Abstract
Patients with combined hyperlipidemia and low high-density lipoprotein (HDL) cholesterol
levels may benefit from combination therapy with a statin and niacin; therefore, we
assessed the efficacy and safety of rosuvastatin and extended-release (ER) niacin
alone and in combination in 270 patients with this atherogenic dyslipidemia. Men and
women ≥18 years with fasting total cholesterol levels ≥200 mg/dl, triglycerides 200
to 800 mg/dl, apolipoprotein B ≥110 mg/dl, and HDL cholesterol <45 mg/dl were randomized
to 1 of 4 treatments in this 24-week, open-label, multicenter trial: rosuvastatin
10 to 40 mg; ER niacin 0.5 to 2 g; rosuvastatin 40 mg/ER niacin 0.5 to 1 g; or rosuvastatin
10 mg/ER niacin 0.5 to 2 g. Percent changes from baseline in low-density lipoprotein
(LDL) cholesterol, non-HDL cholesterol, and other lipid measurements at week 24 were
determined by analysis of variance, with statistical testing performed separately
between the rosuvastatin monotherapy group and each remaining treatment group. Daily
doses of rosuvastatin 40 mg reduced LDL and non-HDL cholesterol significantly more
than either ER niacin 2 g or rosuvastatin 10 mg/ER niacin 2 g (−48% vs −0.1% and −36%
for LDL cholesterol and −49% vs −11% and −38% for non-HDL cholesterol, respectively;
p <0.01 for all comparisons); no additional reduction in LDL or non-HDL cholesterol
was observed with the combination of rosuvastatin 40 mg/ER niacin 1.0 g (−42% and
−47%; p = NS). Triglyceride reductions ranged from −21% (ER niacin monotherapy) to
−39% (rosuvastatin 40 mg/ER niacin 1 g), but no observed differences were statistically
significant. Compared with rosuvastatin alone, rosuvastatin 10 mg/ER niacin 2 g produced
significantly greater increases in HDL cholesterol (11% vs 24%, p <0.001) and apolipoprotein
A-I (5% vs 11%, p <0.017). Similar increases in HDL cholesterol and apolipoprotein
A-I were noted between the monotherapy groups. Over 24 weeks, rosuvastatin alone was
better tolerated than either ER niacin alone or the combinations of rosuvastatin and
ER niacin.
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Article info
Publication history
Accepted:
February 27,
2003
Received in revised form:
February 27,
2003
Received:
October 11,
2002
Footnotes
This study was supported by a grant from AstraZeneca Pharmaceuticals, LP, Wilmington, Delaware.
Identification
Copyright
© 2003 Excerpta Medica Inc. Published by Elsevier Inc. All rights reserved.
