Anticoagulant therapies and outcomes in obese patients with acute venous thromboembolism

Quan, Steven; Smith, Jenna; Wu, Cynthia; Koshman, Sheri L.; Nguyen, Binh; Bungard, Tammy J.

doi:10.1016/j.thromres.2020.01.011

Cited by 19 publications

(19 citation statements)

References 17 publications

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“…After screening, five studies were included in our final analysis ( Fig. 1 shows the PRISMA flow diagram) [28][29][30][31][32]. The total number of patients evaluated in these studies is 6575 patients.…”

Section: Resultsmentioning

confidence: 99%

“…Four studies evaluated each of our primary efficacy (VTE recurrence) and safety (major bleeding) outcomes. One study was excluded from the primary efficacy analysis as it reported VTE recurrence in rates [30]. Another study was excluded from the safety outcome as it reported only a composite of major bleeding events and clinically relevant-non-major bleeding events [29].…”

Section: Resultsmentioning

confidence: 99%

“…This limits the generalizability of our findings to other DOAC analogs. Lastly, DOACs dosing information including drug interactions were not reported except for Quan et al [30].…”

Section: Discussionmentioning

confidence: 99%

“…Four observational studies evaluated and reported the risk of major bleeding events [28,[30][31][32] (Fig. 2).…”

Section: Major Bleedingmentioning

confidence: 99%

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Comparative effectiveness and safety of direct oral anticoagulants compared to warfarin in morbidly obese patients with acute venous thromboembolism: systematic review and a meta-analysis

Elshafei

Mohamed

El-Bardissy

et al. 2020

J Thromb Thrombolysis

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Direct oral anticoagulant (DOAC) agents are becoming the anticoagulation strategy of choice. However, their use in the treatment of acute venous thromboembolism (VTE) in morbidly obese patients (bodyweight of > 120 kg or BMI > 40 kg/ m 2) guarded. This is due to the scarce data supporting their use in this population. As a result, the International Society on Thrombosis and Haemostasis recommended against their use in this cohort of patients. New data emerged supporting the use of DOACs in these patients. Hence, we aimed to systematically review the literature exploring the efficacy and safety of these agents compared to warfarin in VTE treatment in morbidly obese patients. A systematic review of PubMed and EMBASE since inception until 01/04/2020. Subsequently, a non-inferiority (NI of 1.75) meta-analysis utilizing the random-effects model. Five observational studies (6585 patients) were included in our meta-analysis. DOAC analogs were non-inferior compared to warfarin in reducing the primary efficacy outcome of VTE recurrence (OR 1.07, 95% CI 0.93-1.23) and the primary safety outcome (major bleeding events) (OR 0.80, 95% CI 0.54-1.17). Our meta-analysis comprising real-world observational data concludes that the use of DOAC analogs in morbidly obese patients (bodyweight of > 120 kg or BMI > 40 kg/m 2) is non-inferior with regards to efficacy and safety compared to warfarin. This finding helps to resolve the uncertainty associated with the use of DOACs in this cohort. Additionally, it invites for a confirmatory non-inferiority randomized controlled trial testing DOAC vs. Warfarin in this group of patients.

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Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

“…This limits the generalizability of our findings to other DOAC analogs. Lastly, DOACs dosing information including drug interactions were not reported except for Quan et al [30].…”

Section: Discussionmentioning

confidence: 99%

“…Four observational studies evaluated and reported the risk of major bleeding events [28,[30][31][32] (Fig. 2).…”

Section: Major Bleedingmentioning

confidence: 99%

See 2 more Smart Citations

Comparative effectiveness and safety of direct oral anticoagulants compared to warfarin in morbidly obese patients with acute venous thromboembolism: systematic review and a meta-analysis

Elshafei

Mohamed

El-Bardissy

et al. 2020

J Thromb Thrombolysis

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“…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

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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.

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Rivaroxaban in acute venous thromboembolism: UK prescribing experience

Speed

Patel

Cooper

et al. 2021

Research and Practice in Thrombosis and Haemostasis

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Background Rivaroxaban was reported as effective as traditional therapies for the acute treatment of venous thromboembolism (VTE) with fewer major bleeding complications in the seminal Einstein program and is now a recommended option for the treatment of VTE around the world. Objective To report the safety and efficacy of rivaroxaban in daily care for the management of acute VTE in the United Kingdom. Patients/Method The FIRST registry is a UK‐only, multicenter, noninterventional, observational VTE study (NCT 02248610). Consecutive patients diagnosed with acute VTE, managed with rivaroxaban, were recruited and followed for up to 5 years. The primary outcomes were treatment‐emergent symptomatic objectively diagnosed recurrent VTE, major and clinically relevant nonmajor bleeding (CRNMB), and all‐cause mortality. Results A total of 1262 participants were recruited between 2014 and 2018. Participants were heterogeneous, with age range 18 to 95 years, weight 35 to 234 kg, and maximum body mass index 64.4 kg/m 2 . The median duration of treatment exposure was 135 days (interquartile range [IQR], 84‐307) and overall follow‐up 497 days (IQR, 175‐991). There were seven episodes of symptomatic VTE recurrence, 0.6%, (0.74/100 patient‐years; 95% confidence interval [CI], 0.19‐1.28). There were 79 of 1239 (6.4%), 8.66 of 100 patient‐years (95% CI, 6.90‐10.73) first episodes of major or CRNMB, which were most frequently reported by women aged <50 years as abnormal vaginal bleeding. Conclusions Rivaroxaban is an effective and safe single drug modality for the treatment of VTE in daily practice in the United Kingdom. Data to determine the optimal anticoagulation therapy for women of childbearing age are needed.

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Anticoagulant therapies and outcomes in obese patients with acute venous thromboembolism

Cited by 19 publications

References 17 publications

Comparative effectiveness and safety of direct oral anticoagulants compared to warfarin in morbidly obese patients with acute venous thromboembolism: systematic review and a meta-analysis

Comparative effectiveness and safety of direct oral anticoagulants compared to warfarin in morbidly obese patients with acute venous thromboembolism: systematic review and a 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

Rivaroxaban in acute venous thromboembolism: UK prescribing experience

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