Abnormal vaginal bleeding in women of reproductive age treated with edoxaban or warfarin for venous thromboembolism: a post hoc analysis of the Hokusai-VTE study

Ljj Scheres; Mpa Brekelmans; W Ageno; C Ay; H R Büller; S Eichinger; B A Hutten; F A Klok; S Middeldorp; K Schreiber; K Stach; M Blondon; A Delluc

doi:10.1111/1471-0528.15388

Abnormal vaginal bleeding in women of reproductive age treated with edoxaban or warfarin for venous thromboembolism: a post hoc analysis of the Hokusai-VTE study

Ljj Scheres, Mpa Brekelmans, W Ageno, C Ay, H R Büller, S Eichinger, B A Hutten, F A Klok, S Middeldorp, K Schreiber, K Stach, M Blondon, A Delluc

Department for Rheumatology and Spine Diseases

44 Citations (Scopus)

Abstract

OBJECTIVE: To investigate the characteristics and outcome of abnormal vaginal bleeding in women receiving edoxaban or warfarin for treatment of venous thromboembolism (VTE).

DESIGN AND SETTING: Post hoc analysis of the Hokusai-VTE study, a multicentre, randomised, double-blind trial comparing edoxaban with warfarin for acute symptomatic VTE.

POPULATION: Women below 50 years receiving edoxaban or warfarin for treatment of VTE.

METHODS: We collected data on diagnostic measures, treatment, and clinical outcome of abnormal vaginal bleeding events.

MAIN OUTCOME MEASURES: Occurrence of major and clinically relevant nonmajor (CRNM) abnormal vaginal bleeding events.

RESULTS: In all, 628 women aged under 50 years were treated with edoxaban and 665 with warfarin. The rate of abnormal vaginal bleeding was 15/100 person-years (py) (95% CI 11-19) in women receiving edoxaban and 9/100 py (95% CI 6-12) in the warfarin group (hazard ratio: 1.7, 95% CI 1.1-2.5). Major abnormal vaginal bleeding occurred in eight (1.3%) women on edoxaban and in three (0.9%) women receiving warfarin [odds ratio (OR) 2.8; 95% CI 0.8-10.8], and CRNM abnormal vaginal bleeding occurred in 53 (8.4%) women treated with edoxaban and in 37 (5.6%) on warfarin therapy (OR 1.6, 95% CI 1.0-2.4). Over 85% of all vaginal bleeds were characterised by heavy menstrual bleeding. Major bleeds frequently required treatment, and in more than 75% of patients anticoagulant therapy was adjusted. The severity of clinical presentation and course of major and CRNM bleeds was mild in most patients.

CONCLUSIONS: Abnormal vaginal bleeding occurred more frequently in women treated with edoxaban than with warfarin. Reassuringly, most events could be managed conservatively and had a mild outcome.

TWEETABLE ABSTRACT: Abnormal vaginal bleeding occurred more frequently in women treated with edoxaban than with warfarin.

Original language	English
Journal	BJOG : an international journal of obstetrics and gynaecology
Volume	125
Issue number	12
Pages (from-to)	1581-1589
Number of pages	9
ISSN	1470-0328
DOIs	https://doi.org/10.1111/1471-0528.15388
Publication status	Published - Nov 2018

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10.1111/1471-0528.15388

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Scheres, L., Brekelmans, M., Ageno, W., Ay, C., Büller, H. R., Eichinger, S., Hutten, B. A., Klok, F. A., Middeldorp, S., Schreiber, K., Stach, K., Blondon, M., & Delluc, A. (2018). Abnormal vaginal bleeding in women of reproductive age treated with edoxaban or warfarin for venous thromboembolism: a post hoc analysis of the Hokusai-VTE study. BJOG : an international journal of obstetrics and gynaecology, 125(12), 1581-1589. https://doi.org/10.1111/1471-0528.15388

Abnormal vaginal bleeding in women of reproductive age treated with edoxaban or warfarin for venous thromboembolism: a post hoc analysis of the Hokusai-VTE study. / Scheres, Ljj; Brekelmans, Mpa; Ageno, W et al.
In: BJOG : an international journal of obstetrics and gynaecology, Vol. 125, No. 12, 11.2018, p. 1581-1589.

Research output: Contribution to journal › Journal article › Research › peer-review

Scheres, L, Brekelmans, M, Ageno, W, Ay, C, Büller, HR, Eichinger, S, Hutten, BA, Klok, FA, Middeldorp, S, Schreiber, K, Stach, K, Blondon, M & Delluc, A 2018, 'Abnormal vaginal bleeding in women of reproductive age treated with edoxaban or warfarin for venous thromboembolism: a post hoc analysis of the Hokusai-VTE study', BJOG : an international journal of obstetrics and gynaecology, vol. 125, no. 12, pp. 1581-1589. https://doi.org/10.1111/1471-0528.15388

@article{954cbc19f86540bba74a961d6000b04d,

title = "Abnormal vaginal bleeding in women of reproductive age treated with edoxaban or warfarin for venous thromboembolism: a post hoc analysis of the Hokusai-VTE study",

abstract = "OBJECTIVE: To investigate the characteristics and outcome of abnormal vaginal bleeding in women receiving edoxaban or warfarin for treatment of venous thromboembolism (VTE).DESIGN AND SETTING: Post hoc analysis of the Hokusai-VTE study, a multicentre, randomised, double-blind trial comparing edoxaban with warfarin for acute symptomatic VTE.POPULATION: Women below 50 years receiving edoxaban or warfarin for treatment of VTE.METHODS: We collected data on diagnostic measures, treatment, and clinical outcome of abnormal vaginal bleeding events.MAIN OUTCOME MEASURES: Occurrence of major and clinically relevant nonmajor (CRNM) abnormal vaginal bleeding events.RESULTS: In all, 628 women aged under 50 years were treated with edoxaban and 665 with warfarin. The rate of abnormal vaginal bleeding was 15/100 person-years (py) (95\% CI 11-19) in women receiving edoxaban and 9/100 py (95\% CI 6-12) in the warfarin group (hazard ratio: 1.7, 95\% CI 1.1-2.5). Major abnormal vaginal bleeding occurred in eight (1.3\%) women on edoxaban and in three (0.9\%) women receiving warfarin [odds ratio (OR) 2.8; 95\% CI 0.8-10.8], and CRNM abnormal vaginal bleeding occurred in 53 (8.4\%) women treated with edoxaban and in 37 (5.6\%) on warfarin therapy (OR 1.6, 95\% CI 1.0-2.4). Over 85\% of all vaginal bleeds were characterised by heavy menstrual bleeding. Major bleeds frequently required treatment, and in more than 75\% of patients anticoagulant therapy was adjusted. The severity of clinical presentation and course of major and CRNM bleeds was mild in most patients.CONCLUSIONS: Abnormal vaginal bleeding occurred more frequently in women treated with edoxaban than with warfarin. Reassuringly, most events could be managed conservatively and had a mild outcome.TWEETABLE ABSTRACT: Abnormal vaginal bleeding occurred more frequently in women treated with edoxaban than with warfarin.",

author = "Ljj Scheres and Mpa Brekelmans and W Ageno and C Ay and B{\"u}ller, \{H R\} and S Eichinger and Hutten, \{B A\} and Klok, \{F A\} and S Middeldorp and K Schreiber and K Stach and M Blondon and A Delluc",

note = "{\textcopyright} 2018 The Authors. BJOG: An International Journal of Obstetrics and Gynaecology published by John Wiley \& Sons Ltd on behalf of Royal College of Obstetricians and Gynaecologists.",

year = "2018",

month = nov,

doi = "10.1111/1471-0528.15388",

language = "English",

volume = "125",

pages = "1581--1589",

journal = "BJOG : an international journal of obstetrics and gynaecology",

issn = "1470-0328",

publisher = "John Wiley and Sons Inc.",

number = "12",

}

TY - JOUR

T1 - Abnormal vaginal bleeding in women of reproductive age treated with edoxaban or warfarin for venous thromboembolism

T2 - a post hoc analysis of the Hokusai-VTE study

AU - Scheres, Ljj

AU - Brekelmans, Mpa

AU - Ageno, W

AU - Ay, C

AU - Büller, H R

AU - Eichinger, S

AU - Hutten, B A

AU - Klok, F A

AU - Middeldorp, S

AU - Schreiber, K

AU - Stach, K

AU - Blondon, M

AU - Delluc, A

PY - 2018/11

Y1 - 2018/11

N2 - OBJECTIVE: To investigate the characteristics and outcome of abnormal vaginal bleeding in women receiving edoxaban or warfarin for treatment of venous thromboembolism (VTE).DESIGN AND SETTING: Post hoc analysis of the Hokusai-VTE study, a multicentre, randomised, double-blind trial comparing edoxaban with warfarin for acute symptomatic VTE.POPULATION: Women below 50 years receiving edoxaban or warfarin for treatment of VTE.METHODS: We collected data on diagnostic measures, treatment, and clinical outcome of abnormal vaginal bleeding events.MAIN OUTCOME MEASURES: Occurrence of major and clinically relevant nonmajor (CRNM) abnormal vaginal bleeding events.RESULTS: In all, 628 women aged under 50 years were treated with edoxaban and 665 with warfarin. The rate of abnormal vaginal bleeding was 15/100 person-years (py) (95% CI 11-19) in women receiving edoxaban and 9/100 py (95% CI 6-12) in the warfarin group (hazard ratio: 1.7, 95% CI 1.1-2.5). Major abnormal vaginal bleeding occurred in eight (1.3%) women on edoxaban and in three (0.9%) women receiving warfarin [odds ratio (OR) 2.8; 95% CI 0.8-10.8], and CRNM abnormal vaginal bleeding occurred in 53 (8.4%) women treated with edoxaban and in 37 (5.6%) on warfarin therapy (OR 1.6, 95% CI 1.0-2.4). Over 85% of all vaginal bleeds were characterised by heavy menstrual bleeding. Major bleeds frequently required treatment, and in more than 75% of patients anticoagulant therapy was adjusted. The severity of clinical presentation and course of major and CRNM bleeds was mild in most patients.CONCLUSIONS: Abnormal vaginal bleeding occurred more frequently in women treated with edoxaban than with warfarin. Reassuringly, most events could be managed conservatively and had a mild outcome.TWEETABLE ABSTRACT: Abnormal vaginal bleeding occurred more frequently in women treated with edoxaban than with warfarin.

AB - OBJECTIVE: To investigate the characteristics and outcome of abnormal vaginal bleeding in women receiving edoxaban or warfarin for treatment of venous thromboembolism (VTE).DESIGN AND SETTING: Post hoc analysis of the Hokusai-VTE study, a multicentre, randomised, double-blind trial comparing edoxaban with warfarin for acute symptomatic VTE.POPULATION: Women below 50 years receiving edoxaban or warfarin for treatment of VTE.METHODS: We collected data on diagnostic measures, treatment, and clinical outcome of abnormal vaginal bleeding events.MAIN OUTCOME MEASURES: Occurrence of major and clinically relevant nonmajor (CRNM) abnormal vaginal bleeding events.RESULTS: In all, 628 women aged under 50 years were treated with edoxaban and 665 with warfarin. The rate of abnormal vaginal bleeding was 15/100 person-years (py) (95% CI 11-19) in women receiving edoxaban and 9/100 py (95% CI 6-12) in the warfarin group (hazard ratio: 1.7, 95% CI 1.1-2.5). Major abnormal vaginal bleeding occurred in eight (1.3%) women on edoxaban and in three (0.9%) women receiving warfarin [odds ratio (OR) 2.8; 95% CI 0.8-10.8], and CRNM abnormal vaginal bleeding occurred in 53 (8.4%) women treated with edoxaban and in 37 (5.6%) on warfarin therapy (OR 1.6, 95% CI 1.0-2.4). Over 85% of all vaginal bleeds were characterised by heavy menstrual bleeding. Major bleeds frequently required treatment, and in more than 75% of patients anticoagulant therapy was adjusted. The severity of clinical presentation and course of major and CRNM bleeds was mild in most patients.CONCLUSIONS: Abnormal vaginal bleeding occurred more frequently in women treated with edoxaban than with warfarin. Reassuringly, most events could be managed conservatively and had a mild outcome.TWEETABLE ABSTRACT: Abnormal vaginal bleeding occurred more frequently in women treated with edoxaban than with warfarin.

UR - https://www.scopus.com/pages/publications/85050619942

U2 - 10.1111/1471-0528.15388

DO - 10.1111/1471-0528.15388

M3 - Journal article

C2 - 29940089

SN - 1470-0328

VL - 125

SP - 1581

EP - 1589

JO - BJOG : an international journal of obstetrics and gynaecology

JF - BJOG : an international journal of obstetrics and gynaecology

IS - 12

ER -

Abnormal vaginal bleeding in women of reproductive age treated with edoxaban or warfarin for venous thromboembolism: a post hoc analysis of the Hokusai-VTE study

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