Body mass index is an independent predictor of major bleeding in non-valvular atrial fibrillation patients taking dabigatran

Lee, Chen‐Hung; Lin, Tzu-Yu; Chang, Shang‐Hung; Chen, Chi‐Hua; Hsu, Ying-Jen; Hung, Kuo‐Chun; Wen, Ming‐Shien

doi:10.1016/j.ijcard.2016.11.277

Cited by 22 publications

(17 citation statements)

References 52 publications

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“…This analysis involved eight studies (five post hoc analyses of RCTs and three prospective cohorts) with 3,130 cases/106,694 participants. The summary RR for a 5‐unit increase in BMI was 0.96 (95% CI: 0.90‐1.02, I 2 =84%; P =.18) (Figure C).…”

Section: Resultsmentioning

confidence: 99%

“…Moreover, previous meta‐analyses only compared high and low effect sizes using the semiparametric method, and an exposure‐effect association between increasing BMI and AF prognosis has not yet been investigated. Furthermore, because several new high‐quality studies have been published, we conducted an up‐to‐date meta‐analysis of BMI and AF outcomes using only prospective studies to further investigate the exposure‐effect relationship.…”

Section: Introductionmentioning

confidence: 99%

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The obesity paradox for outcomes in atrial fibrillation: Evidence from an exposure‐effect analysis of prospective studies

et al. 2019

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The impact of obesity on the prognosis of atrial fibrillation (AF) remains controversial. We conducted an exposure-effect meta-analysis of prospective studies to clarify the relationship between body mass index (BMI) and outcomes in patients with AF. The Cochrane Library, PubMed, and Embase databases were searched through May 1, 2019. Summary relative risks (RRs) were calculated using random-effects models. Nonlinear associations were explored using restricted cubic spline models. Twenty publications involving 161,922 individuals were included. Categorical variable analysis showed that underweight was associated with an increased risk of all-cause mortality (RR: 2.6), cardiovascular death (RR: 2.91), major bleeding (RR: 1.57), stroke or systemic embolism (RR: 1.62), and a composite endpoint (RR: 2.23). In exposure-effect analysis, the risk per 5 BMI increase was reduced for adverse outcomes (RR=0.86, 95% CI: 0.80-0.92 for all-cause death; RR=0.82, 95% CI: 0.71-0.95 for cardiovascular death; RR=0.89, 95% CI: 0.84-0.95 for stroke or systemic embolism; and RR=0.78, 95% CI: 0.67-0.92 for a composite endpoint).There was a significant "U"-shaped exposure-effect relationship with all-cause death, and the nadir of the curve was observed at a BMI of approximately 28.Our results showed that underweight is associated with a worse prognosis, but that overweight and obesity are associated with improved adverse outcomes in patients with AF. KEYWORDSatrial fibrillation, body mass index, meta-analysis, obesity paradox

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Section: Resultsmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

The obesity paradox for outcomes in atrial fibrillation: Evidence from an exposure‐effect analysis of prospective studies

et al. 2019

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“…If necessary, researchers can apply to review the original EMR in hospitals on a case-by-case basis to acquire specific information not included in CGRD. For example, Lee CH et al performed chart reviews of EMR to obtain variables not available in the CGRD, such as BMI and blood pressures, and found that lower BMI was a predictor of major bleeding in non-valvular atrial fibrillation patients taking dabigatran 15. The non-random enrolment of patients in CGRD may cause a selection bias with more severe patients in this dataset than the national average, because CGMF has the largest referral hospitals in Taiwan.…”

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confidence: 99%

The Chang Gung Research Database—A multi‐institutional electronic medical records database for real‐world epidemiological studies in Taiwan

Shao

Chan

Yang

et al. 2019

Pharmacoepidemiology and Drug

227

222

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Purpose The Chang Gung Research Database (CGRD), the largest multi‐institutional electronic medical records (EMR) collection in Taiwan, provides good access for researchers to efficiently use the standardized patient‐level data. This study evaluates the capacity and representativeness of the CGRD to promote secondary use of EMR data for clinical research with more accurate estimates. Methods The National Health Insurance Research Database (NHIRD) which covers over 99.9% of the Taiwanese population served as the comparator in this study. We compare the data components of the CGRD with the NHIRD, including records for health care facilities, patients, diagnoses, drugs, and procedures. Using the chi‐square test, we compared the distributions of age categories and sex of patients, and the rates of their health conditions between NHIRD and CGRD based on the year 2015. Results The CGRD contains more clinical information such as pathological and laboratory results than the NHIRD. The CGRD includes 6.1% of outpatients and 10.2% of hospitalized patients from the NHIRD. We found the CGRD includes more elderly outpatients (23.5% vs 12.5%) and pediatric inpatients (19.7% vs 14.4%) compared with the NHIRD. We found patients' sex distributions were similar between CGRD and NHIRD, but coverage rates of severe conditions, such as cancer, were higher than other health conditions in CGRD. Conclusions The CGRD could serve as the basis for accurate estimates in medical studies. However, researchers should pay special attention to selection biases since patients' characteristics from CGRD differ from those of the national database.

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“…In patients with advanced cirrhosis who presented with any complications such as ascites, encephalopathy, spontaneous bacterial peritonitis, or prior bleeding from esophageal varices, this benefit from NOACs was diminished, presumably due to reduced drug metabolism and impaired hepatobiliary excretion. 59 Of note, hepatotoxicity has been observed in less than 1% of patients with AF in the NOAC trials at a similar rate to the warfarin arms. 67 Usually, drug withdrawal normalized liver function markers within a few days.…”

Section: Specific Atrial Fibrillation Patient Populations At Risk Of mentioning

confidence: 99%

“…58 However, observational studies suggested that low body mass index (<23.9 kg/m 2 ) may predict bleeding in patients on dabigatran. 59 Of note, frequently coexisting renal insufficiency may make dabigatran a less preferable option for the underweight older patients with AF. Patients with low body weight on oral anticoagulation should be monitored for bleeding risk.…”

Section: Specific Atrial Fibrillation Patient Populations At Risk Of mentioning

confidence: 99%

Bleeding in anticoagulated patients with atrial fibrillation: practical considerations

Undas¹,

Drabik²,

Potpara³

2020

Kardiologia Polska

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or higher, but they are safer and more convenient. 7,8 In a meta-analysis of pivotal phase 3 AF randomized controlled trials (RCTs), NOACs reduced the risk of stroke or SE by 19% compared with warfarin (relative risk [RR], 0.81; 95% CI, 0.73-0.91), largely due to a markedly lower rate of hemorrhagic strokes (RR 0.49, 95% CI, 0.38-0.64) and intracranial bleeding (ICB) (RR, 0.48; 95% CI, 0.39-0.59). 9 However, the use of NOACs (in particular, full-dose dabigatran and rivaroxaban) was significantly associated with an increased risk of gastrointestinal (GI) bleeding (RR, 1.25; 95% CI, 1.01-1.55). 7 Of note, the differences between baseline stroke and bleeding risks among different NOAC trials could have affected the reported bleeding rates (FIGURE 1). Residual incidence of stroke or SE despite NOAC use among patients with AF is estimated at 1.5% to 2.5% per year and that of major bleeding at 2% to 4% per year. 9 As compared with warfarin, NOACs slightly reduced all-cause mortality (RR

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Body mass index is an independent predictor of major bleeding in non-valvular atrial fibrillation patients taking dabigatran

Cited by 22 publications

References 52 publications

The obesity paradox for outcomes in atrial fibrillation: Evidence from an exposure‐effect analysis of prospective studies

The obesity paradox for outcomes in atrial fibrillation: Evidence from an exposure‐effect analysis of prospective studies

The Chang Gung Research Database—A multi‐institutional electronic medical records database for real‐world epidemiological studies in Taiwan

Bleeding in anticoagulated patients with atrial fibrillation: practical considerations

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