V. De Leo et al., Randomized control study of the effects of raloxifene on serum lipids and homocysteine in older women, AM J OBST G, 184(3), 2001, pp. 350-353
OBJECTIVE(S): Raloxifene, a selective estrogen receptor modulator, has bene
ficial estrogen agonist effects on bone and cardiovascular risk factors and
estrogen antagonist effects on the breast and uterus. Limited clinical dat
a have shown a sustained decrease in total cholesterol, low-density lipopro
tein cholesterol, and homocysteine levels; an elevated homocysteine level i
s an independent risk factor for atherosclerosis. All of these studies were
conducted in relatively young populations of women (mean age, 52-54 years)
. Raloxifene does not affect hot flushes, a major immediate symptom of meno
pause. This drug may therefore be useful in older women to prevent osteopor
osis and cardiovascular disease. The aim of this clinical study was to eval
uate the effects of raloxifene on plasma lipids and homocysteine in older w
omen.
STUDY DESIGN: The subjects were 45 healthy postmenopausal women, aged 60 to
70 years. The women were randomly assigned to therapy with raloxifene or p
lacebo, 60 mg/d for 1 year. Twenty-six women received raloxifene and 19 rec
eived placebo. Checkups were performed every 3 months. At baseline and afte
r 3, 6, 9, and 12 months of treatment we measured homocysteine, total serum
cholesterol, triglycerides, and both high-density lipoprotein and low-dens
ity lipoprotein cholesterol.
RESULTS: An effect on lipids was evident by 3 months with no significant ad
ditional modification at 12 months. Mean low-density lipoprotein cholestero
l levels were lowered by 15% and total cholesterol was lowered by 8.5%. No
reduction in high-density lipoprotein cholesterol or triglycerides was obse
rved. After 3 months of therapy, homocysteine was significantly lower than
at baseline (9.9 +/- 1.6 vs 11 +/- 2.1 mu mol/L; P < .05). The greatest red
uction with respect to baseline was reached after 6 months of therapy (-19.
5% +/- 3%; P < .05).
CONCLUSION(S): The results of our study show that raloxifene at a dose of 6
0 mg/d reduces serum concentrations of low-density lipoprotein cholesterol
and total cholesterol in healthy older women. Our study shows that in older
women raloxifene leads to a 19.5% +/- 3% reduction in fasting homocysteine
levels. Raloxifene may have a favorable effect on the incidence of cardiov
ascular disease in older women.