Reducing the risk of venous thromboembolism using apixaban – patient perspectives and considerations. Should more attention be given to females?

Figures & data

Figure 1 Extrapolated events/subjects rate of AEs in the eleven considered RCTs with apixaban.

Abbreviations: AEs, adverse events; RCTs, randomized controlled trials.

Table 1 Type of AEs in studies in which subjects were treated with apixaban

Author	Journal, year	Selection criteria	Total patients	Total serious adverse events	n
Agnelli et al^Citation14	N Engl J Med, 2013	DVT or PE	2,676	All AEs	1,795
				Serious AEs	417
				Bleeding AEs	415
				Discontinuations due to AEs	162
Agnelli et al^Citation15	N Engl J Med, 2013	DVT	1,651	All AEs	1,138
				Serious AEs	219
				Discontinuations due to AEs	128
Goldhaber et al^Citation16	N Engl J Med, 2011	DVT	3,184	Bleeding AEs	246
Lassen et al^Citation17	N Engl J Med, 2009	Postoperative DVT	1,596	All AEs	135
				Serious AEs	–
				Bleeding AEs	85
Lassen et al^Citation18	N Engl J Med, 2010	Postoperative DVT	2,673	All AEs	1,752
				Serious AEs	184
				Bleeding AEs	268
				Discontinuations due to AEs	91
Levine et al^Citation19	J Thromb Haemost, 2012	VTE in cancer patients	93	All AEs	8
				Bleeding AEs	6
Lassen et al^Citation20	J Thromb Haemost, 2007	Postoperative DVT	917	All AEs	797
				Serious AEs	80
				Bleeding AEs	62
				Discontinuations due to AEs	108
Botticelli Investigators et al^Citation21	J Thromb Haemost, 2008	Symptomatic DVT	392	Bleeding AEs	6
				Discontinuations due to AEs	50
Lassen et al^Citation22	Lancet, 2010	Postoperative DVT	1,501	All AEs	786
				Serious AEs	72
				Bleeding AEs	90
				Discontinuations due to AEs	40
				Drug-related AEs	207
				Drug-related serious AEs	16
Nakamura et al^Citation23	Circ J, 2015	DVT	37	All AEs	34
				Serious AEs	3
				Bleeding AEs	7
				Discontinuations due to AEs	0
Barrett et al^Citation24	Thromb Haemost, 2011	DVT	385	Bleeding AEs	44

Abbreviations: AEs, adverse events; DVT, deep vein thrombosis; PE, pulmonary embolism; –, data not given.

Figure 2 Number of patients, AEs, and percentages of AEs comparing apixaban and conventional therapy.

Abbreviations: AEs, adverse events; VTE, venous thromboembolism.

Table 2 AEs in different studies comparing apixaban and conventional therapy

Author	Journal, year	Selection criteria	Total apixaban patients, n	AEs in patients treated with apixaban, n	Total patients in conventional therapy, n	AEs in patients treated with conventional therapy, n
Agnelli et al^Citation14	N Engl J Med, 2013	DVT or PE	2,676	1,795	2,689	1,923
Lassen et al^Citation17	N Engl J Med, 2009	Postoperative DVT	1,596	135	1,588	136
Lassen et al^Citation18	N Engl J Med, 2010	Postoperative DVT	2,673	1,752	2,659	1,811
Lassen et al^Citation20	J Thromb Haemost, 2007	Postoperative DVT	917	797	300	263
Botticelli Investigators et al^Citation21	J Thromb Haemost, 2008	Symptomatic DVT	392	50	128	10
Lassen et al^Citation22	Lancet, 2010	Postoperative DVT	1,501	786	1,508	836
Nakamura et al^Citation23	Circ J, 2015	DVT	40	34	39	37
Barrett et al^Citation24	Thromb Haemost, 2011	DVT	385	44	126	20

Abbreviations: AEs, adverse events; DVT, deep vein thrombosis; PE, pulmonary embolism.

Table 3 Evaluation by sex in the studies comparing apixaban and conventional therapy

Author (journal, year)	Distribution by sex	Apixaban	Anticoagulant	Efficacy by sex	Safety by sex
		No of events/no of patients	No of events/no of patients
Agnelli et al^Citation14 (N Engl J Med, 2013)	Apixaban: M 58.3%	M 9/1,561	M 24/1,591	Apixaban better	Apixaban better
	Eno/War: M 59.1%	F 6/1,115	F 25/1,098	No sex difference	No sex difference
Lassen et al^Citation17 (N Engl J Med, 2009)	Apixaban: F 62.4%	Major 11/1,596	Major 22/1,588	Not given	Not given
	Eno: F 61.8%	Nonmajor 35/1,596	Nonmajor 47/1,588
Lassen et al^Citation18 (N Engl J Med, 2010)	Apixaban: F 52.8%	Major 22/2,673	Major 18/2,659	Not given	Not given
	Eno: F 53.8%	Nonmajor 109/2,673	Nonmajor 120/2,659
Lassen et al^Citation20 (J Thromb Haemost, 2007)	Total: F 63.3%	Major 0%–3.2%	Major: Eno 0%, War 0%	Not given	Not given
	Apixaban	Minor 7.2%	Minor: Eno 4.0%, War 5.3%
	Eno
	Warfarin
Botticelli Investigators et al^Citation21 (J Thromb Haemost, 2008)	Total: M 62%	Major and CRNM 28/392	Major and CRNM 10/128	Not given	Not given
	Apixaban	Minor 19/382	Minor 10/128
	LMWH/VKAs
Lassen et al^Citation22 (Lancet, 2010)	Apixaban: F 71%	Major and CRNM 53/1,501	Major and CRNM 72/1,508	Not given	Not given
	Eno: F 74%	Minor 51/1,501	Minor 54/1,508
Nakamura et al^Citation23 (Circ J, 2015)	Apixaban: F 45%	All bleeds 7/40	All bleeds 17/39	Not given	Not given
	UFH/War: F 57.5%

Abbreviations: M, male; Eno, enoxaparin; War, warfarin; F, female; LMWH, low-molecular weight heparin; VKAs, vitamin K antagonists; CRNM, clinically relevant nonmajor; UFH, unfractionated heparin.

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