ABSTRACT Objective: This analysis compared the efficacy and safety of the sodium-glucose cotransporter-2 (SGLT2) inhibitor, dapagliflozin, and the dipeptidyl peptidase-4 (DPP4) inhibitor, saxagliptin, both added on to metformin. Materials and methods: This was a post-hoc analysis from a double-blind, randomized, 24-week clinical trial (NCT01606007) of patients with type 2 diabetes (T2D) inadequately controlled with metformin. We compared the dapagliflozin 10 mg (n = 179) and saxagliptin 5 mg (n = 176) treatment arms. Results: Dapagliflozin showed significantly greater mean reductions versus saxagliptin in HbA1c (difference versus saxagliptin [95% CI]: −0.32% [-0.54, −0.10]; p < 0.005), fasting plasma glucose (-0.98 [-1.42, −0.54] mmol/L; p < 0.0001), body weight (-2.39 [-3.08, −1.71] kg; p < 0.0001) and systolic blood pressure (SBP) (-3.89 [-6.15, −1.63] mmHg; p < 0.001). More dapagliflozintreated than saxagliptin-treated patients achieved the composite endpoint of HbA1c reduction ≥ 0.5%, weight loss ≥ 2 kg, SBP reduction ≥ 2 mmHg and no major/minor hypoglycemia (24% versus 7%). No major events of hypoglycemia were reported. More patients on dapagliflozin (6%) versus saxagliptin (0.6%) experienced genital infections. Conclusion: Dapagliflozin demonstrated greater glycemic efficacy than saxagliptin with additional benefits on weight and SBP, and the safety profile was consistent with previous studies.

A ocorrência de fraturas osteoporóticas em idosos está relacionada às concentrações reduzidas de vitamina D e conseqüente hiperparatiroidismo secundário, sendo os institucionalizados de maior risco. No Brasil, por seu alto grau de insolação, infere-se que a quantidade de vitamina D da população seja adequada. Neste estudo, objetivamos avaliar as concentrações plasmáticas de 25-hidroxivitamina D (25OHD), paratormônio (PTH) e cálcio ionizado (Cai), assim como analisar a prevalência de hipovitaminose D e de hiperparatiroidismo secundário em idosos moradores da cidade de São Paulo. Estudamos 177 pacientes institucionalizados (125 mulheres e 52 homens) com idade média (DP) de 76,6 (9,0) anos, e 243 idosos ambulatoriais (168 mulheres e 75 homens) com 79,1 (5,9) anos. Nesta avaliação, 71,2% do grupo institucionalizado e 43,8% do ambulatorial possuíam valores de 25OHD menores do que o mínimo recomendado (50 nmol/l), sendo que as mulheres apresentaram valores consideravelmente mais baixos que os homens. O hiperparatiroidismo secundário ocorreu em 61,7% dos pacientes institucionalizados e em 54% dos ambulatoriais. Considerando os resultados obtidos, recomendamos a suplementação com doses eficientes de vitamina D para a população idosa brasileira, alem de sugerir uma discussão para a implementação de políticas de fortificação alimentar com vitamina D, especialmente direcionada àqueles com maior risco.

The occurrence of osteoporotic fractures in the elderly is associated with reduced levels of vitamin D and resulting secondary hyperparathyroidism, and inpatients are the ones at a higher risk. In Brazil, given its high level of insolation, the population’s large amount of vitamin D is inferred to be adequate. In this study we aimed to assess the serum levels of 25-hydroxivitamin D (25OHD), parathormone (PTH) and ionized calcium (Cai), as well as to analyze the prevalence of both hypovitaminosis D and secondary hyperparathyroidism in the elderly living in the city of São Paulo. We studied 177 inpatients (125 women and 52 men) with mean age (SD) 76.6 (9.0) years, and 243 outpatients (168 women and 75 men) aged 79.1 (5.9) years. In this assessment 71.2% in the inpatients group and 43.8% in the outpatients group had 25OHD levels below the minimum recommended (50 nmol/l), with the women presenting with levels considerably lower than the men. Secondary hyperparathyroidism occurred in 61.7% of the inpatients and in 54% of the outpatients. Considering the results achieved, we recommend vitamin D supplementation in effective doses for the Brazilian elderly population, in addition to suggesting a discussion for the implementation of vitamin D-enhanced food policies, particularly oriented to the ones at a greater risk.

Em situações fisiológicas os processos de reabsorção e formação ósseas são fenômenos acoplados e dependentes. O predomínio de um sobre o outro resulta em ganho ou perda de massa óssea. É esta capacidade de avaliação dinâmica que se deseja em um marcador de remodelação óssea. A osteocalcina sérica intacta e fosfatase alcalina óssea melhor representam o processo de formação óssea enquanto as piridinolinas e fragmentos telopeptídeos carboxi e amino-terminais do colágeno tipo I melhor refletem a reabsorção óssea. Na avaliação da resposta ao tratamento, marcadores de reabsorção têm grande sensibilidade e especificidade, sendo que a queda de seus valores após tratamento com anti-reabsortivos correlaciona-se com o ganho de massa óssea obtido. Os marcadores de remodelação, apesar de terem trazido grandes avanços no entendimento das doenças ósseas, ainda necessitam de melhor sensibilidade e especificidade para que sua larga utilização na clínica diária seja estimulada. Entretanto, podem auxiliar no diagnóstico e decisão terapêutica em casos difíceis e no acompanhamento do tratamento.

In physiological circumstances, bone resorption and formation are coupled processes. When, however, one predominates over the other the result is a gain or a loss of bone mass. To study this dynamic process, biochemical bone markers have been developed. Osteocalcin and bone alkaline phosphatase better represent bone formation, while pyridinoline, deoxypyridinoline and collagen type I cross-linking (amino and carboxi-terminal) telopeptides, the bone resorption. In the follow up of osteoporosis treatment, the bone resorption markers are more specific and sensitive than the formation markers. During the treatment of post-menopausal osteoporosis with anti-reabsortive therapy, the rate of fall from basal values of resorption markers at 3 or 6 months are related to the increase on bone mass after long-term treatment. The bone markers have applications in a number of diseases of the skeleton including osteoporosis, and helped to understand the pathophysiological mechanisms of many diseases that affect bone tissue. Although they still need better sensibility and specificity to be strongly recommended in the clinical routine, their use should be encouraged to assess risk of fractures in special cases, to aid treatment decisions, and to monitor treatment.