A 2-year, randomized, comparative, placebo-controlled study on the effects of raloxifene on lipoprotein(a) and homocysteine.
OBJECTIVE
Lipoprotein(a) (Lp(a)) and homocysteine (Hcy) are independent cardiovascular risk factors, which have been shown to be lowered by hormone replacement therapy (HRT). In this 2-year study, the long-term effects of raloxifene (Rlx) in two doses, on Lp(a) and Hcy, were studied and compared with the effects of continuously combined hormone replacement therapy (ccHRT).


METHODS
In a prospective, randomized, double-blind, placebo-controlled 2-year study, 95 healthy, non-hysterectomized, early postmenopausal women, received daily either oral Rlx 60 mg (N=24) or 150 mg (N=23), ccHRT (conjugated equine estrogens 0.625 mg plus medroxyprogesterone acetate 2.5 mg; N=24) or placebo (N=24). Fasting serum Lp(a) and plasma Hcy concentrations were measured at baseline and at 6, 12 and 24 months.


RESULTS
The mean individual changes compared to baseline after 24 months were for Lp(a): Rlx 60: - 5%, Rlx 150: -7%, ccHRT: -34%, placebo: +1% and for Hcy: Rlx 60: -3%, Rlx 150: -4%, ccHRT: -4%, placebo: +6%. ANCOVA was significant for Lp(a) under ccHRT versus placebo (P=0.001) and for Lp(a) under ccHRT versus each of the two Rlx groups (P<0.05).


CONCLUSIONS
Long-term treatment with Rlx was not as effective as ccHRT in lowering Lp(a). Although not significant and without an obvious dose-related response, the Hcy values showed the same trend for each treatment arm, which is in line with data reported earlier.
Smolders
Raimond G V
RG
Department of Obstetrics and Gynecology, Institute for Cardiovascular Research, VU University Medical Centre, P.O. Box 7057, 1007 MB, Amsterdam, The Netherlands.
Vogelvang
Tatjana E
TE
Mijatovic
Velja
V
van Baal
W Marchien
WM
Neele
Simone J M
SJ
Netelenbos
J Coen
JC
Kenemans
Peter
P
van der Mooren
Marius J
MJ
D002318:Cardiovascular Diseases / Q000097:blood / Q000517:prevention & control*; D004311:Double-Blind Method; D004966:Estrogens, Conjugated (USP) / Q000008:administration & dosage; D005260:Female; D006710:Homocysteine / Q000097:blood*; D020249:Hormone Replacement Therapy; D006801:Humans; D017270:Lipoprotein(a) / Q000097:blood*; D017258:Medroxyprogesterone Acetate / Q000008:administration & dosage; D008875:Middle Aged; D011446:Prospective Studies; D020849:Raloxifene Hydrochloride / Q000008:administration & dosage / Q000627:therapeutic use*; D020845:Selective Estrogen Receptor Modulators / Q000008:administration & dosage / Q000627:therapeutic use*
D004966:Estrogens, Conjugated (USP); D017270:Lipoprotein(a); D020845:Selective Estrogen Receptor Modulators; D006710:Homocysteine; D020849:Raloxifene Hydrochloride; D017258:Medroxyprogesterone Acetate