Background Statin–fibrate combinations are very effective
in the treatment of familial combined hyperlipidaemia (FCHL). Nonetheless, they
have not been extensively used because of the fear of side effects. Thus, a
therapeutic alternative is required for this lipid disorder.
Objective To compare the long-term (one-year) efficacy of
atorvastatin monotherapy with those of four statin–fibrate
combinations in 675 FCHL patients.
Methods Patients were randomly assigned to atorvastatin monotherapy
(A 20 mg/day) n=134, or pravastatin
(P 20 mg/day)+gemfibrozil (G 1200
mg/day) n=135, simvastatin (S 20
mg/day)+G (1200 mg/day) n=137, P (20
mg/day)+ciciprofibrate (C 100 mg/day)
n=135, and S (20 mg/day)+C (100 mg/day)
n=134.
Results Twelve patients on statin–fibrate combinations
were withdrawn from the study because of side effects: Three because of CK
elevation, two because of myalgia and seven due to increase in serum
transaminase levels. One patient on A was withdrawn because of persistent
epigastric discomfort. Atorvastatin reduced low density lipoprotein cholesterol
and apoprotein B more than all four combinations (−45% vs.
maximum −40% of S+C, and
−39% vs. maximum −32% of the same
combination, respectively, P < 0.001 for both), but
had a lesser effect on triglycerides (−38% vs. maximum
−53% of S+C,
P=0.0002) and high density lipoprotein cholesterol
(6% vs. maximum 21% of S+G,
P=0.0003). The effect of A on plasma fibrinogen was
analogous to that of G combinations (−8% vs.
−9% of P+G and −11% of
S+G, P=NS vs. baseline and among each
other) and inferior to that of the ciprofibrate combinations
(−8% vs. −24% of P+C,
P=0.0002 and −26%
S+C, P=0.0001). A had a lower treatment
cost and better patient compliance, P=0.04 vs. C
combinations and P=0.02 vs. G combinations.
Conclusions The data suggest that statin–fibrate
combinations have a beneficial effect on all lipid parameters. Atorvastatin
monotherapy has a better effect on LDL-C and apoprotein B than
statin–fibrate combinations, but a lesser effect on HDL-C, TG and in
the case of ciprofibrate combinations, fibrinogen. The clinical significance of
these findings should be tested in a large, long-term survival study.
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