[Safety and effectiveness of nicotinic acid in the management of patients with chronic renal disease and hyperlipidemia associated to hyperphosphatemia].

OBJECTIVE: To establish if the nicotinic acid in patients with chronic renal disease reduce significantly and with security the levels of lipids and serum phosphate in refractory patients to the classical management.

DESIGN: Observational study Place: Renal Unity RTS Ltda Caldas Santa Sofìa Hospital.

PATIENTS: All the patients with chronic renal disease in dialysis therapy to whom the classical treatment for their hyperlipidaemia and hyperphosphatemia didn't manage a satisfactory reduce of their serum levels.

METHODS: It was identified that those patients who in the 3 previous months to the intervention hadn't presented changes in the lipids profile even though they received low fats diet and a lipid lowering therapies (statin o fibric acid derivates). It was determined in them whether they presented levels of serum phosphorus greater than 5.5 mg/dl even though having received nutritional recommendations and treatment with oral phosphate binding agents (Aluminum hydroxide, Calcium salts or Sevelamer). In them it was proceeded to administrate nicotinic acid via oral at night until a doses of 1,000 milligrams was reached (preceded of 100 mgs of acetylsalicylic acid 1 hour before) during a period of 8 months, observing its therapeutical effectivity and security profile to improve the lipids profile and reduce the serum phosphorus.

RESULTS: 9 patients complied with the requirements, average time in dialysis 34 months, 3 in hemodialysis and 6 in peritoneal dialysis. All patients started with 500 mgs and 3 months later correctly tolerated the dose of 1,000 mgs. Between the evaluated variables, the most important changes were: the phosphorus reduced reaching a significant value at eight months: initial 6.46+/-0.53, four months 4.37+/-0.63 (p>0.05) and eight months 3.94+/-0.76 (p<0.01); the product Ca x P obtained important reductions at four and eight months; the total Cholesterol and Triglyceride was significant reduced at all periods, not being so for the LDL, although the HDL elevated to significant values at eight months. There were no significant modifications in the LDL cholesterol, intact PTH, hemoglobin, platelet count, hepatic function tests (AST, ALT and Bilirubin), coagulation tests (TTP and TP), uric acid, glycemic control, albumin, creatinine, BUN, % transferring saturation, ferritin, folic acid and Vitamin B12. No patient presented collateral or clinical effects of importance, being the adherence to the medicament 100%.

CONCLUSIONS: The nicotinic acid is efficient, very well tolerated and economical in comparison with others drugs, which makes it ideal for the treatment of patients with hyperlipidaemia and refractory hyperphosphatemia to the classical treatments.