scholarly journals Characteristics of Apixaban-Treated Patients, Evaluation of the Dose Prescribed, and the Persistence of Treatment

2018 ◽  
Vol 23 (6) ◽  
pp. 494-501 ◽  
Author(s):  
Ainhoa Gomez-Lumbreras ◽  
Jordi Cortes ◽  
Maria Giner-Soriano ◽  
M. Angeles Quijada-Manuitt ◽  
Rosa Morros

Background: Apixaban is a direct oral anticoagulant, which inhibits factor Xa. It has demonstrated clinical efficacy in prevention of stroke and systemic embolism in adult patients with nonvalvular atrial fibrillation and a better safety profile compared to warfarin. Objectives: (1) To describe the characteristics of patients with nonvalvular atrial fibrillation beginning treatment with apixaban, (2) to analyze concomitant prescriptions of medications that could potentially interact with apixaban, (3) to evaluate the level of appropriate usage according to the recommended dosage, and (4) to estimate the level of apixaban persistence among naive and non-naive patients. Methods: Cohort study using data from primary care (System for Research in Primary Care database, users of the Institut Català de la Salut; Catalonia, Spain) from August 2013 to December 2015. Results: Mean age for apixaban-treated patients was 71.8 years (standard deviation = 11.1) and 55.6% were male. In all, 3.2% of patients receiving apixaban were taking drugs described as potentially related to either pharmacokinetic or pharmacodynamic interactions. According to the summary of product characteristics, 81.1% of patients with a recommended dose of 2.5 mg twice daily and 51.8% with a recommended dose of 5 mg twice daily actually took this dose. After 1 year of follow-up, 62.6% of the apixaban users showed good adherence. Conclusion: The prescribed dose of apixaban did not fully follow the recommended dose, particularly in patients who were treatment naive. Patients with a prior history of anticoagulant treatment were more likely to remain persistent to treatment with apixaban.

Author(s):  
Michael H Kim ◽  
Kelly F Bell ◽  
Dinara Makenbaeva ◽  
Daniel Wiederkehr ◽  
Jay Lin ◽  
...  

Objective: To evaluate the annual healthcare burden associated with dyspepsia among nonvalvular atrial fibrillation (NVAF) patients Methods: NVAF patients ≥18 years of age with continuous medical/prescription coverage were identified (1/1/2007-12/31/2009) from the MarketScan ® Commercial and Medicare Research Databases. Patients with at least 1 inpatient or 2 outpatient dyspepsia diagnoses within 12 months following any NVAF diagnosis were grouped into the dyspeptic cohort, with patients without any dyspepsia diagnosis during the entire study period grouped into the non-dyspeptic cohort. The date of first dyspepsia diagnosis after NVAF diagnosis and a random date within 12 months after NVAF diagnosis were selected as the index dates for dyspeptic and non-dyspeptic patients, respectively. Baseline and follow-up periods were each 12 months. Of the overall dyspeptic and non-dyspeptic cohorts, patients were matched (1:1) by key patient characteristics. The dyspeptic cohort was further categorized as having a prior history of dyspepsia (chronic) or no dyspepsia (non-chronic) during the baseline period. Healthcare utilization and costs were evaluated and compared during the follow-up for matched cohorts. Results: Of 142,322 NVAF patients included in the overall study population (mean age: dyspeptic: 73.68, non-dyspeptic: 72.09 years, p<0.001), 10.2% were diagnosed with dyspepsia, with 67% of them having no history of prior dyspepsia during the baseline. Among the matched study population (N=28,172), patients had similar baseline characteristics: mean Charlson Comorbidity Index score of 2.3 in both cohorts and mean CHADS 2 scores of 1.9 and 1.8 for the non-dyspeptic and dyspeptic cohort, respectively. During the follow-up period, healthcare resource utilization and related costs were significantly greater for the dyspeptic cohort vs. the non-dyspeptic cohort (Table). Patients with chronic dyspepsia were the least likely to receive warfarin in the follow-up period (non-dyspeptic: 57.2%, non-chronic: 50.4%, chronic: 46.6%, p<0.001). Conclusions: NVAF patients with dyspepsia used healthcare resources to a greater extent and had greater healthcare costs than NVAF patients without dyspepsia. Warfarin usage appeared to be lower among NVAF patients with dyspepsia.


2017 ◽  
Vol 31 (5) ◽  
pp. 503-506 ◽  
Author(s):  
Evan Sasson ◽  
Marian James ◽  
Mark Russell ◽  
Darko Todorov ◽  
Henry Cohen

Introduction: Rivaroxaban is a novel oral anticoagulant with several indications, one of which is for stroke prevention in nonvalvular atrial fibrillation. We present a case of probable rivaroxaban-induced rash. Case Summary: A 79-year-old female with a medical history of atrial fibrillation experienced a stroke, after which she was prescribed rivaroxaban 20 mg. After several days, she developed a rash requiring admission to the emergency department and several days of treatment. The rash resolved and she was switched from rivaroxaban to apixaban and did not experience any adverse drug events. Discussion: Onset of symptoms occurred within days of rivaroxaban initiation. The patient had no allergy history and never reported a similar reaction while on concurrent home medication regimen. The resolution of rash and toleration of apixaban suggest a rivaroxaban-specific reaction. The mechanism of this rash is currently unclear. Conclusion: We report one of the first cases of probable rivaroxaban-induced rash, whereas the patient tolerated apixaban. Further investigation is warranted, but prescribers should be cognizant of this potential issue when choosing a factor Xa inhibitor for anticoagulation.


Circulation ◽  
2020 ◽  
Vol 142 (Suppl_3) ◽  
Author(s):  
Randy Ip ◽  
Zulfiqar Qutrio Baloch ◽  
manel boumegouas ◽  
Abdullah Al abcha ◽  
Steven Do ◽  
...  

Introduction: Certain patient demographics and biomarkers have been shown to predict survival in patients infected with COVID-19. However, predictors of outcome in patients who are critically ill and require advanced respiratory support are unclear. Methods: We performed a multicenter analysis of 159 consecutive patients with confirmed COVID-19 who were admitted to Intensive Care Unit (ICU) between March 01, 2020 and April 30, 2020. Patients were then followed until May 23, 2020. Demographic data (age, sex, race, BMI) and past medical history (hypertension, diabetes, COPD, CKD, history of cardiac ischemic disease, atrial fibrillation and heart failure) were recorded. Laboratory values (troponin, CPK, pro-BNP, ferritin, LDH and d-dimer) were analyzed. Patient status was classified as either alive or deceased at hospital discharge or the end of follow up period. Results: Mean patient age was 66+/-15 and 53% were male. Mean BMI was 31+/- 9. Mean hospital ICU stay was 11+/-8 days. Mortality rate of this ICU cohort at the end of follow-up was 63%. Fifty-five (34%) patients were discharged from the hospital. A multivariable logistic regression analysis identified four factors (age, prior history of diabetes, prior history of atrial fibrillation and elevated troponin) that had significant and independent contributions to the likelihood of survival. Each increase in decade of age above 40 (p = 0.010) was predicted to reduce survival by 30%, the presence of diabetes (p = 0.041) by 57%, a prior history of atrial fibrillation (p= 0.011) by 75%, and each increase of 0.1 ng/mL of troponin above 0.05 ng/ml (p = 0.001) by 55%. Conclusion: Mortality of critically ill COVID-19 patients is high. Early aggressive treatment of high-risk patients identified in this study (advanced age, history of diabetes and atrial fibrillation and elevated troponin) could improve clinical outcome. The highly predictive value of elevated troponin levels on survival may indicate cardiac involvement of COVID-19 infection as a determinant of mortality. Additionally, of available published literature at this time, this is the first study that suggests a relationship between atrial fibrillation and increased mortality from COVID-19. Larger studies are needed to confirm these findings.


2020 ◽  
pp. 2000918
Author(s):  
Hannah R. Whittaker ◽  
Chloe Bloom ◽  
Ann Morgan ◽  
Deborah Jarvis ◽  
Steven J. Kiddle ◽  
...  

Accelerated lung function decline has been associated with increased risk of cardiovascular disease (CVD) in a general population, but little is known about this association in chronic obstructive pulmonary disease (COPD). We investigated the association between accelerated lung function decline and CVD outcomes and mortality in a primary care COPD population.COPD patients without a history of CVD were identified in the Clinical Practice Research Datalink (CPRD-GOLD) primary care dataset (n=36 282). Accelerated FEV1 decline was defined using the fastest quartile of the COPD population's decline. Cox regression assessed the association between baseline accelerated FEV1 decline and a composite CVD outcome over follow-up (myocardial infarction, ischaemic stroke, heart failure, atrial fibrillation, coronary artery disease, and CVD mortality). The model was adjusted for age, gender, smoking status, BMI, history of asthma, hypertension, diabetes, statin use, mMRC dyspnoea, exacerbation frequency, and baseline FEV1 percent predicted.6110 (16.8%) COPD patients had a CVD event during follow-up; median length of follow-up was 3.6 years [IQR 1.7–6.1]). Median rate of FEV1 decline was –19.4 mL·year−1 (IQR, –40.5 to 1.9); 9095 (25%) patients had accelerated FEV1 decline (>–40.5 mL·year−1), 27 287 (75%) did not (≤ –40.5 mL·year−1). Risk of CVD and mortality was similar between patients with and without accelerated FEV1 decline (HRadj 0.98 [95%CI, 0.90–1.06]). Corresponding risk estimates were 0.99 (95%CI 0.83–1.20) for heart failure, 0.89 (95%CI 0.70–1.12) for myocardial infarction, 1.01 (95%CI 0.82–1.23) for stroke, 0.97 (95%CI 0.81–1.15) for atrial fibrillation, 1.02 (95%CI 0.87–1.19) for coronary artery disease, and 0.94 (95%CI 0.71–1.25) for CVD mortality. Rather, risk of CVD was associated with mMRC score ≥2 and ≥2 exacerbations in the year prior.CVD outcomes and mortality were associated with exacerbation frequency and severity and increased mMRC dyspnoea but not with accelerated FEV1 decline.


2021 ◽  
Author(s):  
Tiantian Pang ◽  
Lindsay Murn ◽  
Dana Williams ◽  
Maayan Lawental ◽  
Anya Abhayakumar ◽  
...  

Background: Post-traumatic stress disorder (PTSD) is a psychiatric disorder commonly caused by a traumatic event(s) and prevalent among service members and veterans. Accelerated Resolution Therapy (ART) is an emerging "mind-body" psychotherapy for PTSD that is generally briefer and less expensive than current first-line treatments, such as cognitive processing therapy (CPT) and prolonged exposure (PE) therapy. Objective: This study aimed to examine the results of ART for treatment of military-related PTSD, with stratification by prior history of PTSD treatment, including refractory PTSD following receipt of guideline-driven first-line psychotherapy. Methods: The study compares the PTSD treatment results of ART between (military service members and/or) veterans with a prior history of PTSD treatment (medication only, n=40; first-line psychotherapy, n=33; other psychotherapy, n=42) and a treatment-naive group (n=33). Participants were assessed at baseline, post-treatment, and 3- or 6-month follow-up using PCL-M scores (PTSD checklist). Results: Mean age was 43.8 years, 95% male, 84% white race. The treatment completion rate was 72% with a mean of 3.5 treatment sessions. Within-group standardized effect sizes for pre-to-post changes in PTSD scores (PCL-M) were large at 1.11, 1.88, 1.03, and 1.48 for the medication only, first-line psychotherapy, other psychotherapy, and treatment-naive groups, respectively (p=0.02 for between-group comparison). Similar results were observed for measures of depression and anxiety, and baseline to follow-up results was generally similar. Conclusions: In a brief treatment period, ART appears to result in substantial reductions in symptoms of PTSD among veterans, including those previously treated (unsuccessfully) with first-line psychotherapies endorsed by the U.S. Department of Defense (DoD) and Veterans Affairs (VA). These results suggest that ART be considered as a treatment modality for veterans with refractory PTSD.


Blood ◽  
2015 ◽  
Vol 126 (23) ◽  
pp. 2933-2933 ◽  
Author(s):  
Mohammed Farooqui ◽  
Janet Valdez ◽  
Susan Soto ◽  
Amanda Bray ◽  
Xin Tian ◽  
...  

Abstract INTRODUCTION: Ibrutinib is approved for treatment (tx) of CLL in patients (pts) with previously treated disease and CLL with deletion (del) 17p. It has shown substantial improvements in progression free survival (PFS) and overall survival (OS) with a tolerable safety profile. Atrial fibrillation (Afib) has been observed in pts treated with ibrutinib, particularly in pts with cardiac risk factors, acute infections, and history of Afib. In the RESONATE study 3% of pts on ibrutinib developed Afib (median follow-up (f/u) 8.6 months (mo)) while 1% of pts on ofatumumab (median f/u 5.3 mo) developed Afib. Here we assessed the incidence of Afib in an independent cohort of pts with long f/u enrolled in our investigator-initiated trial of single agent ibrutinib. PATIENTS AND METHODS: This phase II trial (NCT01500733) enrolled 86 pts (Cohort 1: ≥ 65 years old (yo) without del 17p (n=35); Cohort 2: ≥ 18 yo with presence of del 17p (n=51)) who were treated with ibrutinib 420 mg daily continuously. Treatment-naive and previously treated pts in need of treatment (tx) were eligible. Safety data for Afib was compiled on all pts who received tx. All pts who developed Afib (per patient report or incidental finding) stopped ibrutinib therapy and underwent a cardiology evaluation which may have included an echocardiogram, stress test, and/or holter monitor at the discretion of the evaluating cardiologist. The annualized exposure adjusted incidence rate of Afib was estimated and compared between subgroups. RESULTS: At a median follow-up of 28 mo, 14 (16%) of 86 patients were found to have Afib while on study, 11 pts were ≥65 yo; 3 pts < 65 yo. In 9 (10%) pts this was the first recorded event, while 5 (6%) had a prior history of Afib. One patient developed Afib during pneumonia and in all other pts no contributing factors were identified. The median time to the first event on study was 18.24 (IQR: 10.8-26.0) mo. The annualized incidence was 0.052 (95% CI, 0.024- 0.099) events per person-year of treatment exposure among pts (n=81) without a prior history of Afib, 0.061 (95% CI: 0.025-0.126) in pts ≥65 yo (n=52), and 0.035 (95% CI: 0.004-0.125) in pts <65 yo (n=29, P =0.43 for difference in incidence based on age). In 11 (79%) of 14 pts Afib was grade 2, and in 3 (21%) grade 3. The grade 3 events required hospitalization and control of Afib through intravenous medications. All 3 pts had resolution of Afib and completed cardiology evaluation prior to restarting ibrutinib at a lower dose (280 mg), one received only aspirin (ASA) 81 mg, one received ASA 81 mg and an antiarrhythmic (sotalol), and one patient was anticoagulated with apixaban. Of 11 pts with grade 2 events, 6 (55%) pts currently do not have any symptoms or EKG findings of Afib, 3 (27%) pts intermittently have symptoms or EKG findings of Afib, and 2 (18%) pts have ongoing Afib. All of these 11 pts restarted ibrutinib at the same dose (420 mg); 5 received ASA 81 mg, 2 were on dabigatran transiently and then continued ASA 81 mg, and the other 4 pts started apixiban. F/u on apixiban ranges from 7-17 mo with no bleeding-related adverse events grade >1. CONCLUSION: The rate of Afib in this study at 16% is higher than previously reported, likely due to longer f/u. Indeed, the estimated Afib rate at 17 mo in RESONATE was 5.1%, similar to 5.6% at the same timepoint in our study. The annualized incidence rate of Afib in our study at 0.052 (95% CI, 0.024- 0.099) is higher than the estimated rate of 0.0124 per person-year in the general population (Schnabel et al, Lancet 2015). Given that the rate of Afib is higher in illness, longer follow-up in randomized studies will be needed to distinguish disease from drug-related factors. Notably, none of our pts had to discontinue ibrutinib because of Afib. Furthermore, there is currently no evidence that the severity of Afib in pts on ibrutinib differs from the general population. Given that the majority of our patients have del 17p and/or previously treated disease we feel that the risk-benefit profile favors continued ibrutinib treatment. In a small number of pts and with limited duration of observation we have not noted any serious bleeding complications in pts on ibrutinib and concurrent apixaban or 81 mg ASA. Research supported by the Intramural Research Program of NHLBI. We thank our patients for participation. We acknowledge Pharmacyclics for providing study drug. Disclosures Wiestner: Pharmacyclics: Research Funding.


2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
J Benezet Mazuecos ◽  
A Devesa Arbiol ◽  
C S Garcia Talavera ◽  
J A Iglesias ◽  
E Serrano ◽  
...  

Abstract Introduction Both atrial and ventricular pacing (AP/VP) have been related to a higher risk of clinical atrial fibrillation (AF) documented on ECG. Subclinical AF is detected as atrial high rate episodes (AHRE) by cardiac implantable electronic devices and is related to a higher risk of stroke. Purpose The aim of this study was to determine whether the percentage of AP and/or VP in patients with pacemakers and no history of AF is related with the future development of subclinical AF (AHRE) and/or clinical AF (ECG documented). Methods From February 2012 to September 2015 we recruited patients with dual chamber pacemakers and no prior history of AF. Patients were followed at 3 months and every year then after. Subclinical AF, clinical AF and cardiovascular events were registered. AHRE (subclinical AF) was defined as an episode of atrial rate ≥225 bpm with a minimum duration of 5 min. Clinical AF was defined as ECG documented AF. Percentage of AP/VP was determined as the mean AP/VP during the first three visits. Mortality and cardiovascular events (including AF, stroke and hospitalization for heart failure) were also recorded. Results 249 patients (57% men; 75±9 years-old) were included. Mean time from pacemaker implantation was 9 months and the main indication was AV-block in 53% of the patients. Mean CHA2DS2-VASc score was 3.5±1.5. After a mean follow-up of 33±11 months, 38.5% of patients developed subclinical AF and 10.4% clinical AF. Patients with AP≥50% presented significantly higher risk of AHRE (62.5% vs 32.3%, OR 3.48; 95% CI [1.93–6.4] p<0.01) and clinical AF (18.7% vs 8.6%, OR 2.4; 95% CI [1.05–5.52] p<0.05). Patients with VP≥50% presented significantly higher risk of AHRE (46.4% vs 31.6%, OR 1.87; 95% CI [1.10–3.24] p<0.05) and clinical AF (25.9% vs 9.7%, OR 2.7; 95% CI [1.13–7.72] p<0.05). The percentage of AP and VP were not related to a higher risk of cardiovascular events or mortality. Multivariate analysis showed that AP≥50% was an independent predictor for AHRE (OR 2.4; 95% CI [1.19–4.97] p=0.014). Conclusions Pacing is related to a higher risk for developing subclinical and clinical AF in patients with dual-chamber pacemakers and no history of previous AF. Our data suggest, that patients presenting a high percentage of AP and VP should be closely followed during routinely pacemaker check-ups assessing for subclinical AF, especially in those with AP ≥50%.


TH Open ◽  
2017 ◽  
Vol 01 (02) ◽  
pp. e139-e145 ◽  
Author(s):  
Vinai Bhagirath ◽  
John Eikelboom ◽  
Jack Hirsh ◽  
Michiel Coppens ◽  
Jeffrey Ginsberg ◽  
...  

Background In patients with nonvalvular atrial fibrillation (AF), apixaban is given in doses of 5 or 2.5 mg twice daily, according to clinical characteristics. The usual on-treatment range of apixaban drug levels, as determined by apixaban-calibrated anti-factor Xa (anti-Xa) activity, has previously been measured in small cohorts; however, the association between anti-Xa activity and clinical outcomes and the predictors of variability in anti-Xa activity have not been well studied in the AF population. Methods and Results Anti-Xa activity was measured before taking the morning dose, 3 months after enrollment in the AVERROES study using a calibrated anti-Xa assay (Rotachrom). Patients with two of the following criteria—age >80; weight <60 kg; or creatinine >133 μg/L—received 2.5 mg twice daily (n = 145), while all others received 5 mg twice daily (n = 2,247). A total of 2,392 patients were included, with median follow-up of 1.1 years. Median apixaban anti-Xa activity was 122 ng/mL (interquartile range [IQR]: 63–198 ng/mL) for the entire group; 99 ng/mL (IQR: 60–146 ng/mL) for the 2.5-mg group; and 125 ng/mL (IQR: 64–202 ng/mL) for the 5-mg group (p = 0.003). A relationship was evident between bleeding and anti-Xa activity (p = 0.01), which was driven by minor bleeding. No relationship was evident between major bleeding or stroke/systemic embolism and anti-Xa activity. In those receiving the 5-mg dose, estimated glomerular filtration rate, sex, and age had the strongest association with anti-Xa activity. Conclusion There is considerable variability in anti-Xa activity among AF patients receiving apixaban. Rates of major bleeding and stroke/systemic embolism were low irrespective of anti-Xa activity. Clinical Trial Registration ClinicalTrials.gov NCT00496769; https://clinicaltrials.gov/ct2/show/NCT00496769.


Circulation ◽  
2014 ◽  
Vol 130 (suppl_2) ◽  
Author(s):  
John Camm ◽  
Samuel Z Goldhaber ◽  
Giuseppe Ambrosio ◽  
Petr Jansky ◽  
Wael Al Mahmeed ◽  
...  

Purpose: To evaluate the influence of gender on baseline characteristics and 1-year clinical outcomes in patients with non-valvular atrial fibrillation (AF). Methods: In the ongoing, international registry GARFIELD, a total of 12,458 prospective patients were enrolled at 739 randomly selected sites in 30 countries between March 2010 and January 2013. Results: Compared with men, women with AF were more likely to be older and have a history of hypertension or venous thromboembolism, but less likely to have a history of vascular disease. Use of antithrombotic therapy was similar in the two groups. At 1-year follow-up, the hazard ratio for women versus men, adjusted for age group, use of vitamin K antagonist, Factor Xa inhibitor, direct thrombin inhibitor, and antiplatelet, congestive cardiac failure, hypertension, diabetes, stroke/transient ischaemic attack, and vascular disease, was 0.815 (95% confidence interval, 0.695-0.957) for the incidence of all-cause mortality, 1.414 (1.053-1.899) for the incidence of stroke/systemic embolism (SE), and 1.024 (0.714-1.470) for the incidence of major bleeding. Conclusion: These findings suggest that women with non-valvular AF have a lower mortality rate despite a higher stroke/SE rate compared with men.


Circulation ◽  
2020 ◽  
Vol 142 (Suppl_3) ◽  
Author(s):  
Aung N Lin ◽  
Gary Peng ◽  
Edmond Obeng-Gyimah ◽  
Naga K Pothineni ◽  
Soe P Winn ◽  
...  

Introduction: Patients undergoing typical atrial flutter (AFL) ablation remain at risk of developing atrial fibrillation (AF). However, it is unknown whether common risk factors associated with AF occurrence, particularly race, bear out in this population. Hypothesis: We sought to compare the occurrence of new AF in male veteran African-American (AA) and Caucasian (Cau) patients with AFL following successful cavo-tricuspid isthmus ablation. Methods: A retrospective review of patients undergoing AFL ablation between 2002 and 2019 was performed. Patients with prior history of AF were excluded. Records were reviewed and demographics, comorbidities and post-ablation outcomes including new AF and stroke were recorded. The overall incidence of AF and cases per 1000 person-years (CPTPY) were determined. Results: The study cohort comprised 217 patients (age: 66±9.3 years, AA: 97 [45%], Cau:108 [50%]; see Table) with a mean follow-up of 55±42 months after AFL ablation. New AF was detected in 30 (31%) AA and 45 (42%) Cau patients (p=0.21 by Log Rank test). Overall incidence of AF was 78 CPTPY (67 and 91 CPTPY cases in AA and Cau patients, respectively). Time to occurrence of AF was earlier in Cau than AA patients (p=<0.001). New stroke events occurred in 9 (4.4%) patients (4 AA, 5 Cau; p=0.86). Conclusions: Male AA and Cau patients have similar significant risks for developing AF and experiencing stroke after AFL ablation.


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