Combined oral contraceptive containing drospirenone does not modify 24-h ambulatory blood pressure but increases heart rate in healthy young women: prospective study

Effects of two contraceptives containing drospirenone on blood pressure in normotensive women

“…However, the volunteers presented with polycystic ovary syndrome and consequently may have had outcomes distinct from those of women without the syndrome. Our data indicate no changes in BP, which is consistent with most other studies that evaluated DRSP as the progestogen combined with EE [3,12,22,24,25]. Of these studies, only two were randomized clinical trials, and they used casual measurements rather than ABPM to assess BP.…”

“…Increased blood pressure (BP) is one of these side effects [6], and systemic arterial hypertension is a contraindication to the use of COCs [7]. In normotensive patients, COCs can increase BP [8][9][10][11][12]. In addition, increases in BP levels of 4-5 mmHg have been documented with the use of COCs containing low doses of ethinylestradiol (EE) [10,13,14], and these results were confirmed by other studies using ambulatory blood pressure monitoring (ABPM) [11].…”

“…Considering the 24-h mean DBP values among women of reproductive age before beginning the use of COCs [12], 16 women would be required per group with an α value of 5% and power of 80% to achieve a difference of at least 10% in daytime 24-h mean DBP between the groups. This difference was chosen because lower values would not be clinically relevant.…”

“…Studies assessing BP during the use of contraceptives containing DRSP are limited [12,[21][22][23][24] and, most of them are limited to casual measurement of BP during study follow-up [3,[22][23][24][25]. Therefore, considering the absence of randomized clinical trials assessing the effect of COCs containing DRSP on BP measured by ABPM, the primary objective of this study was to compare the effect of two COCs with different EE doses (30 mcg EE + DRSP and 20 mcg EE + DRSP) on BP assessed by ABPM after 6 months of treatment.…”

“…Most progestogens used are ineffective in antagonizing the effects of estrogen, particularly on BP [17]. However, drospirenone (DRSP), a derivative of spironolactone with an antimineralocorticoid action, can counteract the increase in BP associated with the use of estrogen in COCs [12,18].…”