Pharmacotherapeutic follow-up in patients with type 1 diabetes in context of judicialization: possibility optimize costs

Abstract In Brazil, insulin analogs stand out as one of the most demanded medications by judicial means. However, the guarantee of judicial access does not guarantee rational use. In context, pharmacotherapeutic follow-up (PF) is shown to be clinical effective strategy for patients with diabetes. To evaluate direct medical costs one year after performing PF in patients with type 1 diabetes mellitus using insulin analogs ordered by court in Public Health System (Sistema Único de Saúde - SUS). This is a partial economic analysis, nested within a quasi-experimental study. Patients with T1DM who receive insulin analogs by judicialization in a medium-sized Brazilian city participated. The PF was conducted following the method adapted from the Pharmacotherapy workup (PW). Data were collected considering the period of one year before the start of the intervention and one year after the start of the intervention. Direct medical costs were evaluated and the difference in costs was calculated. 28 patients participated in the intervention. After PF, direct costs were -$3,696.78. Sensitivity analysis showed that there is a 33.4 % chance for PF to present cost savings when compared to baseline. The PF has the potential to reduce direct medical costs from the perspective of the SUS.

Effectiveness of insulin analogs compared with human insulins in pregnant women with diabetes mellitus: systematic review and meta-analysis / Efetividade dos análogos da insulina comparados às insulinas humanas em gestantes com diabetes mellitus: Revisão sistemática com metanálise

Abstract Diabetes during pregnancy has been linked to unfavorable maternal-fetal outcomes. Human insulins are the first drug of choice because of the proven safety in their use. However, there are still questions about the use of insulin analogs during pregnancy. The objective of the present study was to determine the effectiveness of insulin analogs compared withhuman insulin in the treatment of pregnant women with diabetes througha systematic review withmeta-analysis. The search comprised the period since the inception of each database until July 2017, and the following databases were used:MEDLINE, CINAHL, EMBASE, ISIWeb of Science, LILACS, Scopus, SIGLE andGoogle Scholar.We have selected 29 original articles: 11 were randomized clinical trials and 18 were observational studies.We have explored data from 6,382 participants. All of the articles were classified as having an intermediate to high risk of bias. The variable that showed favorable results for the use of insulin analogs was gestational age, with a mean difference of - 0.26 (95 % confidence interval [CI]: 0.03-0.49; p = 0.02), but with significant heterogeneity (Higgins test [I2] = 38%; chi-squared test [χ2] = 16.24; degree of freedom [DF] = 10; p = 0.09). This result, in the clinical practice, does not compromise the fetal well-being, since all babies were born at term. There was publication bias in the gestational age and neonatal weight variables. To date, the evidence analyzed has a moderate-to-high risk of bias and does not allow the conclusion that insulin analogs are more effective when compared with human insulin to treat diabetic pregnant women.

Resumo Diabetes durante a gestação tem sido relacionado a desfechos materno-fetais desfavoráveis. As insulinas humanas são a primeira escolha medicamentosa, devido à comprovada segurança no seu uso. Entretanto, ainda há questionamentos sobre o uso dos análogos da insulina na gestação. O objetivo do presente estudo foi determinar a efetividade dos análogos da insulina comparados às insulinas humanas no tratamento de gestantes com diabetes por meio de uma revisão sistemática com metanálise. A busca compreendeu desde o início de cada base de dados até julho de 2017, e foi realizada nos seguintes bancos de dados: MEDLINE, CINAHL, EMBASE, ISI Web of Science, LILACS, Scopus, SIGLE e Google Scholar. Selecionamos 29 artigos originais, sendo 11 ensaios clínicos randomizados e 18 estudos observacionais. Exploramos dados de 6.382 participantes. Todos os artigos foram classificados como sendo de intermediário a alto risco de viés. A variável que demonstrou resultado favorável ao uso dos análogos da insulina foi idade gestacional, com uma diferençamédia de - 0.26 (95% índice de confiança [IC]: 0.03-0.49; p = 0.02), porém com heterogeneidade significativa (teste de Higgins [I2] = 38%; teste do qui quadrado [χ2] =16.24; graus de liberdade [GL] =10; p = 0.09). Esse resultado, na prática clínica, não compromete o bem-estar fetal, uma vez que todos os bebês nasceram a termo. Houve viés de publicação nas variáveis idade gestacional e peso neonatal. Até o momento, as evidências analisadas possuem um risco de viés moderado a elevado e não permitem concluir que os análogos da insulina sejam mais efetivos em comparação às insulinas humanas para tratar gestantes diabéticas.

Advances in the research of long-acting strategy of insulin and GLP-1 analogs / 中国药科大学学报

@#Insulin as well as glucagon-like peptide 1(GLP-1)and its analogs are commonly used in treating type II diabetes. Both insulin and GLP-1 are endogenous peptides, and have advantages such as high efficiency and selectivity. However, there are some disadvantages to using regular insulin with slow effect, short-time effect and risk of hypoglycemia. Due to the elimination of kidneys and the metabolism of enzymes, the half-life of GLP-1 is so short that neither of them can stabilize glucose. Therefore, it is of great significance to study the long-acting strategy of insulin and GLP-1. Based on the long-acting strategy and pharmacological assessment of peptide drugs, this paper reviewed the latest progress of the related drugs that already on the market and under research to provide references for the design of novel long-acting insulin and GLP-1 analogs.

Quality of life perception of type 1 diabetic patients treated with insulin analogs and receiving medication review with follow-up in a public health care service from Ponta Grossa-PR, Brazil

ABSTRACT Glycemic control in patients with diabetes mellitus type 1 (DM1) reduces the risk of complications but requires a rigorous health care routine. Thus, diabetes education is central to increasing treatment compliance and self-care practices. This study aimed to evaluate the quality of life (QoL) and glycemic control of DM1 patients being treated with insulin analogs and receiving medication review with follow-up. This was a transversal study that included 110 patients registered at the 3rd Health Regional of Ponta Grossa-PR, aged ≥ 18 years, and receiving pharmaceutical care for at least 1 year. The Diabetes Quality of Life Measure (DQOL)-Brazil was used to evaluate QoL. The data were statistically analyzed using SPSS version 17.0 with 95% confidence levels. Of the 110 patients, 58.2% were women. The average age was 33.7 years (±10.5), and the average glycated hemoglobin (HbA1c) value was 8% (±1.4). The mean total DQOL-Brazil score was 2.11 (95% confidence interval, 2.02 - 2.21). All DQOL-Brazil scores were lower in patients with HbA1c ≤ 8%, indicating a better QoL. Good glycemic control, thus, appears to have a positive influence on the QoL, and pharmaceutical interventions are able to contribute to the achievement of therapeutic targets.

Clinical Application Analysis of Insulin and Its Analogs in Hospitals of Nanjing during 2011-2013 / 中国药师

Objective:To evaluate the application status and change trends of insulin and its analogs in Nanjing area during 2011 to 2013. Methods:The varieties, sales amount and DDDs of insulin and its analogs in 43 hospitals of Nanjing during 2011 to 2013 were analyzed. Results:The use of insulin and its analogs was increased year by year from 2011 to 2013 with the average annual growth rate of 16%. Glargine, pre-mixed insulin 30R, aspart 30, human insulin and aspart ranked the top five in the sum of money with the proportion above 80%. Pre-mixed insulin 30R, aspart 30, glargine, human insulin and common insulin ranked the top 5 in DDDs. Conclusion:The application of insulin and its analogs is wide in clinics, and the usage and sum of money both show rapid growth trend.

El estudio A1chieve: un estudio observacional, de no intervención en pacientes con diabetes tipo 2 que inician o cambian a un tratamiento con análogos de insulina: datos de la población argentina / The A1chieve study: An observational non-interventional study of patients with type 2 diabetes initiating or changing to insulin analogue therapy: data from the Argentinean population

Objetivos: el objetivo de este artículo es informar acerca de la seguridad y la efectividad de iniciar o cambiar a un tratamiento con insulinas análogas en la subpoblación argentina del estudio A1chieve. Materiales y métodos: estudio observacional, de no intervención. En la cohorte argentina participaron 607 pacientes con diabetes tipo 2 (DM2), con o sin tratamiento previo con insulina, quienes inciaron un tratamiento con insulina aspártica bifásica 30, insulina detemir o insulina aspártica con o sin antidiabéticos orales (ADOs). Resultados: el grado de control metabólico al inicio del estudio, medido por HbA1c basal (± DE) fue pobre: 9,4 ± 2,1 %. A los 6 meses, se observó una reducción de HbA1c de -1,8 ± 2,1 % en la cohorte completa, y -2,3 ± 2,1% y -1,1 ± 1,8 % para los pacientes sin tratamiento previo con insulina y con tratamiento previo con insulina, respectivamente. En general, la tasa de hipoglucemia se incrementó en aquellos pacientes que recibieron insulina por primera vez, mientras que se observó una disminución en los pacientes que, previamente, recibían otras insulinas. Se observó un incremento del peso corporal (± DE) en los pacientes sin tratamiento previo con insulina (0,8 ± 4,3 kg). Conclusiones: en la población argentina del estudio A1chieve, se observó un control metabólico deficiente. Se logró una mejoría de la HbA1c al iniciar un tratamiento con análogos de insulina, ya sea en pacientes naïve usuarios previos de insulina,siendo una gran oportunidad para lograr amplias mejorías en el autocuidado y en el control metabólico, independientemente del tipo de regimen insulínico utilizado, con buena tolerabilidad y seguridad. Estos hallazgos coinciden con los resultados obtenidos en la cohorte completa del estudio.

Objectives: The aim of this paper is to report the safety and effectiveness of initiating or switching to insulin analogue therapy in the Argentinean subpopulation of the A1chieve study. Materials and methods: Observational, non-interventional study. The Argentinean cohort included 607 patients with type 2 diabetes (T2D), both insulin-naïve and prior insulin users, who initiated treatment with biphasic insulin aspart 30, insulin detemir or insulin aspart ± oral antidiabetic agents. Results: Baseline HbA1c (±SD) was poor: 9.4 ± 2.1 %. At 6 months, a reduction in the HbA1c of -1.8 ± 2.1 % was observed in the entire cohort, and of -2.3 ± 2.1 % and -1.1 ± 1.8 % in insulin-naïve patients and prior insulin users, respectively. Overall, the rate of hypoglycaemia increased in insulin-naïve patients, whereas a reduction was observed in those switching from other insulins. An increase in the body weight (±SD) was noted in insulin-naïve patients (0.8 ± 4.3 kg). Conclusions: Poor glycemic control was observed in the Argentinean population of the A1chieve study. The initiation of insulin analogue therapy showed an improvement in HbA1c, in both insulin-naïve patients and previous insulin users, which was a good opportunity for improvements in self-care and metabolic control, regardless of the type of insulin regimen used, with a good tolerability and safety profile. These findings are consistent with those obtained from the entire A1chieve study cohort.

Novas opções na terapia insulínica: [revisão] / New options in insulin therapy: [review]

OBJETIVO: Revisar as novas opções nas terapêuticas insulínicas para controlar o diabetes melito de crianças e adolescentes. FONTES DOS DADOS: Foram revisados artigos indexados no PubMed buscados conforme as palavras insulin analogs in children and adolescents e incluídas informações contidas nos consensos da American Diabetes Association e Sociedade Brasileira de Diabetes. SÍNTESE DOS DADOS: São apresentadas informações sobre os novos análogos da insulina e, para comparação, são também revisadas as outras diferentes modalidades de insulina que estão atualmente disponíveis, focalizando nas terapias insulínicas que tentam fornecer uma aproximação mais fisiológica das estratégias basal-bolos no tratamento. Com o objetivo de obter melhor controle metabólico, mais e mais crianças estão em regimes de múltiplas injeções diárias ou usando infusões subcutâneas contínuas de insulina. Atingir controle glicêmico ótimo nas crianças é difícil devido ao maior risco de hipoglicemia decorrente da grande variabilidade em hábitos de ingerir alimentos e em níveis de atividade física. Se aplicados em bolos, subcutâneos, no diabetes tipo 1, os análogos de ação rápida, comparados com insulina humana regular, geralmente reduzem os episódios de hipoglicemia e glicemia pós-prandial, enquanto os análogos basais tendem a reduzir particularmente a hipoglicemia noturna. CONCLUSÃO: Embora os benefícios nos desfechos individuais metabólicos e clínicos pareçam modestos, a maioria dos estudos demonstra benefícios quando são usados análogos de insulina no tratamento do diabetes tipo 1 ou 2.

OBJECTIVE:To review the new options in insulin therapy for controlling diabetes mellitus in children and adolescents. SOURCES: Articles indexed in PubMed were located using the search terms insulin analogs in children and adolescents and reviewed. Information was also obtained from American Diabetes Association and Sociedade Brasileira de Diabetes consensus documents. SUMMARY OF THE FINDINGS: Information is presented on new analogs of insulin and, for purposes of comparison, the other insulin modalities currently available are also reviewed, focusing on insulin therapies which attempt to approximate basal-bolus treatment strategies to physiology. With the objective of obtaining improved metabolic control, more and more children are being put on multiple daily injection regimes or using continuous subcutaneous insulin infusion. It is difficult to achieve optimum glycemic control in children due to the increased risk of hypoglycemia resulting from the great variability in dietary intake habits and in physical activity levels. With diabetes type 1, if rapid-acting analogs are given subcutaneously in bolus, they generally reduce hypoglycemia episodes and postprandial glycemia levels, compared with regular human insulin, while basal analogs tend to reduce particularly the number of episodes of nocturnal hypoglycemia. CONCLUSIONS: Although the benefits to individual metabolic and clinical outcomes appear modest, the majority of studies demonstrate benefits when insulin analogs are used in the treatment of diabetes type 1 or 2.