Correction: Cost-effectiveness of apixaban compared to other anticoagulants in patients with atrial fibrillation in the real-world and trial settings.
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ABSTRACT:
SUBMITTER: de Jong LA
PROVIDER: S-EPMC8970364 | biostudies-literature | 2022
REPOSITORIES: biostudies-literature
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Correction: Cost-effectiveness of apixaban compared to other anticoagulants in patients with atrial fibrillation in the real-world and trial settings.
de Jong Lisa A LA Groeneveld Jessie J Stevanovic Jelena J Rila Harrie H Tieleman Robert G RG Huisman Menno V MV Postma Maarten J MJ van Hulst Marinus M
PloS one 20220331 3
[This corrects the article DOI: 10.1371/journal.pone.0222658.]. ...[more]
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Project description:IntroductionRandomized clinical trials (RCTs) and real-world data (RWD) in patients with atrial fibrillation have shown that-compared to vitamin K antagonists (VKAs)-non-VKA oral anticoagulants (NOACs) are at least as effective in the prevention of ischaemic stroke, while decreasing the risk of bleeding.ObjectiveWe aim to evaluate the cost-effectiveness of the NOAC apixaban versus other NOACs (dabigatran, edoxaban and rivaroxaban) and VKA, for stroke prevention in patients with atrial fibrillation by including the available data both from RCT and real-world analyses of all NOACs into one integrative previously published model.MethodsThe model was updated to the current Dutch healthcare situation. The incremental cost-effectiveness ratio was calculated using either efficacy/effectiveness and safety data derived from a network meta-analysis (NMA) synthesizing NOAC RCTs or RWD. We conducted a systematic literature search to identify eligible publication to best inform the RWD-based analysis. Additional sensitivity and scenario analyses were conducted to test the robustness of the outcomes.ResultsIn the NMA-based analysis, apixaban appeared to be cost-effective compared to VKA (€3,506 per quality adjusted life-year) and dominant (cost-saving and more effective) over dabigatran 110 mg, dabigatran 150 mg, edoxaban and rivaroxaban. In the RWD-based analysis, apixaban was dominant over all other anticoagulants. In the scenario analysis apixaban appeared to be not cost-effective compared to dabigatran 150 mg, when using equal event-unrelated treatment discontinuation rates for each drug. In all other scenarios apixaban is cost-effective or cost-saving compared to VKA and other NOACs.ConclusionBased on RCTs as well as RWD, we conclude that apixaban is generally cost-effective or even cost-saving (less costly and more effective) compared to VKA and other NOACs in the overall population of patients with atrial fibrillation.
| S-EPMC6748426 | biostudies-literature
Project description:This study aims to measure the plasma levels of rivaroxaban and apixaban among Asian patients with atrial fibrillation and compare the results with expected drug levels from clinical studies. A total of 73 patients taking rivaroxaban and 105 patients taking apixaban were enrolled. Peak and trough levels were measured using ultra-high performance liquid chromatography with tandem mass spectrometry. The percentage of those with drug levels within the expected range reported in clinical studies was significantly higher in the apixaban group than in the rivaroxaban group, both for trough (84.8% vs. 64.4%; P = 0.002) and peak levels (76.9% vs. 33.8%; P < 0.001). After adjusting for age, sex, kidney function, appropriate dose, and adherence, patients taking rivaroxaban were still less likely to have peak and trough levels within the expected drug levels. Our real-world data suggests that Asian patients taking rivaroxaban are more likely to have out-of-expected drug levels than those taking apixaban.
| S-EPMC6977317 | biostudies-literature
Project description:Discontinuation of oral anticoagulants may expose non-valvular atrial fibrillation (NVAF) patients to an increased risk of stroke. This study describes the real-world discontinuation rates and compared the risk of drug discontinuation among NVAF patients initiating apixaban, warfarin, dabigatran, or rivaroxaban. This retrospective cohort study evaluated newly-anticoagulated NVAF patients in the MarketScan® data population from 01/01/2012 through 12/31/2014. Discontinuation was defined as a lack of subsequent prescription of the index drug within 30 days after the last supply day of the last prescription. A Cox model was used to estimate the hazard ratio (HR) of discontinuation, adjusted for age, sex, and comorbidities. Among 45,361 eligible NVAF patients, 15,461 (34.1%) initiated warfarin; 7,438 (16.4%) apixaban; 4,661 (10.3%) dabigatran; and 17,801 (39.2%) initiated rivaroxaban treatment. Compared to warfarin, patients who initiated dabigatran (adjusted HR [aHR]: 0.84, 95% confidence interval [CI]: 0.80-0.87, P<0.001), rivaroxaban (aHR: 0.70, 95% CI: 0.68-0.73, P<0.001), or apixaban (aHR: 0.57, 95% CI: 0.55-0.60, P<0.001) were 16%, 30%, and 43% less likely to discontinue treatment, respectively. When compared to apixaban, patients who initiated dabigatran (aHR: 1.46, 95% CI: 1.38-1.54, P<0.001) or rivaroxaban (aHR: 1.23, 95% CI: 1.17-1.28, P<0.001) were more likely to discontinue treatment. Among newly-anticoagulated NVAF patients in the real-world setting, initiation on rivaroxaban, dabigatran, or apixaban was associated with a significantly lower risk of discontinuation compared to warfarin. When compared to apixaban, patients who initiated treatment with warfarin, dabigatran, or rivaroxaban were more likely to discontinue treatment.
| S-EPMC5927458 | biostudies-literature
Project description:Background/Objectives: The use of direct oral anticoagulants (DOACs) in obese patients is scarcely studied despite having many advantages over warfarin. Consequently, this study aims to assess the real-world safety and effectiveness of apixaban compared to warfarin in treating atrial fibrillation (AF) in obese patients. Methods: A retrospective cohort study examined consecutive AF patients with a BMI of ≥ 30 kg/m2 treated with apixaban or warfarin. Patients were started on these medications between January 2015 and December 2021. Efficacy outcomes included ischemic stroke and venous thromboembolism (VTE) occurrences, while safety outcomes encompassed bleeding incidents and mortality rates. Outcomes were assessed following propensity score matching. Results: We identified 876 patients treated with either apixaban (414) or warfarin (462). Their mean age was 76.9, with a mean CHA2DS2VASc score of 4.9 ± 1.97. After matching and compared to warfarin, apixaban was correlated with a lower incidence of all-cause mortality (19.7% vs. 33.7%, p < 0.001). The incidences of stroke, venous thromboembolism (VTE), and bleeding events were (4.7% vs. 4.7%, p = 1.000), (1.0% vs. 2.6%, p = 0.107), and (3.9% vs. 6.2%, p = 0.139), respectively. Using Cox-regression model, apixaban was associated with lower mortality risk (HR = 0.728, 95% CI: 0.55-0.97; p = 0.030) which remained significant after adjusting for the conventional cardiovascular risk factors and BMI values. Conclusions: Apixaban is associated with a trend of reduced incidence of thromboembolism among obese patients with atrial fibrillation and significantly lowers all-cause mortality. Despite earlier concerns, the use of apixaban is an effective and safe alternative to warfarin among obese patients with AF.
| S-EPMC11853457 | biostudies-literature
Project description:Objective: Little is known about initial prescription of currently used oral anticoagulants (OAC), and correlated characteristics in real-world practice. We aimed to assess patterns of initiation of Vitamin K antagonists (VKA) and non-VKA oral anticoagulants (NOAC) in naive patients with non-valvular atrial fibrillation and the factors associated with starting treatment with NOAC. Methods: Population-based retrospective cohort study of all patients with NVAF who had a first prescription of OAC from November 2011 to February 2014 in the Valencia region, Spain (n = 21,881). Temporal trends of OAC initiation are described for the whole population and by type of OAC and therapeutic agent. Factors associated with starting treatment with NOAC (vs. VKA) were identified using logistic multivariate regression models. Results: Among the patients initiating OAC, 25% started with NOAC 2 years after market release. Regarding temporal trends, prescription of NOAC doubled during the study period. VKA prescription also increased (by around 13%), resulting in a 30% rise in total treatment initiation with OAC during 2011-2014. NOAC initiation (vs. VKA) was associated with a lower baseline risk of thromboembolism and higher income. Conclusions: In this Spanish population-based cohort, initiation of OAC therapy saw a rapid increase, mainly but not exclusively, due to a two-fold rise in the use of NOAC. Initiation with NOAC was associated with a lower baseline risk of thromboembolism and higher income, which opposes the indications of NOAC use and reflects disparities in care. Inadequate prescription patterns might threaten the effectiveness and safety of these therapies, thus monitoring OAC prescription is necessary and should be setting-specific.
| S-EPMC5314137 | biostudies-literature
Project description:Background and purposeThis study aimed to evaluate the comparative efficacy and safety of 4 non-vitamin K antagonist oral anticoagulants (NOACs) and warfarin in Asians with non-valvular atrial fibrillation in real-world practice through a network meta-analysis of observational studies.MethodsWe searched multiple comprehensive databases (PubMed, Embase, and Cochrane library) for studies published until August 2020. Hazard ratios and 95% confidence intervals were used for the pooled estimates. Efficacy outcomes included ischemic stroke (IS), stroke/systemic embolism (SSE), myocardial infarction (MI), and all-cause mortality, and safety outcomes included major bleeding, gastrointestinal (GI) bleeding, and intracerebral hemorrhage (ICH). The P score was calculated for ranking probabilities. Subgroup analyses were separately performed in accordance with the dosage range of NOACs ("standard-" and "low-dose").ResultsA total of 11, 6, and 8 studies were allocated to the total population, standard-dose group, and low-dose group, respectively. In the total study population, edoxaban ranked the best in terms of IS and ICH prevention and apixaban ranked the best for SSE, major bleeding, and GI bleeding. In the standard-dose regimen, apixaban ranked the best in terms of IS and SSE prevention. For major bleeding, GI bleeding, and ICH, edoxaban ranked the best. In the low-dose regimen, edoxaban ranked the best for IS, SSE, GI bleeding, and ICH prevention. For major bleeding prevention, apixaban ranked best.ConclusionsAll 4 NOACs had different efficacy and safety outcomes according to their type and dosage. Apixaban and edoxaban might be relatively better and more well-balanced treatment for Asian patients with non-valvular atrial fibrillation.
| S-EPMC8360482 | biostudies-literature
Project description:There is no direct evidence comparing the 2 most commonly prescribed direct oral anticoagulants, apixaban and rivaroxaban, used for stroke prevention in nonvalvular atrial fibrillation (NVAF). A number of network meta-analyses (NMAs) of randomized control trials and real-world evidence (RWE) studies comparing the efficacy, effectiveness, and safety of apixaban and rivaroxaban have been published; however, a comprehensive evidence review across the available body of evidence is lacking. In this study, we aimed to systematically review and evaluate the clinical outcomes of apixaban and rivaroxaban using a combination of data gleaned from both NMAs and RWE studies. The review identified 21 NMAs and 5 RWE studies. The data demonstrated that apixaban was associated with fewer major bleeding events compared to rivaroxaban. There was no difference in the efficacy/effectiveness profiles between these treatments. Bleeding is a serious complication of anticoagulation therapy for the management of NVAF, and is associated with increased rates of hospitalization, morbidity, mortality, and health-care expenditure. The majority of studies in this comprehensive evidence review suggests that apixaban has a lower risk of major bleeding events compared to rivaroxaban in patients with NVAF.
| S-EPMC7098208 | biostudies-literature
Project description:Purpose:We conducted this study to assess the real-world prevalence, nature, predictors, and clinical necessity of apixaban pharmacokinetic (PK) and pharmacodynamic (PD) drug interactions in patients with non-valvular atrial fibrillation (NVAF) at a tertiary medical institution in Saudi Arabia. Patients and Methods:An observational retrospective cohort analysis was conducted in adult patients diagnosed with NVAF receiving apixaban for stroke prevention from the period of June 2015 to May 2019. Results:Of the 1271 patients included in the analysis, 611 (48.1%) patients had potential PD- or PK-drug interactions with apixaban. Of those, 490 (38.6%) patients had potential PD drug-drug interactions (DDIs) and 121 (9.5%) patients had potential PK-DDIs. PD-DDIs with apixaban were mainly with antiplatelet therapy followed by non-steroidal anti-inflammatory drugs and antidepressants. PK-DDIs with apixaban were mainly with combined P-gp/CYP3A4 inhibitors or inducers. History of minor bleeding was positively correlated with PD-DDIs with apixaban, ß coefficient = 0.455 (OR 1.58; 95% CI 1.01-2.45); p<0.05. History of acute coronary syndrome was positively correlated with PD-DDIs with apixaban, ß coefficient = 0.515 (OR 1.60; 95% CI 1.36-1.99); p<0.05. History of heart failure was positively correlated with PK-DDIs with apixaban, ß coefficient = 0.459 (OR 1.58; 95% CI 1.07-2.35); p<0.05. Almost 15% of the included patients had no clinical indication to receive the potential interacting drug with apixaban and about 20% of them were assuming an inappropriate apixaban dose according to the product package insert. Conclusion:Pharmacodynamics and pharmacokinetics interactions are common in more than half of the patients with NVAF receiving apixaban for stroke prevention in this real-world analysis. Some of these interacting medications are not indicated. Drug-drug interactions should always be considered and monitored with apixaban with a regular assessment of the need for any interacting medication.
| S-EPMC7383111 | biostudies-literature
Project description:BackgroundStroke prevention is complicated in patients with atrial fibrillation (AF) and coronary artery disease (CAD). We compared the risk of major bleeding among Japanese patients with AF and CAD commencing warfarin, dabigatran, or rivaroxaban.MethodsThis study included adults with AF and CAD who were newly prescribed the non-vitamin K antagonist oral anticoagulants (NOACs) dabigatran or rivaroxaban, or warfarin, and registered between 18 April 2011 through 31 December 2020 in the Medical Data Vision hospital-based clinical database. The primary outcome was major bleeding, and the secondary outcome was a composite of stroke, systemic embolism, myocardial infarction, all-cause inpatient mortality, major bleeding, major gastrointestinal bleeding, and intracerebral hemorrhage. Cox proportional hazard models with stabilized inverse probability treatment weighting were used to estimate hazard ratios (HRs) with 95 % CIs via a two-step approach; first between warfarin and each NOAC, then between NOACs if sample size conditions were met.ResultsDabigatran, rivaroxaban, and warfarin groups included 6712, 20,329, and 12,316 patients, respectively. Major bleeding risk was lower in NOACs versus warfarin (dabigatran: HR 0.50, 95 % CI: 0.40-0.62; rivaroxaban: HR 0.78, 95 % CI: 0.69-0.90); this risk was lower with dabigatran compared with rivaroxaban (HR 0.64, 95 % CI: 0.51─0.79). Net clinical benefit was superior to warfarin in both NOACs (dabigatran: HR 0.78, 95 % CI: 0.71-0.85; rivaroxaban: HR 0.83, 95 % CI: 0.78-0.88).ConclusionsAmong real-world Japanese patients with AF and CAD, NOACs were associated with better clinical outcomes than warfarin. Treatment with dabigatran had a lower risk of major bleeding than rivaroxaban.Clinical trial registration: NCT05051904 (ClinicalTrials.gov).
| S-EPMC10651495 | biostudies-literature
Project description:ObjectiveTo compare the cost-effectiveness of apixaban vs warfarin for secondary stroke prevention in patients with atrial fibrillation (AF).MethodsUsing standard methods, we created a Markov decision model based on the estimated cost of apixaban and data from the Apixaban for Reduction in Stroke and Other Thromboembolic Events in Atrial Fibrillation (ARISTOTLE) trial and other trials of warfarin therapy for AF. We quantified the cost and quality-adjusted life expectancy resulting from apixaban 5 mg twice daily compared with those from warfarin therapy targeted to an international normalized ratio of 2-3. Our base case population was a cohort of 70-year-old patients with no contraindication to anticoagulation and a history of stroke or TIA from nonvalvular AF.ResultsWarfarin therapy resulted in a quality-adjusted life expectancy of 3.91 years at a cost of $378,500. In comparison, treatment with apixaban led to a quality-adjusted life expectancy of 4.19 years at a cost of $381,700. Therefore, apixaban provided a gain of 0.28 quality-adjusted life-years (QALYs) at an additional cost of $3,200, resulting in an incremental cost-effectiveness ratio of $11,400 per QALY. Our findings were robust in univariate sensitivity analyses varying model inputs across plausible ranges. In Monte Carlo analysis, apixaban was cost-effective in 62% of simulations using a threshold of $50,000 per QALY and 81% of simulations using a threshold of $100,000 per QALY.ConclusionsApixaban appears to be cost-effective relative to warfarin for secondary stroke prevention in patients with AF, assuming that it is introduced at a price similar to that of dabigatran.
| S-EPMC3525294 | biostudies-literature