Efficacy and safety of biphasic insulin aspart 30/70 in the treatment of patients with type 2 diabetes mellitus.

OBJECTIVE: To assess the safety and efficacy of biphasic insulin aspart 30/70 in patients with type 2 diabetes mellitus (DM2). MATERIAL AND METHODS: We performed an observational, multicenter, prospective study in 3,054 DM2 patients from primary care and specialized settings, treated with biphasic insulin aspart 30/70 (started within 15 days prior to inclusion). In all patients,the following information was available before starting insulin treatment: HbA(1c) levels, fasting plasma glucose (FPG), 4-point glucose profile (before and 90 minutes after breakfast and dinner) and number of hypoglycemic episodes/week. A total of 2,887 patients completed the study (26 ± 1 week). The variables evaluated were rate of adverse events (AE), number of hypoglycemic episodes/week, HbA(1c), FPG and 4-point glucose profile. RESULTS: At least one AE occurred in 10.7% of the patients (2.3% related to the study drug and 1.4% severe). There was a significant decrease (end of study vs baseline; p < 0.0001 for all the comparisons) in HbA(1c) (7.3% and 8.9%, respectively), the mean number of minor (0.3/0.5) and major (0.02/0.07) hypoglycemic episodes/week, FPG (145/207 mg/dl) and postprandial glycemia (162/225 mg/dl). The improvement in metabolic control was achieved both in patients previously treated with oral antidiabetic drugs and in those treated with insulin. The number of hypoglycemic episodes decreased in patients previously treated with insulin. CONCLUSIONS: Treatment with biphasic insulin aspart 30/70 in patients with DM2 improves glycemic control, irrespective of previous treatment, with a low rate of AE and fewer hypoglycemic episodes in patients previously treated with insulin.

Tumores suprarrenales feminizantes en España: aportación de un caso y revisión de los cinco pacientes descritos / Feminizing adrenal tumors in Spain: report of a case and review of the five previously published patients

Los tumores adrenales feminizantes son muy raros. Se presenta el estudio clínico y hormonal de un varón de 49 años hasta su fallecimiento, 6 años después del diagnóstico, junto con una revisión de los otros 5 casos descritos en España. El paciente consultó por ginecomastia y disminución de la libido; se halló gran elevación de estrógenos, testosterona en el límite bajo de la normalidad y un tumor suprarrenal derecho que, al extirparlo, se observó que era de histología benigna, informado como adenoma. Tres años después, reapareció la clínica junto con aumento de estrógenos, glucocorticoides y andrógenos; se objetivó recidiva tumoral en el polo superior del riñón derecho y metástasis peritoneales, hepáticas y pulmonares. Tratado con mitotano y aminoglutetimida, las concentraciones hormonales descendieron transitoriamente, pero volvieron a aumentar hasta su fallecimiento a los 6 años del diagnóstico inicial. Resalta en este caso el carácter aparentemente benigno y unisecretor del tumor para recidivar a los 3 años con carácter maligno y plurisecretor y metástasis generalizadas sin respuesta al tratamiento médico (AU)

Feminizing adrenal tumours are very rare. We report the clinical and hormonal study of a case, a 49 years old male, since his first consultation until his death 6 years after the initial diagnosis, and a review of the other 5 Spanish patients previously published. His initial symptoms were gynecomastia and libido decrease, with increase of plasmatic and urinary oestrogen levels, plasma testosterone near low normal level and a right adrenal gland tumour that, after its removal, showed a benign histology and was classified as an adrenocortical adenoma. Three years after, initial symptoms returned, with oestrogen, glucocorticoid and androgen hypersecretion, tumour local relapse and peritoneal, liver and lung metastasis. After mitotane and aminoglutethimide therapy, hormonal concentrations fell temporary and then raised again until his death 3 years later. The main special feature of this case is the apparently benign initial adrenal tumour with only oestrogen hypersecretion, and its relapse 3 years later with secretion of several steroid hormones, generalized metastasis and no response to medical therapy (AU)

Eficacia y seguridad de la insulina aspartato bifásica 30/70 en el tratamiento de pacientes con diabetes mellitus tipo 2 / Efficacy and safety of biphasic insulin aspart 30/70 in the treatment of patients with type 2 diabetes mellitus

Objetivo: Evaluar la seguridad y la eficacia de la insulina aspartato bifásica 30/70 en pacientes con diabetes mellitus tipo 2 (DM2). Material y métodos: Estudio observacional, multicéntrico y prospectivo. Participaron en el estudio 3.054 pacientes con DM2 procedentes de atención primaria y especializada en tratamiento con insulina aspartato bifásica 30/70 (iniciado en los 15 días previos a la inclusión). De todos ellos se disponía de la siguiente información previa al inicio del tratamiento con dicha insulina: glucohemoglobina (HbA1c), glucemia en ayunas (GA), perfil de glucosa 4 puntos (antes y 90 min después de desayuno y cena) y número de hipoglucemias/semana; 2.887 completaron el estudio (26 ± 1 semana). Las variables analizadas fueron: frecuencia de acontecimientos adversos, hipoglucemias/semana, HbA1c, GA y perfil glucémico de 4 puntos. Resultados: El 10,7% de los pacientes presentaron algún acontecimiento adverso (el 2,3% relacionados con el tratamiento y el 1,4%, graves). Hubo un descenso significativo (final del estudio frente a basal, p < 0,0001 en todas las comparaciones) de las cifras de HbA1c (el 7,3 y el 8,9%, respectivamente), media de hipoglucemias/semana menores (0,3 y 0,5) y mayores (0,02 y 0,07), GA (145 y 207 mg/dl) y glucemia posprandial (162 y 225 mg/dl). La mejoría en el control metabólico se consiguió tanto en pacientes tratados previamente con antidiabéticos orales como con insulina. El número de hipoglucemias disminuyó en los tratados previamente con insulina. Conclusiones: El tratamiento con insulina aspartato bifásica 30/70 en pacientes con DM2 mejora el control glucémico con independencia del tratamiento previo, con una tasa baja de acontecimientos adversos y un número menor de hipoglucemias que en los tratados previamente con insulina (AU)

Objective: To assess the safety and efficacy of biphasic insulin aspart 30/70 in patients with type 2 diabetes mellitus (DM2). Material and methods: We performed an observational, multicenter, prospective study in 3,054 DM2 patients from primary care and specialized settings, treated with biphasic insulin aspart 30/70 (started within 15 days prior to inclusion). In all patients, the following information was available before starting insulin treatment: HbA1c levels, fasting plasma glucose (FPG), 4-point glucose profile (before and 90 minutes after breakfast and dinner) and number of hypoglycemic episodes/week. A total of 2,887 patients completed the study (26 ± 1 week). The variables evaluated were rate of adverse events (AE), number of hypoglycemic episodes/week, HbA1c, FPG and 4-point glucose profile. Results: At least one AE occurred in 10.7% of the patients (2.3% related to the study drug and 1.4% severe). There was a significant decrease (end of study vs baseline; p < 0.0001 for all the comparisons) in HbA1c (7.3% and 8.9%, respectively), the mean number of minor (0.3/0.5) and major (0.02/0.07) hypoglycemic episodes/week, FPG (145/207 mg/dl) and postprandial glycemia (162/225 mg/dl). The improvement in metabolic control was achieved both in patients previously treated with oral antidiabetic drugs and in those treated with insulin. The number of hypoglycemic episodes decreased in patients previously treated with insulin. Conclusions: Treatment with biphasic insulin aspart 30/70 in patients with DM2 improves glycemic control, irrespective of previous treatment, with a low rate of AE and fewer hypoglycemic episodes in patients previously treated with insulin (AU)