A randomized placebo-controlled double-blind trial of lipid-lowering strategies in patients with renal insufficiency: diet modification with or without fenofibrate.
BACKGROUND
Renal insufficiency is characterized by lipoprotein abnormalities including elevated triglyceride levels.


METHODS
The safety and efficacy of micronized fenofibrate as a treatment for dyslipidemia in patients with progressive renal insufficiency was evaluated in a randomized, placebo-controlled double-blind study comparing fenofibrate and dietary modification to dietary modification alone. Patients were evaluated following a 3-month pre-randomization period of dietary counseling. Twenty-eight patients with moderate renal insufficiency and triglyceride levels 2.3 mmol/l or LDL/HDL ratio 5 were randomized to placebo (n = 12) or fenofibrate (n = 16) therapy. Treatment and dietary counseling continued for 6 months.


RESULTS
Ten of 16 patients (63%) treated with fenofibrate achieved a 30% reduction in triglyceride levels or LDL/HDL ratio reduction < 5 compared to 2 of 17% in the placebo group (p = 0.015). Triglyceride levels were significantly reduced in the fenofibrate group (-31%) versus placebo (+1.3%, p = 0.003). In compliant patients (n = 25) there was also a significantly greater increase in HDL cholesterol levels in the fenofibrate group (+19.9%) compared to placebo (-4.7%, p = 0.001). Changes in measured creatinine clearance were not significantly different between the groups and there were no serious adverse effects of treatment.


CONCLUSIONS
Fenofibrate therapy combined with dietary modification effectively reduced triglyceride levels in renal insufficiency patients without serious adverse effects.
Levin
A
A
Division of Nephrology, University of British Columbia, Vancouver, Canada.
Duncan
L
L
Djurdjev
O
O
Shapiro
R J
RJ
Frohlich
J
J
Belanger
A
A
Dumas
R
R
Ross
S
S
D000328:Adult; D000368:Aged; D003131:Combined Modality Therapy; D004311:Double-Blind Method; D005260:Female; D011345:Fenofibrate / Q000627:therapeutic use*; D006801:Humans; D006949:Hyperlipidemias / Q000097:blood / Q000178:diet therapy / Q000188:drug therapy; D000960:Hypolipidemic Agents / Q000627:therapeutic use*; D007676:Kidney Failure, Chronic / Q000097:blood / Q000178:diet therapy* / Q000188:drug therapy*; D008055:Lipids / Q000097:blood; D008297:Male; D008875:Middle Aged; D010919:Placebos
D000960:Hypolipidemic Agents; D008055:Lipids; D010919:Placebos; D011345:Fenofibrate