Quality of Life of Patients with Type 1 Diabetes Mellitus Using Insulin Analog Glargine Compared with NPH Insulin: A Systematic Review and Policy Implications

INTRODUCTION: Insulin analogue glargine (GLA) has been available as one of the therapeutic options for patients with type 1 diabetes mellitus to enhance glycemic control. Studies have shown that a decrease in the frequency of hypoglycemia episodes improves the Quality of Life (QoL) of diabetic patients. However, there are appreciable acquisition cost differences between different insulins. Consequently, a need to assess their impact on QoL to provide future guidance to health authorities. METHOD: A Systematic review (SR) of multiple databases including Medline, LILACS, Cochrane and EMBASE databases with several combinations of agreed terms involving randomized controlled trials (RCTs) and cohorts, as well as manual searches and gray literature was undertaken. The primary outcome measure was a change in QoL. The quality of the studies and the risk of bias was also assessed. RESULTS: Eight studies were eventually included in the systematic review out of 634 publications. Eight different QoL instruments were used (2 generic, 2 mixed and 4 specific), in which the Diabetes Treatment Satisfaction Questionnaire (DTSQs) was the most used. The systematic review did not consistently show any significant difference overall in QoL scores whether as part of subsets or combined into a single score with the use of GLA versus NPH insulin. Only in patients’ satisfaction measured by DTSQ was a better result consistently seen with GLA versus NPH insulin but not using the WED scale. However, none of the cohort studies scored a maximum on the Newcastle-Ottawa scale for quality and they generally were of moderate quality with bias in the studies. CONCLUSION: There was no consistent difference in QoL or patient reported outcomes when the findings from the eight studies were collated. In view of this, we believe the current price differential between GLA and NPH insulin in Brazil cannot be justified by these findings

The clinical effectiveness of insulin glargine in patients with Type I diabetes in Brazil: findings and implications

Aims: Published studies have challenged the cost-effectiveness of insulin glargine versus NPH insulins in Brazil with limited evidence of increased effectiveness despite considerably higher acquisition costs. However, still a controversy. Consequently, a need to address this. Methods: Retrospective cohort study of type 1 diabetes patients receiving insulin glargine in Brazil following NPH insulin who met the criteria. Results: 580 patients were enrolled. HbA1c varied from 8.80 ± 1.98% in NPH insulin users to 8.54 ± 1.88% after insulin glargine for six months, which is not clinically significant. Frequency of glycemic control varied from 22.6% with NPH insulin to 26.2% with insulin glargine. No statistically significant difference was observed between controlled and still uncontrolled groups for all analyzed factors including type and frequency of insulin use and carbohydrate counting. Conclusions: Limited differences between NPH insulins and insulin analogues in routine clinical care does not justify an appreciable cost difference

Perfil epidemiológico dos pacientes em terapia renal substitutiva no Brasil, 2000-2004

OBJECTIVE: To describe the clinical and epidemiological profile of patients under renal replacement therapies, identifying risk factors for death. METHODS: This is a non-concurrent cohort study of data for 90,356 patients in the National Renal Replacement Therapies Database. A deterministic-probabilistic linkage was performed using the Authorization System for High Complexity/Cost Procedures and the Mortality Information System databases. All patients who started dialysis between 1/1/2000 and 12/31/2004 were included and followed until death or the end of 2004. Age, sex, region of residence, primary renal disease and causes of death were analyzed. A proportional hazards model was used to identify factors associated with risk of death. RESULTS: The prevalence of patients under renal replacement therapies increased an average of 5.5%, while incidence remained stable during the period. Hemodialysis was the predominant initial modality (89%). The patients were majority male with mean age 53 years, residents of the Southeast region and presented unknown causes as the main cause of chronic renal disease, followed by hypertension, diabetes and glomerulonephritis. Of these patients, 42% progressed to death and 7% underwent kidney transplantation. The patients on peritoneal dialysis were older and had higher prevalence of diabetes. The death rate varied from 7% among transplanted patients to 45% among non-transplanted patients. In the final Cox proportional hazards model, the risk of mortality was associated with increasing age, female sex, having diabetes, living in the North and Northeast region, peritoneal dialysis as a first modality and not having renal transplantation. CONCLUSIONS: There was an increased prevalence of patients on renal therapy in Brazil. Increased risk of death was associated with advanced age, diabetes, the female sex, residents of the North and Northeast region and lack of renal transplant.OBJETIVO: Describir el perfil epidemiológico y clínico de pacientes en terapia renal substitutiva, identificando factores asociados al riesgo de muerte. MÉTODOS: Estudio de observación, prospectivo no concurrente, a partir de datos de 90.356 pacientes de la Base Nacional en Terapias Renales Substitutivas, en Brasil. Fue realizado reracionamiento determinístico-probabilístico del Sistema de Información de Mortalidad. Fueron incluidos todos los pacientes incidentes que iniciaron diálisis entre 1/1/2000 y 31/12/2004, acompañados hasta la muerte o final de 2004. Edad, sexo, región de residencia, enfermedad renal primaria, causa del óbito fueron analizados. Se ajustó un modelo de riesgos proporcionales para identificar factores asociados al riesgo de muerte. RESULTADOS: Ocurrió un aumento promedio de 5,5% en la prevalencia de pacientes en terapia, con relación a la incidencia se mantuvo estable en el período. Hemodiálisis fue la modalidad inicial predominante (89%). La mayoría de los pacientes era del sexo masculino, con edad promedio de 53 años, residente en la región Sureste y presentaba causa indeterminada como principal causa básica de la enfermedad renal crónica, seguida de la hipertensión, diabetes y glomerulonefritis. De esos pacientes, 7% realizaron transplante renal y 42% evolucionaron a óbito. Los pacientes en diálisis peritoneal eran más ancianos y presentaban mayor prevalencia de diabetes. Entre los no transplantados, 45% fueron a óbito y, entre los transplantadas 7%. En el modelo final de riesgos proporcionales de Cox, el riesgo de mortalidad estuvo asociado con el aumento de la edad, sexo femenino, tener diabetes, residir en la región Norte y Noreste, diálisis peritoneal como modalidad de entrada y no haber realizado transplante renal. CONCLUSIONES: Hubo aumento de la prevalencia de pacientes en terapia renal en Brasil. Pacientes con edad avanzada, diabetes, del sexo femenino, residentes en la región Norte y Noreste y sin transplante renal presentan mayor riesgo de muerte.OBJETIVO: Descrever o perfil epidemiológico e clínico de pacientes em terapia renal substitutiva, identificando fatores associados ao risco de morte. MÉTODOS: Estudo observacional, prospectivo não concorrente, a partir de dados de 90.356 pacientes da Base Nacional em Terapias Renais Substitutivas, no Brasil. Foi realizado relacionamento determinístico-probabilístico do Sistema de Autorização de Procedimentos de Alta Complexidade/Custo e do Sistema de Informação de Mortalidade. Foram incluídos todos os pacientes incidentes que iniciaram diálise entre 1/1/2000 e 31/12/2004, acompanhados até a morte ou final de 2004. Idade, sexo, região de residência, doença renal primária, causa do óbito foram analisados. Ajustou-se um modelo de riscos proporcionais para identificar fatores associados ao risco de morte. RESULTADOS: Ocorreu um aumento médio de 5,5% na prevalência de pacientes em terapia enquanto a incidência manteve-se estável no período. Hemodiálise foi a modalidade inicial predominante (89%). A maioria dos pacientes era do sexo masculino, com idade média de 53 anos, residente na região Sudeste, e apresentava causa indeterminada como principal causa básica da doença renal crônica, seguida da hipertensão, diabetes e glomerulonefrites. Desses pacientes, 7% realizou transplante renal e 42% evoluiu para o óbito. Os pacientes em diálise peritoneal eram mais idosos e apresentavam maior prevalência de diabetes. Entre os não transplantados, 45% foi a óbito e, entre os transplantados, 7%. No modelo final de riscos proporcionais de Cox, o risco de mortalidade foi associado com o aumento da idade, sexo feminino, ter diabetes, residir nas regiões Norte e Nordeste, diálise peritoneal como modalidade de entrada e não ter realizado transplante renal. CONCLUSÕES: Houve aumento da prevalência de pacientes em terapia renal no Brasil. Pacientes com idade avançada, diabetes, do sexo feminino, residentes nas regiões Norte e Nordeste e sem transplante renal apresentam maior risco de morte

Effectiveness and safety of insulin glargine versus detemir analysis in patients with type 1 diabetes: systematic review and meta-analysis

INTRODUCTION: Diabetes mellitus type 1 (DM1) is an autoimmune disease characterized by metabolic destruction of pancreatic cells responsible for insulin production, with treatment based on replacing insulin. Long-acting insulin analogs are indicated for patients with DM1 who exhibit important oscillations of their daily glycemia despite their higher costs. OBJECTIVE: To evaluate the effectiveness and safety of two long acting insulins. insulin glargine and detemir in treating patients with DM1. METHODS: Systematic review with meta-analysis of observational studies (cohort and registry), available in the database, gray literature and complementary search in Diabetes Care Journal. Outcomes assessed were: glycated hemoglobin concentration, fasting plasma glucose or capillary, occurrence of episodes of severe hypoglycemia and occurrence of nocturnal hypoglycemia. The assessment of methodological quality was performed using the Newcastle score. The meta-analyses were performed on software Review Manager ® 5.2. RESULTS: Out of 705 publications, 8 cohort studies were included. The quality of these studies was classified as high. In the meta-analysis results regarding episodes of severe hypoglycemia (p = 0.02) and fasting glucose (p = 0.01) were in favour of detemir. The glycated hemoglobin (p = 0.49; I2= 89) showed high heterogeneity and no statistically significant difference between the two. The meta-analysis of total insulin dose favored glargine (p = 0.006; I2= 75). The rates of nocturnal hypoglycemia (NH) were evaluated only for one study and showed a significant reduction of NH after therapy with detemir, (p < 0.0001). CONCLUSION: Although some outcomes were favourable to determir insulin analogue, it has not been possible to identify important differences of effectiveness and safety between the two analogs. These results can help in the current debate on the inclusion of long-acting analogs on the list of reimbursed medicines in the Brazil especially with the recent introduction of insulin glargine biosimilar at considerably lower prices

Perfil epidemiológico dos pacientes em terapia renal substitutiva no Brasil, 2000-2004 Perfil epidemiológico de los pacientes en terapia renal substitutiva en Brasil, 2000-2004 Epidemiological profile of patients on renal replacement therapy in Brazil, 2000-2004

OBJETIVO: Descrever o perfil epidemiológico e clínico de pacientes em terapia renal substitutiva, identificando fatores associados ao risco de morte. MÉTODOS: Estudo observacional, prospectivo não concorrente, a partir de dados de 90.356 pacientes da Base Nacional em Terapias Renais Substitutivas, no Brasil. Foi realizado relacionamento determinístico-probabilístico do Sistema de Autorização de Procedimentos de Alta Complexidade/Custo e do Sistema de Informação de Mortalidade. Foram incluídos todos os pacientes incidentes que iniciaram diálise entre 1/1/2000 e 31/12/2004, acompanhados até a morte ou final de 2004. Idade, sexo, região de residência, doença renal primária, causa do óbito foram analisados. Ajustou-se um modelo de riscos proporcionais para identificar fatores associados ao risco de morte. RESULTADOS: Ocorreu um aumento médio de 5,5% na prevalência de pacientes em terapia enquanto a incidência manteve-se estável no período. Hemodiálise foi a modalidade inicial predominante (89%). A maioria dos pacientes era do sexo masculino, com idade média de 53 anos, residente na região Sudeste, e apresentava causa indeterminada como principal causa básica da doença renal crônica, seguida da hipertensão, diabetes e glomerulonefrites. Desses pacientes, 7% realizou transplante renal e 42% evoluiu para o óbito. Os pacientes em diálise peritoneal eram mais idosos e apresentavam maior prevalência de diabetes. Entre os não transplantados, 45% foi a óbito e, entre os transplantados, 7%. No modelo final de riscos proporcionais de Cox, o risco de mortalidade foi associado com o aumento da idade, sexo feminino, ter diabetes, residir nas regiões Norte e Nordeste, diálise peritoneal como modalidade de entrada e não ter realizado transplante renal. CONCLUSÕES: Houve aumento da prevalência de pacientes em terapia renal no Brasil. Pacientes com idade avançada, diabetes, do sexo feminino, residentes nas regiões Norte e Nordeste e sem transplante renal apresentam maior risco de morte.<br>OBJETIVO: Describir el perfil epidemiológico y clínico de pacientes en terapia renal substitutiva, identificando factores asociados al riesgo de muerte. MÉTODOS: Estudio de observación, prospectivo no concurrente, a partir de datos de 90.356 pacientes de la Base Nacional en Terapias Renales Substitutivas, en Brasil. Fue realizado reracionamiento determinístico-probabilístico del Sistema de Información de Mortalidad. Fueron incluidos todos los pacientes incidentes que iniciaron diálisis entre 1/1/2000 y 31/12/2004, acompañados hasta la muerte o final de 2004. Edad, sexo, región de residencia, enfermedad renal primaria, causa del óbito fueron analizados. Se ajustó un modelo de riesgos proporcionales para identificar factores asociados al riesgo de muerte. RESULTADOS: Ocurrió un aumento promedio de 5,5% en la prevalencia de pacientes en terapia, con relación a la incidencia se mantuvo estable en el período. Hemodiálisis fue la modalidad inicial predominante (89%). La mayoría de los pacientes era del sexo masculino, con edad promedio de 53 años, residente en la región Sureste y presentaba causa indeterminada como principal causa básica de la enfermedad renal crónica, seguida de la hipertensión, diabetes y glomerulonefritis. De esos pacientes, 7% realizaron transplante renal y 42% evolucionaron a óbito. Los pacientes en diálisis peritoneal eran más ancianos y presentaban mayor prevalencia de diabetes. Entre los no transplantados, 45% fueron a óbito y, entre los transplantadas 7%. En el modelo final de riesgos proporcionales de Cox, el riesgo de mortalidad estuvo asociado con el aumento de la edad, sexo femenino, tener diabetes, residir en la región Norte y Noreste, diálisis peritoneal como modalidad de entrada y no haber realizado transplante renal. CONCLUSIONES: Hubo aumento de la prevalencia de pacientes en terapia renal en Brasil. Pacientes con edad avanzada, diabetes, del sexo femenino, residentes en la región Norte y Noreste y sin transplante renal presentan mayor riesgo de muerte.<br>OBJECTIVE: To describe the clinical and epidemiological profile of patients under renal replacement therapies, identifying risk factors for death. METHODS: This is a non-concurrent cohort study of data for 90,356 patients in the National Renal Replacement Therapies Database. A deterministic-probabilistic linkage was performed using the Authorization System for High Complexity/Cost Procedures and the Mortality Information System databases. All patients who started dialysis between 1/1/2000 and 12/31/2004 were included and followed until death or the end of 2004. Age, sex, region of residence, primary renal disease and causes of death were analyzed. A proportional hazards model was used to identify factors associated with risk of death. RESULTS: The prevalence of patients under renal replacement therapies increased an average of 5.5%, while incidence remained stable during the period. Hemodialysis was the predominant initial modality (89%). The patients were majority male with mean age 53 years, residents of the Southeast region and presented unknown causes as the main cause of chronic renal disease, followed by hypertension, diabetes and glomerulonephritis. Of these patients, 42% progressed to death and 7% underwent kidney transplantation. The patients on peritoneal dialysis were older and had higher prevalence of diabetes. The death rate varied from 7% among transplanted patients to 45% among non-transplanted patients. In the final Cox proportional hazards model, the risk of mortality was associated with increasing age, female sex, having diabetes, living in the North and Northeast region, peritoneal dialysis as a first modality and not having renal transplantation. CONCLUSIONS: There was an increased prevalence of patients on renal therapy in Brazil. Increased risk of death was associated with advanced age, diabetes, the female sex, residents of the North and Northeast region and lack of renal transplant