Efficacy and safety of liraglutide versus placebo added to basal insulin analogues (with or without metformin) in patients with type 2 diabetes: a randomized, placebo-controlled trial.

AIM: To confirm the superiority, compared with placebo, of adding liraglutide to pre-existing basal insulin analogue ± metformin in adults with inadequately controlled type 2 diabetes [glycated haemoglobin (HbA1c) 7.0-10.0% (53-86 mmol/mol)]. METHODS: In this 26-week, double-blind, parallel-group study, conducted in clinics or hospitals, 451 subjects were randomized 1 : 1 to once-daily liraglutide 1.8 mg (dose escalated from 0.6 and 1.2 mg/day, respectively, for 1 week each; n = 226) or placebo (n = 225) added to their pre-existing basal insulin analogue (≥20 U/day) ± metformin (≥1500 mg/day). After randomization, insulin adjustments above the pre-study dose were not allowed. The primary endpoint was HbA1c change. RESULTS: After 26 weeks, HbA1c decreased more with liraglutide [-1.3% (-14.2 mmol/mol)] than with placebo [-0.1% (-1.2 mmol/mol); p < 0.0001]. More subjects on liraglutide reached HbA1c targets: <7.0% (59% vs 14%; p < 0.0001) and ≤6.5% (43% vs 4%; p < 0.0001) using slightly less insulin (35.8 IU vs 40.1 IU). Greater decreases from baseline (estimated treatment differences vs placebo; p < 0.0001) occurred in fasting plasma glucose (-1.3 mmol/l), seven-point glucose profiles (-1.6 mmol/l), body weight (-3.1 kg) and systolic blood pressure (-5.0 mmHg). Transient gastrointestinal adverse events (nausea: 22.2% vs 3.1%) and minor hypoglycaemia (18.2% vs 12.4%) were more frequent with liraglutide than placebo, and pulse increased (4.5 beats/min) compared with placebo. No severe hypoglycaemia or pancreatitis occurred. CONCLUSIONS: Adding liraglutide to a basal insulin analogue ± metformin significantly improved glycaemic control, body weight and systolic blood pressure compared with placebo. Typical gastrointestinal symptoms and minor hypoglycaemia were more frequent with liraglutide.

[Psycho-pathological risk factor of arterial disease (prevalence, superposition or vinculation with other factors)]. / Estudio oncativo: factores de riesgo psicopatológicos de enfermedad arterial (prevalencia, superposición o vínculo con otros factores).

Alexitimia and depression may or not coexist with others risk factors (comportment o physical). Frecuently they have relation with socio-echonomic status and with ethnia. Sometimes are determinants of the atherosclerotic process by increasing the vascular reactivity by the alteration of the evolution. There is no information in our country about this problem in general population. The present study result of the investigation of these aspects and the comportamental and physical factors of arterial disease, in a population of Cordoba province (Argentina Republic).

Estudio oncativo: factores de riesgo psicopatológicos de enfermedad arterial (prevalencia, superposición o vínculo con otros factores) / Psycho-pathological risk factor of arterial disease (prevalence, superposition or vinculation with other factors)

Entidades psicopatológicas como alexitimia y depresión, pueden coexistir o no con factores de riesgo de enfermedad arterial o ser entidades independientes. Tienen frecuentemente relación con aspectos socio-económico-culturales y con la etnia; a veces son determinantes del proceso ateroesclerótico por alterar la reactividad vascular (Alexitimai) o agravadores del proceso evolutivo (depresión). Materiales y métodos: Existe escasa información sobre esta tematica en nuestro país: la existente se refiere a los mismos en muestras seleccionadas, no de poblaciones generales (urbanas o rurales). Resultados: se exponen los resultados obtenidos de lainvestigación de esos factores en una población de la Provincia de Córdoba (RA), donde simultáneamente se estudiaron factores de orden fisico y conductual. Conclusiones: La prevalencia de la depresión es más elevada que en otras poblaciones

Alexitimia and depression may or not coexist with others risk factors (comportment o physical). Frecuently they have relation with socio-echonomic status and with ethnia. Sometimes are determinants of the atherosclerotic process by increasing the vascular reactivity by the alteration of the evolution. There is no information in our country about this problem in general population. The present study result of the investigation of these aspects and the comportamental and physical factors of arterial disease, in a population of Cordoba province (Argentina Republic).

Prevalence of diabetes, obesity, hypertension and hyperlipidemia in the central area of Argentina.

OBJECTIVES: There is little information available about the prevalence of chronic metabolic diseases in many Latin American countries. Between 1995 and 1998, studies on the prevalence of obesity, hypertension, hyperlipidemia and diabetes were carried out in four cities located in central Argentina: Dean Funes, Oncativo, Pehuajo and Venado Tuerto. The data provided by these surveys are reanalysed here in order to determine prevalence of obesity, hypertension, hyperlipidemia and diabetes using new epidemiological criteria. METHODS: Representative samples of the population, based on a multistage probabilistic sampling design, were taken from each of the four cities. The sample size was calculated to obtain a precision of 4% for the prevalence assessment. The subjects included were aged 20 years and over. Standardization of the prevalence rates used the entire study sample as the reference population. RESULTS: Age-standardised prevalence rates for the cities ranged between 22.4% and 30.8% for obesity, 27.9% and 43.6% for hypertension, 24.2% and 36.4% for hyperlipidemia, and 6.5% and 7.7% for diabetes mellitus. All these prevalences increased with age. 58.1% of the obese subjects and 51.2% of the diabetic subjects had hypertension, while 43.2% of the obese subjects and 52.8% of the diabetic subjects had hyperlipidemia. CONCLUSIONS: While the prevalence of diabetes mellitus was between 6% and 8%, the prevalence of obesity was close to 26% and hypertension and hyperlipidemia affected one third of the population. These data can be considered as indicative of the prevalences of these four diseases in the population aged 20 years and over, in the central region of Argentina.