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Abstract Background and Aims The integrated very low protein diet (sVLPD) has proven effective in slowing the progression of stage 5 chronic renal failure and in postponing the start of dialysis treatment (1)SVLPD with keto analogues is difficult to implement due to the high number of tablets to be taken (2), therefore, to increase compliance we decided to prescribe, in compliance with the guidelines of normal clinical practice, SVLPD (0.3 g/prot/day) integrated with only essential amino acid drugs without the use of keto analogues, in stage 5 patients and we have verified its effectiveness, safety and clinical and economic effects(3). Method 129 patients were started on dietary therapy (middle age 75.2 ± 13.7, 60.5%male, all with hypertension, 40.3% with diabetes and 24.8% with heart disease) who were tested at the beginning of the observation, every 3 months and for 24 months, characterizing blood chemistry tests and body composition (with impedance analysis). Results During the 24-month observation period 91 patients (70.5%) were compliant with dietary therapy. Chronic kidney disease progression is slowed with average eGFR 11.6 ± 3.3 (compliant) vs. 9.3 ± 2.7 (no compliant) mL/min/1.73 m2, p 0.001) Urea (mg/dL) 116.1 ± 31.7 (compliant) 174.2 ± 42.2 (no compliant) p 0.002; and initiation of dialysis treatment (adjusted HR = 0.361, CI 0.200–0.650, p = 0.001) was delayed without evidence of malnutrition, in compliant versus noncompliant patients. Metabolic acidosis was well compensated in both groups with an improving trend in bicarbonate levels in compliant patients. Hemoglobin, uricemia, serum albumin, glycemia (downward trend NS), potassium, sodium, chlorium, calcium, magnesium, pH, lipids remained within normal values. Better blood pressure control was observed in compliant patients compared to non-compliant patients (SBP (mmHg) 136.9 ± 11.8 vs 150.1 ± 7 0.01), DBP (mmHg) 75 ± 3.1 vs 79.4 ± 1 0.001) During the observation, there were 24 deaths (13 patients older than 85 years), 20 peritoneal dialysis hospitalizations, 36 hemodialysis hospitalizations, 4 preventive living transplants and 15 renal functional recoveries with eGFR consistently 15 mL/min/ 1.73 m2. The months of dialysis avoided generated gross savings in terms of healthcare expenditure equal to EUR 3,076,470; the expenditure sustained by the Marche region for protein-free products (EUR 90 per patient per month) was EUR 158,358. As a result, the total net savings were EUR 2,918,112. Conclusion This non-interventional longitudinal observational study is part of standard clinical practice and suggests that VLPD supplemented with only essential amino acids is safe and effective and could be widely used to reduce the incidence of dialysis treatments, with a favorable economic impact on the National Health Service.
Cecchi et al. (Wed,) studied this question.