Clinical and metabolic effects of drospirenone-estradiol in menopausal women: a prospective study.
OBJECTIVE
To describe the effects of low-dose hormonal replacement therapy (HRT) on quality of life, metabolic parameters and blood pressure in postmenopausal women.


METHODS
Postmenopausal women untreated with HRT or sex steroids in the previous 12 months were randomized to treatment with 17β-estradiol (1 mg/day) plus drospirenone (2 mg/day) (E2+DRSP) or to calcium (controls). Quality of life was evaluated by the Women's Health Questionnaire (WHQ) at baseline and after 6 and 12 weeks of treatment. Anthropometric, metabolic and blood pressure measurements were performed before and after 3 months of treatment.


RESULTS
WHQ domain scores for vasomotor and somatic symptoms, anxiety/fears, depressed mood, sexual behavior and sleep problems decreased significantly in the E2+DRSP group relative to both baseline and control values (p < 0.05). Body mass index was unchanged, while waist circumference decreased significantly (p < 0.001) after E2+DRSP treatment. Significant decreases were also observed after E2+DRSP treatment for blood insulin values, insulin resistance (estimated by homeostasis model assessment) and systolic blood pressure (p < 0.001, all). In subjects with systolic blood pressure < 130 mmHg at baseline, no changes in systolic values were registered, while women with baseline high-normal systolic blood pressure (130-139 mmHg) showed significant decreases (p < 0.0069). E2+DRSP did not modify diastolic blood pressure values. In the calcium-treatment group, there were no significant changes in WHQ scores or in anthropometric, metabolic or blood pressure measurements.


CONCLUSIONS
In postmenopausal women, E2+DRSP administration improves vasomotor symptoms and general aspects of quality of life and may positively influence cardiovascular risk factors.
Gambacciani
M
M
Department of Reproductive Medicine and Child Development, Division of Obstetrics and Gynecology Piero Fioretti, Pisa University Hospital, University of Pisa, Via Roma 67, Pisa, Italy.
Rosano
G
G
Cappagli
B
B
Pepe
A
A
Vitale
C
C
Genazzani
A R
AR
D000736:Androstenes / Q000008:administration & dosage*; D001007:Anxiety; D001794:Blood Pressure; D003863:Depression / Q000453:epidemiology; D004958:Estradiol / Q000008:administration & dosage*; D004967:Estrogens / Q000008:administration & dosage*; D005239:Fear; D005260:Female; D020249:Hormone Replacement Therapy; D006801:Humans; D007328:Insulin / Q000097:blood; D007333:Insulin Resistance; D008875:Middle Aged; D000451:Mineralocorticoid Receptor Antagonists / Q000008:administration & dosage*; D017698:Postmenopause; D011446:Prospective Studies; D011788:Quality of Life; D012725:Sexual Behavior; D012893:Sleep Wake Disorders / Q000453:epidemiology; D013599:Systole; D055105:Waist Circumference
D000736:Androstenes; D004967:Estrogens; D007328:Insulin; D000451:Mineralocorticoid Receptor Antagonists; D004958:Estradiol; C035144:drospirenone