1 In COCs, the estrogen component, mainly ethinylestradiol (EE), induces a hypercoagulative state, and progestins seem to modify the overall effect depending on androgenic activity. The use of combined oral contraceptives (COCs) is a well-established risk factor for venous thromboembolism (VTE), increasing the risk two- to four-fold compared with non-use. The lower thrombin generation measures after treatment with EV + DNG indicate less enhancement of coagulation potential and suggest that EV may be favorable to EE as a component of combined oral contraceptives.Ĭontinuous exposure to the combined oral contraceptive containing ethinylestradiol + dienogest enhanced in vitro thrombin generation compared with estradiol valerate + dienogest, suggesting that the substitution of ethinylestradiol with estradiol valerate in combined oral contraceptives may beneficially lower coagulation potential. Conclusionsīoth in vitro and in vivo thrombin generation was lower after exposure to EV + DNG compared with EE + DNG. DNG alone did not affect these biomarkers. The within-group change in D-dimer levels was not significant in any of the groups. Lag time and time to thrombin peak remained unaltered after exposure to EV + DNG, whereas EE + DNG shortened both lag time (mean percentage change −24%, 95% confidence interval −32% to −15% p < 0.01) and time to thrombin peak (−26%, 95% CI −37% to −16% p < 0.01).
#45 meg persecond vs 95 meg persecond trial
Clinical trial registration: NCT02352090. In vivo coagulation assessment was based on levels of prothrombin fragment 1 + 2 (F1 + 2) (thrombin generation) and D-dimer (fibrin turnover). Thrombin generation was evaluated by lag time, time to thrombin peak, thrombin peak, and endogenous thrombin potential in response to tissue factor (1 p m). We assessed coagulation in vitro by thrombin generation using the Calibrated Automated Thrombogram. Blood samples were collected at baseline and after 9 weeks. The participants were randomly allocated to 9 weeks of continuous treatment with EV 2 mg + DNG 2–3 mg ( n = 20), EE 0.03 mg + DNG 2 mg ( n = 20), or DNG 2 mg ( n = 19). We enrolled 59 healthy, 18- to 35-year-old, non-smoking women, of whom three discontinued. We could compare the specific effects of the different estrogen components owing to the inclusion of preparations containing the same progestin. This study represents secondary outcomes of a randomized trial comparing combined oral contraceptives containing EV + dienogest (DNG), EE + DNG, and DNG alone on selected coagulation biomarkers. However, studies comparing the effects of combined oral contraceptives containing EE and low-potency estrogens (ie, estradiol and estradiol valerate ) on coagulation biomarkers are limited. Contraceptives containing ethinylestradiol (EE) induce changes in the coagulation system and are associated with a risk of venous thromboembolism.
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