (amylase, lipase and protease) effective and safe when it is prescribed for children with pancreatic insufficiency? Utilized electronic databases PubMed and Cochrane Search strategies (systematic review) AND (pancreatic enzyme [all fields] OR pancreatic insufficiency OR cystic fibrosis) Giuliano CA, Dehoorne-Smith ML, Kale-Pradhan PB. Pancreatic enzyme products: digesting the changes. The Annals of pharmacotherapy. 2011;45(5): OBJECTIVE: To review the pharmacology, dosage regimens, efficacy, and safety of currently marketed pancreatic enzyme products (PEPs). DATA SOURCES: Studies were identified by PubMed (1966-January 2011), clinicaltrials.gov, fda.gov, and International Pharmaceutical Abstracts. Search terms included pancreatic enzyme, lipase, Creon, Zenpep, Pancreaze, and exocrine pancreatic insufficiency (EPI). DATA SYNTHESIS: PEPs are composed of porcine lipase, amylase, and protease and are used in patients with EPI secondary to cystic fibrosis, chronic pancreatitis, and pancreatectomy. In 1938, PEPs were exempted from the Food, Drug, and Cosmetic Act of 1938 and never underwent a formal Food and Drug Administration (FDA) review process. In response to reports of treatment failures during product interchange, the FDA conducted a review of available PEP products. This review found a large variability of response between the unapproved PEP products, which resulted in the FDA requiring approval of all PEP products by April The 3 delayed-release, enteric-coated PEPs currently approved by the FDA (Creon, Zenpep, and Pancreaze) have demonstrated efficacy and safety in EPI secondary to cystic fibrosis. Creon has also demonstrated safety and efficacy in EPI secondary to chronic pancreatitis and pancreatectomy. Cost difference between the 3 products is minimal. Treatment-related adverse events in clinical studies for all PEPs were less than or similar to those with placebo.

2 CONCLUSION The 3 delayed-release, enteric-coated PEPs currently ap- proved by the FDA (Creon, Zenpep, and Pancreaze) have demonstrated efficacy and safety in the treatment of EPI. New formulations are regulated by the FDA, which will al- low for consistent enzyme unit strength in new and future PEPS. At this time, Cmn appears to be the most appropriate first-line agent, as it has been approved for treatment of chronic pancreatitis, pancreatectomy, and cystic fibrosis.

3 Taylor JR, Gardner TB, Waljee AK, Dimagno MJ, Schoenfeld PS. Systematic review: efficacy and safety of pancreatic enzyme supplements for exocrine pancreatic insufficiency. Alimentary pharmacology & therapeutics. 2010;31(1): AIM: To determine if pancreatic enzyme supplements are: (i) superior to placebo for treating fat malabsorption and (ii) superior to other supplements based on randomized cross-over trials. METHODS: A computer-assisted search of MEDLINE and EMBASE was performed to identify relevant studies. Data extraction on study design, improvement in coefficient of fat absorption, diarrhoea and adverse events using prespecified forms.

4 Stallings VA, Stark LJ, Robinson KA, Feranchak AP, Quinton H. Evidence-based practice recommendations for nutrition-related management of children and adults with cystic fibrosis and pancreatic insufficiency: results of a systematic review. Journal of the American Dietetic Association. 2008;108(5): Background The Subcommittee developed a series of questions related to energy intake and PERT for children and adults with CF and PI. A systematic review of evidence was conducted to inform the guideline development process. Four specific questions were addressed: What is the evidence of a relationship between energy intake and nutritional and growth status? For this report, nutritional and growth status included weight, stature, and weight-for-stature. What is the evidence that nutritional and growth status is associated with health outcomes? What is the evidence for an association between the dose of PERT and the coefficient of fat absorption (CFA), and nutritional and growth status? What is the evidence for the effect of using generic rather than name brand PERT on the CFA and on nutritional and growth status? Methods Investigators at Johns Hopkins University conducted a systematic review in spring 2005 to assist the Subcommittee in making recommendations. English-language articles published from January 1988 to February 2005 reporting studies addressing the questions were identified for review. Searches were conducted in PubMed, EMBASE, the Cochrane Central Register of Controlled Trials, PASCAL, Allied and Complementary Medicine, and Agricultural On-line Access. A total of 1,008 publications were reviewed and resulted in 57 eligible publications addressing questions pertaining to energy intake and 10 eligible publications for PERT.

5 [Randomized controlled trial] Stern RC, Eisenberg JD, Wagener JS, Ahrens R, Rock M, dopico G, et al. A comparison of the efficacy and tolerance of pancrelipase and placebo in the treatment of steatorrhea in cystic fibrosis patients with clinical exocrine pancreatic insufficiency. The American journal of gastroenterology. 2000;95(8): OBJECTIVE: The safety and efficacy of Minimicrospheres, which are enteric-coated, delayed-release pancrelipase capsules, on fat absorption in pediatric/adolescent and adult cystic fibrosis (CF) patients was assessed. Exocrine pancreatic insufficiency, common in CF patients, causes steatorrhea due to insufficient release of pancreatic enzymes. METHODS: In the open-label phase, 97 CF patients with pancreatic insufficiency and steatorrhea were stabilized on a high-fat diet and administered pancrelipase. Seventy-four patients with >80% coefficient of fat absorption received placebo or pancrelipase in the double-blind phase. Fat intake and excretion, stool frequency and consistency, and clinical global improvement were recorded.

6 Complete search strategy PubMed (n=856) (((pancreatic enzyme) OR ((cystic fibrosis[mesh Terms]) OR pancreatic insufficiencies[mesh Terms]))) AND (((((systematic review [ti] OR meta-analysis [pt] OR meta-analysis [ti] OR systematic literature review [ti] OR this systematic review [tw] OR pooling project [tw] OR (systematic review [tiab] AND review [pt]) OR meta synthesis [ti] OR meta synthesis [ti] OR integrative review [tw] OR integrative research review [tw] OR rapid review [tw] OR consensus development conference [pt] OR practice guideline [pt] OR drug class reviews [ti] OR cochrane database syst rev [ta] OR acp journal club [ta] OR health technol assess [ta] OR evid rep technol assess summ [ta] OR jbi database system rev implement rep [ta]) OR (clinical guideline [tw] AND management [tw]) OR ((evidence based[ti] OR evidence-based medicine [mh] OR best practice* [ti] OR evidence synthesis [tiab]) AND (review [pt] OR diseases category[mh] OR behavior and behavior mechanisms [mh] OR therapeutics [mh] OR evaluation studies[pt] OR validation studies[pt] OR guideline [pt] OR pmcbook)) OR ((systematic [tw] OR systematically [tw] OR critical [tiab] OR (study selection [tw]) OR (predetermined [tw] OR inclusion [tw] AND criteri* [tw]) OR exclusion criteri* [tw] OR main outcome measures [tw] OR standard of care [tw] OR standards of care [tw]) AND (survey [tiab] OR surveys [tiab] OR overview* [tw] OR review [tiab] OR reviews [tiab] OR search* [tw] OR handsearch [tw] OR analysis [ti] OR critique [tiab] OR appraisal [tw] OR (reduction [tw]and (risk [mh] OR risk [tw]) AND (death OR recurrence))) AND (literature [tiab] OR articles [tiab] OR publications [tiab] OR publication [tiab] OR bibliography [tiab] OR bibliographies [tiab] OR published [tiab] OR pooled data [tw] OR unpublished [tw] OR citation [tw] OR citations [tw] OR database [tiab] OR internet [tiab] OR textbooks [tiab] OR references [tw] OR scales [tw] OR papers [tw] OR datasets [tw] OR trials [tiab] OR meta-analy* [tw] OR (clinical [tiab] AND studies [tiab]) OR treatment outcome [mh] OR treatment outcome [tw] OR pmcbook)) NOT (letter [pt] OR newspaper article [pt]))))) Filters: Humans Cochrane (n= 107) #1 MeSH descriptor: [Cystic Fibrosis] explode all trees 1207 #2 MeSH descriptor: [Exocrine Pancreatic Insufficiency] explode all trees 77 #3 pancreatic enzyme:ti,ab,kw (Word variations have been searched) 650 #4 (#1 or #2) and (#3) 107