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1.
JAMA Netw Open ; 5(11): e2243307, 2022 Nov 01.
Artigo em Inglês | MEDLINE | ID: mdl-36413365

RESUMO

Importance: There are emerging concerns from case reports and pharmacovigilance analyses of a possible risk of interstitial lung disease (ILD) associated with the use of factor Xa (FXa) inhibitors. Objective: To evaluate the risk of incident ILD associated with the use of oral anticoagulants (OACs) in patients with nonvalvular atrial fibrillation (NVAF). Design, Setting, and Participants: This nationwide retrospective cohort study used data from the Taiwan National Health Insurance Research Database. Patients with NVAF without preexisting lung disease who received OACs from June 1, 2012, to December 31, 2017, were included. Propensity score stabilized weighting (PSSW) was used to balance covariates across the medication groups (FXa inhibitors, dabigatran, and warfarin, with warfarin as the reference). Patients were followed up from the drug index date until the onset of ILD, death, or end of the study (December 31, 2019), whichever occurred first. Data were analyzed from September 11, 2021, to August 3, 2022. Exposures: Patients with NVAF were treated with FXa inhibitors, dabigatran, or warfarin. Main Outcomes and Measures: New-onset idiopathic ILD. Results: Among the 106 044 patients (mean [SD] age, 73.4 [11.9] years; 59 995 men [56.6%]) included in the study, 64 555 (60.9%) received FXa inhibitors (apixban [n = 15 386], edoxaban [n = 12 413], and rivaroxaban [n = 36 756]), 22 501 (21.2%) received dabigatran, and 18 988 (17.9%) received warfarin at baseline. The FXa inhibitors were associated with a higher risk of incident ILD (0.29 vs 0.17 per 100 patient-years; hazard ratio, 1.54 [95% CI, 1.22-1.94]; P < .001), whereas dabigatran was associated with a nonsignificant difference in risk of incident ILD compared with warfarin (reference) after PSSW. The higher risk of incident ILD for FXa inhibitors vs warfarin was consistent with several high-risk subgroups. Conclusions and Relevance: Results of this study suggest that FXa inhibitors were associated with lung injury among patients with NVAF who were treated with OACs. Physicians should be vigilant in monitoring for any potential adverse lung outcomes associated with the use of these drugs.


Assuntos
Fibrilação Atrial , Doenças Pulmonares Intersticiais , Masculino , Humanos , Idoso , Fibrilação Atrial/complicações , Fibrilação Atrial/tratamento farmacológico , Fibrilação Atrial/epidemiologia , Varfarina/efeitos adversos , Dabigatrana/efeitos adversos , Estudos Retrospectivos , Taiwan/epidemiologia , Anticoagulantes/efeitos adversos , Doenças Pulmonares Intersticiais/epidemiologia , Doenças Pulmonares Intersticiais/induzido quimicamente
2.
Int J Mol Sci ; 23(22)2022 Nov 12.
Artigo em Inglês | MEDLINE | ID: mdl-36430433

RESUMO

Novel oral anticoagulants (NOACs) are drugs approved for the prevention and treatment of many thromboembolic cardiovascular conditions as a safer alternative to warfarin. We reviewed studies published in PubMed®, UpToDate®, Web of Science®, and Cochrane® about NOACs' risks and benefits in patients requiring anticoagulation, with a focus on gastrointestinal bleeding and on molecular and pathophysiological mechanisms underlying the risk of bleeding in patients treated with them. Apixaban resulted in a lower rate of gastrointestinal bleeding compared to dabigatran and rivaroxaban. However, data reported that gastrointestinal bleeding in patients treated with NOACs was less severe compared to warfarin. Studies show promising results on the increased and widespread use of NOACs in patients who require anticoagulation (for example-in case of atrial fibrillation or high risk of venous thromboembolism), reporting an overall lower risk of major bleeding events. The profile of NOACs was more effective and secure compared to warfarin, but a more careful medical prescription is required in patients who are at high risk of gastrointestinal bleeding.


Assuntos
Anticoagulantes , Varfarina , Humanos , Anticoagulantes/efeitos adversos , Varfarina/efeitos adversos , Administração Oral , Dabigatrana/efeitos adversos , Hemorragia Gastrointestinal/induzido quimicamente , Hemorragia Gastrointestinal/tratamento farmacológico
3.
N Z Med J ; 135(1563): 52-61, 2022 Oct 07.
Artigo em Inglês | MEDLINE | ID: mdl-36201730

RESUMO

AIM: The safety of dabigatran is poorly studied in patients with liver cirrhosis and has rarely been compared to warfarin in terms of bleeding risks. METHOD: We undertook a retrospective cohort study across three tertiary centres in Auckland, New Zealand, between 2008 to 2020. Adults 18 years and over and those with a clinically confirmed diagnosis of cirrhosis were included. Data collected included demographic data and clinical characteristics, baseline medication and comorbidities. The primary outcome measure was the incidence of any bleeding event that resulted in hospital admission. RESULTS: Overall, 100 patients were included in this study. A total of 52 patients took warfarin, and 48 took dabigatran. Baseline characteristics for both groups were generally similar. The incidence rate of bleeds for patients taking warfarin was 14.4 per 100 person-years (95% CI, 8.8-23.5) compared to 9.1 per 100 person-years (95% CI, 4.5-18.1) for patients taking dabigatran. The incidence rate ratio comparing dabigatran to warfarin was 0.63 (95% CI, 0.23-1.60), p=0.25. CONCLUSION: Our study found that patients on dabigatran may have a lower bleeding risk than patients taking warfarin, but this was not statistically significant.


Assuntos
Fibrilação Atrial , Acidente Vascular Cerebral , Administração Oral , Adolescente , Adulto , Anticoagulantes/efeitos adversos , Fibrilação Atrial/complicações , Fibrilação Atrial/tratamento farmacológico , Fibrilação Atrial/epidemiologia , Dabigatrana/efeitos adversos , Hemorragia/induzido quimicamente , Hemorragia/tratamento farmacológico , Hemorragia/epidemiologia , Humanos , Cirrose Hepática/complicações , Nova Zelândia/epidemiologia , Estudos Retrospectivos , Rivaroxabana/efeitos adversos , Acidente Vascular Cerebral/epidemiologia , Varfarina/efeitos adversos
4.
J Coll Physicians Surg Pak ; 32(10): 1266-1271, 2022 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-36205269

RESUMO

OBJECTIVE: To evaluate the comparison of direct-acting oral anticoagulants (DOACs) and warfarin for their effects on major bleeding and hospital outcomes in patients with acute nonvariceal upper gastrointestinal bleeding (NVUGIB). STUDY DESIGN: An observational study. PLACE AND DURATION OF STUDY: Tekirdag Namik Kemal University Hospital, Hitit University Erol Olçok Education and Research Hospital, between January and December 2021. METHODOLOGY: Adult patients prescribed warfarin and DOACs were followed up for one year. Their length of hospital stay, need for intensive care unit admission, need for red blood cell transfusion, and major bleeding rates were compared. RESULTS: Thirty-two patients (61.5%) were user of DOACs (DOAC group), and 20 patients (38.5%) were users of warfarin (warfarin group). No statistically significant difference was determined between patients in warfarin group and DOAC group for the number of packed red blood cells transfused [median 3 (0-6) units, 3 (0-10) units, p=0.229, respectively], length of hospital stay [median 5 days (3-10), and 4.5 days (2-20), p=0.739, respectively], rate of intensive care unit admission [(n=9, 45%; and n=10 (31%), p=0.623, respectively] and the occurrence of major bleeding events (warfarin-70%; DOACs-78%; p=0.529). CONCLUSION: Major bleeding episodes and hospital outcomes of acute NVUGIB were similar between patients receiving warfarin and DOACs. KEY WORDS: Direct-acting oral anticoagulants, Warfarin, Gastrointestinal bleeding, Outcome, Mortality.


Assuntos
Fibrilação Atrial , Varfarina , Administração Oral , Adulto , Anticoagulantes/efeitos adversos , Fibrilação Atrial/tratamento farmacológico , Inibidores do Fator Xa/uso terapêutico , Hemorragia Gastrointestinal/tratamento farmacológico , Hospitais , Humanos , Estudos Retrospectivos , Varfarina/efeitos adversos
5.
Sci Rep ; 12(1): 16795, 2022 Oct 07.
Artigo em Inglês | MEDLINE | ID: mdl-36207370

RESUMO

Recently, direct oral anticoagulants (DOACs) have been widely used as antithrombotic agents to replace warfarin, but their clinical impact in patients with gastrointestinal bleeding is unclear. We compared the effects of warfarin and DOACs on the outcomes of patients with colonic diverticular bleeding. The patients were divided into warfarin and DOAC groups. We compared the clinical outcomes and the effect of the DOAC dosing and examined any readmissions due to colonic diverticular bleeding within 1 year. A total of 95 events (warfarin group: n = 43 and DOAC group: n = 52) were included. Compared with the warfarin group, the DOAC group was significantly older, had a lower rate of concomitant antiplatelet agents, and a shorter hospital stay, but no significant differences were found in the other clinical outcomes. Thirty-seven patients (71.2%) in the DOAC group had appropriate dosing, whereas 15 patients (28.9%) had an inappropriate dose. The patients with overdose or contraindications had significantly lower minimum hemoglobin levels. In the univariate analysis, prior hospitalization for colonic diverticular bleeding was a significant predictor of readmission. Compared with warfarin, patients with colonic diverticular bleeding treated with DOACs were older and had shorter hospital stays, and the inappropriate use of DOACs may worsen outcomes.


Assuntos
Fibrilação Atrial , Doenças Diverticulares , Administração Oral , Anticoagulantes/efeitos adversos , Fibrilação Atrial/tratamento farmacológico , Doenças Diverticulares/tratamento farmacológico , Fibrinolíticos/uso terapêutico , Hemoglobinas/uso terapêutico , Humanos , Inibidores da Agregação Plaquetária/uso terapêutico , Estudos Retrospectivos , Varfarina/efeitos adversos
6.
PLoS One ; 17(10): e0275103, 2022.
Artigo em Inglês | MEDLINE | ID: mdl-36227869

RESUMO

AIM: Data on the use of non-vitamin K antagonist oral anticoagulants (NOACs) in relation to the risk of cardiovascular (CV) disease and renal protection among patients with atrial fibrillation (AF), are relatively sparse. We aimed to compare the effectiveness and safety of NOACs with those of warfarin for vascular protection in a large-scale, nationwide Asian population with AF. METHODS AND RESULTS: Patients with AF who were prescribed oral anticoagulants according to the Korean Health Insurance Review and Assessment database between 2014 and 2017 were analyzed. The warfarin and NOAC groups were balanced using propensity score weighting. Clinical outcomes included ischemic stroke, myocardial infarction, angina pectoris, peripheral artery disease, chronic kidney disease (CKD), end-stage renal disease (ESRD), CV death, and all-cause death. NOAC use was associated with a lower risk of angina pectoris (HR, 0.79 [95% CI, 0.69-0.89] p<0.001), CKD stage 4 (HR, 0.5 [95% CI, 0.28-0.89], p = 0.02), and ESRD (HR, 0.15[95% CI, 0.08-0.32], p<0.001) than warfarin use. NOACs and warfarin did not significantly differ with respect to stroke reduction (HR, 1.05 [95% CI, 0.88-1.25], p = 0.19). NOAC use was associated with a lower risk of intracranial hemorrhage (HR, 0.6 [95% CI, 0.44-0.83], p = 0.0019), CV death (HR, 0.55 [95% CI, 0.43-0.70], p<0.001), and all-cause death (HR, 0.6 [95% CI, 0.52-0.69], p<0.001) than warfarin use. CONCLUSION: NOACs were associated with a significantly lower risk of adverse CV and renovascular outcomes than warfarin in patients with AF.


Assuntos
Fibrilação Atrial , Falência Renal Crônica , Insuficiência Renal Crônica , Acidente Vascular Cerebral , Administração Oral , Angina Pectoris/complicações , Anticoagulantes/efeitos adversos , Fibrilação Atrial/complicações , Fibrilação Atrial/tratamento farmacológico , Fibrilação Atrial/epidemiologia , Humanos , Falência Renal Crônica/tratamento farmacológico , Insuficiência Renal Crônica/induzido quimicamente , Insuficiência Renal Crônica/complicações , Insuficiência Renal Crônica/tratamento farmacológico , Acidente Vascular Cerebral/epidemiologia , Acidente Vascular Cerebral/etiologia , Acidente Vascular Cerebral/prevenção & controle , Varfarina/efeitos adversos
7.
Artigo em Inglês | MEDLINE | ID: mdl-36232216

RESUMO

We aimed to compare the ability to balance baseline covariates and explore the impact of residual confounding between conventional and machine learning approaches to derive propensity scores (PS). The Health Insurance Review and Assessment Service database (January 2012-September 2019) was used. Patients with atrial fibrillation (AF) who initiated oral anticoagulants during July 2015-September 2018 were included. The outcome of interest was stroke/systemic embolism. To estimate PS, we used a logistic regression model (i.e., a conventional approach) and a generalized boosted model (GBM) which is a machine learning approach. Both PS matching and inverse probability of treatment weighting were performed. To evaluate balance achievement, standardized differences, p-values, and boxplots were used. To explore residual confounding, E-values and negative control outcomes were used. In total, 129,434 patients were identified. Although all baseline covariates were well balanced, the distribution of continuous variables seemed more similar when GBM was applied. E-values ranged between 1.75 and 2.70 and were generally higher in GBM. In the negative control outcome analysis, slightly more nonsignificant hazard ratios were observed in GBM. We showed GBM provided a better ability to balance covariates and had a lower impact of residual confounding, compared with the conventional approach in the empirical example of comparative effectiveness analysis.


Assuntos
Fibrilação Atrial , Acidente Vascular Cerebral , Administração Oral , Anticoagulantes/uso terapêutico , Fibrilação Atrial/induzido quimicamente , Fibrilação Atrial/complicações , Fibrilação Atrial/tratamento farmacológico , Pesquisa Comparativa da Efetividade , Humanos , Aprendizado de Máquina , Estudos Retrospectivos , Rivaroxabana/efeitos adversos , Acidente Vascular Cerebral/induzido quimicamente , Resultado do Tratamento , Varfarina/efeitos adversos
8.
J Cardiovasc Pharmacol Ther ; 27: 10742484221128124, 2022.
Artigo em Inglês | MEDLINE | ID: mdl-36189934

RESUMO

BACKGROUND: Because of logistic challenges associated with the COVID-19 pandemic, direct oral anticoagulants (DOAC) were favored over warfarin in patients presenting postoperative atrial fibrillation (AF) after cardiac surgery in our institution. Considering the limited evidence supporting the use of DOAC in this context, we sought to evaluate the safety and efficacy of this practice change. METHODS: A retrospective study was performed with patients from the Quebec City metropolitan area who were hospitalized at the Institut universitaire de cardiologie et de pneumologie de Québec-Université Laval following cardiac surgery and who required oral anticoagulant (OAC) for postoperative AF. The primary objective was to compare the pre- and peri-COVID-19 period for OAC prescribing patterns and the incidence of thrombotic and bleeding events at 3 months post-surgery. The secondary objective was to compare DOAC to warfarin in terms of thrombotic events and bleeding events. RESULTS: A total of 233 patients were included, 142 from the pre-COVID-19 and 91 from the peri-COVID-19 period, respectively. Both groups had equivalent proportions of preoperative AF (48%) and new-onset postoperative AF (52%). The proportion of patients treated with a DOAC increased from 13% pre-COVID-19 to 82% peri-COVID-19. This change in practice was not associated with a significant difference in the incidence of thrombotic or bleeding events 3 months postoperatively. However, compared to DOAC, warfarin was associated with a higher incidence of major bleeding. Only 1 thrombotic event was reported with warfarin, and none were reported with DOAC. CONCLUSION: This study suggests that DOAC are an effective and safe alternative to warfarin to treat postoperative AF after cardiac surgery and that this practice can be safely maintained.


Assuntos
Fibrilação Atrial , COVID-19 , Procedimentos Cirúrgicos Cardíacos , Acidente Vascular Cerebral , Administração Oral , Anticoagulantes/efeitos adversos , Fibrilação Atrial/diagnóstico , Fibrilação Atrial/tratamento farmacológico , Fibrilação Atrial/epidemiologia , Procedimentos Cirúrgicos Cardíacos/efeitos adversos , Hemorragia/induzido quimicamente , Hemorragia/epidemiologia , Humanos , Pandemias , Estudos Retrospectivos , Acidente Vascular Cerebral/epidemiologia , Varfarina/efeitos adversos
9.
Clin Appl Thromb Hemost ; 28: 10760296221131033, 2022.
Artigo em Inglês | MEDLINE | ID: mdl-36198012

RESUMO

Direct Oral Anticoagulants (DOACs) , which partially replace warfarin, have been developed as a safe and effective therapy for patients with stable coronary artery disease (SCAD) and atrial fibrillation (AF). However, the choice of DOACs and warfarin remains controversial. We conducted a network meta-analysis (NMA) using randomized controlled trials (RCTs) through a systematic literature review to evaluate the the efficacy and safety of DOACs in SCAD and AF patients. Five RCTs with 6524 patients were included. The results showed that patients taking DOACs had a lower risk of stroke/systemic embolism (OR, 0.64; 95% CI, 0.54-0.76, P < .00001, I2 = 89%), intracranial bleeding (OR, 0.41; 95% CI, 0.26-0.64, P = .0001, I2 = 0%), major bleeding (OR, 0.98; 95% CI, 0.81-1.148, P = .80, I2 = 88%), and all-cause mortality (OR, 1.04; 95% CI, 0.88-1.22, P = .66, I2 = 51%) than those taking warfarin. Compared to warfarin, rivaroxaban (20 mg, once/day) was more advantageous in preventing stroke/systemic embolism, as was apixaban (5 mg or 2.5 mg, twice/day) in reducing major bleeding (OR, 0.79; 95% CI, 0.48-1.3) and all-cause mortality (OR, 0.97; 95% CI, 0.69-1.4). Different doses of DOACs showed obvious advantages against intracranial hemorrhage, without significant differences. Thus, DOACs have more effective than warfarin in clinical efficacy and safety.


Assuntos
Fibrilação Atrial , Doença da Artéria Coronariana , Embolia , Acidente Vascular Cerebral , Administração Oral , Anticoagulantes/efeitos adversos , Fibrilação Atrial/complicações , Fibrilação Atrial/tratamento farmacológico , Doença da Artéria Coronariana/complicações , Doença da Artéria Coronariana/tratamento farmacológico , Embolia/tratamento farmacológico , Embolia/etiologia , Embolia/prevenção & controle , Hemorragia/induzido quimicamente , Hemorragia/tratamento farmacológico , Humanos , Metanálise em Rede , Rivaroxabana/uso terapêutico , Acidente Vascular Cerebral/prevenção & controle , Varfarina/efeitos adversos
10.
Clin Appl Thromb Hemost ; 28: 10760296221130058, 2022.
Artigo em Inglês | MEDLINE | ID: mdl-36198021

RESUMO

BACKGROUND: Direct oral anticoagulants (DOACs) are commonly used to prevent stroke and systemic embolism in patients with atrial fibrillation (AF). However, studies into their effectiveness and safety in the Thai population have so far been limited. OBJECTIVES: To study the effectiveness and safety of warfarin and DOACs among Thai AF patients. METHODS: A retrospective cohort study was conducted on AF patients at Ramathibodi Hospital from 2013 to 2018. All patients were followed for at least 1 year. Relevant clinical information was collected and compared between AF patient groups receiving warfarin, dabigatran, rivaroxaban, and apixaban. The primary outcome was a composite of major bleeding, ischemic stroke, and systemic thromboembolism. The secondary outcomes were all-cause mortality and disease-specific mortality caused by major bleeding, ischemic stroke, and systemic thromboembolism. RESULTS: A total of 1680 AF patients were enrolled in the study (warfarin 1193, apixaban 140, dabigatran 193, rivaroxaban 114). The estimated incidence of composite outcome was 16% [95% CI, 14-18%] and 12.4% [95% CI, 9.4-15.3%] in the warfarin and DOAC group, respectively, given a number needed to treat of 28 [95% CI, 3-52]. Compared with warfarin, DOACs were associated with both lower rate of all-cause mortality (4.9% [22/447] vs 8% [98/1193]) and lower disease-specific mortality (0.4% [2/447] and 1% [12/1193]). CONCLUSIONS: This study suggests DOACs were associated with a lower risk of major bleeding, ischemic stroke, and systemic thromboembolism compared to warfarin in Thai patients with AF. Patients receiving DOAC also had a lower rate of all-cause mortality and disease-specific mortality.


Assuntos
Fibrilação Atrial , AVC Isquêmico , Acidente Vascular Cerebral , Tromboembolia , Administração Oral , Anticoagulantes/efeitos adversos , Fibrilação Atrial/complicações , Fibrilação Atrial/tratamento farmacológico , Fibrilação Atrial/epidemiologia , Dabigatrana/efeitos adversos , Hemorragia/tratamento farmacológico , Humanos , Estudos Retrospectivos , Rivaroxabana/uso terapêutico , Acidente Vascular Cerebral/tratamento farmacológico , Acidente Vascular Cerebral/etiologia , Acidente Vascular Cerebral/prevenção & controle , Tailândia/epidemiologia , Tromboembolia/tratamento farmacológico , Varfarina/efeitos adversos
11.
BMC Med ; 20(1): 374, 2022 10 26.
Artigo em Inglês | MEDLINE | ID: mdl-36284318

RESUMO

BACKGROUND: Observational studies support a role for oral anticoagulation to reduce the risk of dementia in atrial fibrillation patients, but conclusive data are lacking. Since dabigatran offers a more stable anticoagulation, we hypothesized it would reduce cognitive decline when compared to warfarin in old patients with atrial fibrillation. METHODS: The GIRAF trial was a 24-month, randomized, parallel-group, controlled, open-label, hypothesis generating trial. The trial was done in six centers including a geriatric care unit, secondary and tertiary care cardiology hospitals in São Paulo, Brazil. We included patients aged ≥ 70 years and CHA2DS2-VASc score > 1. The primary endpoint was the absolute difference in cognitive performance at 2 years. Patients were assigned 1:1 to take dabigatran (110 or 150 mg twice daily) or warfarin, controlled by INR and followed for 24 months. Patients were evaluated at baseline and at 2 years with a comprehensive and thorough cognitive evaluation protocol of tests for different cognitive domains including the Montreal Cognitive Assessment (MoCA), Mini-Mental State Exam (MMSE), a composite neuropsychological test battery (NTB), and computer-generated tests (CGNT). RESULTS: Between 2014 and 2019, 5523 participants were screened and 200 were assigned to dabigatran (N = 99) or warfarin (N = 101) treatment. After adjustment for age, log of years of education, and raw baseline score, the difference between the mean change from baseline in the dabigatran group minus warfarin group was - 0.12 for MMSE (95% confidence interval [CI] - 0.88 to 0.63; P = 0.75), 0.05 (95% CI - 0.07 to 0.18; P = 0.40) for NTB, - 0.15 (95% CI - 0.30 to 0.01; P = 0.06) for CGNT, and - 0.96 (95% CI - 1.80 to 0.13; P = 0.02) for MoCA, with higher values suggesting less cognitive decline in the warfarin group. CONCLUSIONS: For elderly patients with atrial fibrillation, and without cognitive compromise at baseline that did not have stroke and were adequately treated with warfarin (TTR of 70%) or dabigatran for 2 years, there was no statistical difference at 5% significance level in any of the cognitive outcomes after adjusting for multiple comparisons. TRIAL REGISTRATION: Cognitive Impairment Related to Atrial Fibrillation Prevention Trial (GIRAF), NCT01994265 .


Assuntos
Fibrilação Atrial , Acidente Vascular Cerebral , Idoso , Humanos , Varfarina/efeitos adversos , Dabigatrana/efeitos adversos , Fibrilação Atrial/tratamento farmacológico , Fibrilação Atrial/complicações , Anticoagulantes/efeitos adversos , Brasil/epidemiologia , Acidente Vascular Cerebral/complicações , Cognição
12.
J Manag Care Spec Pharm ; 28(11): 1304-1315, 2022 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-36282935

RESUMO

BACKGROUND: Direct oral anticoagulants (DOACs) have become widely used for the prevention of stroke in nonvalvular atrial fibrillation (AF) and for the treatment of venous thromboembolism (VTE). Warfarin, the standard of care prior to DOACs, requires monitoring and dose adjustment to ensure patients remain appropriately anticoagulated. DOACs do not require monitoring but are significantly more expensive. We sought to examine real-world effectiveness and costs of DOACs and warfarin in patients with AF and VTE. OBJECTIVE: To examine clinical and economic outcomes. The clinical objectives were to determine the bleeding and thrombotic event rates associated with DOACs vs warfarin. The economic objectives were to determine the cost associated with these events, as well as the all-cause medical and pharmacy costs associated with DOACs vs warfarin. METHODS: This analysis was an observational, propensity-matched comparison of retrospective medical and pharmacy claims data for members enrolled in an integrated health plan between October 1, 2015, and September 30, 2020. Members who were older than 18 years of age with at least 1 30-day supply of warfarin or a DOAC filled within 30 days of a new diagnosis of VTE or nonvalvular AF were eligible for the analysis. Cox hazard ratios were used to compare differences in clinical outcomes, where paired t-tests were used to evaluate economic outcomes. RESULTS: After matching, there were 893 patients in each group. Among matched members, warfarin was associated with increased risk of nonmajor bleeds relative to apixaban (hazard ratio [HR] = 1.526; P = 0.0048) and increased risk of pulmonary embolism relative to both DOACs (apixaban: HR = 1.941 [P = 0.0328]; rivaroxaban: HR = 1.833 [P = 0.0489]). No statistically significant difference was observed in hospitalizations or in length of stay between warfarin and either DOAC. The difference-in-difference (DID) in total costs of care per member per month for apixaban and rivaroxaban relative to warfarin were $801.64 (P = 0.0178) and $534.23 (P = 0.0998) more, respectively. DID in VTE-related cost for apixaban was $177.09 less, relative to warfarin (P = 0.0098). DID in all-cause pharmacy costs for apixaban and rivaroxaban relative to warfarin were $342.47 (P < 0.0001) and $386.42 (P < 0.001) more, respectively. CONCLUSIONS: Warfarin use was associated with a significant decrease in total cost of care despite a significant increase in VTE-related costs vs apixaban. Warfarin was also associated with a significant increase in other nonmajor bleeds relative to apixaban, as well as a significant increase in pulmonary embolism relative to both DOACs. Warfarin was associated with a significant reduction in all-cause pharmacy cost compared with either DOAC. DISCLOSURES: The authors of this study have nothing to disclose.


Assuntos
Fibrilação Atrial , Embolia Pulmonar , Acidente Vascular Cerebral , Tromboembolia Venosa , Humanos , Lactente , Varfarina/efeitos adversos , Rivaroxabana/efeitos adversos , Tromboembolia Venosa/prevenção & controle , Estudos Retrospectivos , Revisão da Utilização de Seguros , Anticoagulantes/efeitos adversos , Fibrilação Atrial/complicações , Fibrilação Atrial/tratamento farmacológico , Piridonas/efeitos adversos , Hemorragia , Acidente Vascular Cerebral/etiologia , Acidente Vascular Cerebral/prevenção & controle , Embolia Pulmonar/prevenção & controle , Embolia Pulmonar/induzido quimicamente , Embolia Pulmonar/complicações , Administração Oral
13.
South Med J ; 115(10): 794-798, 2022 10.
Artigo em Inglês | MEDLINE | ID: mdl-36191918

RESUMO

OBJECTIVES: This study evaluated the occurrence of major bleeding following the initiation of oral anticoagulation therapy in patients with end-stage kidney disease (ESKD) in a community teaching hospital. METHODS: This was a single-center retrospective study that enrolled patients admitted to the study hospital with ESKD and who received oral anticoagulation (warfarin or nonvitamin K oral antagonists [NOACs]). The primary endpoint was the occurrence of major bleeding at any time while taking oral anticoagulation. Key secondary endpoints included occurrence of minor bleeding, thrombotic events, and hospitalizations because of bleeding or thrombosis. RESULTS: There were 36 patients who received warfarin and 32 patients who received a NOAC. A major bleeding event occurred in 15 of 36 patients (42%) in the warfarin group and in 5 of 32 patients (16%) in the NOAC group (P = 0.032). Hospitalizations as a result of either a bleeding event or a thrombosis occurred in 19 of 36 patients (53%) in the warfarin group and in 8 of 32 patients (25%) in the NOAC group (P = 0.026). The majority of patients in the NOAC group (69%) received a reduced dose for the indication. CONCLUSIONS: Warfarin increased the risk of major bleeding in patients with ESKD compared with NOACs and did not reduce the risk of thrombotic events.


Assuntos
Fibrilação Atrial , Falência Renal Crônica , Acidente Vascular Cerebral , Administração Oral , Anticoagulantes/efeitos adversos , Fibrilação Atrial/complicações , Fibrilação Atrial/tratamento farmacológico , Fibrilação Atrial/epidemiologia , Hemorragia/induzido quimicamente , Humanos , Falência Renal Crônica/complicações , Falência Renal Crônica/terapia , Estudos Retrospectivos , Acidente Vascular Cerebral/epidemiologia , Varfarina/efeitos adversos
14.
Medicina (Kaunas) ; 58(9)2022 Aug 29.
Artigo em Inglês | MEDLINE | ID: mdl-36143848

RESUMO

Background and Objectives: Warfarin and a skeletal muscle relaxant are co-treatments in nearly a quarter-million annual United States (US) office visits. Despite international calls to minimize patient harm arising from anticoagulant drug interactions, scant data exist on clinical outcomes in real-world populations. We examined effects of concomitant use of warfarin and individual muscle relaxants on rates of hospitalization for thromboembolism among economically disadvantaged persons. Materials and Methods: Using 1999-2012 administrative data of four US state Medicaid programs, we conducted 16 retrospective self-controlled case series studies: half included concomitant users of warfarin + one of eight muscle relaxants; half included concomitant users of an inhaled corticosteroid (ICS) + one of eight muscle relaxants. The ICS analyses served as negative control comparisons. In each study, we calculated incidence rate ratios (IRRs) comparing thromboembolism rates in the co-exposed versus warfarin/ICS-only exposed person-time, adjusting for time-varying confounders. Results: Among ~70 million persons, we identified 8693 warfarin-treated subjects who concomitantly used a muscle relaxant, were hospitalized for thromboembolism, and met all other inclusion criteria. Time-varying confounder-adjusted IRRs ranged from 0.31 (95% confidence interval: 0.13-0.77) for metaxalone to 3.44 (95% confidence interval: 1.53-7.78) for tizanidine. The tizanidine finding was robust after quantitatively adjusting for negative control ICS findings, and in numerous prespecified secondary analyses. Conclusions: We identified a potential >3-fold increase in the rate of hospitalized thromboembolism in concomitant users of warfarin + tizanidine vs. warfarin alone. Alternative explanations for this finding include confounding by indication, a native effect of tizanidine, or chance.


Assuntos
Fármacos Neuromusculares , Tromboembolia , Anticoagulantes/efeitos adversos , Humanos , Estudos Retrospectivos , Tromboembolia/epidemiologia , Varfarina/efeitos adversos
15.
BMC Nephrol ; 23(1): 310, 2022 09 09.
Artigo em Inglês | MEDLINE | ID: mdl-36085017

RESUMO

BACKGROUND: Performing percutaneous renal biopsy procedures in lupus nephritis (LN) and nephrotic syndrome presents a unique challenge to the nephrologist because of the risk of bleeding from the procedure and the hypercoagulable state in hypoalbuminemia. The management of a patient with venous thrombosis with perinephric hematoma post renal biopsy can be difficult if occurred. CASE PRESENTATION: We are presenting a case of perinephric hematoma following percutaneous renal biopsy in a 23-year-old man with lupus nephritis, nephrotic syndrome, and lower limbs deep vein thrombosis (DVT). The patient developed persistent frank haematuria, flank pain and acute urinary retention post-procedure. We have withheld his oral warfarin three days before the procedure, and no anticoagulation was given subsequently. Initial CT Angiography (CTA) renal showing stable hematoma and no visible evidence of vascular injury. Three weeks later, the patient still has persistent frank haematuria and a repeated CTA renal revealed new bilateral renal vein thrombosis. Considering the high risk of worsening symptomatic venous thrombosis, we gave subcutaneous enoxaparin sodium and restart oral warfarin despite ongoing haematuria. The frank haematuria resolved within two days of anticoagulation with no radiological evidence of worsening of the perinephric hematoma. The follow-up ultrasonography a month later showed resolution of the hematoma and renal vein thrombosis with no adverse effect. CONCLUSION: Our experience, in this case, highlighted the importance of case selection for percutaneous renal biopsy among high-risk patients. Additionally, a prolonged frank haematuria in post-renal biopsy with nephrotic syndrome warranted a reassessment, as a clinical presentation of post-procedure perinephric hematoma and renal vein thrombosis can overlap. We also demonstrated that restarting anticoagulation earlier than four weeks in a patient with renal vein thrombosis and post-renal biopsy perinephric hematoma can be safe in the selective case.


Assuntos
Nefropatias , Nefrite Lúpica , Síndrome Nefrótica , Doenças Ureterais , Trombose Venosa , Adulto , Biópsia/efeitos adversos , Enoxaparina/análogos & derivados , Hemorragia Gastrointestinal , Hematoma/diagnóstico por imagem , Hematoma/etiologia , Hematúria/etiologia , Humanos , Nefropatias/complicações , Nefrite Lúpica/complicações , Masculino , Síndrome Nefrótica/complicações , Veias Renais/diagnóstico por imagem , Doenças Ureterais/complicações , Trombose Venosa/complicações , Trombose Venosa/etiologia , Varfarina/efeitos adversos , Adulto Jovem
16.
Front Biosci (Schol Ed) ; 14(3): 21, 2022 07 21.
Artigo em Inglês | MEDLINE | ID: mdl-36137976

RESUMO

The most frequent arrhythmia treated is atrial fibrillation (AF), which necessitates the use of oral anticoagulants (OACs) to reduce the risk of thromboembolism and stroke. Patients with chronic kidney disease are more likely to develop AF, with a 10% frequency among those on chronic dialysis. Warfarin is the most widely prescribed OAC for individuals with end-stage kidney disease (ESKD). On the other hand, direct OACs (DOACs) are generally safer than warfarin, with fewer fatal bleeding events and a fixed dose that does not require close international normalized ratio (INR) monitoring. For those patients, warfarin and apixaban appear to be FDA-approved, whereas dabigatran, rivaroxaban, and edoxaban are not recommended yet. Due to a lack of large randomized studies, data from major trials cannot be extended to dialysis patients. In this review, we summarize the available data and literature referring to patients on chronic hemodialysis with concomitant AF. Due to the scarcity of data, we try to assist clinicians in selecting the appropriate therapy according to the specific characteristics of each patient. Finally, future directions are provided in two key areas of focus: left atrial appendage closure therapies and genetic research.


Assuntos
Fibrilação Atrial , Acidente Vascular Cerebral , Administração Oral , Anticoagulantes/uso terapêutico , Fibrilação Atrial/complicações , Fibrilação Atrial/tratamento farmacológico , Dabigatrana/uso terapêutico , Humanos , Diálise Renal , Rivaroxabana/uso terapêutico , Acidente Vascular Cerebral/complicações , Acidente Vascular Cerebral/tratamento farmacológico , Varfarina/efeitos adversos
17.
Open Heart ; 9(2)2022 09.
Artigo em Inglês | MEDLINE | ID: mdl-36104096

RESUMO

AIMS: To describe the use of warfarin and direct oral anticoagulants (DOACs) in patients with atrial fibrillation (AF) and chronic kidney disease (CKD), to evaluate changes in renal function over time and predictors of rapid decline, and to describe time in therapeutic range (TTR) and predictors of poor TTR among patients on warfarin. METHODS AND RESULTS: Using data from AuriculA, the Swedish oral anticoagulation registry, patients with AF on warfarin or DOAC were identified between 2013 and 2018 (N=6567). Estimated glomerular filtration rate (eGFR) was calculated and categorised into normal (≥90 mL/min/1.73 m2), mild CKD (60-89 mL/min/1.73 m2), moderate CKD (30-59 mL/min/1.73 m2), severe CKD (15-29 mL/min/1.73 m2) and end-stage CKD (<15 mL/min/1.73 m2)/dialysis. TTR was estimated using international normalised ratio (INR) measurements. Predictors of eGFR decline over time and of poor TTR were estimated using regression analysis. Between 2013 and 2018, use of DOAC increased from 9.2% to 89.3%, with a corresponding decline in warfarin. A similar trend was observed in patients with mild to moderate CKD, while DOAC over warfarin increased slower among patients with severe to end-stage CKD/dialysis. In patients treated with warfarin, the median TTR was 77.1%. Worse TTR was observed among patients with severe CKD (70.0%) and end-stage CKD/dialysis (67.5%). A gradual annual decline in eGFR was observed (-1.1 mL/min/1.73 m2), with a more rapid decline among patients with older age, female sex, diabetes mellitus and/or heart failure. CONCLUSION: In patients with AF, use of DOAC has steadily increased across different CKD stages, but not in patients with severe to end-stage CKD/dialysis despite these patients having poor INR control. Patients with AF have a gradual decline in renal function, with a more rapid decline among a subgroup of patients.


Assuntos
Fibrilação Atrial , Insuficiência Renal Crônica , Anticoagulantes/efeitos adversos , Fibrilação Atrial/complicações , Fibrilação Atrial/diagnóstico , Fibrilação Atrial/tratamento farmacológico , Feminino , Humanos , Rim/fisiologia , Insuficiência Renal Crônica/complicações , Insuficiência Renal Crônica/diagnóstico , Varfarina/efeitos adversos
18.
PLoS One ; 17(9): e0265998, 2022.
Artigo em Inglês | MEDLINE | ID: mdl-36048754

RESUMO

BACKGROUND: We investigated differences in risk of stroke, with all-cause mortality as a competing risk, in people newly diagnosed with atrial fibrillation (AF) who were commenced on either direct oral anticoagulants (DOACs) or warfarin treatment. METHODS AND RESULTS: We conducted a retrospective cohort study of the Oxford Royal College of General Practitioners (RCGP) Research and Surveillance Centre (RSC) database (a network of 500 English general practices). We compared long term exposure to DOAC (n = 5,168) and warfarin (n = 7,451) in new cases of AF not previously treated with oral anticoagulants. Analyses included: survival analysis, estimating cause specific hazard ratios (CSHR), Fine-Gray analysis for factors affecting cumulative incidence of events occurring over time and a cumulative risk regression with time varying effects.We found no difference in CSHR between stroke 1.08 (0.72-1.63, p = 0.69) and all-cause mortality 0.93 (0.81-1.08, p = 0.37), or between the anticoagulant groups. Fine-Gray analysis produced similar results 1.07 (0.71-1.6 p = 0.75) for stroke and 0.93 (0.8-1.07, p = 0.3) mortality. The cumulative risk of mortality with DOAC was significantly elevated in early follow-up (67 days), with cumulative risk decreasing until 1,537 days and all-cause mortality risk significantly decreased coefficient estimate:: -0.23 (-0.38-0.01, p = 0.001); which persisted over seven years of follow-up. CONCLUSIONS: In this large, contemporary, real world primary care study with longer follow-up, we found no overall difference in the hazard of stroke between warfarin and DOAC treatment for AF. However, there was a significant time-varying effect between anti-coagulant regimen on all-cause mortality, with DOACs showing better survival. This is a key methodological observation for future follow-up studies, and reassuring for patients and health care professionals for longer duration of therapy.


Assuntos
Fibrilação Atrial , Acidente Vascular Cerebral , Administração Oral , Anticoagulantes/efeitos adversos , Fibrilação Atrial/complicações , Fibrilação Atrial/diagnóstico , Fibrilação Atrial/tratamento farmacológico , Seguimentos , Hemorragia/epidemiologia , Humanos , Estudos Retrospectivos , Acidente Vascular Cerebral/epidemiologia , Varfarina/efeitos adversos
19.
Medicine (Baltimore) ; 101(35): e30335, 2022 Sep 02.
Artigo em Inglês | MEDLINE | ID: mdl-36107558

RESUMO

RATIONALE: Spontaneous intramural small-bowel hematoma (SISBH) is a rare complication of anticoagulation therapy. Presentation of SISBH can vary from mild abdominal pain to an acute abdomen. PATIENT CONCERNS: A 70-year-old woman was brought to the emergency department because of severe abdominal pain for 1 day. She had a medical history of coronary artery disease and paroxysmal atrial fibrillation and was receiving anticoagulation therapy with warfarin for 3 years. DIAGNOSIS: Computed tomography disclosed disproportional dilatation of the segmental small bowel and near-total obstruction of the intestinal lumen at the level of the jejunum, indicating an acute abdomen. INTERVENTIONS: We performed laparoscopic exploration and found a segmental distal jejunum was tense, heavy, firm, and discolored with a blue hue. Histopathological examination of the resected jejunum revealed diffuse hemorrhage and necrosis at the mucosa and submucosal layers, indicating SISBH. OUTCOMES: The patient had an uneventful recovery and was discharged in a relatively stable condition. LESSONS: Warfarin-induced SISBH presenting as an acute abdomen is an emergency condition that needs early diagnosis and timely management. Surgical intervention may be indicated for intestinal obstruction, ischemia, perforation, peritonitis, and intra-abdominal hemorrhage.


Assuntos
Abdome Agudo , Varfarina , Abdome Agudo/induzido quimicamente , Dor Abdominal/etiologia , Idoso , Anticoagulantes/efeitos adversos , Feminino , Hemorragia Gastrointestinal/induzido quimicamente , Hemorragia Gastrointestinal/complicações , Hematoma/diagnóstico , Hematoma/diagnóstico por imagem , Humanos , Varfarina/efeitos adversos
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