The addition of bevacizumab to chemotherapy did not statistically significantly increase the risk of VTEs versus chemotherapy alone. The risk for VTEs is driven predominantly by tumor and host factors.
Nutritional markers, such as lean body mass (LBM) and serum albumin, predict outcome in dialysis patients, in whom protein-energy malnutrition is associated with increased morbidity and mortality. The metabolic effects of human growth hormone (hGH) may improve the nutritional and cardiovascular health of these patients and consequently reduce morbidity and mortality. The aim of this study was to establish clinical proof of concept of hGH treatment for the improvement of the nutritional status in adult patients who are on maintenance hemodialysis. A total of 139 adult patients who were on maintenance hemodialysis and had serum albumin levels Յ40 g/L were randomly assigned to 6 mo of treatment with placebo or 20, 35, or 50 g/kg per d hGH. Change in LBM and serum albumin (primary outcomes), health-related quality of life, and secondary efficacy and safety parameters were monitored. The study showed that hGH treatment increased LBM significantly at all dosage levels (2.5 kg [95% confidence interval 1.8 to 3.1] versus Ϫ0.4 kg [95% confidence interval Ϫ1.4 to 0.6]; P Ͻ 0.001 for pooled hGH groups versus placebo). Serum albumin tended to increase (P ϭ 0.076), serum transferrin (P ϭ 0.001) and serum HDL (P Ͻ 0.038) increased, and plasma homocysteine was reduced (P ϭ 0.029). TNF-␣ also tended to decrease with treatment (P ϭ 0.134). An improvement in the Role Physical SF-36 quality-of-life subscale was observed (P ϭ 0.042). There were no differences in clinically relevant adverse events between groups. In conclusion, hGH therapy safely improves LBM, other markers of mortality and morbidity, and health-related quality of life in adult patients who are on maintenance hemodialysis. A long-term study is warranted to investigate whether these treatment benefits result in reduced mortality and morbidity.
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