Is the multinational, surveillance PRO-E2 study informative for all countries? The Italian data on VTE and contraceptive effectiveness

Abstract

Purpose

To evaluate whether the thromboembolic risk and contraceptive effectiveness of NOMAC-E2 observed in the PRO-E2 study can be extended to each participating country, as lifestyle, cardiovascular risk factors and prescribing habits may differ geographically. This analysis was performed on the PRO-E2 Italian subpopulation, where smoking habit and women over 35 years were more prevalent compared with the overall study population.

Materials and methods

Data from NOMAC-E2 or levonorgestrel-containing COCs (COC_LNG) new users were descriptively analysed. Incidence rates of thrombosis (events/10,000 women-years [WY]) and the Pearl Index (pregnancies/100 WY) were calculated.

Results

Overall, 11,179 NOMAC-E2 and 8,504 COC_LNG users were followed up to 2 years (34,869 WY). The NOMAC-E2 cohort included more women over 35 vs. COC_LNG (37.7% vs. 31.8%; p = 0.001). A comparable low risk of combined deep venous thrombosis of lower extremities (DVT) and pulmonary embolism (PE) was observed in NOMAC-E2 (1.7/10,000 WY; 95% CI: 0.21–6.2) and COC_LNG users (6.6/10,000 WY; 95% CI: 2.4–14.4). Similar results were obtained by considering all thromboembolic events (VTE). Unintended pregnancies did not differ between NOMAC-E2 (0.12/100 WY; 95% CI: 0.06–0.21) and COC_LNG (0.15/100 WY; 95% CI: 0.08–0.26) cohorts.

Conclusion

Despite the higher age and tobacco use, findings from the Italian subpopulation were broadly consistent with overall PRO-E2 results, confirming a similar low thromboembolic risk and high contraceptive effectiveness of NOMAC-E2 and COC_LNG.

Short condensation

This subgroup analysis of the PRO-E2 study provides comprehensive epidemiological data on the use of combined oral contraceptives in a large Italian cohort, with a higher prevalence of women over 35 years and smokers. The study confirms the low thromboembolic risk and high contraceptive effectiveness of NOMAC-E2 pill.

摘要

目的：为了评估在PRO-E2研究中观察到的NOMAC-E2的血栓栓子风险和避孕效果是否可以推广到每个参与国家, 因为生活方式、心血管风险因素和处方习惯可能存在地域差异。本研究是在PRO-E2的意大利亚组人群上进行, 与总体研究人群相比, 意大利人群吸烟和35岁以上的女性更普遍。

材料和方法：描述性分析NOMAC-E2或新应用含左旋诺孕酮的COCS(COC_LNG)者的数据。计算血栓发生率(事件/10,000妇女年[WY])和珀尔指数(怀孕/100WY)。

结果：总体而言, 11,179名NOMAC-E2和8504名COC_LNG应用者获得了长达2年的随访(34,869 WY)。NOMAC-E2队列纳入了更多35岁以上的女性(37.7% vs 31.8%；p=0.001)。NOMAC-E2 (1.7/10,000 WY；95%CI：0.21-6.2)和COC_LNG应用者(6.6/10,000 WY；95%CI：2.4-14.4)合并下肢深静脉血栓形成(DVT)和肺栓塞(PE)的风险相对较低。考虑所有血栓栓塞性事件(VTE)也得到了类似的结果。意外妊娠在NOMAC-E2 (0.12/100WY；95%CI：0.06-0.21)和COC_LNG (0.15/100WY；95%CI：0.08-0.26)队列中没有差异。

结论：尽管年龄更大、烟草者更多, 但来自意大利人群的研究结果与总体PRO-E2结果大体一致, 证实了NOMAC-E2和COC_LNG具有相似的低血栓栓塞率和高避孕效果。

概括

PRO-E2研究的这一亚组分析提供了有关在35岁以上妇女和吸烟者较多的意大利队列中复方口服避孕药的全面流行病学数据。这项研究证实了NOMAC-E2的低血栓栓塞率和高避孕效果。

Keywords:

• NOMAC-E2
• nomegestrol acetate
• oestradiol
• levonorgestrel
• venous thromboembolism
• unintended pregnancy
• Italy

Acknowledgements

The authors would like to thank the Berlin Center for Epidemiology and Health Research (ZEG) whose contribution to the study and the present cohort analyses was invaluable. The authors would also like to acknowledge Eleonora Comi, PhD of PRINEOS S.r.l. for medical writing support.

Disclosure statement

Franca Fruzzetti has served as speaker and advisory board member for Theramex, Gedeon-Richeter, Bayer, Organon, Exeltis, Italfarmaco. Angelo Cagnacci has served as speaker and advisory board member for Theramex, Gedeon-Richetr, Bayer, Organon, Exeltis, Italfarmaco. Mitra Boolell is a full-time employee at Theramex HQ Ltd. Costantino Di Carlo had past financial relationships (lecturer, member of advisory boards and/or consultant) with: Theramex, Bayer, Organon, Gedeon Richter, Shionogi and Exeltis. Vincenzina Bruni has served as speaker and advisory board member for Theramex, Gedeon Richter, Exeltis and Bayer.

Data availability statement

The data supporting the findings of this study cannot be made available as containing proprietary information.