Low-dose estrogen and drospirenone combination: effects on glycoinsulinemic metabolism and other cardiovascular risk factors in healthy postmenopausal women

Fertil Steril. 2011 Jan;95(1):158-63. doi: 10.1016/j.fertnstert.2010.07.001. Epub 2010 Aug 21.

Abstract

Objective: To evaluate the effects of a daily E2 (1 mg) plus drospirenone oral formulation (2 mg) on glycoinsulinemic metabolism, lipid profile, and endothelial function in symptomatic healthy menopausal women.

Design: Randomized, double-blind study.

Setting: Operative Division of Endocrinological Gynecology, Catholic University of the Sacred Heart, Rome, Italy.

Patient(s): Forty postmenopausal women.

Intervention(s): Patients were randomly submitted to receive treatment with an oral dose of E2 (1 mg) plus drospirenone (2 mg) (group A) or placebo (group B).

Main outcome measure(s): Hormonal and lipid assessment; evaluation of glucose and insulin metabolism by the clamp test and the oral glucose tolerance test; evaluation of endothelial function by the vascular reactivity test.

Result(s): Total cholesterol levels, low-density lipoprotein cholesterol levels, and nonesterified fatty acids levels significantly decreased both after 3 and 6 months. No changes in high-density lipoprotein, triglycerides, apolipoprotein A1, apolipoprotein B, and lipoprotein (a) were found. Treatment resulted in few changes in glycoinsulinemic metabolism. We observed a significant reduction of the area under curve of insulin after 6 months of therapy. Endothelial function was significantly influenced by treatment, and an improvement in both flow-mediated dilatation and nitrate-mediated dilatation values after 6 months was observed.

Conclusion(s): Low-dose E2/drospirenone treatment did not reveal any negative effect on carbohydrate metabolism, acting in a neutral way on insulin sensitivity. The treatment induced favorable changes in lipid profile and showed a significant improvement of vascular reactivity.

Publication types

  • Randomized Controlled Trial

MeSH terms

  • Androstenes / administration & dosage*
  • Blood Glucose / metabolism*
  • Cardiovascular Diseases / epidemiology
  • Cardiovascular Diseases / metabolism
  • Cardiovascular Diseases / prevention & control*
  • Drug Combinations
  • Drug Therapy, Combination
  • Endothelium, Vascular / drug effects
  • Energy Metabolism / drug effects
  • Estradiol / administration & dosage*
  • Estrogen Replacement Therapy / methods
  • Female
  • Glucose Intolerance / epidemiology
  • Glucose Intolerance / metabolism
  • Glucose Intolerance / prevention & control*
  • Glucose Tolerance Test
  • Humans
  • Insulin / blood*
  • Middle Aged
  • Placebo Effect
  • Postmenopause / drug effects
  • Postmenopause / metabolism*
  • Risk Factors
  • Vasodilation / drug effects

Substances

  • Androstenes
  • Blood Glucose
  • Drug Combinations
  • Insulin
  • estradiol-drospirenone combination
  • Estradiol