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Safety and efficacy of a 52‐mg levonorgestrel‐releasing intrauterine system in women with cardiovascular disease
Author(s) -
Ueda Yusuke,
Kamiya Chizuko A.,
Horiuchi Chinami,
Miyoshi Takekazu,
Hazama Ryoichi,
Tsuritani Mitsuhiro,
Iwanaga Naoko,
Neki Reiko,
Ikeda Tomoaki,
Yoshimatsu Jun
Publication year - 2019
Publication title -
journal of obstetrics and gynaecology research
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.597
H-Index - 50
eISSN - 1447-0756
pISSN - 1341-8076
DOI - 10.1111/jog.13828
Subject(s) - medicine , levonorgestrel , hemoglobin , white blood cell , anemia , intrauterine device , population , obstetrics , family planning , environmental health , research methodology
Aim We sought to examine the safety and efficacy of a 52‐mg levonorgestrel‐releasing intrauterine system (LNG‐IUS), and to evaluate the changes in biomarkers of infection, anemia and cardiovascular conditions after LNG‐IUS insertion in women with cardiovascular disease. Methods We prospectively followed women with a cardiovascular disease in whom a 52‐mg LNG‐IUS was inserted between 2009 and 2015. The primary outcome was the frequency of cardiovascular and gynecologic side effects due to the LNG‐IUS over the year after LNG‐IUS insertion. The secondary outcomes were the changes in menstrual blood loss and biomarkers, e.g., white blood cell count and the levels of C‐reactive protein, hemoglobin and brain natriuretic peptide. We also evaluated the 24‐month continuation rate of LNG‐IUS. Results A total of 34 women were prospectively followed‐up, including two women with pulmonary hypertension. No cardiovascular side effects were identified during the 1 year after LNG‐IUS insertion, other than one case of mild vasovagal reaction at insertion. Neither the white blood cell count nor the C‐reactive protein value increased after LNG‐IUS insertion. The menstrual blood loss was decreased in most subjects and the median hemoglobin levels increased significantly within 1 year after insertion ( P < 0.001 and P = 0.002). Moreover, brain natriuretic peptide levels tended to decrease in correspondence with the hemoglobin elevation ( P = 0.074). The 24‐month LNG‐IUS continuation rate was 97% (95% confidence interval 85–100). Conclusion No clinically significant cardiovascular event was identified during the 1 year after 52‐mg LNG‐IUS insertion among women with cardiovascular disease. The 52‐mg LNG‐IUS may have specific favorable effects by decreasing the risk of iron deficiency anemia in these women.