ABSTRACT
AIMS: To study the response of clinical variables (HbA1c , body weight, lipid profile and blood pressure) over 24 months of liraglutide treatment in a real-world clinical setting, and to describe the evolution of HbA1c and body weight reduction in response to liraglutide treatment by employing generalized additive mixed models (GAMMs). METHODS: We included people aged ≥ 18 years with Type 2 diabetes mellitus that initiated liraglutide treatment between November 2011 and May 2015. Demographic and clinical data were retrieved retrospectively over 24 months from electronic medical records with a median duration of observation of 7.0 (IQR 3.0-12.0) months. RESULTS: Individuals that initiated liraglutide therapy were obese (BMI 39.1 kg/m2 ), with inadequate HbA1c (68 mmol/mol [8.4%]), blood pressure and lipid levels. Upon liraglutide treatment, HbA1c , body weight, mean systolic and diastolic blood pressure, and lipid levels decreased gradually. GAMMs demonstrated that longer treatment with liraglutide was a predictor of improved HbA1c response, whereas higher baseline HbA1c , longer Type 2 diabetes duration and treatment with insulin were predictors of worse HbA1c response. Higher baseline weight, longer treatment with liraglutide and the interaction between metformin and time were predictors of improved weight response. CONCLUSIONS: In this real-world study, we showed the effectiveness of liraglutide in improving body weight, HbA1c , mean systolic and diastolic blood pressure, and lipid levels. GAMMs indicated that baseline HbA1c and weight, time of treatment with liraglutide, diabetes duration and the use of metformin or insulin are predictors of clinical response to liraglutide.
Subject(s)
Biological Variation, Population , Diabetes Mellitus, Type 2/drug therapy , Diabetes Mellitus, Type 2/epidemiology , Liraglutide/therapeutic use , Adolescent , Adult , Aged , Aged, 80 and over , Female , Humans , Male , Middle Aged , Retrospective Studies , Spain/epidemiology , Treatment Outcome , Young AdultABSTRACT
BACKGROUND AND OBJECTIVE: To perform a cost-effectiveness analysis of the use of Atorvastatin 10 mg in the primary prevention of cardiovascular disease in patients with type 2 diabetes (DM2). METHOD: A deterministic and retrospective model by a decision analysis based on CARDS study (Collaborative Atorvastatin Diabetes Study) was performed. In the CARDS study, a significant reduction in cardiovascular morbimortality by the use of Atorvastatin 10 mg versus placebo (5.8 vs. 9.0%, p=0.001) in DM2 patients with an additional condition, had previously been demonstrated. In the present cost-effectiveness analysis, effectiveness units were life years gained (LYG) and quality adjusted life years (QALY), obtained from differences in morbimortality and life expectancy in DM2 patients, with and without previous cardiovascular events. Costs of the evaluated alternatives were obtained from the CARDS results. RESULTS: Incremental cost-effectiveness ratio of using Atorvastin 10 mg versus placebo was 5,886 euro per LYG and 8,046 euro per QALY. Sensitivity analyses confirmed the model stability. CONCLUSIONS: In the primary prevention of the cardiovascular disease in type 2 diabetic patients, the use of Atorvastatin 10 mg is cost-effective, with a cost per LYG and per QALY below that of other alternatives widely used in the Spanish National Health System, and also below a value considered as a reasonable threshold for our country, which might unofficialy be around 30,000 euro/ QALY.