Impact of BMI on clinical outcomes of NOAC therapy in daily care - Results of the prospective Dresden NOAC Registry (NCT01588119)

Tittl, Luise; Endig, S.; Marten, Sandra; Reitter, Antje; Beyer-Westendorf, Ines; Beyer‐Westendorf, Jan

doi:10.1016/j.ijcard.2018.03.060

Cited by 79 publications

(66 citation statements)

References 36 publications

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“…A pharmacokinetic study of healthy volunteers taking rivaroxaban reported that the area under the curve (AUC) was unaffected by BW,23 the volume of distribution was moderately influenced by BW in patients taking rivaroxaban,24 and a mean increase in BW of 83% resulted in a limited 23% decrease of the AUC in healthy volunteers taking apixaban 25. A large prospective study of real‐life patients receiving DOACs for treatment of atrial fibrillation or VTE, which included 98 patients with BMI >40 kg/m 2 , did not find any indication that high BMI is associated with reduced DOAC efficacy or safety 26. Lastly, a pharmacokinetic study of 101 patients taking rivaroxaban for prevention or treatment of VTE (six patients had a BMI ≥ 40 kg/m 2 ) reported that BW alone did not significantly affect rivaroxaban pharmacokinetics 27…”

Section: Resultsmentioning

confidence: 95%

“…25 A large prospective study of real-life patients receiving DOACs for treatment of atrial fibrillation or VTE, which included 98 patients with BMI >40 kg/m 2 , did not find any indication that high BMI is associated with reduced DOAC efficacy or safety. 26 Lastly, a pharmacokinetic study of 101 patients taking rivaroxaban for prevention or treatment of VTE (six patients had a BMI ≥ 40 kg/m 2 ) reported that BW alone did not significantly affect rivaroxaban pharmacokinetics. 27 Our study has limitations.…”

Section: Resultsmentioning

confidence: 99%

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Peak plasma concentration of direct oral anticoagulants in obese patients weighing over 120 kilograms: A retrospective study

Piran

Traquair

Chan

et al. 2018

Research and Practice in Thrombosis and Haemostasis

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BackgroundDue to a paucity of data on the efficacy and safety of direct oral anticoagulants (DOACs) in patients with a body mass index >40 kg/m2 or a weight >120 kg, the use of DOACs in this group is not recommended.ObjectivesTo determine the proportion of obese patients with body weight >120 kg with a peak plasma concentration of DOACs lower than the expected median trough level derived from population pharmacokinetic studies for each DOAC.MethodsPatients with body weight >120 kg taking DOACs for any indication underwent a peak drug concentration measurement at steady state.Results38 patients were included in the analysis. The mean age was 64 ± 11 years, and 30 (79%) were males. The median body weight was 132.5 kg (interquartile range [IQR] 127‐146.5). The median peak concentrations (IQR) were 148 ng/mL (138‐240), 138 ng/mL (123‐156.5), 215 ng/mL (181‐249) for apixaban, dabigatran, and rivaroxaban, respectively. Two patients (5%, 95% confidence interval [CI]: 0.5%‐18%) had a peak plasma concentration lower than the median trough and eight (21%, 95% CI: 11%‐37%) had a peak plasma concentration below the fifth percentile (10th percentile for dabigatran) peak concentration.ConclusionsMost patients in our study had peak plasma concentration higher than the median trough level for each of the three DOACs. However, 21% had a peak plasma concentration that was below the usual on‐therapy range of peak concentration for the corresponding DOAC.

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Section: Resultsmentioning

confidence: 95%

Section: Resultsmentioning

confidence: 99%

Peak plasma concentration of direct oral anticoagulants in obese patients weighing over 120 kilograms: A retrospective study

Piran

Traquair

Chan

et al. 2018

Research and Practice in Thrombosis and Haemostasis

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“…These data were recently confirmed by a study from the Dresden NOAC registry, including 3432 AF patients, of whom 1,077 (31.4%) were obese 28 . The Authors found a progressive reduction of the incidence of the combined endpoint of stroke/TIA/systemic embolism of VTE according to BMI categories 28 .…”

Section: A N U S C R I P Tmentioning

confidence: 64%

Update and Unmet Needs on the Use of Nonvitamin K Oral Anticoagulants for Stroke Prevention in Patients With Atrial Fibrillation

Menichelli¹,

Ettorre²,

Pani³

et al. 2021

Current Problems in Cardiology

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“…The key findings of this study in Japanese patients with NVAF receiving rivaroxaban can be summarized as follows: first, baseline characteristics varied across BMI categories; second, the incidences of stroke/non-CNS SE/MI and all-cause mortality were significantly higher in those who were underweight than in those of normal weight; third, none of the BMI categories emerged as an independent predictor of major bleeding or stroke/ non-CNS SE/MI; fourth, in multivariable analyses, being underweight was found to be an independent predictor of all-cause mortality. Limited conclusions could be drawn from previous global studies investigating the impact of BMI on outcomes in patients with AF receiving anticoagulants because very few patients included in these analyses were underweight [7,[12][13][14]. The efficacy and safety of rivaroxaban in patients with NVAF were established in the global Rivaroxaban Once Daily Oral Direct Factor Xa Inhibition Compared with Vitamin K Antagonism for Prevention of Stroke and Embolism Trial in Atrial Fibrillation (ROCKET AF) and Japan-specific J-ROCKET AF phase 3 studies [15,16].…”

Section: Discussionmentioning

confidence: 99%

Impact of body mass index on real-world outcomes of rivaroxaban treatment in Japanese patients with non-valvular atrial fibrillation

et al. 2020

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This sub-analysis of the XAPASS, a prospective, single-arm, observational study, aimed to evaluate relationships between body mass index (BMI) and safety (major bleeding and all-cause mortality) and effectiveness [stroke/non-central nervous system (non-CNS) systemic embolism (SE)/myocardial infarction (MI)] outcomes in Japanese patients with non-valvular atrial fibrillation (NVAF) receiving rivaroxaban. Patients were categorized according to BMI (kg/m 2 ) as underweight (< 18.5), normal weight (18.5 to < 25), overweight (25 to < 30), or obese (≥ 30). In total, 9578 patients with NVAF completed the 1-year follow-up and were evaluated; of these, 7618 patients had baseline BMI data. Overall, 542 (5.7%), 4410 (46.0%), 2167 (22.6%), and 499 (5.2%) patients were underweight, normal weight, overweight, and obese, respectively. Multivariable Cox regression analysis demonstrated that none of the BMI categories were independent predictors of major bleeding whereas being underweight was independently associated with increased all-cause mortality [hazard ratio (HR) 3.56, 95% confidence interval (CI) 2.40-5.26, p < 0.001]. The incidence of stroke/non-CNS SE/MI was higher in patients who were underweight than in those of normal weight (HR 2.11, 95% CI 1.20-3.70, p = 0.009). However, in multivariable analyses, being underweight was not identified as an independent predictor of stroke/non-CNS SE/MI (HR 1.64, 95% CI 0.90-2.99, p = 0.104). In conclusion, the high incidence of thromboembolic events and all-cause mortality in patients who were underweight highlights that thorough evaluation of disease status and comorbidities may be required in this population.

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Impact of BMI on clinical outcomes of NOAC therapy in daily care - Results of the prospective Dresden NOAC Registry (NCT01588119)

Cited by 79 publications

References 36 publications

Peak plasma concentration of direct oral anticoagulants in obese patients weighing over 120 kilograms: A retrospective study

Peak plasma concentration of direct oral anticoagulants in obese patients weighing over 120 kilograms: A retrospective study

Update and Unmet Needs on the Use of Nonvitamin K Oral Anticoagulants for Stroke Prevention in Patients With Atrial Fibrillation

Impact of body mass index on real-world outcomes of rivaroxaban treatment in Japanese patients with non-valvular atrial fibrillation

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