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- Title
Low-dose simvastatin is safe in hyperlipidaemic renal transplant patients.
- Authors
Hernandez, B. E. Martinez; Persaud, J. W.; Varghese, Z.; Moorhead, J. F.
- Abstract
Hyperlipidaemia is common after renal transplantation, and because of its association with atherosclerosis, interest has increased in the use of lipid-lowering drugs in transplant patients. Dietary approaches have not been consistently successful, and multiple pharmacotherapy and drug interactions have led to difficulties in establishing lipid-lowering drug regimes. The statins reduce plasma cholesterol by inhibiting the rate-limiting step in cholesterol synthesis, and although some side-effects have been reported in their use after transplantation, the efficacy and safety of low doses has not been formally established. A randomized single-blind placebo crossover study designed to determine the safety and effectiveness of simvastatin in a single daily 5-mg evening dose was therefore conducted in 26 stable renal transplant patients, 14 of whom were receiving cyclosporin A. The results demonstrated no difference between total cholesterol levels in the baseline simvastatin and placebo periods: 7.97 ± 1.2 and 7.59±1.5 mmol/l respectively. After 8 weeks of simvastatin, the total cholesterol declined significantly to 6.72±0.87 mmol/l (<0.001). A significant difference was found when the placebo and simvastatin cholesterol levels were compared at 4 and 8 weeks (<0.01). LDL cholesterol decreased from 4.74 ± 0.87 to 3.78 ± 0.78 mmol/l after 8 weeks on simvastatin (<0.001), and apo B fell from 142 ± 31 to 112 ± 22 mg/dl (<0.001). The difference in LDL cholesterol and apo B after 8 weeks of simvastatin when compared with the corresponding values on placebo was also significant (<0.01). A slight but not significant increment in HDL cholesterol from 1.10 ± 0.47 to 1.13 ± 55 mmol/l (NS) was seen after 8 weeks on simvastatin. Triglycerides and serum creatinine did not change during the study in any of the groups. Creatine kinase (CK.) remained in the normal range (0–200 U/l), except for one patient not taking cyclosporin who had a CK value slightly above the upper limit of normal during the simvastatin period, without abnormal clinical signs. Repeated cyclosporin measurements remained within the therapeutic range (50–150 ng/ml). These results suggest that low-dose simvastatin is effective and safe in reducing total cholesterol and LDL cholesterol in renal transplant patients.
- Publication
Nephrology Dialysis Transplantation, 1993, Vol 8, Issue 7, p637
- ISSN
0931-0509
- Publication type
Article