NDLI: Incretin-mimetics associated pancreatitis: evidence from the spontaneous adverse drug reactions reporting in Italy.

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Incretin-mimetics associated pancreatitis: evidence from the spontaneous adverse drug reactions reporting in Italy.

Content Provider	World Health Organization (WHO)-Global Index Medicus
Author	Delfino, Marcello Motola, Domenico Benini, Angela Franzè, Gian Pietro Barotto, Marcella Campi, Anna Monda, Vincenzo Maria
Spatial Coverage	Italy
Description	Country affiliation: Italy Author Affiliation: Delfino M ( Hospital and Community Pharmaceutical Assistance, Department of Pharmacy, Local Health Authority of Ferrara , Ferrara , Italy.)
Abstract	OBJECTIVE: New incretin-mimetics increased the treatment options for type 2 diabetes mellitus. Studies on the safety of incretin-based therapy showed a risk of hypersensitivity reactions, acute pancreatitis, renal failure, infection, thyroid and pancreas cancer. We contributed to safety assessment of these new drugs by evaluating the spontaneous adverse drug reactions (ADRs) reporting in Italy. RESEARCH AND METHODS: Reports of suspected ADRs associated with incretin-mimetics were selected from the Italian Spontaneous ADR Reporting Database. For a subgroup of cases belonging to the Hospital of Cento (Ferrara), levels of pancreatic enzymes, amylase and lipase, before and after the therapy with the incretin-mimetics were available. RESULTS: As of December 2012, the reports of ADR associated with hypoglycemic drugs (excluding insulin) were 2443, 1169 (47.85%) concerned the incretin-mimetics. A total of 90 reports described pancreatitis (44) and elevated pancreatic enzymes (46). Out of 90 cases, 34 were serious (37%). Data on amylase/lipase values for 10 patients were provided and an analysis of the published literature was performed. CONCLUSIONS: Our data from the daily clinical practice add up and confirm the information available on the association between incretin-mimetics and pancreatic damage and suggest caution in the prescribing of these new drugs and a close monitoring of exposed patients.
File Format	HTM / HTML
ISSN	14740338
Issue Number	2
Volume Number	13
e-ISSN	1744764X
Journal	Expert Opinion on Drug Safety
Language	English
Publisher	Taylor & Francis
Publisher Date	2014-02-01
Publisher Place	Great Britain (UK)
Access Restriction	One Nation One Subscription (ONOS)
Subject Keyword	Discipline Pharmacology Drug-related Side Effects And Adverse Reactions Etiology Incretins Adverse Effects Pancreatitis Chemically Induced Adult Adverse Drug Reaction Reporting Systems Aged Databases, Factual Female Humans Italy Male Middle Aged Young Adult Journal Article
Content Type	Text
Resource Type	Article
Subject	Pharmacology (medical)

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