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Combination of Basal Insulin and GLP-1 Receptor Agonist

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Combination of Basal Insulin and GLP-1 Receptor Agonist Moreira et al. Diabetol Metab Syndr (2018) 10:26 https://doi.org/10.1186/s13098-018-0327-4 Diabetology & Metabolic Syndrome REVIEW Open Access Combination of basal insulin and GLP‑1 receptor agonist: is this the end of basal insulin alone in the treatment of type 2 diabetes? Rodrigo Oliveira Moreira1*†, Roberta Cobas2† and Raquel C. Lopes Assis Coelho3† Abstract Glycemic control has been considered a major therapeutic goal within the scope of diabetes management, as sup- ported by robust observational and experimental evidence. However, the coexistence of micro and macrovascular disease is associated with the highest cardiovascular risks which highlights the importance that pharmacological treatment of type 2 diabetes mellitus provides not only glycemic control, but also cardiovascular safety. Basal insulin is a highly efective treatment in reducing fasting blood glucose, but it is associated with considerable risk of hypogly- cemia and weight gain. Glucagon like peptide 1 receptor agonists (GLP-1 RAs) are also efective in terms of glycemic control and associated with weight loss and low risk of hypoglycemia. The potential benefts of combining GLP-1RAs with basal insulin are contemplated in the current position statement of several diferent position statement and guidelines. This article reviews the efcacy and safety of diferent strategies to initiate and intensify basal insulin, with focus on new fxed ratio combinations of basal insulin with GLP-1 RAs available for use in a single injection pen (insu- lin degludec/liraglutide and insulin glargine/lixisenatide). Keywords: Type 2 diabetes mellitus, Basal insulin, Glucagon-like peptide 1 receptor agonist, Fixed combination Background not only glycemic control, but also cardiovascular safety Glycemic control has been considered a major thera- and clinically sound benefts in terms of reducing cardio- peutic goal within the scope of diabetes management, as vascular events. supported by robust observational and experimental evi- Basal insulin is a highly efective treatment in reduc- dence. Diferent guidelines [1, 2] have shown the impor- ing fasting blood glucose. However, it is associated with tance of reaching and keeping haemoglobin A1c (A1c) in considerable risk of hypoglycemia and weight gain [5]. target; specially to prevent microvascular complications. Because of these clinical concerns, basal insulin initiation As diabetes is a progressive disease, intensifcation of and intensifcation is often delayed by prescribers. On treatment is often needed to achieve and maintain glyce- the other hand, glucagon like peptide 1 receptor agonists mic control [3]. (GLP-1 RAs) are also efective in terms of glycemic con- Macrovascular disease is also a major concern in type 2 trol (both fasting and postprandial) and associated with diabetes mellitus (T2DM) treatment. Te coexistence of weight loss and low risk of hypoglycemia. However, their micro and macrovascular disease was associated with the use may cause gastrointestinal side efects, especially highest cardiovascular risks [4]. In this sense, it is impor- nausea, which is dose-related and may be prevented by tant that pharmacological treatment of T2DM provides slow dose escalation [6]. Te potential benefts of combining GLP-1RAs with *Correspondence: [email protected] basal insulin are contemplated in the current position †Rodrigo Oliveira Moreira, Roberta Cobas and Raquel C. Lopes Assis statement of both the American Diabetes Association Coelho contributed equally to the elaboration of this manuscript (ADA) [1] and the American Association of Clinical 1 Instituto Estadual de Diabetes e Endocrinologia, Rua Moncorvo Filho 90, CEP 22280‑110 Rio de Janeiro, Brazil Endocrinologists (AACE) [2]. Although this is an efec- Full list of author information is available at the end of the article tive strategy, it requires multiple injections. Tis is why © The Author(s) 2018. This article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/ publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated. Moreira et al. Diabetol Metab Syndr (2018) 10:26 Page 2 of 10 fxed-ratio combination products that require only one and home glucose monitoring, among others. For more injection per day have been developed. than a decade the World Health Organization (WHO) Tis article reviews the efcacy and safety of difer- has published a report highlighting the relevance of con- ent strategies to initiate and intensify basal insulin, with sidering low adherence to treatment in health policy focus on new fxed ratio combinations of basal insulin decisions and its marked economic and health conse- with GLP-1 RAs available for use in a single injection quences [9]. Studies assessing adherence behaviours in pen (insulin degludec/liraglutide and insulin glargine/ diabetes and its determinants concluded that high adher- lixisenatide). ence was associated with better glycemic control [10, 11] and fewer need of hospital admissions and depart- Materials and methods ment visits and also lower overall costs [11]. A systematic Tis article is based on the review of previously published review of 76 studies using electronic monitoring to com- data and does not involve any new studies on human or pare mean compliance with diferent dosing schedule animal subjects performed by any of the authors. regimens demonstrated an inverse relationship between A PubMed search was conducted using a structured number of doses per day and compliance [12]. search strategy comprising the following terms: combina- Regarding specifcities of diabetes and its treatment, tion GLP-1RA and basal insulin; fxed ratio combination; the psychological resistance to insulin regimens is an IDegLira; IGlarLixi. Te search also included abstracts important issue. Tis has been investigated in 708 T2DM published in the last American Diabetes Association patients, mean age 57 years-old, 66% women, with a (ADA) Scientifc Sessions. Current guidelines for T2DM mean duration of diabetes of 7 years attending a diabe- management from ADA and Te American Association tes conference in several cities in USA. Interestingly, only of Clinical Endocrinologists (AACE) were consulted. We 28.2% of the patients were classifed as unwilling to ini- considered for this review articles published in English tiate insulin. Te most common reasons for resistance from 2000 to 2018. Te authors’ consensus identifed rel- to initiate insulin were restrictiveness (‘insulin therapy evant articles. Reference lists of included articles were would restrict my life’), low self-efcacy (‘I am not conf- also screened to identify further relevant studies. dent I could handle the demands of insulin therapy’), per- sonal failure (‘insulin therapy would mean I had failed’) Results and permanence (‘once you start insulin you can never Importance of glycemic control and adherence quit’) [13]. It is worth mentioning that most of the rea- to treatment in T2DM sons could be demystifed with proper diabetes education Considering the increasing expected prevalence of and with the new, easier-to-use and painless devices to T2DM worldwide [7], strategies to improve metabolic deliver insulin and monitor blood glucose. In fact, a sys- control must be emphasized to reduce diabetes morbidity tematic review aiming to identify factors associated with and its social and economic impact. Early tight glycemic adherence to insulin therapy in type 1 and type 2 diabetes control in T2DM is a well-established recommendation showed that adherence is generally poor and suggested with supporting evidence [3, 4]. Nevertheless, a retro- that more fexible regimen may improve it as well as facil- spective analysis of T2DM treatment in UK showed that itating insulin deliver by switching to a pen device [14]. the mean time to add a second oral agent in patients with A1c above 7.0, 7.5 and 8.0%, was 2.9, 1.9 and 1.6 years, Basal insulin initiation and intensifcation: current position respectively. Te mean time to intensifcation of treat- statements ment with insulin was 7.1, 6.1 and 6.0 years for those tak- Regardless of the type of treatment to be instituted, ing one, two or three oral drugs. Also, the mean A1c level emphasis should be placed on the importance of early at intensifcation with either an oral agent or insulin was glycemic control and avoiding therapeutic inertia. 8.7, 9.1 and 9.7% for patients taking one, two or three oral According to the ADA 2018 Guidelines [1], treatment agents [8]. Tese data reinforce the importance of avoid- for T2DM should start with monotherapy unless A1c is ing clinical inertia and identifying the limiting factors greater or equal than 9.0%, when dual therapy must be that may infuence this delay in treatment intensifcation, considered. For patients with symptoms, A1c greater or particularly to start insulin. equal than 10% or blood glucose greater or equal than Adherence to treatment in chronic diseases is an old 300 mg/dL, combined injectable therapy should be con- but still relevant problem involving factors related to the sidered, including basal insulin plus bolus insulin or treatment regimen, the patient
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