期刊
NUTRITION METABOLISM AND CARDIOVASCULAR DISEASES
卷 24, 期 12, 页码 1346-1353出版社
ELSEVIER SCI LTD
DOI: 10.1016/j.numecd.2014.07.014
关键词
Type 2 diabetes; Incretin-mimetics and incretin-enhancers; DPP4 inhibitors and GLP1 receptor agonists; Real clinical practice; Monitoring registry
资金
- Boehringer Ingelheim
- Eli Lilly
- NovoNordisk
- Sanofi
Background and aims: In Italy, the reimbursed use of incretin mimetics and incretin enhancers was subject to enrollment of patients into a web-based system recording the general demographic and clinical data of patients. We report the utilization data of glucagon-like peptide 1 (GLP1) receptor agonists and dipeptidylpeptidase-4 (DPP4) inhibitors in clinical practice as recorded by the Italian Medicines Agency (AIFA) Monitoring Registry. Methods and results: From February 2008 to August 2010, 75,283 patients with type 2 diabetes were entered into the registry and treated with exenatide, sitagliptin, or vildagliptin. The treatment was administered to patients in a wide range of ages (>= 75 years, n = 6125 cases), body mass index (BMI) (>= 35 kg/m(2), n = 22,015), and metabolic control (HbA(1c) >= 11% ((96 mmol/mol), n = 3151). Overall, 1116 suspected adverse drug reactions were registered, including 12 cases of acute pancreatitis (six on exenatide). Hypoglycemic episodes mainly occurred in combination with sulfonylureas. Treatment discontinuation for the three drugs (logistic regression analysis) was negatively associated with the male gender and positively with baseline HbA(1c), diabetes duration, and, limitedly to DPP-4 inhibitors, with BMI. Treatment discontinuation (including loss to follow-up, accounting for 21-26%) was frequent. Discontinuation for treatment failure occurred in 7.7% of cases (exenatide), 3.8% (sitagliptin), and 4.1% (vildagliptin), respectively, corresponding to 27-40% of all discontinuations, after excluding lost to follow-up. HbA(1c) decreased on average by 0.9-1.0% (9 mmol/mol). Body weight decreased by 3.5% with exenatide and by 1.0-1.5% with DPP-4 inhibitors. Conclusions: In the real world of Italian diabetes centers, prescriptions of incretins have been made in many cases outside the regulatory limits. Nevertheless, when appropriately utilized, incretins may grant results at least in line with pivotal trials. (C) 2014 Elsevier B.V. All rights reserved.
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