Drospirenone as estrogen-free pill and hemostasis: coagulatory study results comparing a novel 4 mg formulation in a 24 + 4 cycle with desogestrel 75 μg per day
ESC Congress Library. Regidor P. 05/10/18; 208156; ESC230 Disclosure(s): Dr Regidor is Exeltis employee
Mr. Pedro Antonio Regidor
Mr. Pedro Antonio Regidor
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Abstract
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Objectives: The contraceptive pills is a very effective and safe method. It was developed 60 years ago, and the composition has been the same since it was first developed (estrogen and progestone), along the years the concentration of ethinyl estradiol has been reduced to improve tolerability. Ethinyl estradiol has no contraceptive effect, but it affects cycle control which is a very important for user tolerability. On the other side estrogens induce coagulation thus being responsible for side effects like thrombosis or even pulmonary embolism. Currently there is only one contraceptive pill containing only progestogens. A novel drospirenone (DRSP) only pill - Slinda® has been developed to improve compliance and side effects especially regarding cycle control. The aim of the study was to determine if 4mg DRSP in a regime of a daily use for 24 days followed by 4 placebo days has an impact on coagulation factors and hereby can enhance or not possible thrombotic risks from a hemostaseological point of view. As a comparative group, users of desogestrel were analyzed. Design and Methods: 39 patients received 4mg drospirenone in a regime intake of 24 days followed by 4 placebos and 29 patients desogestrel 75 µg per day continuously for a period of 9 complete cycles. The following hemostaseological parameters were evaluated: Apc resistance, Antithrombin III, D-Dimer, Clotting factor VII, Clotting factor VIII and Protein C reactivity. Data were obtained after randomization before starting the intake and after 9 months of treatment and the values compared using a 2-sample t test. Results: Factor VII felt down from 1.123 to 1.066 in the DRSP group and from 1.241 to 1.034 in the desogestrel group (p=0.0088). Mean protein C activity in the DRSP group was lower than in the desogestrel group after the 9 cycles of treatment (1.108 (0.1688 SD)) versus (1.136 (0.2230 SD)). The difference in change of mean protein C activity from baseline to endpoint was: -0.0332 in the DRSP versus -0.157 in the desogestrel group (p = 0.0249). A relevant reduction in the amount of D-Dimer could be observed in the DRSP group. From baseline values of 264,9 ng/mL they felt down to 215,0 ng/mL whereas in the desogestrel group there was a rise from 201,4 ng/mL to 281,5 ng/m. Conclusions: The use of this novel DRSP only pill can be considered as safe, in regard of potential changes of the blood coagulation as it does not influence hemostasis. 
Objectives: The contraceptive pills is a very effective and safe method. It was developed 60 years ago, and the composition has been the same since it was first developed (estrogen and progestone), along the years the concentration of ethinyl estradiol has been reduced to improve tolerability. Ethinyl estradiol has no contraceptive effect, but it affects cycle control which is a very important for user tolerability. On the other side estrogens induce coagulation thus being responsible for side effects like thrombosis or even pulmonary embolism. Currently there is only one contraceptive pill containing only progestogens. A novel drospirenone (DRSP) only pill - Slinda® has been developed to improve compliance and side effects especially regarding cycle control. The aim of the study was to determine if 4mg DRSP in a regime of a daily use for 24 days followed by 4 placebo days has an impact on coagulation factors and hereby can enhance or not possible thrombotic risks from a hemostaseological point of view. As a comparative group, users of desogestrel were analyzed. Design and Methods: 39 patients received 4mg drospirenone in a regime intake of 24 days followed by 4 placebos and 29 patients desogestrel 75 µg per day continuously for a period of 9 complete cycles. The following hemostaseological parameters were evaluated: Apc resistance, Antithrombin III, D-Dimer, Clotting factor VII, Clotting factor VIII and Protein C reactivity. Data were obtained after randomization before starting the intake and after 9 months of treatment and the values compared using a 2-sample t test. Results: Factor VII felt down from 1.123 to 1.066 in the DRSP group and from 1.241 to 1.034 in the desogestrel group (p=0.0088). Mean protein C activity in the DRSP group was lower than in the desogestrel group after the 9 cycles of treatment (1.108 (0.1688 SD)) versus (1.136 (0.2230 SD)). The difference in change of mean protein C activity from baseline to endpoint was: -0.0332 in the DRSP versus -0.157 in the desogestrel group (p = 0.0249). A relevant reduction in the amount of D-Dimer could be observed in the DRSP group. From baseline values of 264,9 ng/mL they felt down to 215,0 ng/mL whereas in the desogestrel group there was a rise from 201,4 ng/mL to 281,5 ng/m. Conclusions: The use of this novel DRSP only pill can be considered as safe, in regard of potential changes of the blood coagulation as it does not influence hemostasis. 
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