[Pharmacological and clinical characteristics of Insulin Faster Aspart (Fiasp®)]. / Características farmacológicas y clínicas de Insulina Aspártica Más Rápida (Fiasp®).

Fast acting aspart insulin is a faster-acting formulation of aspart insulin, having nicotinamide and Larginine added to the molecule, in order to achieve a faster absorption through the subcutaneous cellular tissue. Pharmacokinetic and pharmacodynamic studies showed a left-shifted mean serum concentration-time profile compared to the conventional formulation. Its efficacy profile is highlighted in terms of early postprandial glycemic control. In addition, fast acting aspart insulin allows a more flexible treatment schedule, as it may be administrated at mealtime, immediately before or up to 20 minutes after; this schedule represents an advantage regarding quality of life in patients with diabetes treated with prandial insulin, especially in populations such as children, pregnant women or elderly subjects. The safety and tolerability profiles are comparable to conventional aspart insulin.

La insulina aspártica de acción rápida es una formulación más rápida de la insulina aspártica convencional, a la que se adicionan nicotinamida y L-arginina para lograr una absorción más rápida en el tejido celular subcutáneo. Estudios farmacocinéticos y farmacodinámicos demostraron un desplazamiento de las curvas de concentración sérica de insulina/tiempo hacia la izquierda en comparación con la formulación convencional. Su perfil de eficacia se destaca en términos del control de la glucemia posprandial temprana. Además, la insulina aspártica de acción rápida aporta flexibilidad al tratamiento, ya que puede aplicarse al momento de la comida, inmediatamente antes o hasta 20 minutos después, lo que constituye una ventaja en cuanto a calidad de vida en los pacientes con diabetes en tratamiento con insulina prandial, especialmente en poblaciones como los niños, las embarazadas o los ancianos. El patrón de seguridad y tolerabilidad es comparable al de la insulina aspártica convencional.

Características farmacológicas y clínicas de insulina aspártica más rápida (Fiasp®) / Pharmacological and clinical characteristics of Insulin Faster Aspart (Fiasp®)

Resumen La insulina aspártica de acción rápida es una formulación más rápida de la insulina aspártica convencional, a la que se adicionan nicotinamida y L-arginina para lograr una absorción más rápida en el tejido celular subcutáneo. Estudios farmacocinéticos y farmacodinámicos demostraron un desplazamiento de las curvas de concentración sérica de insulina/tiempo hacia la izquierda en comparación con la formulación conven cional. Su perfil de eficacia se destaca en términos del control de la glucemia posprandial temprana. Además, la insulina aspártica de acción rápida aporta flexibilidad al tratamiento, ya que puede aplicarse al momento de la comida, inmediatamente antes o hasta 20 minutos después, lo que constituye una ventaja en cuanto a calidad de vida en los pacientes con diabetes en tratamiento con insulina prandial, especialmente en poblaciones como los niños, las embarazadas o los ancianos. El patrón de seguridad y tolerabilidad es comparable al de la insulina aspártica convencional.

Abstract Fast acting aspart insulin is a faster-acting formulation of aspart insulin, having nicotinamide and L-arginine added to the molecule, in order to achieve a faster absorption through the subcutaneous cellular tissue. Pharmacokinetic and pharmacodynamic studies showed a left-shifted mean serum concentration-time profile compared to the conventional formulation. Its efficacy profile is highlighted in terms of early postprandial glycemic control. In addition, fast acting aspart insulin allows a more flexible treatment schedule, as it may be administrated at mealtime, immediately before or up to 20 minutes after; this schedule represents an advantage regarding quality of life in patients with diabetes treated with prandial insulin, especially in populations such as children, pregnant women or elderly subjects. The safety and tolerability profiles are comparable to conventional aspart insulin.

The SimpleMix study with biphasic insulin aspart 30: a randomized controlled trial investigating patient-driven titration versus investigator-driven titration.

OBJECTIVE: The study aimed to confirm the efficacy, through non-inferiority, of patient-driven versus investigator-driven titration of biphasic insulin aspart 30 (BIAsp 30) in terms of glycemic control assessed by HbA1c change. METHODS: SimpleMix was a 20 week, open-label, randomized, two-armed, parallel-group, multicenter study in five countries (Argentina, China, India, Poland, and the UK). Patients with type 2 diabetes were randomized into either patient-driven or investigator-driven BIAsp 30 titration groups. RESULTS: Non-inferiority of patient-driven vs. investigator-driven titration based on change in HbA1c from baseline to week 20 could not be demonstrated. Mean (SE) estimated change from baseline to week 20 was -0.72 (0.08)% in the patient-driven group and -0.97 (0.08)% in the investigator-driven group; estimated difference 0.25% (95% CI: 0.04; 0.46). Estimated mean change (SE) in fasting plasma glucose from baseline to week 20 was similar between groups: -0.94 (0.21) mmol/L for patient-driven and -1.07 (0.22) mmol/L for investigator-driven (difference non-significant). Both treatment arms were well tolerated, and hypoglycemic episode rates were similar between groups, with a rate ratio of 0.77 (95% CI: 0.54; 1.09; p = 0.143) for all hypoglycemic episodes and 0.78 (95% CI: 0.42; 1.43; p = 0.417) for nocturnal hypoglycemic episodes. CONCLUSIONS: Non-inferiority of patient-driven versus investigator-driven titration with regard to change from baseline to end-of-treatment HbA1c could not be confirmed. It is possible that a clinic visit 12 weeks after intensification of treatment with BIAsp 30 in patients with type 2 diabetes inadequately treated with basal insulin may benefit patient-driven titration of BIAsp 30. A limitation of the study was the relatively small number of patients recruited in each country, which does not allow country-specific analyses to be performed. Overall, treatment with BIAsp 30 was well tolerated in both treatment groups.

[Risk factors for arterial disease]. / Factores de riesgo de enfermedad arterial.

The risk factors of arterial disease (FREA) predict a future damage over the vascular system of the human body. Its detection are considered a key for the diagnostic as well as for the preventive and even curative strategies. For a long time, scientist considered those factors originated as a consecuence of large studies during the middle of the last century, with current validity up to our days. A simple classification spoke of them as traditionals. Further investigations described the so called new or emergents.factors that where joint together accordingly to their actions: coagulation factors, psicosocial, inflamatories and infectious. A recent classification, taking into account the type of impact, divided them into; causatives, predisposals and conditionals. Also, it was described a mechanism, the oxidative power, with consecuences over the endothelium, in the last part of the process. Before, another mechanism was described: the insulin resistance and the hiperinsulinism, bases for the Metabolic Syndrome, that includes a number of traditional risk factors.

Factores de riesgo de enfermedad arterial / [Risk factors for arterial disease]

The risk factors of arterial disease (FREA) predict a future damage over the vascular system of the human body. Its detection are considered a key for the diagnostic as well as for the preventive and even curative strategies. For a long time, scientist considered those factors originated as a consecuence of large studies during the middle of the last century, with current validity up to our days. A simple classification spoke of them as traditionals. Further investigations described the so called new or emergents.factors that where joint together accordingly to their actions: coagulation factors, psicosocial, inflamatories and infectious. A recent classification, taking into account the type of impact, divided them into; causatives, predisposals and conditionals. Also, it was described a mechanism, the oxidative power, with consecuences over the endothelium, in the last part of the process. Before, another mechanism was described: the insulin resistance and the hiperinsulinism, bases for the Metabolic Syndrome, that includes a number of traditional risk factors.

Factores de riesgo de enfermedad arterial. / [Risk factors for arterial disease]

The risk factors of arterial disease (FREA) predict a future damage over the vascular system of the human body. Its detection are considered a key for the diagnostic as well as for the preventive and even curative strategies. For a long time, scientist considered those factors originated as a consecuence of large studies during the middle of the last century, with current validity up to our days. A simple classification spoke of them as traditionals. Further investigations described the so called new or emergents.factors that where joint together accordingly to their actions: coagulation factors, psicosocial, inflamatories and infectious. A recent classification, taking into account the type of impact, divided them into; causatives, predisposals and conditionals. Also, it was described a mechanism, the oxidative power, with consecuences over the endothelium, in the last part of the process. Before, another mechanism was described: the insulin resistance and the hiperinsulinism, bases for the Metabolic Syndrome, that includes a number of traditional risk factors.