D. Hunninghake et al., Coadministration of colesevelam hydrochloride with atorvastatin lowers LDLcholesterol additively, ATHEROSCLER, 158(2), 2001, pp. 407-416
Citations number
52
Categorie Soggetti
Cardiovascular & Respiratory Systems","Cardiovascular & Hematology Research
Colesevelam hydrochloride is a novel, potent, non-absorbed lipid-lowering a
gent previously shown to reduce low density lipoprotein (LDL) cholesterol.
To examine the efficacy and safety of co administration of colesevelam and
atorvastatin, administration of these agents alone or in combination was ex
amined in a double-blind study of 94 hypercholesterolemic men and women (ba
seline LDL cholesterol greater than or equal to 160 mg/dl). After 4 weeks o
n the American Heart Association Step I diet, patients were randomized amon
g five groups: placebo; colesevelam 3.8 g/day; atorvastatin 10 mg/day; coad
minstered colesevelam 3.8 g/day plus atorvastatin 10 mg/day; or atorvastati
n 80 mg/day. Fasting lipids were measured at screening, baseline and 2 and
4 weeks of treatment. LDL cholesterol decreased by 12-53% in all active tre
atment groups (P<0.01). LDL cholesterol reductions with combination therapy
(48%) were statistically superior to colesevelam (12%) or low-dose atorvas
tatin (38%) alone (P <0.01), but similar to those achieved with atorvastati
n 80 mg/day (53%). Total cholesterol decreased 6-39% in all active treatmen
t groups (P < 0.05). High density lipoprotein cholesterol increased signifi
cantly for all groups including placebo (P < 0.05). Triglycerides decreased
in patients taking atorvastatin alone (P < 0.05), but were unaffected by c
olesevelam alone or in combination. The frequency of side effects did not d
iffer among groups. At recommended starting doses of each agent. cc adminis
tration of colesevelam and atorvastatin was well tolerated, efficacious and
produced additive LDL cholesterol reductions comparable to those observed
with the maximum atorvastatin dose. (C) 2001 Elsevier Science Ireland Ltd.
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