Neither long-term treatment with raloxifene nor hormone replacement therapy modulate cardiac function in healthy postmenopausal women: two randomized, placebo-controlled, 2-year studies

Am J Obstet Gynecol. 2002 Apr;186(4):729-36. doi: 10.1067/mob.2002.122092.

Abstract

Objective: Our purpose was to investigate the long-term effects of raloxifene, compared with opposed and unopposed estrogen replacement therapy, on echocardiographic parameters of left ventricular systolic function in healthy postmenopausal women. A total of 157 women were studied in 2 randomized, double-blind, placebo-controlled, 2-year studies.

Study design: In study I, 60 postmenopausal women who had undergone hysterectomy received daily raloxifene, 60 mg (n = 15); raloxifene, 150 mg (n = 15); conjugated equine estrogens (CEE), 0.625 mg (n = 15); or placebo (n = 15). In study II, 97 postmenopausal women who had not undergone hysterectomy received daily raloxifene, 60 mg (n = 24); raloxifene, 150 mg (n = 24); CEE, 0.625 mg, plus medroxyprogesterone acetate (MPA), 2.5 mg (n = 24); or placebo (n = 25). M-mode, quantitative 2-dimensional and Doppler echocardiographic measurements were performed at baseline and after 1 and 2 years.

Results: Neither after 1 year nor after 2 years of treatment were echocardiographic parameters found to differ from baseline in both raloxifene groups, as well as in the unopposed CEE and the CEE/MPA groups, compared with the placebo group.

Conclusion: Within 2 years of raloxifene treatment, no effect on echocardiographic parameters of left ventricular systolic function was found. Unopposed CEE or CEE/MPA also showed no effect.

Publication types

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

MeSH terms

  • Double-Blind Method
  • Echocardiography
  • Estrogen Antagonists / therapeutic use*
  • Estrogen Replacement Therapy*
  • Estrogens, Conjugated (USP) / therapeutic use
  • Female
  • Heart Diseases / prevention & control*
  • Humans
  • Medroxyprogesterone Acetate / therapeutic use
  • Middle Aged
  • Placebos
  • Raloxifene Hydrochloride / therapeutic use*
  • Systole
  • Ventricular Function, Left

Substances

  • Estrogen Antagonists
  • Estrogens, Conjugated (USP)
  • Placebos
  • Raloxifene Hydrochloride
  • Medroxyprogesterone Acetate