The aim of this study was to investigate the safety and efficacy of combined treatment with fluvastatin (F) and gemfibrozil (G) in hypercholesterolemic renal transplant recipients (RTR). Ten hypercholesterolemic (total cholesterol [TC] > 220 mg/dl) RTR (7 men) with mean age 44 years (range 25-56 years) who remained hypercholesterolemic after 3 months of treatment (period A) with fluvastatin (40 mg/d) continued taking the same dose of F plus G (600 mg/dl) for another 3-month period (B). Serum total cholesterol, high density lipoprotein cholesterol (HDL-C), LDL cholesterol (LDL-C), triglyceride, serum creatinine (creatinine phosphokinase (CPK), serum glutamic-oxaloacetic transaminase (SGOT), and serum glutamate pyruvate transaminase (SGPT) were measured before treatment and at the end of periods A and B. Mean TC levels were 360.30 +/- 62.42 mg/dl, 324.10 +/- 100.53 mg/dl, 270.80 +/- 67.77 mg/dl; mean LDL-C levels were 259.33 +/- 71.43 mg/dl, 219.60 +/- 81.31 mg/dl, 189.70 +/- 65.51 mg/dl; mean HDL-C levels were 37.10 +/- 11.68 mg/dl, 39.80 +/- 13.21 mg/dl, 41.00 +/- 12.94 mg/dl; mean triglyceride levels were 354.60 +/- 183.29 mg/dl, 349.30 +/- 242.94 mg/dl, 207.00 +/- 85.35 mg/dl before treatment and at the end of periods A and B, respectively. There was a statistically significant fall of serum TC (P = 0.002), LDL-C (P = 0.016), and triglyceride (P = 0.029) levels at the end of periods A and B. Kidney and liver function did not change. F and G combined treatment is safe and useful in patients who do not respond satisfactorily to monotherapy with F. Gemfibrozil augments the effect of F on TC, LDL-C, and triglyceride levels.