Liraglutide and cardiovascular outcomes in a real world type 2 diabetes cohort.

Autor: Mirani M; Metabolic Disease and Diabetes, Humanitas Research Hospital, Rozzano, Milan, Italy., Favacchio G; Metabolic Disease and Diabetes, Humanitas Research Hospital, Rozzano, Milan, Italy., Serone E; CORESEARCH - Center for Outcomes Research and Clinical Epidemiology, Pescara, Italy., Lucisano G; CORESEARCH - Center for Outcomes Research and Clinical Epidemiology, Pescara, Italy., Rossi MC; CORESEARCH - Center for Outcomes Research and Clinical Epidemiology, Pescara, Italy., Berra CC; Metabolic Disease and Diabetes, Humanitas Research Hospital, Rozzano, Milan, Italy. Electronic address: Cesare.berra@humanitas.it.
Jazyk: angličtina
Zdroj: Pharmacological research [Pharmacol Res] 2018 Nov; Vol. 137, pp. 270-279. Date of Electronic Publication: 2018 Sep 10.
DOI: 10.1016/j.phrs.2018.09.003
Abstrakt: In the last years, due to new regulatory guidelines requiring a stringent documentation of cardiovascular (CV) safety of novel drugs for type 2 diabetes, cardiovascular outcomes safety trials (CVOTs) are requested. CVOTs increase the knowledge about the safety profile of the new drugs, but they have intrinsic limits that make difficult their transferability to clinical practice. For this reason, real world evidence is considered an important complement to experimental data. Among the glucagon-like peptide-1 receptor agonists, liraglutide in the LEADER CVOT demonstrated superiority in reducing the risk of major CV events (MACEs) vs. placebo. We conducted an observational, retrospective, longitudinal study based on 307 patients with T2DM treated with liraglutide under routine clinical practice conditions. Real world impact of liraglutide on metabolic control, CV risk factors, hypoglycemia and CV events was assessed. Improvements during 36 months were found in HbA 1c (-1.0%; p < 0.0001), fasting blood glucose (-17.6 mg/dL; p < 0.0001), body weight (-3.2 kg; p < 0.0001), waist circumference (-1.45 cm; p = 0.004), systolic blood pressure (-10.41 mmHg; p < 0.0001), diastolic blood pressure (-3.69 mmHg; p < 0.0001), total cholesterol (-7.96 mg/dL; p =0.008) and triglycerides (-20.60 mg/dl; p = 0.01). No severe hypoglycemia occurred. Incidence of MACEs in this cohort was lower than in the LEADER study (2.59 vs. 3.4 events per 100 person-years), confirming CV safety of liraglutide even in the real world. On the other hand, a higher incidence of CV event in patients with established CV disease was documented (8.1 events per 100 person-years), in spite of the use of liraglutide. In conclusion, 36-month durability and CV safety of liraglutide were documented in a real world cohort of T2DM patients, with sustained benefits on a large array of CV risk factors.
(Copyright © 2018 Elsevier Ltd. All rights reserved.)
Databáze: MEDLINE
Externí odkaz: