Non-vitamin K antagonist oral anticoagulation agents in patients with atrial fibrillation: Insights from Italian monitoring registries

Olimpieri, Pier Paolo; Lenarda, Andrea Di; Mammarella, Federica; Gozzo, Lucia; Cirilli, Alessia; Cuomo, Marcello; Gulizia, Michele Massimo; Colivicchi, Furio; Murri, G.; Gabrielli, Domenico; Trotta, Francesco

doi:10.1016/j.ijcha.2019.100465

Cited by 22 publications

(47 citation statements)

References 36 publications

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“…The present observational study showed how there are major differences between the baseline characteristics of NVAF patients newly treated with DOACs in a RW southern Italian setting compared to patients enrolled in pivotal RCTs. Our results are consistent with several RW studies on DOAC use and outcomes [ 18 , 19 , 20 ]. In an Australian RW study, clinical characteristics of patients receiving dabigatran and apixaban were fairly more similar with those included in RCT than rivaroxaban [ 18 ].…”

Section: Discussionsupporting

confidence: 93%

“…This has important implications about DOAC effectiveness and safety in females, as they frequently use DOACS but are under-represented in RCTs. A recent Italian study identified patients with NVAF who were prescribed a DOAC through the AIFA drug registries during the same study period as the present study (i.e., 2013–2017) [ 19 ]; these web-based monitoring registries are one of the many instruments adopted by the Italian National Health Service (NHS) in order to manage budget impact, uncertain clinical outcomes, and appropriate use of DOACs [ 19 ]. This study collected data for 683,172 patients from all the Italian regions, except the Emilia Romagna region.…”

Section: Discussionmentioning

confidence: 99%

See 1 more Smart Citation

Comparison of Direct Oral Anticoagulant Use for the Treatment of Non-Valvular Atrial Fibrillation in Pivotal Clinical Trials vs. the Real-World Setting: A Population-Based Study from Southern Italy

et al. 2021

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Patients enrolled into pivotal randomized controlled trials (RCTs) may differ substantially from those treated in a real-world (RW) setting, which may result in a different benefit–risk profile. The aim of the study was to assess the external validity of pivotal RCT findings concerning direct oral anticoagulants (DOACs) for the treatment of nonvalvular atrial fibrillation (NVAF) by comparing patients recruited in RCTs to those treated with DOACs registered in a southern Italian local health unit (LHU) in the years 2013–2017. The Palermo LHU claims database was used to describe the baseline characteristics of incident DOAC users (washout > 1 year) with NVAF compared with those of enrolled patients in DOAC pivotal RCTs. In the RW, DOAC treatment discontinuation was calculated during the follow-up and compared with DOAC treatment discontinuation of enrolled patients in DOAC pivotal RCTs. Rates of effectiveness and safety outcomes during the follow-up were calculated in an unmatched and in a simulated RCT population, by matching individual incidental RW and RCT DOAC users (excluding edoxaban users) on age, sex, and CHADS2 score. Overall, 42,336 and 7092 incident DOAC users with NVAF were identified from pivotal RCTs and from the RW setting, respectively. In RCTs, DOAC use was more common among males (62.6%) compared with an almost equal sex distribution in the RW. RCT patients were younger (mean age ± standard deviation: 70.7 ± 9.2 years) than RW patients (76.0 ± 8.6 years). Compared with RCTs, a higher proportion of RW dabigatran users (30.4% vs. 19.6%) and a lower proportion of RW apixaban (15.9% vs. 25.3%) and rivaroxaban (20.4% vs. 23.7%) users discontinued the treatment during the follow-up (p-value < 0.001). The rate of ischemic stroke was lower in RW high-dose dabigatran users (unmatched/-matched population: 0.40–0.11% per year) than in the Randomized Evaluation of Long-Term Anticoagulation Therapy (RE-LY) population (0.93% per year). Major bleeding rates were lower in RW users than in RCT users. In conclusion, except for dabigatran, a lower proportion of DOAC discontinuers was observed in the real-world than in pivotal RCT settings. This study provides reassurance to practicing physicians that DOAC use appears to be effective in stroke prevention and is likely safer in RW patients than in RCT enrolled patients. These results may be related to a lower burden of comorbidities despite more advanced age in the RW population compared to the pivotal RCT population.

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Section: Discussionsupporting

confidence: 93%

Section: Discussionmentioning

confidence: 99%

Comparison of Direct Oral Anticoagulant Use for the Treatment of Non-Valvular Atrial Fibrillation in Pivotal Clinical Trials vs. the Real-World Setting: A Population-Based Study from Southern Italy

et al. 2021

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“…Conversely, one third of patients on low dose reported by Coleman et al [29], in comparison with ours [6], were younger and with lower CHA₂DS₂-VASc, but with similar renal disease and risk of bleeding. Remarkably, patients on reduced dose in this study showed a trend towards a higher risk of ischemic stroke versus VKA users.…”

Section: Discussioncontrasting

confidence: 43%

“…Factors associated with the prescription of reduceddose of NOACs included older age, renal disease, bleeding risk and the concomitant use of drugs predisposing to bleeding. Given that treatment with reduced doses is dependent largely on clinical and demographic characteristics, the high prevalence of older patients observed to be on adjusted doses in our unselected nationwide population is not unexpected [6]. Indeed, these percentages are much higher than the frequency reported in key trials [8][9][10][11] (dabigatran 50%, rivaroxaban 21%, apixaban 5% and edoxaban 25%) and in real-world data from observational studies and registries [15][16][17].…”

Section: Discussionmentioning

confidence: 87%

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Starting dose and dose adjustment of Non-vitamin K antagonist oral anticoagulation agents in a nationwide cohort of patients with atrial fibrillation

Gozzo

Lenarda²,

Mammarella

et al. 2020

Preprint

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Purpose This study aims to provide real-world data about starting-dose of NOACs and dose- adjustment in patients with AF. In fact, even if new oral anticoagulation agents (NOACs) have a predictable effect without need for regular monitoring, dose-adjustments should be performed according to the summary of product information and international guidelines. Methods We employed the Italian Medicines Agency monitoring registries comprising data on a nationwide cohort of patients with AF treated with NOACs from 2013 to 2018. Logistic regression analysis was used to evaluate the determinants of dosage choice. Results During the reference period, treatment was commenced for 866539 patients. Forty-five percent of the first prescriptions were dispensed at a reduced-dose (dabigatran 60.3%, edoxaban 45.2%, apixaban 40.9%, rivaroxaban 37.4%). The prescription of reduced-dose was associated with older age, renal disease, bleeding risk and the concomitant use of drugs predisposing to bleeding, but not with CHA₂DS₂-VASc and HAS-BLED. A relative reduction of the proportion of patients treated with low-dosages was evident overtime for dabigatran and rivaroxaban; whereas prescription of low-dose apixaban and edoxaban increased progressively among elderly patients. Conclusions Evidence based on real-world data shows a high frequency of low-dose prescriptions of NOACs in AF patients. Except for older age, renal disease, bleeding risk and the concomitant use of drugs predisposing to bleeding, other factors that may determine the choice of reduced-dose could not be ascertained. There may be potential under-treatment of AF patients, but further evaluation is warranted.

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Impact of the COVID‐19 pandemic on prescription of sacubitril/valsartan in Italy

Rosano

Celant

Olimpieri

et al. 2022

European J of Heart Fail

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Aims The present study sought to examine the effect of the COVID‐19 pandemic and lockdown measures on the prescription of sacubitril/valsartan in patients with heart failure (HF) in Italy. Methods and results Data from Italian Medicines Agency (AIFA) monitoring registries were analysed. The sacubitril/valsartan monitoring registry is based on 6‐month prescriptions. A monthly aggregation on new activations throughout the observational period was computed. From March to December 2020, the initiation of new HF patients on sacubitril/valsartan decreased by nearly 40% with prescriptions dropping to values similar to 2018 when the registry was still operated off‐line. A slight increase in prescriptions was observed after the lockdown measures were lifted, but prescriptions remained constantly below the pre‐lockdown period. Conclusion A marked and worrisome decline during the COVID‐19 pandemic in the activation of a life‐saving treatment such as sacubitril/valsartan was observed. This decline was clearly linked to the lockdown measures instated to counteract the COVID‐19 pandemic. Upcoming studies should analyse the occurrence of new cases of HF as well as the severity of patients admitted to hospitals and their mortality compared to pre‐pandemic levels.

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Non-vitamin K antagonist oral anticoagulation agents in patients with atrial fibrillation: Insights from Italian monitoring registries

Cited by 22 publications

References 36 publications

Comparison of Direct Oral Anticoagulant Use for the Treatment of Non-Valvular Atrial Fibrillation in Pivotal Clinical Trials vs. the Real-World Setting: A Population-Based Study from Southern Italy

Comparison of Direct Oral Anticoagulant Use for the Treatment of Non-Valvular Atrial Fibrillation in Pivotal Clinical Trials vs. the Real-World Setting: A Population-Based Study from Southern Italy

Starting dose and dose adjustment of Non-vitamin K antagonist oral anticoagulation agents in a nationwide cohort of patients with atrial fibrillation

Impact of the COVID‐19 pandemic on prescription of sacubitril/valsartan in Italy

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