Abstract
IntroductionThe aim of the study was to evaluate whether the reduction in glycated hemoglobin (HbA1c) observed in clinical trials with liraglutide in type 2 diabetes (T2D) could be attained in routine clinical practice.MethodsReaL was a multicenter, non-interventional, observational, retrospective, longitudinal study on the effectiveness of liraglutide, a human glucagon-like peptide-1 analog, in individuals with T2D treated in daily practice in Italy. Between 26 March and 16 November 2015, data were taken from clinical records of patients aged ≥ 18 years with treatment follow-up data of up to 24 months and who received their first prescription of liraglutide in 2011.ResultsA total of 1723 patients were included in the analysis. At baseline, mean age was 58.9 years, duration of diabetes was 9.6 years, and HbA1c was 8.3%. At 12 months, 36.1% of patients were prescribed the maximum 1.8 mg dose; 43.5% [95% confidence interval (CI): 40.9; 46.2] of patients attained the primary outcome of a reduction in HbA1c of ≥ 1% point at 12 months. At 24 months, 40.9% (95% CI 38.1; 43.7) of patients had attained the HbA1c target of ≤ 7%. Additionally, body weight significantly decreased by 3.4 kg (95% CI − 3.6; − 3.1, p < 0.0001).ConclusionIn this observational study conducted in routine clinical practice for up to 2 years, treatment with liraglutide improved HbA1c and reduced body weight in a similar fashion to that observed under randomized clinical trial conditions. The data support the use of liraglutide as an effective treatment for T2D in clinical practice.FundingNovo Nordisk S.p.A.Trial RegistrationClinicalTrials.gov identifier, NCT02255266.Electronic supplementary materialThe online version of this article (10.1007/s12325-017-0652-2) contains supplementary material, which is available to authorized users.
Highlights
The aim of the study was to evaluate whether the reduction in glycated hemoglobin (HbA1c) observed in clinical trials with liraglutide in type 2 diabetes (T2D) could be attained in routine clinical practice.Enhanced content To view enhanced content for this article go to http://www.medengine.com/Redeem/ 5DFCF0605568025C.Electronic supplementary material The online version of this article contains supplementary material, which is available to authorized users
The American Diabetes Association (ADA)/European Association for the Study of Diabetes (EASD) position statement emphasized the importance of an individualized glycemic target, as well as an individualized approach to diabetes therapy, based on a variety of patient- and disease-specific factors [1, 2]
A total of 1788 patient records were extracted from an electronic clinical record (ECR) system widely used for the routine management of patients with T2D in diabetes centers across Italy between 26 March and 16 November 2015
Summary
The aim of the study was to evaluate whether the reduction in glycated hemoglobin (HbA1c) observed in clinical trials with liraglutide in type 2 diabetes (T2D) could be attained in routine clinical practice. Enhanced content To view enhanced content for this article go to http://www.medengine.com/Redeem/ 5DFCF0605568025C. N. Simioni Presidio Ospedaliero di Cittadella, Cittadella, Padua, Italy. C. Bette Novo Nordisk Spa, Rome, Italy. The LEADER trial reported cardiovascular benefits with liraglutide when used in individuals with T2D at increased risk of cardiovascular disease [14]. Following the regulatory approval of liraglutide, providing real-world evidence for the effectiveness and safety of liraglutide under routine clinical practice conditions is an important step in ensuring appropriate use of the drug in daily practice and confirming the clinical benefits/ risks expected, based on the approved label
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