Pancreatic safety of incretin-based drugs - FDA and EMA assessment

New England Journal of Medicine

Volumn 370, Issue 9, 2014, Pages 794-797

  Egan, Amy G ^a   Blind, Eberhard ^b   Dunder, Kristina ^c   De Graeff, Pieter A ^d   Hummer, B Timothy ^a   Bourcier, Todd ^a   Rosebraugh, Curtis ^a  

^a CENTER FOR DRUG EVALUATION AND RESEARCH   (United States)

^b EUROPEAN MEDICINES AGENCY   (United Kingdom)

^c MEDICAL PRODUCTS AGENCY   (Sweden)

^d MEDICINES EVALUATION BOARD   (Netherlands)

Author keywords

[No Author keywords available]

Indexed keywords

ALOGLIPTIN; INCRETIN; PLACEBO; SAXAGLIPTIN;

CAUSAL ATTRIBUTION; DISEASE ASSOCIATION; DRUG SAFETY; HUMAN; NONHUMAN; PANCREAS CANCER; PANCREATITIS; PATIENT SAFETY; POSTMARKETING SURVEILLANCE; PRIORITY JOURNAL; RISK ASSESSMENT; RISK BENEFIT ANALYSIS; SHORT SURVEY;

ANIMALS; DIABETES MELLITUS, TYPE 2; DRUG APPROVAL; DRUG EVALUATION, PRECLINICAL; EUROPEAN UNION; HUMANS; HYPOGLYCEMIC AGENTS; INCRETINS; MICE; PANCREATIC NEOPLASMS; PANCREATITIS; RATS; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 84896731936     PISSN: 00284793     EISSN: 15334406     Source Type: Journal    
DOI: 10.1056/NEJMp1314078     Document Type: Article

References (5)

1. Butler AE, Campbell-Thompson M, Gurlo T, Dawson DW, Atkinson M, Butler PC. Marked expansion of exocrine and endocrine pancreas with incretin therapy in humans with increased exocrine pancreas dysplasia and the potential for glucagon-producing neuroendocrine tumors. Diabetes 2013;62:2595-604.
2. European Medicines Agency. Assessment report for GLP-1 based therapies. July 25, 2013 (http://www.ema.europa.eu/docs/en-GB/document-library/Report/2013/ 08/WC500147026.pdf).
3. Engel SS, Round E, Golm GT, Kaufman KD, Goldstein BJ. Safety and tolerability of sitagliptin in type 2 diabetes: pooled analysis of 25 clinical studies. Diabetes Ther 2013;4:119-45.
4. Scirica BM, Bhatt DL, Braunwald E, et al. Saxagliptin and cardiovascular outcomes in patients with type 2 diabetes mellitus. N Engl J Med 2013;369:1317-26.
5. White WB, Cannon CP, Heller SR, et al. Alogliptin after acute coronary syndrome in patients with type 2 diabetes. N Engl J Med 2013;369:1327-35.