Rivaroxaban Use in Patients with Hemoglobinopathies

Apostolou, Chrysa; Klonizakis, Philippos; Mainou, Maria; Kapsali, Eleni; Kafantari, Katerina; Kotsiafti, Aggeliki; Vetsiou, Evaggelia; Vakalopoulou, Sofia; Vlachaki, Efthymia

doi:10.1080/03630269.2017.1374969

Cited by 18 publications

(11 citation statements)

References 8 publications

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“…Only one study tested the effectiveness of rivaroxaban in a very small group of patients with β-thalassemia and AF. In five patients, the direct inhibitor of factor X was administered, while in three patients, warfarin was prescribed; during the follow-up none of the eight patients suffered from any event of either ischemic or hemorrhagic type [ 60 ]. Further data are therefore necessary in order to assess the non-inferiority of DOACs respect to vitamin K inhibitors in patients with hemoglobinopathies.…”

Section: Treatment Optionsmentioning

confidence: 99%

Atrial Fibrillation in β-Thalassemia: Overview of Mechanism, Significance and Clinical Management

Malagù

Marchini

Fiorio

et al. 2022

Biology

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Thalassemia is an inherited blood disorder with worldwide distribution. Transfusion and chelation therapy have radically improved the prognosis of β-thalassemic patients in the developed world, but this has led to the development of new chronic cardiac complications like atrial fibrillation (AF). Prevalence of AF in patients with β-thalassemia is higher than in the general population, ranging from 2 to 33%. Studies are lacking, and the little evidence available comes from a small number of observational studies. The pathophysiology is not well understood but, while iron overload seems to be the principal mechanism, AF could develop even in the absence of iron deposition. Furthermore, the clinical presentation is mainly paroxysmal, and patients are highly symptomatic. The underlying disease, the pathophysiology, and the clinical presentation require a different management of AF in β-thalassemia than in the general population. Rhythm control should be preferred over rate control, and the most important antiarrhythmic therapy is represented by chelation drugs. Thromboembolic risk is high, but the available risk scores are not validated in β-thalassemia, and the choice of anticoagulation therapy should be considered early. The main purpose of this review is to summarize the actual knowledge about AF in β-thalassemia, with a specific focus on the clinical management of these complex patients.

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Section: Treatment Optionsmentioning

confidence: 99%

Atrial Fibrillation in β-Thalassemia: Overview of Mechanism, Significance and Clinical Management

Malagù

Marchini

Fiorio

et al. 2022

Biology

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“…Warfarin is the most used anticoagulant. Only one study explored the effectiveness of the new oral anticoagulant rivaroxaban in a small group of patients with β-TM and AF, and none of the patients experienced any thrombotic or bleeding event during follow-up [36]. Again, drug interactions should be carefully taken into consideration.…”

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confidence: 99%

Atrial fibrillation in β-thalassemia Major Patients: Diagnosis, Management and Therapeutic Options

et al. 2018

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The prevalence of atrial fibrillation (AF) in β-thalassemia major (β-TM) patients has increased in the last few years, reaching up to 33.0%. Several factors may drive this value to even more in the next years. We summarized the main challenges in the management and therapy of AF in this very specific group of patients. KEYWORD Arrhythmia; atrial fibrillation (AF); β-thalassemia (β-thal); iron overload β-Thalassemia major (β-TM) is a hereditary hemoglobin (Hb) disorder caused by reduced synthesis of β-globin chain and resulting in a chronic hemolytic anemia that typically requires lifelong transfusion therapy. If left untreated, this could result in growth retardation, bone marrow expansion, extramedullary hematopoiesis, splenomegaly, greater intestinal iron absorption, hypercoagulability and higher susceptibility to infections till death occurs [1-3]. Although traditionally prevalent in the Mediterranean Basin, Middle East, North India, and Southeast Asia, migration of those populations to North America and Western Europe has rendered β-thalassemia (β-thal) a global health problem. According to the Thalassemia International Federation, (Nicosia, Cyprus), about 200,000 people are affected by β-TM and registered as receiving regular treatment around the world [4]. The highest carrier frequency is reported in Cyprus (14.0%), Sardinia (10.3%) and Southeast Asia [5].

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“…The reason for this is uncertain as the subjects appeared to be adherent to study drug based on pill count. While there are no large controlled studies of direct oral anticoagulants (DOACs) in SCD patients with venous thromboembolism, small cohort studies suggest that these agents are efficacious at approved doses 9,10 . In laser Doppler velocimetry studies, no significant improvements were observed in the measures of microvascular flow, TH1 and AH/AO, following treatment with rivaroxaban.…”

Section: Discussionmentioning

confidence: 99%

A pilot study of the effect of rivaroxaban in sickle cell anemia

et al. 2021

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Introduction The contribution of coagulation activation to the pathogenesis of sickle cell disease (SCD) remains incompletely defined. We evaluated the efficacy and safety of rivaroxaban, an oral direct factor Xa inhibitor, in subjects with sickle cell anemia. Materials and Methods In this pilot, single‐center, randomized, double‐blind, placebo‐controlled, crossover study, eligible subjects with sickle cell anemia received rivaroxaban or placebo. The effect of rivaroxaban on coagulation activation, endothelial activation, inflammation, and microvascular blood flow was evaluated. Results Fourteen patients (HbSS – 14; females – 9) with mean age of 38 ± 10.6 years were randomized to receive rivaroxaban 20 mg daily or placebo for 4 weeks and, following a 2‐week washout phase, were “crossed‐over” to the treatment arm opposite to which they were initially assigned. Mean adherence to treatment with rivaroxaban, assessed by pill counts, was 85.6% in the first treatment period and 93.6% in the second period. Treatment with rivaroxaban resulted in a decrease from baseline of thrombin‐antithrombin complex versus placebo (−34.4 ug/L [95% CI: −69.4, 0.53] vs. 0.35 ug/L [95% CI: −3.8, 4.5], p = .08), but the difference was not statistically significant. No significant differences were observed in changes from baseline of D‐dimer, inflammatory, and endothelial activation markers or measures of microvascular blood flow. Rivaroxaban was well tolerated. Conclusions Rivaroxaban was safe but did not significantly decrease coagulation activation, endothelial activation, or inflammation. Rivaroxaban did not improve microvascular blood flow. Adequately powered studies are required to further evaluate the efficacy of rivaroxaban in SCD. http://clinicaltrials.gov Identifier: NCT02072668.

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Rivaroxaban Use in Patients with Hemoglobinopathies

Cited by 18 publications

References 8 publications

Atrial Fibrillation in β-Thalassemia: Overview of Mechanism, Significance and Clinical Management

Atrial Fibrillation in β-Thalassemia: Overview of Mechanism, Significance and Clinical Management

Atrial fibrillation in β-thalassemia Major Patients: Diagnosis, Management and Therapeutic Options

A pilot study of the effect of rivaroxaban in sickle cell anemia

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