Efficacy and safety of dapagliflozin monotherapy in people with Type 2 diabetes: a randomized double-blind placebo-controlled 102-week trial.

AIMS: To assess initial pharmacotherapy of Type 2 diabetes with the sodium-glucose cotransporter-2 inhibitor dapagliflozin. METHODS: This double-blind, placebo-controlled trial, randomly allocated people with Type 2 diabetes aged 18-77 years and inadequate glycaemic control on diet and exercise [HbA1c 53-86 mmol/mol (7.0-10.0%)] to receive placebo (n = 75) or dapagliflozin monotherapy 2.5 mg (n = 65), 5 mg (n = 64) or 10 mg (n = 70) once daily in the morning. After 24 weeks, low-dose double-blind metformin 500 mg/day was added to the placebo group regimen (placebo+low-dose metformin group). Changes in HbA1c level, fasting plasma glucose and body weight, as well as adverse events, were assessed over 102 weeks. RESULTS: Of the 274 participants randomized, 167 completed the study (60.9%). At 102 weeks, significant differences vs placebo+low-dose metformin with dapagliflozin 5 and 10 mg were observed for HbA1c (-5.8 mmol/mol [-0.53%], P = 0.018; and -4.8 mmol/mol [-0.44%], P = 0.048), respectively); and for FPG (-0.69 mmol/L, P = 0.044; and -1.12 mmol/l, P = 0.001, respectively). For body weight, the difference between the dapagliflozin 10-mg group and the placebo+low-dose metformin group was significant (-2.60 kg; P = 0.016). Hypoglycaemic events were uncommon, with rates of 5.3% for placebo+low-dose metformin group and 0-4.6% for the dapagliflozin groups. Genital infections and urinary tract infections were more common in the dapagliflozin groups than in the placebo+low-dose metformin group. CONCLUSIONS: Dapagliflozin as monotherapy in treatment-naïve people with early Type 2 diabetes improved glycaemic control and reduced weight without increasing hypoglycaemia over 102 weeks. Dapagliflozin may provide an alternative initial pharmacotherapy in such people.

[Electroechocardiography correlation in the diagnosis of left ventricular hypertrophy in patients with systemic arterial hypertension]. / Correlación electroecocardiográfica en el diagnóstico de hipertrofia ventricular izquierda en pacientes con hipertensión arterial sistémica.

To evaluate the surface (12 derivations) electrocardiogram in its possibility to predict left ventricular hypertrophy, the diastolic thickness of the posterior wall of the left ventricle was determined by M mode echocardiography in 12 normal persons and 47 hypertensive patients. In all cases the echocardiographic findings concerning diastolic thickness of the free wall of the left ventricle were studied as well as their relation ship to several electrocardiographic criteria mentioned in literature as indicative of left ventricle hypertrophy. The sensitivity, specificity and precision were calculated for each EKG criterion. The electrocardiographic criteria in general are little sensitive, highly specific and very variable in its accuracy. The most sensitive criteria found as indicative of left ventricle hypertrophy were the T positive wave in V1 higher than the T in V6 and the intrinsecoid deflection time inscription higher than 0.04 sec.

[Asymptomatic myocardial ischemia]. / Isquemia miocárdica asintomática.

The concept, physiopathology, epidemiology, diagnostic procedures, prognosis and treatment of asymptomatic myocardial ischemia are reviewed. Hypotheses given to explain the absence of pain in the presence of myocardial ischemia are analyzed; Cohn's classification of asymptomatic myocardial ischemia is described and complemented with other clinical entities of painless myocardial ischemia. Prevalence of asymptomatic myocardial ischemia in different groups of patients is also discussed as well as the most important characteristics of diagnostic procedures. Finally the prognosis of asymptomatic myocardial ischemia is analyzed and the present therapeutic possibilities are discussed.