A single center retrospective cohort study evaluating use of direct oral anticoagulants (DOACs) in morbidly obese veteran population

Patil, Tanvi; Lebrecht, Morgan

doi:10.1016/j.thromres.2020.04.015

Cited by 22 publications

(31 citation statements)

References 32 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…A post-hoc analysis of the ROCKET AF trial showed that both rivaroxaban and warfarin are effective in stroke prevention across various BMI subgroups with no significant difference among subgroups (interaction p ¼ .537) 36 . Subsequent observational studies, including the present study, further substantiated this evidence [17][18][19][20][21][22][23] 21 . However, these findings were evaluated over a relatively short follow-up period of $10 months, which may explain part of the differences with the current study when evaluating patients with morbid obesity.…”

Section: Discussionsupporting

confidence: 79%

“…However, since this advisement, growing evidence in support of the safety and efficacy of DOACs in obese patients has emerged. In particular, emerging evidence suggests that DOACs are associated with a similar or lower risk of stroke/SE or major bleeding relative to the vitamin K antagonist warfarin in morbidly obese [17][18][19][20][21][22] and obese 23 patients with AF. However, much of this evidence is based on pooled data from patients who initiated different DOACs 17,18,20 , despite evidence that not all DOACs have the same pharmacokinetic profile in obese patients 24 .…”

Section: Introductionmentioning

confidence: 99%

See 1 more Smart Citation

Real-world effectiveness and safety of rivaroxaban versus warfarin among non-valvular atrial fibrillation patients with obesity in a US population

Berger

Laliberté

Kharat

et al. 2021

Current Medical Research and Opinion

View full text Add to dashboard Cite

Objectives: Current evidence indicates that the pharmacokinetic profile of rivaroxaban is not significantly impacted by body weight. However, real-world data are needed to better assess the potential clinical benefits and risks associated with rivaroxaban in non-valvular atrial fibrillation (NVAF) patients with obesity. Thus, our objectives were to assess the real-world effectiveness and safety of rivaroxaban versus warfarin among NVAF patients with obesity in the US nationally representative commerciallyinsured population. Methods: Health insurance claims data from the IQVIA PharMetrics Plus database (January 2010-September 2019) were used to identify NVAF patients with obesity (based on diagnosis codes) initiated on rivaroxaban or warfarin. Inverse probability of treatment weighting (IPTW) was used to adjust for imbalances between groups. Study outcomes of interest were evaluated up to 36 months post-treatment initiation and included the composite of stroke or systemic embolism (stroke/SE) and major bleeding. Outcomes were compared using Cox proportional hazards regression models with hazard ratios (HR) and 95% confidence intervals (CIs). Results: A total of 10,555 patients were initiated on rivaroxaban and 5080 patients on warfarin. Following IPTW, the risk of stroke/SE was 26% lower among patients prescribed rivaroxaban relative to warfarin (HR: 0.74, 95% CI: 0.60, 0.91, p ¼ .004) at 36 months. Rivaroxaban-initiated patients had a risk of major bleeding similar to that of warfarin-initiated patients (HR: 0.85, 95% CI: 0.71, 1.02, p ¼ .085). Conclusions: These results suggest that rivaroxaban is an effective and safe treatment option among NVAF patients with obesity in a commercially-insured US population.

show abstract

Section: Discussionsupporting

confidence: 79%

Section: Introductionmentioning

confidence: 99%

Real-world effectiveness and safety of rivaroxaban versus warfarin among non-valvular atrial fibrillation patients with obesity in a US population

Berger

Laliberté

Kharat

et al. 2021

Current Medical Research and Opinion

View full text Add to dashboard Cite

show abstract

“…Six studies with DOAC-treated patients (all observational), 23,24,28,35,37,41 and 4 studies with VKA-treated patients (all observational) 28,35,37,41 were included in the meta-analysis (Figure 2C and 2D). The pooled incidence rate of major bleeding in patients with morbid obesity treated with DOACs was 1.63 (95% CI 1.17-2.28; I² = 0%) per 100 person-years, compared to 2.97 (95% CI 1.21-7.27; I² = 74%) per 100 person-years in those treated with VKAs (Table 2 and Figure 2C and 2D).…”

Section: Major Bleedingmentioning

confidence: 99%

Oral Anticoagulant Use in Patients with Morbid Obesity: A Systematic Review and Meta-Analysis

et al. 2021

View full text Add to dashboard Cite

Objectives: Obesity is associated with increased risks of atrial fibrillation (AF) and venous thromboembolism (VTE) for which anticoagulation is commonly used. However, data on the efficacy and safety of oral anticoagulants in patients with morbid obesity are limited. Methods: We conducted a systematic review and meta-analysis to evaluate the efficacy and safety of direct oral anticoagulants (DOACs) or vitamin K antagonists (VKAs) for AF or VTE in patients with morbid obesity. Results: We included 3 randomized controlled trials (5 studies) and 18 observational studies in adult patients with a body weight ≥ 120 kg, body mass index (BMI) ≥ 40 kg/m2 or classified as morbid obesity who received DOACs or VKAs for AF or VTE (N=77,687). The primary efficacy outcome was stroke/systemic embolism or recurrent VTE, and the primary safety outcome was major bleeding. DOACs were associated with a pooled incidence rate of stroke/systemic embolism of 1.16 per 100 person-years, compared to 1.18 with VKAs. The incidence of recurrent VTE on DOACs was 3.83 per 100 person-years, compared to 6.81 on VKAs. In both VTE and AF populations, DOACs were associated with lower risks of major bleeding compared to VKAs. However, all observational studies had moderate to serious risks of bias. Conclusions: Patients with morbid obesity on DOACs had similar risks of stroke/systemic embolism, lower rates of recurrent VTE and major bleeding events compared to those on VKAs. However, the certainty of evidence was low given that studies were mostly observational with high risk of confounding.

show abstract

“…In a study from the Veterans Affairs Medical Center, obese patients receiving a DOAC had about one-half the rate of recurrent VTE, but more than double the rate of major bleeding compared with warfarin (►Table 6). 83 Although these findings seem like meaningful differences, it should be noted that the follow-up for patients receiving warfarin was almost 1 year longer than patients receiving DOACs, giving less time for events to occur in patients receiving DOACs. This study also included patients with NVAF, and patients with VTE comprised only 38% of the total patients.…”

Section: Data From Observational Studiesmentioning

confidence: 89%

“…There have been several observational studies that have evaluated the efficacy and safety of DOACs in patients with VTE and obesity (►Table 6). [83][84][85][86][87][88][89][90][91] As previously mentioned, observational studies have several limitations. These studies also have mixed objectives, with some studies primarily comparing outcomes in obese versus nonobese patients, and others comparing DOACs versus warfarin in obese patients.…”

Section: Data From Observational Studiesmentioning

confidence: 99%

Direct Oral Anticoagulants in the Treatment of Venous Thromboembolism: Use in Patients with Advanced Renal Impairment, Obesity, or Other Weight-Related Special Populations

Dobesh

Kernan

Lueshen

2021

Semin Respir Crit Care Med

View full text Add to dashboard Cite

There are currently more than 7 million patients taking a direct oral anticoagulant (DOAC), with more new prescriptions per year than warfarin. Despite impressive efficacy and safety data for the treatment of venous thromboembolism, patients with obesity or advanced renal impairment represented a small portion of the patients enrolled in the phase 3 clinical trials. Therefore, to evaluate the potential use of DOACs in these special populations, clinicians need to have an understanding of the pharmacokinetics and pharmacodynamics of these agents in these settings. Since data from randomized controlled trials are limited, data from observational trials are helpful in gaining comfort with the use of DOACs in these special populations. Selecting the appropriate dose for each agent is imperative in achieving optimal patient outcomes. We provide an extensive review of the pharmacokinetics, pharmacodynamics, phase 3 clinical trials, and observational studies on the use of DOACs in patients with advanced renal impairment, obesity, or other weight-related special populations to provide clinicians with a comprehensive understanding of the data for optimal drug and dose selection.

show abstract

A single center retrospective cohort study evaluating use of direct oral anticoagulants (DOACs) in morbidly obese veteran population

Cited by 22 publications

References 32 publications

Real-world effectiveness and safety of rivaroxaban versus warfarin among non-valvular atrial fibrillation patients with obesity in a US population

Real-world effectiveness and safety of rivaroxaban versus warfarin among non-valvular atrial fibrillation patients with obesity in a US population

Oral Anticoagulant Use in Patients with Morbid Obesity: A Systematic Review and Meta-Analysis

Direct Oral Anticoagulants in the Treatment of Venous Thromboembolism: Use in Patients with Advanced Renal Impairment, Obesity, or Other Weight-Related Special Populations

Contact Info

Product

Resources

About