Effects of a contraceptive containing drospirenone and ethinyl estradiol on blood pressure and autonomic tone: a prospective controlled clinical trial.
BACKGROUND
The use of combined oral contraceptives has been associated with an increased risk of adverse cardiovascular events. Whether these drugs alter cardiac autonomic nervous system control is not completely determined.


OBJECTIVE
To evaluate the effect of a contraceptive containing 20mcg of ethinyl estradiol and 3mg of drospirenone on the heart rate variability, baroreflex sensitivity and blood pressure of healthy women.


METHODS
Prospective controlled trial with 69 healthy women allocated in two groups: 36 volunteers under oral combined contraceptive use and 33 volunteers using of non-hormonal contraceptive methods. Subjects were tested before the introduction of the contraceptive method and 6 months after its use. For data acquisition, we used continuous non-invasive beat-to-beat blood pressure curve recordings. Multiple ANOVA was used to determine differences between groups and moments and p< 0.05 was considered statistically significant.


RESULTS
At baseline, there were no differences in demographic and autonomic parameters between groups. Comparing cardiac sympatho-vagal modulation, baroreceptor sensitivity and blood pressure measurements between baseline and after 6 months, no significant difference was detected in each group or between groups.


CONCLUSIONS
A contraceptive containing 20mcg of ethinyl estradiol and 3mg of drospirenone causes no significant changes in clinical, hemodynamic and autonomic parameters of normal women.
Gynecology Department, Clinics Hospital, University of São Paulo Medical School, São Paulo 05403-000, Brazil. Electronic address: mgnisen@hotmail.com.
Marcelo Gil
MG
Nisenbaum
Gynecology Department, Clinics Hospital, University of São Paulo Medical School, São Paulo 05403-000, Brazil.
Nilson Roberto
NR
de Melo
Gynecology Department, Clinics Hospital, University of São Paulo Medical School, São Paulo 05403-000, Brazil.
Cassiana Rosa Galvão
CR
Giribela
Universidade Nove de Julho, (UNINOVE), São Paulo 01504-000, Brazil.
Tércio Lemos
TL
de Morais
Hypertension Unit, Heart Institute (InCor), University of São Paulo, São Paulo 05403-000, Brazil.
Grazia Maria
GM
Guerra
Universidade Nove de Julho, (UNINOVE), São Paulo 01504-000, Brazil.
Katia
K
de Angelis
Hypertension Unit, Heart Institute (InCor), University of São Paulo, São Paulo 05403-000, Brazil.
Cristiano
C
Mostarda
Gynecology Department, Clinics Hospital, University of São Paulo Medical School, São Paulo 05403-000, Brazil.
Edmund Chada
EC
Baracat
Hypertension Unit, Heart Institute (InCor), University of São Paulo, São Paulo 05403-000, Brazil; Universidade Nove de Julho, (UNINOVE), São Paulo 01504-000, Brazil.
Fernanda Marciano
FM
Consolim-Colombo
D000328:Adult; D000736:Androstenes / Q000009:adverse effects*; D001341:Autonomic Nervous System / Q000187:drug effects*; D003277:Contraceptives, Oral, Combined / Q000009:adverse effects*; D004967:Estrogens / Q000009:adverse effects; D004997:Ethinyl Estradiol / Q000009:adverse effects*; D005260:Female; D006439:Hemodynamics / Q000187:drug effects*; D006801:Humans; D000451:Mineralocorticoid Receptor Antagonists / Q000009:adverse effects; D011446:Prospective Studies
D000736:Androstenes; D003277:Contraceptives, Oral, Combined; D004967:Estrogens; D000451:Mineralocorticoid Receptor Antagonists; D004997:Ethinyl Estradiol; C035144:drospirenone
Autonomic nervous system; Blood pressure; Cardiovascular risk; Oral contraceptive