We here describe our 15-year experience and report both on methodological problems (proposing a new datasheet and biochemical techniques) and on organizational ones (we discuss our patient approach ...and useful reporting for the physician).
Background. International guidelines have not reached a complete agreement about the optimal amount of dietary proteins in chronic kidney disease(CKD). The aim of this study was to compare, with a ...randomized-controlled design, the metabolic effects of two diets with different protein content (0.55 vs 0.80 g/kg/day) in patients with CKD stages 4–5. Methods. Study design and sample size calculations were based on previously published experience of our group with low protein diet. The primary outcome of the study was the modification of serum urea nitrogen concentration. From 423 patients randomly assigned to the two diets 392 were analysed: 200 for the 0.55-Group and 192 for the 0.8-Group. The follow-up ranged 6–18 months. Results. Mean age was 61±18 years, 44% were women, mean eGFR was 18±7 ml/min/month. Three months after the dietary assignment and throughout the study period the two groups had a significantly different protein intake (0.72 vs 0.92 g/kg/day). The intention-to-treat analysis did not show any difference between the two groups. Compliance to the two test diets was significantly different (P < 0.05): 27% in the 0.55-Group and 53% in the 0.8-Group, with male gender and protein content (0.8 g/kg/day) predicting adherence to the assigned diet. The per protocol analysis, conversely, showed that serum urea nitrogen, similar at the time of randomization, significantly increased in the 0.8-Group vs 0.55-Group by 15% (P < 0.05). Serum phosphate, PTH and bicarbonate resulted similar in the two groups throughout the study. The 24 h urinary urea nitrogen significantly decreased after the first 3 months in 0.55-Group (P < 0.05), as well as the excretion of creatinine, sodium and phosphate (P < 0.05 vs baseline) and were significantly lower than the 0.8-Group. The prescription of phosphate binders, allopurinol, bicarbonate supplements and diuretics resulted significantly less frequent in the 0.55-Group (P < 0.05). Conclusions. This study represents the first evidence that in CKD patients a protein intake of 0.55 g/kg/day, compared with a 0.8 g/kg/day, guarantees a better metabolic control and a reduced need of drugs, without a substantial risk of malnutrition.
The purpose of this article is to review the literature on the pharmacoeconomics of treatment for intermittent claudication and to discuss the importance of quality-of-life assessment for evaluating ...treatment strategies. Systemic risk reduction is the primary objective in the treatment of patients with intermittent claudication, as these patients have a high future risk of cardiovascular morbidity and mortality. Modification of cardiovascular risk factors accompanied by antiplatelet therapy is likely to improve overall survival, reduce myocardial infarction and stroke, and will, perhaps, also reduce the risk of ulcers and amputation at acceptable cost-effectiveness ratios. The second goal in the treatment of patients with intermittent claudication is to improve their walking capacity and community-based functional status. Supervised exercise training is the most effective noninvasive intervention to improve walking capacity, but may have elevated indirect costs. Among patients with disabling claudication who are candidates for invasive therapeutic procedures, angioplasty is cost effective in those with femoropopliteal stenosis or occlusion and in those with critical limb ischaemia and a stenosis. For all these therapeutic strategies there is a need to relate the costs to a relevant and comprehensive measure of effectiveness. Quality-of-life evaluation by using questionnaires exploring the specific problems encountered by patients with intermittent claudication in their daily life appear to be the most appropriate tool to evaluate the net result of a treatment. Cost-utility studies by combining pecuniary and quality-of-life evaluations provide information that is extremely useful to patients with intermittent claudication, regulatory authorities, the pharmaceutical industry and healthcare providers.
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EMUNI, FIS, FZAB, GEOZS, GIS, IJS, IMTLJ, KILJ, KISLJ, MFDPS, NLZOH, NUK, OBVAL, OILJ, PNG, SAZU, SBCE, SBJE, SBMB, SBNM, UKNU, UL, UM, UPUK, VKSCE, ZAGLJ
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