A new progestin-only pill (POP): the impact of drospirenone-only pill 4 mg 24 + 4 on coagulation markers and bleeding patterns

Abstract

Purpose

Progestin-only pills (POPs), compared to combined, are not associated with an increased risk of venous thromboembolism, but are associated with a poor cycle control. The aim of this study was to evaluate the impact of a new POP [4 mg drospirenone (DRSP) for 24 days with a 4-day hormone-free interval] on some coagulation markers (both procoagulant and fibrinolytic) and to describe its impact on bleeding patterns.

Materials and methods

This is a prospective trial, based on serum evaluation of following coagulation markers and tests: Factor (F) X, F VIII, F V, INR, aPTT, Protein S and antithrombin III. A ‘bleeding diary’ was used to categorise women as having (1) unscheduled bleeding, (2) scheduled bleeding and (3) amenorrhoea. Thirty patients were followed for six 28-day intake cycles, with a follow-up at the end of the 3rd and 6th cycles.

Results

There was a significant decrease of F X (p = 0.03) (-5.7% at cycle 6). No significant changes have been observed for F VII, F V and INR. A significant increase in aPTT (p = 0.01 at 3 cycles), Protein S (p = 0.0006 at 3 cycles) and antithrombin III (p < 0.0001 at 3 cycles) was recorded. This non-deteriorating coagulation impact was associated with a significant and progressive reduction of days of scheduled and unscheduled bleeding in users between cycles 4 and 6 (from 1.3 ± 0.2 days at cycle 4 to 0.8 ± 0.1 days at cycle 6 and from 2.6 ± 0.4 days at cycle 4 to 0.6 ± 0.2 days at cycle 6, respectively, p < 0.0001).

Conclusions

DRSP 24 + 4 use was associated with a non-deteriorating effect on coagulation markers and a significant progressive reduction of days of scheduled and unscheduled bleeding.

SHORT CONDENSATION

Contraception with DRSP 24 + 4 was associated with a non-deteriorating effect on coagulation markers and a significant progressive reduction of days of scheduled and unscheduled bleeding.

摘要

目的: 与联合用药相比, 纯孕激素避孕药(POP)与静脉血栓栓塞症的风险增加无关, 但与周期控制不良有关。本研究的目的是评估一种新的POP[4 mg屈螺酮(DRSP)24天, 间歇4天无激素]对某些凝血标志物(促凝和纤溶)的影响, 并描述其对出血模式的影响。

材料和方法: 这是一项前瞻性试验, 基于对凝血因子(F)X、F VIII、F V、INR、aPTT、蛋白S和抗凝血酶III的血清评估。采用“出血日记”将妇女分为(1)非计划性出血、(2)计划性出血和(3)闭经。对30名患者共随访6个28天的摄食周期, 并在第3个和第6个周期结束时进行随访。

结果: FX明显下降(p = 0.03)(第6周期-5.7%)。F-VII、F-V和INR无明显变化。aPTT(第3周期p = 0.01), 蛋白S(第3周期p = 0.0006)和抗凝血酶III(第3周期p < 0.0001)均显著升高。在第4周期和第6周期之间, 这种非恶化的凝血影响与使用者的计划和非计划出血天数显著和渐进地减少有关(分别从周期4的1.3 ± 0.2天减少到周期6的0.8 ± 0.1天和从周期4的2.6 ± 0.4天减少到周期6的0.6 ± 0.2天, p < 0.0001)。这种非恶化的凝血影响与使用者在第4周期至第6周期之间的计划内和计划外出血天数的显著减少(从第4周期的1.3 ± 0.2天到第6周期的0.8 ± 0.1天, 从第4周期的2.6 ± 0.4天到第6周期的0.6 ± 0.2天, p < 0.0001)相关。

结论: DRSP24 + 4的使用与凝血标志物的非恶化效应以及计划内和计划外出血天数的显著减少有关。

Keywords:

• Drospirenone
• progestin-only pill
• coagulation
• bleeding
• contraception
• oral contraceptive

Disclosure statement

G. Grandi received honoraria for sponsored lectures and participation in advisory boards from Bayer AG, Teva/Theramex, Exeltis, Organon, Italfarmaco, Opocrin and Gedeon Richter. The authors have no other relevant affiliations or financial involvement with any organisation or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.