Abstract
IntroductionLinagliptin is a high-cost oral antidiabetic that has been widely used, and studies on its effectiveness and safety for the treatment of type 2 diabetes mellitus (DM2) in the real world is rare and necessary.ObjectiveTo analyze the values of glycated hemoglobin (HbA1c) and adverse events before and after the use of linagliptin in the post-marketing context of a pilot study.MethodsThis is a descriptive observational and exploratory study with a retrospective longitudinal approach, conducted between January 2014 and December 2016. All patients who participated in the study were over 18 years of age, with DM2, assisted by the Brazilian Public Health System (Sistema Único de Saúde – SUS) and had been indicated for use of linagliptin. The users were followed up and the variables of interest were collected from a computerized health information system (sistema informatizado de saúde – SIS) and patient records. For effectiveness analysis, HbA1c before (T0) and after (T1) the use of linagliptin was considered in patients registered as having collected linagliptin at the pharmacy for at least three consecutive months. For safety analysis, registered adverse events (AE) were verified in patients’ records. The sample was stratified according to the pharmacotherapeutic scheme of the users. To compare the means before (T0) and after (T1), a paired t-test (data with normal distribution) and Wilcoxon Signed Rank Sum test (non-normal distribution data) were performed.ResultsConsidering the total population of the study, in a different pharmacotherapeutic regimen, a median reduction in HbA1c of -0.86% (p < 0.05) was observed. After stratification by pharmacotherapeutic regimen, the most significant reduction of HbA1c was -1.07% (p = 0.014) for the linagliptin group associated with insulins and oral antidiabetic agents (n = 13). On the other hand, patients taking linagliptin in monotherapy had the lowest HbA1c reduction, -0.48% (p > 0.05). AE occurred in 12 (36.4%) patients, and 16.7% were in monotherapy.ConclusionLinagliptin did not presented, in real world, the desired performance as showed in randomized premarketing clinical trials and it should be carefully evaluated in public health services.
Highlights
Linagliptin is a high-cost oral antidiabetic that has been widely used, and studies on its effectiveness and safety for the treatment of type 2 diabetes mellitus (DM2) in the real world is rare and necessary
Regarding the choice of pharmacological therapy, this should take into consideration the mechanisms of insulin resistance, secretory capacity of the pancreas, metabolic disorders involved, and the complications of Diabetes mellitus type 2 (DM2) present (American Diabetes Association [ADA], 2018)
Glucagon-like peptide 1 (GLP-1) and glucosedependent insulinotropic polypeptide (GIP), which are intestinal hormones or incretins, account for up to 70% of the insulin response, as they contribute to the modulation of pancreatic betacell activity, stimulating insulin secretion (Morris et al, 2013; American Diabetes Association [ADA], 2018)
Summary
Linagliptin is a high-cost oral antidiabetic that has been widely used, and studies on its effectiveness and safety for the treatment of type 2 diabetes mellitus (DM2) in the real world is rare and necessary. The main objectives of DM2 treatment are metabolic control, the reduction of microvascular and macrovascular complications associated with the disease, as well as the reduction of its acute manifestations To meet these goals it is necessary that blood glucose reach normal levels, both in fasting and in the postprandial period. In DM2 there is a reduced response of the insulin effect, which alters the regulation of the amount of glucose present in the blood, contributing to a lack of glycemic control of the sick individual. In this sense, incretin analogs and inhibitors of the enzyme Dipeptidyl peptidase-4 (DPP-4) have been developed in order to potentiate the function of these endogenous hormones. Studies demonstrate the efficacy of these substances in glycemic control as well as in the weight reduction of these patients (International Diabetes Federation [IDF], 2017; American Diabetes Association [ADA], 2018)
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