A 2-year, randomized, comparative, placebo-controlled study on the effects of raloxifene on lipoprotein(a) and homocysteine

Maturitas. 2002 Feb 26;41(2):105-14. doi: 10.1016/s0378-5122(01)00280-8.


Objectives: 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.

Publication types

  • Clinical Trial
  • Comparative Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Cardiovascular Diseases / blood
  • Cardiovascular Diseases / prevention & control*
  • Double-Blind Method
  • Estrogens, Conjugated (USP) / administration & dosage
  • Female
  • Homocysteine / blood*
  • Hormone Replacement Therapy*
  • Humans
  • Lipoprotein(a) / blood*
  • Medroxyprogesterone Acetate / administration & dosage
  • Middle Aged
  • Prospective Studies
  • Raloxifene Hydrochloride / administration & dosage
  • Raloxifene Hydrochloride / therapeutic use*
  • Selective Estrogen Receptor Modulators / administration & dosage
  • Selective Estrogen Receptor Modulators / therapeutic use*


  • Estrogens, Conjugated (USP)
  • Lipoprotein(a)
  • Selective Estrogen Receptor Modulators
  • Homocysteine
  • Raloxifene Hydrochloride
  • Medroxyprogesterone Acetate