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This information is intended for US healthcare professionals to access current scientific information about J&J Innovative Medicine products. It is prepared by Medical Information and is not intended for promotional purposes, nor to provide medical advice.

XARELTO® (rivaroxaban)

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Real-World Evidence of XARELTO: Effects of Body Weight

Last Updated: 09/11/2024

Summary

Large, randomized, controlled trials that specifically investigated the efficacy and safety of XARELTO in obese patients have not been conducted.
The use of XARELTO is not contraindicated in patients with extremes in body weight.¹
There are no specific dosing recommendations based on body weight in the XARELTO prescribing information.¹
Real-world evidence available has been summarized within following tables:
Additional data pertaining to the use of XARELTO in patients with Class III obesity (BMI ≥40 kg/m²) can be found here: XARELTO- Class III obesity
Additional citations are included in the REFERENCES section for your review.²^-¹²

Real-World Evidence

Effectiveness and Safety of XARELTO vs Warfarin

Study Objective	Patients	Outcomes
Berger et al (2022)¹³ Retrospective, weighted-cohort study. Patient source Health insurance claims data from the IQVIA PharMetrics^® Plus database from November 02, 2011, to September 30, 2019 Study groups XARELTO (N=8666) Warfarin (N=5946)	Inclusion criteria Age ≥18 years Obesity/BMI ≥30 kg/m² Continuous health insurance enrollment of ≥12 months Patients with VTE Key demographics In the weighted XARELTO and warfarin cohorts, respectively, Mean age was 51.1 years and 51.3 years 51.8% and 51.6% were women 41.1% and 41.9% had morbid obesity (BMI ≥40 kg/m²)	Effectiveness outcome^a Recurrent VTE (hospitalization with a primary diagnosis of VTE): 7.0% in the XARELTO cohort (N=5045) and 8.2% in the warfarin cohort (N=3391; HR, 0.85; 95% CI, 0.75-0.97; P=0.015) at 12 months in the ITT population. The mean observation period was 9.6 months in the XARELTO cohort and 9.7 months in the warfarin cohort. Safety outcome^a,b Major bleeding: 4.1% in the XARELTO cohort (N=1808) and 3.6% in the warfarin cohort (N=1221; HR, 1.11; 95% CI, 0.891.37; P=0.354) at 12 months in the on-treatment population. The mean on-treatment period was 6.1 months for the XARELTO and warfarin cohorts.
Berger et al (2021)¹⁴ Retrospective, observational, weighted-cohort study Patient source Health insurance claims data from the IQVIA PharMetrics^® Plus database from January 2010 to September 2019 Study groups XARELTO (N=10,555) Warfarin (N=5080)	Inclusion criteria Age ≥18 years Obesity/BMI ≥30 kg/m² Continuous health insurance enrollment of ≥12 months Patients with NVAF Key demographics In the weighted XARELTO and warfarin cohorts, respectively, Mean age was 59.3 years and 59.4 years 31.0% and 31.9% were women 37.7% and 39.0% had morbid obesity (BMI ≥40 kg/m²) Mean CHA₂DS₂-VASc score was 2.65 and 2.70	Primary effectiveness outcome^a: Over the 36 month follow up, XARELTO compared to warfarin showed a 26% lower risk of stroke/SE (HR, 0.74; 95% CI, 0.60-0.91; P=0.004). In morbidly obese patients, the risk of stroke/SE was significantly lower in patients treated with XARELTO compared to warfarin (HR, 0.66; 95% CI, 0.48-0.91; P=0.011). Primary safety outcome^b The risk of major bleeding (safety outcome) was similar between XARELTO and warfarin (HR, 0.85; 95% CI, 0.71-1.02; P=0.085) up to 36 months of follow-up. In morbidly obese patients, the risk of major bleeding was significantly lower in patients treated with XARELTO compared with those treated with warfarin (HR, 0.72; 95% CI, 0.55-0.95; P=0.020).
Perales et al (2020)¹⁵ Retrospective cohort study Patient source 2 academic medical centers from November 1, 2013, to September 30, 2017 Study groups XARELTO (N=84) Warfarin (N=92)	Inclusion criteria Age ≥18 years BMI >40 kg/m² or weight >120 kg Initiated on warfarin or XARELTO for AF or VTE while admitted to the hospital Key demographics In the XARELTO and warfarin groups, respectively, Mean age was 56 years and 55 years 48.0% and 45.0% were women Median (IQR) BMI was 45 (41-51) kg/m² and 44 (41-50) kg/m²	Primary outcome The incidence of clinical failure^c was not statistically significant with XARELTO compared with warfarin (5% vs 13%, respectively; P=0.06). Additionally, there were no reports of stroke and mortality within 12 months. Other outcomes Patients on XARELTO had a significantly shorter hospital stay compared with those on warfarin (median [IQR]: 2 [1-3] days vs 4 [2-7] days; P<0.01). XARELTO was associated with a higher incidence of bleeding^d complications compared with warfarin (8% vs 2%; P=0.06).
Costa et al (2021)¹⁶ Retrospective cohort study Patient source US Optum^® De-identified EHRs from November 1, 2011, to September 30, 2018 Study groups XARELTO (N=6755) Warfarin (N=6755)	Inclusion criteria Patients with a BMI ≥30 kg/m²who received XARELTO or warfarin as their first OAC within 7 days after an acute VTE (index date) and had ≥12 months of EHR activity prior to the index date and received treatment from at least 1 provider in the last 12 months Key demographics Median age was 55 years overall 22% had a PE±DVT In the XARELTO and warfarin groups, respectively, 53.7% and 54.7% were women 25.4% and 27.1% had a BMI ≥40 kg/m²	Primary effectiveness outcome^a: XARELTO was associated with a reduced risk of recurrent VTE compared to warfarin. At 3 months: HR 0.61, 95% CI 0.51-0.72 At 6 months: HR 0.65, 95% CI 0.55-0.77 At 12 months: HR 0.63, 95% CI 0.54-0.74 Primary safety outcome^b: No significant difference in major bleeding was found between XARELTO and warfarin. At 3 months: HR 0.99, 95% CI 0.68-1.44 At 6 months: HR 0.90, 95% CI 0.64-1.26 At 12 months: HR 1.00, 95% CI 0.73-1.36
Costa et al (2020)¹⁷ Retrospective cohort study Patient source US Optum^® De-identified EHRs from November 1, 2010, to September 30, 2018 Study groups XARELTO (N=35,613) Warfarin (N=35,613)	Inclusion criteria Patients with NVAF with a BMI ≥30 kg/m²who had ≥12 months of EHR activity prior to the index date and received treatment from at least 1 provider in the last 12 months Key demographics In the XARELTO and warfarin groups, respectively, Median age was 67 years and 69 years 39.5% and 40.2% were women 25.2% and 25.4% had BMI ≥40 kg/m²	Primary effectiveness outcome^a: XARELTO was associated with a reduced incidence of stroke/SE compared to warfarin (1.20% vs 1.88%; HR, 0.83; 95% CI, 0.73-0.94) Primary safety outcome^b: XARELTO was associated with a reduced incidence of major bleeding compared to warfarin (2.46% vs 3.88%; HR, 0.82; 95% CI, 0.75-0.89).
Peterson et al (2019)¹⁸ Retrospective cohort study Patient source Two US healthcare claims databases, Truven MarketScan Commercial Claims and Encounters and Medicare Supplemental, from December 1, 2010, to December 31, 2016 Study groups After propensity score matching, XARELTO (N=3563) Warfarin (N=3563)	Inclusion criteria Patients initiated on XARELTO or warfarin who had ≥1 medical claim with an AF diagnosis, a diagnostic code for morbid obesity (BMI ≥40 kg/m²or body weight >120 kg), and ≥12 months of continuous enrollment before and 3 months after treatment initiation Key demographics In the XARELTO and warfarin groups, respectively, Mean age was 62.97 years and 62.89 years 46.1% and 46.0% were women	Primary and secondary outcomes^a XARELTO-treated patients and warfarin-treated patients had similar risks of ischemic stroke/SE (1.5% vs 1.7%, respectively; OR, 0.88; 95% CI, 0.60-1.28; P=0.5028) and major bleeding^b (2.2% vs 2.7%, respectively; OR, 0.80; 95% CI, 0.59-1.08; P=0.1447). The number of ischemic stroke/SE events (PPPY) was similar between the groups (XARELTO, 0.001; warfarin, 0.002; P=0.3592). Mean time to first composite ischemic stroke/SE event was 111.9 days vs 125.9 days with XARELTO vs warfarin, respectively (P=0.5690). The number of major bleeding^b events (PPPY) was the same for both groups (0.03; P=0.2570). Mean time to first major bleeding event was 128.0 days vs 147.6 days with XARELTO vs warfarin, respectively (P=0.1878).
Spyropoulos et al (2019)¹⁹ Retrospective cohort study Patient source Combined Truven MarketScan Commercial Claims and Encounters and Medicare Supplemental claims databases from December 1, 2011 to December 31, 2016 Study groups After propensity score matching, XARELTO (N=2890) Warfarin (N=2890)	Inclusion criteria Patients who initiated treatment with either XARELTO or warfarin, based on ≥1 pharmacy claim within 28 days of the VTE diagnosis index date. Due to a lack of BMI data in claims databases, ≥1 diagnosis of morbid obesity was required during the 12-month baseline period through 3 months after the drug index date. Key demographics In the XARELTO and warfarin groups, respectively, Mean age was 53.3 years and 53.1 years 60.5% and 60.2% were women	Primary outcome^a The risk of recurrent VTE^e was similar among XARELTO- and warfarin-treated patients in the ITT analysis (16.8% vs 15.9%, respectively; OR, 0.99; 95% CI, 0.85-1.14; P=0.8443). Secondary outcome^a,b The risk of major bleeding was numerically lower in the XARELTO cohort vs the warfarin cohort in the on-treatment analysis but did not reach statistical significance (1.4% vs 1.8%, respectively; OR, 0.75; 95% CI, 0.47-1.19; P=0.2266).
Abbreviations: AF, atrial fibrillation; BMI, body mass index; CHA₂DS₂-VASc, congestive heart failure, hypertension, age ≥75 (doubled), diabetes, stroke (doubled), vascular disease, age 65 to 74, and sex category (female); CI, confidence interval; DVT, deep vein thrombosis; EHR, electronic health record; HR, hazard ratio; IQR, interquartile range; ISTH, International Society on Thrombosis and Haemostasis; ITT, intent-to-treat; MB, major bleeding; NVAF, nonvalvular atrial fibrillation; OAC, oral anticoagulant; OR, odds ratio; PE, pulmonary embolism; PPPY, per patient per year; SD, standard deviation; SE, systemic embolism; US, United States; VTE, venous thromboembolism.^aResults were adjusted to try to control for potential confounding factors.^bMajor bleeding was defined using a validated claims-based algorithm by Cunningham et al.^cClinical failure during anticoagulation therapy, defined as VTE recurrence, stroke incidence, or mortality within the first 12 months of therapy initiation.^dMajor bleeding was defined according to the ISTH criteria.^eThe primary outcome compared between the treatment cohorts was the risk of recurrent VTE, defined as a hospitalization (inpatient service) or emergency room visit with a primary diagnosis of VTE during the follow-up period.

Effectiveness and Safety of XARELTO vs Apixaban

Study Objective	Patients	Outcomes
Burnham et al (2023)²⁰ Retrospective chart review Patient source Patients were included from an outpatient cardiovascular clinic from October 2014 to January 2021 Study groups XARELTO (N=121) Apixaban (N=212)	Inclusion criteria Age ≥18 years Diagnosis of NVAF Prescription of XARELTO or apixaban for ≥3 months BMI ≥30 kg/m² Key demographics In the XARELTO and apixaban cohorts, respectively, Mean age was 69.5 years and 71.4 years 54.5% and 58.5% were men Mean BMI was 38.3 kg/m² and 37.2 kg/m² 26.4% and 28.8% were morbidly obese (BMI ≥40 kg/m²)		XARELTO, n (%)	Apixaban, n (%)	P-Value
		Primary effectiveness outcome: composite of arterial thrombus, MI, stroke, TIA	2 (1.7)	8 (3.8)	0.28
		Primary safety outcome: composite of CRNMB and major bleeding^a	2 (1.7)	6 (2.8)	0.50
Abbreviations: BMI, body mass index; CRNMB, clinically relevant non-major bleeding; ISTH, International Society on Thrombosis and Haemostasis; MI, myocardial infarction; NVAF, nonvalvular atrial fibrillation; TIA, transient ischemic attack.^aCRNMB and Major bleeding were defined according to the ISTH criteria.

Effectiveness and Safety in Obese Special Populations

Study Objective	Patients	Outcomes
Morbid Obesity
Weaver et al (2022)²¹ conducted a retrospective cohort study to evaluate the effectiveness and safety of XARELTO vs warfarin in patients with morbid obesity. Patient source Patients admitted to one of the Ascension Health Systems between January 1, 2012 and December 31, 2019 Study groups XARELTO (N=487) Warfarin (N=785)	Inclusion criteria Age >18 years Diagnosis of VTE BMI ≥40 kg/m²or weight >120 kg Key demographics In the XARELTO and warfarin cohorts, respectively, Mean age was 56.6 years and 57.7 years 47.9% and 56.3% were women Mean weight was 134.1 kg and 139.2 kg Mean BMI was 44.8 kg/m²and 47.1 kg/m²	Primary effectiveness outcome^a The use of XARELTO was not associated with an increased hazard of VTE events compared with warfarin (HR, 0.69; 95% CI, 0.42-1.08; P=0.12). Primary safety outcome^a There were no significant differences in major bleeding^b events with XARELTO and warfarin (HR, 1.21; 95% CI, 0.62-2.34; P=0.58). No differences were found in all-cause mortality and switch in anticoagulation therapy during 12 months between the XARELTO and warfarin groups.
Dobry et al (2024)²² conducted a retrospective cohort study to evaluate the effectiveness and safety of Factor Xa inhibitors vs warfarin in patients with morbid obesity. Patient source Patients admitted to one of the Ascension Health Systems between January 2, 2012 and December 31, 2019 Study groups Factor Xa inhibitor (N=1760 [apixaban, 1086; XARELTO, 674]) Warfarin (N=1396) Total N=3156. Only XARELTO vs warfarin outcomes are reported (N=2070) A prespecified subgroup analysis was performed in patients with a BMI >50 kg/m²and/or weight >140 kg XARELTO (N=558) Warfarin (N=491) (No patients in the apixaban group had a BMI >50 kg/m²).	Inclusion criteria Age ≥18 years BMI ≥40 kg/m²and/or weight>120 kg Diagnosis of NVAF and discharged on warfarin or Factor Xa inhibitors Key demographics In the Factor Xa inhibitor and warfarin cohorts, respectively, Mean age was 65.2 years and 65.8 years 41.9% and 46.8% were men Mean weight was 133.2 kg and 135.3 kg Mean BMI was 44.1 kg/m²and 45.4 kg/m² Subgroup analysis Average BMI was 51.8 kg/m² Average weight was 161.1 kg	Primary outcome^a Stroke or SE (XARELTO vs warfarin): OR, 0.93; 95% CI, 0.51-1.69; P=0.82 Major bleeding^b (XARELTO vs warfarin): OR, 1.22; 95% CI, 0.73-2.05; P=0.44 Secondary outcome^a CRNMB^d (XARELTO vs warfarin): OR, 1.31; 95% CI, 0.74-2.31; P=0.35 Subgroup analysis outcome XARELTO vs warfarin Stroke or SE (2.5% vs 3.3%; P=0.47) Major bleeding^b (2.2% vs 3.7%; P=0.14) CRNMB^d (2.3% vs 3.3%; P=0.36)
Obesity and Diabetes
Weir et al (2021)²³ conducted a retrospective cohort study to evaluate the effectiveness and safety of XARELTO vs warfarin in patients with both obesity and diabetes. Patient source Claims from Optum’s de-identified Clinformatics Data Mart Database between December 1, 2011, and March 2020 Study groups After propensity score matching, XARELTO (N=9999) Warfarin (N=9999)	Inclusion criteria Age ≥18 years Diagnosis of NVAF and diabetes Obesity or BMI ≥30 kg/m² Key demographics In the XARELTO and warfarin cohorts, respectively, Mean age was 70.0 years and 70.2 years 41.2% and 42.0% were women 43.8% and 42.6% had BMI ≥40 kg/m²	Primary effectiveness outcome^a The composite risk of stroke/SE was significantly lower in the XARELTO cohort (7.2%) compared with the warfarin cohort (9.1%). Patients who received XARELTO had an 18% reduction in the composite risk of stroke or SE compared with those who received warfarin (HR, 0.82; 95% CI, 0.74-0.90) in the ITT analysis. Primary safety outcome^a The risk of major bleeding^c was not significantly different between the XARELTO and warfarin cohorts (HR, 0.92; 95% CI, 0.78-1.09).
Obesity and Concomitant AF/Atrial flutter and HF
Chugh et al (2023)²⁴ conducted a retrospective observational study to evaluate the effectiveness and safety of apixaban, dabigatran, and XARELTO in patients with obesity and concomitant AF/atrial flutter and HF. Patient source Records of all inpatients hospitalized at Montefiore Medical Center from January 1, 2011 to September 1, 2015 Study groups Obese (BMI ≥30and <40 kg/m²) XARELTO (N=238) Apixaban (N=101) Dabigatran (N=275) Morbidly obese (BMI ≥40 kg/m²) XARELTO (N=97) Apixaban (N=54) Dabigatran (N=118)	Inclusion criteria Age ≥18 years Diagnosis of NVAF and/or atrial flutter and concurrent HF BMI ≥30 kg/m² Taking apixaban, dabigatran, XARELTO Key demographics In the XARELTO, apixaban, and dabigatran obese groups, respectively, Median age was 70, 78.4, and 71 years 53.4%, 52.5%, and 51.3% were men Median BMI was 33.4, 33.7, and 33.4 kg/m² In the XARELTO, apixaban, and dabigatran morbidly obese groups, respectively, Median age was 62, 67.4, and 65.5 years 46.4%, 40.7%, and 37.3% were men Median BMI was 45.7, 46.1, and 45.3 kg/m²	Obese (BMI ≥30and <40 kg/m²) First inpatient admission for ischemic stroke or SE^a: Apixaban vs XARELTO: HR, 2.2; 95% CI, 0.6-8.2; P=0.22 Dabigatran vs XARELTO: HR, 3.6; 95% CI, 0.7-19.1; P=0.13 First inpatient admission for bleeding event^a,e: Apixaban vs XARELTO: HR, 0.21; 95% CI, 0.084-0.52; P=0.0007 Dabigatran vs XARELTO: HR, 0.72; 95% CI, 0.49-1.036; P=0.76 Morbidly obese (BMI ≥40 kg/m²) First inpatient admission for ischemic stroke or SE^a: Apixaban vs XARELTO: HR, 0.22; 95% CI, 0.035-1.44; P=0.23 Dabigatran vs XARELTO: HR, 0.26; 95% CI, 0.086-0.78; P=0.016 First inpatient admission for bleeding event^a,e: Apixaban vs XARELTO: HR, 0.55; 95% CI, 0.19-1.60; P=0.27 Dabigatran vs XARELTO: HR, 0.95; 95% CI, 0.47-1.92; P=0.89
Obesity and Polypharmacy
Alberts et al (2022)²⁵ conducted a retrospective cohort study to evaluate the effectiveness and safety of XARELTO vs warfarin patients with obesity and polypharmacy. Patient source Two claims databases (IBM MarketScan Commercial Claims and Encounters and IBM MarketScan Medicare Supplemental) from December 1, 2011, to March 1, 2020 Study groups After propensity score matching, XARELTO (N=21,547) Warfarin (N=21,547)	Inclusion criteria Age ≥18 years One or more medical claims with a diagnosis of AF Obesity or BMI ≥30 kg/m² Polypharmacy status was categorized as 1-4, 5-9, and ≥10 concurrent medications on the index date (first claim date for the initiation of XARELTO or warfarin) Key demographics In the XARELTO and warfarin cohorts, respectively, Mean age was 65.14 years and 65.28 years 36.0% and 36.1% were women 34.6% and 34.7% had BMI ≥40 kg/m²	Primary effectiveness outcome^a The overall composite risk of stroke and SE^f was significantly lower in the XARELTO cohort compared with the warfarin cohort (4.3% vs 5.6%; HR, 0.77; 95% CI, 0.70-0.84; P<0.001) over a mean follow-up time of 25 months. Primary safety outcome^a The risk of major bleeding^c was not significantly different between the XARELTO and warfarin cohorts (2.0% each; HR, 0.93; 95% CI, 0.81-1.06; P=0.2842) over a mean follow-up time of 12 and 11 months, respectively. These results were consistent across the 3 polypharmacy groups.
Berger et al (2021)²⁶ conducted a retrospective weighted-cohort study to evaluate the effectiveness and safety of XARELTO vs warfarin in patients with obesity and polypharmacy. Patient source IQVIA PharMetrics^® Plus database from January 1, 2010, to September 30, 2019 Study groups After IPTW, the weighted cohorts included XARELTO (N=7000) Warfarin (N=3920)	Inclusion criteria Age ≥18 years Diagnosis of AF Obesity or BMI ≥30 kg/m² Polypharmacy (≥5 concurrent medications) and ≥12 months of continuous health plan enrollment Key demographics In the XARELTO and warfarin cohorts, respectively, Mean age was 60.2 years and 60.1 years 31.1% and 32.2% were women 40.0% and 41.4% had BMI ≥40 kg/m²	Primary effectiveness outcome^a XARELTO was associated with a 29% lower risk of stroke/SE^b relative to warfarin (HR, 0.71; 95% CI, 0.57-0.90; P=0.004) at 36 months. Primary safety outcome^a Risk of major bleeding^c was numerically but not significantly lower in the XARELTO cohort compared with the warfarin cohort at 36 months of follow-up (HR, 0.85; 95% CI, 0.70-1.03; P=0.089).
Body Weight Association with Adverse Clinical Outcomes
Nwanosike et al (2024)²⁷ conducted a retrospective, hospital-based cohort study to explore the association between different body weight categories and adverse clinical outcomes in patients on DOAC therapy (apixaban, XARELTO, edoxaban, and dabigatran). Patient source Adult patients receiving DOACs in Calderdale and Huddersfield NHS Foundation Trust Hospitals between May 1, 2017, and October 31, 2021 Study groups Overall, 97,413 patients were included in the study. Of them, 13,849 (14.2%) were on XARELTO.	Inclusion criteria Patients on DOAC therapy for Management/prevention of ischemic stroke in AF Treatment and prevention of VTE Key demographics Overall, Mean age was 78.8 years 52.5% were women Mean weight was 74.4 kg Mean BMI was 27.2 kg/m² 23.8% were obese and 4.4% were morbidly obese	Mortality rates were higher in the dabigatran and XARELTO groups compared with the apixaban and edoxaban groups (log-rank P<0.001) regardless of the obesity status. In the morbid obesity subgroup, the mortality rate was higher in the apixaban group compared with the XARELTO group (log-rank P=0.001), whereas in the obesity and overweight subgroups, the mortality rate was lower in the apixaban group compared with the XARELTO group (log-rank P=0.001, P=0.001).
Abbreviations: AF, atrial fibrillation; BMI, body mass index; CI, confidence interval; CRNMB, clinically relevant non-major bleeding; DOAC, direct oral anticoagulant; HF, heart failure; HR, hazard ratio; ISTH, International Society on Thrombosis and Haemostasis; IPTW, inverse probability of treatment weighting; ITT, intent-to-treat; NHS, National Health Services; NVAF, nonvalvular atrial fibrillation; OR, odds ratio; SE, systemic embolism; US, United States; VTE, venous thromboembolism. ^aResults were adjusted to try to control for potential confounding factors.^bMajor bleeding was defined according to the ISTH criteria.^cMajor bleeding was defined using a validated claims-based algorithm by Cunningham et al.^dCRNMB was defined according to the ISTH criteria.^eThe primary safety endpoint was the patient’s first inpatient admission for a bleeding event, including intracranial hemorrhage, gastrointestinal hemorrhage, or bleeding from other sites.^fStroke and SE were defined as a hospitalization or emergency room visit with a primary diagnosis of stroke (ischemic or hemorrhagic) or SE.

LITERATURE SEARCH

A literature search of MEDLINE^®, EMBASE^®, BIOSIS Previews^®, DERWENT^® (and/or other resources, including internal/external databases) was conducted on 23 July 2024.

References

Show

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