RESUMO
Tecnologia: Insulinas análogas de liberação prolongada versus insulina NPH (protamina neutra de Hagedorn). Indicação: Tratamento de adultos com diabetes mellitus tipo 2. Pergunta: Há diferenças de efeito nos principais desfechos de eficácia e segurança entre insulinas análogas de liberação prolongada versus insulina NPH no tratamento de pacientes com DM2? Métodos: Revisão rápida de evidências (overview) de revisões sistemáticas, com levantamento bibliográfico realizado na base de dados PUBMED, utilizando estratégia estruturada de busca. A qualidade metodológica das revisões sistemáticas foi avaliada com AMSTAR-2 (Assessing the Methodological Quality of Systematic Reviews). Resultados: Foi selecionada e incluída uma revisão sistemática. Conclusão: As insulinas análogas (glargina e detemir) não demonstraram superioridade nos desfechos de eficácia e segurança quando comparadas à insulina NPH, não demonstraram redução significativa em relação à mortalidade por todas as causas e complicações secundárias ao DM2. Quando comparadas à insulina NPH, foi observado redução na hipoglicemia confirmada e hipoglicemia noturna a favor das insulinas análogas e na hipoglicemia grave a favor da insulina detemir
Technology: Long-acting insulin analogues versus NPH insulin (human isophane insulin). Indication: Treatment of adults with type 2 diabetes mellitus. Question: Are there effect differences in key efficacy and safety outcomes between long-acting insulin analogues versus NPH insulin in the treatment of DM2 patients? Methods: Rapid review of evidence (overview) of systematic reviews, with a bibliographic survey carried out in the PUBMED database, using a structured search strategy. The methodological quality of systematic reviews was assessed with AMSTAR-2 (Assessing the Methodological Quality of Systematic Reviews). Results: A systematic review was selected and included. Conclusion: Analog insulins (glargine and detemir) did not demonstrate superiority in efficacy and safety outcomes when compared to NPH insulin, did not demonstrate a significant reduction in all-cause mortality and complications secondary to DM2. When compared to NPH insulin, a reduction in confirmed hypoglycemia and nocturnal hypoglycemia in favor of analogue insulins and in severe hypoglycemia in favor of insulin detemir was observed
Assuntos
Humanos , Masculino , Feminino , Adulto , Pessoa de Meia-Idade , Idoso , Idoso de 80 Anos ou mais , Adulto Jovem , Diabetes Mellitus Tipo 2/tratamento farmacológico , Insulina Detemir/uso terapêutico , Insulina Glargina/uso terapêutico , Insulina Isófana/uso terapêutico , Pesquisa Comparativa da Efetividade , Hipoglicemia/complicaçõesRESUMO
AIMS: There is limited evidence with respect to the cost-effectiveness of starting insulin in people with diabetes outside the 'western' world. The aim of this study was to assess the cost-effectiveness of starting basal insulin treatment with insulin detemir in people with type 2 diabetes (T2D) inadequately controlled on oral glucose-lowering drugs (OGLDs) in Mexico, South Korea, India, Indonesia, and Algeria. METHODS: The IMS CORE Diabetes Model was used to project clinical and cost outcomes over a 30-year time horizon. Clinical outcomes, baseline characteristics and health state utility data were taken from the A1chieve study. A 1-year analysis was also conducted based on treatment costs and quality-of-life data. Incremental cost-effectiveness ratios (ICERs) were expressed as a fraction of GDP per capita, and WHO-CHOICE recommendations (ICER < 3.0) used to define cost-effectiveness. RESULTS: Starting insulin detemir was associated with a projected increase in life expectancy (≥1 year) and was considered cost-effective in all of the studied populations with ICERs of -0.02 (Mexico), 0.00 (South Korea), 0.48 (India), 0.12 (Indonesia), and 0.88 (Algeria) GDP/quality-adjusted life-year. Cost-effectiveness was maintained after conducting sensitivity analyses in the 30-year and 1-year analyses. A projected increase in treatment costs was partially offset by a reduction in complications. The difference in overall costs between insulin detemir and OGLDs alone was USD518, 1431, 3510, 15, and 5219, respectively. CONCLUSION: Changes in clinical outcomes associated with starting insulin detemir in insulin-naïve individuals with T2D resulted in health gains that made the intervention cost-effective in five countries with distinct healthcare resources.
Assuntos
Diabetes Mellitus Tipo 2/tratamento farmacológico , Hipoglicemiantes/economia , Hipoglicemiantes/uso terapêutico , Insulina Detemir/economia , Insulina Detemir/uso terapêutico , Adulto , Idoso , Análise Custo-Benefício , Países em Desenvolvimento , Feminino , Hemoglobinas Glicadas , Produto Interno Bruto , Humanos , Hipoglicemiantes/efeitos adversos , Insulina Detemir/efeitos adversos , Expectativa de Vida , Masculino , México , Pessoa de Meia-Idade , Modelos Econométricos , Anos de Vida Ajustados por Qualidade de VidaRESUMO
OBJECTIVE: To estimate and compare type 2 diabetes mellitus treatment costs in insulin-naive patients following initiation of therapy with either insulin glargine (IG) or insulin detemir (ID) over 1-year time horizon from a payers' perspective in Argentina. METHODS: We used a pharmacoeconomic model based on a randomized trial comparing IG and ID (Rosenstock J, Davies M, Home PD, et al. A randomised, 52-week, treat-to-target trial comparing insulin detemir with insulin glargine when administered as add-on to glucose-lowering drugs in insulin-naive people with type 2 diabetes. Diabetologia 2008;51:408-16) and Argentinean sources. Clinical, resource use, and cost data were combined to estimate direct medical costs (insulin, test strips, and needles) during the first year. Price per international unit of insulin is similar for IG and ID in the local market. Deterministic analysis was performed on insulin unit cost and probabilistic sensitivity analyses on clinical, resource use, and unit costs to evaluate contribution to variance on the difference in total annual treatment cost. RESULTS: Annual mean treatment cost (Argentinean pesos 2013) was AR $6229 for IG and AR $9257 for ID, showing 33% total cost reduction with IG (AR $3028; exchange rate US $1.00 = AR $5.30). Probabilistic sensitivity analysis showed that IG was cost saving in 88% of the simulations. The most influential parameter was the difference in insulin dose requirements. Threshold analysis showed that if the unit price of ID is reduced by 43%, ceteris paribus, the total annual costs per person for both insulin regimens would be the same. CONCLUSIONS: From a payer's perspective in Argentina, cost savings related to the use of IG represented one third of total treatment costs. Sensitivity analyses confirmed the robustness of these results.
RESUMO
AIMS: This study assessed the efficacy and safety of once-daily insulin initiation using insulin detemir (detemir) or insulin glargine (glargine) added to existing metformin in type 2 diabetes (T2D). METHODS: This 26-week, multinational, randomized, treat-to-target trial involved 457 insulin-naïve adults with T2D (HbA1c 7-9%). Detemir or glargine was added to current metformin therapy [any second oral antidiabetic drug (OAD) discontinued] and titrated to a target fasting plasma glucose (FPG) ≤90 mg/dl (≤5.0 mmol/l). Primary efficacy endpoint was change in HbA1c. RESULTS: Mean (s.d.) HbA1c decreased with detemir and glargine by 0.48 and 0.74%-points, respectively, to 7.48% (0.91%) and 7.13% (0.72%) [estimated between-treatment difference, 0.30 (95% CI: 0.14-0.46)]. Non-inferiority for detemir at the a priori level of 0.4%-points was not established. The proportions of patients reaching HbA1c ≤ 7% at 26 weeks were 38% and 53% (p = 0.026) with detemir and glargine, respectively. FPG decreased â¼43.2 mg/dl (â¼2.4 mmol/l) in both groups [non-significant (NS)]. Treatment satisfaction was good for both insulins. Hypoglycaemia, which occurred infrequently, was observed less with detemir than glargine [rate ratio 0.73 (95% CI 0.54-0.98)]. The proportions of patients reaching HbA1c ≤ 7% without hypoglycaemia in the detemir and glargine groups were 32% and 38% (NS), respectively. Weight decreased with detemir [-0.49 (3.3) kg] and increased with glargine [+1.0 (3.1) kg] (95% CI for difference: -2.17 to -0.89 kg). CONCLUSION: While both detemir and glargine, when added to metformin therapy, improved glycaemic control, glargine resulted in greater reductions in HbA1c, while detemir demonstrated less weight gain and hypoglycaemia.
Assuntos
Peso Corporal/efeitos dos fármacos , Diabetes Mellitus Tipo 2/tratamento farmacológico , Hipoglicemia/tratamento farmacológico , Hipoglicemiantes/administração & dosagem , Insulina de Ação Prolongada/administração & dosagem , Metformina/administração & dosagem , Argentina/epidemiologia , Glicemia/efeitos dos fármacos , Índice de Massa Corporal , Diabetes Mellitus Tipo 2/sangue , Diabetes Mellitus Tipo 2/epidemiologia , Esquema de Medicação , Quimioterapia Combinada , Jejum , Feminino , Hemoglobinas Glicadas/metabolismo , Humanos , Hipoglicemia/sangue , Hipoglicemia/epidemiologia , Insulina Detemir , Insulina Glargina , Masculino , Pessoa de Meia-Idade , Satisfação do Paciente , República da Coreia/epidemiologia , Tailândia/epidemiologia , Resultado do Tratamento , Estados Unidos/epidemiologiaRESUMO
Pregnancy affects both maternal and fetal metabolism, and even in non-diabetic women, it exerts a diabetogenic effect. Among pregnant women, 2% to 14% develop gestational diabetes. Pregnancy can also occur in women with preexisting diabetes, which may predispose the fetus to many alterations in organogenesis, restrict growth, and the mother, to some diabetes-related complications, such as retinopathy and nephropathy, or to acceleration of the course of these complications, if they are already present. Women with gestational diabetes generally start their treatment with diet and lifestyle changes; when these changes are not enough for optimal glycemic control, insulin therapy must then be considered. Women with type 2 diabetes using oral hypoglycemic agents are advised to change to insulin therapy. Those with preexisting type 1 diabetes should start intensive glycemic control. As basal insulin analogues have frequently been used off-label in pregnant women, there is a need to evaluate their safety and efficacy. The aim of this review is to report the use of both short- and long-acting insulin analogues during pregnancy and to enable clinicians, obstetricians, and endocrinologists to choose the best insulin treatment for their patients.
A gravidez afeta tanto o metabolismo materno quanto o fetal e, mesmo em mulheres não diabéticas, apresenta um efeito diabetogênico. Entre as mulheres grávidas, 2% a 14% desenvolvem o diabetes gestacional. A gravidez pode ocorrer também em mulheres já diabéticas, o que pode predispor o feto a muitas alterações na organogênese, restrição de crescimento e a mãe a algumas complicações relacionadas ao diabetes, tais como retinopatia e nefropatia, ou acelerar o curso dessas complicações se já estiverem presentes. Pacientes com diabetes gestacional geralmente iniciam seu tratamento com dieta e mudanças no estilo de vida; porém, quando essas medidas falham em atingir um controle glicêmico adequado, a insulinoterapia deve ser considerada. Pacientes com diabetes tipo 2 em uso de hipoglicemiantes orais são aconselhadas a iniciar o uso de insulina. Pacientes com diabetes tipo 1 preexistente devem iniciar um controle glicêmico estrito. Em função do fato de os análogos basais de insulina estarem sendo utilizados muito frequentemente off-label em pacientes grávidas, faz-se necessário avaliar sua segurança e eficácia nessa condição. O objetivo desta revisão é avaliar o uso de tais análogos, tanto de ação curta como prolongada, durante a gravidez, para possibilitar médicos clínicos, obstetras e endocrinologistas escolher o melhor regime terapêutico para suas pacientes.