The Atrial FibriLlatiOn (FLOW-AF) Registry in the Middle East and North Africa: Patient Characteristics, Treatment Patterns and Outcomes.

INTRODUCTION: Limited data on atrial fibrillation (AF) are available from the Middle East and North Africa region (MENA). The aim of the FLOW-AF registry was to evaluate the characteristics, treatment patterns, and clinical and economic outcomes of patients with newly diagnosed non-valvular atrial fibrillation (NVAF) in MENA. METHODS: This multi-center, prospective, observational study (the FLOW-AF registry) enrolled patients newly diagnosed with NVAF across Egypt, Lebanon, Kingdom of Saudi Arabia, and United Arab Emirates. The data collection occurred at enrollment (baseline) and after 6- and 12-months (follow-up). Baseline data included demographics, AF characteristics, medical history, and anti-thrombotic treatment patterns. Clinical events, healthcare resource utilization, and direct costs were collected at follow-up. RESULTS: The study enrolled a total of 1418 patients (52.7% males and 47.3% females). The mean age of the patients was 64.5 years and 90.6% were white. The mean (standard deviation) CHA2DS2-VASc and HAS-BLED risk scores were 2.7 (1.6) and 1.6 (1.2), respectively. Non-vitamin K antagonist oral anticoagulants, antiplatelet therapy, and vitamin K antagonists were prescribed to 65.8%, 16.4%, and 12.9% patients, respectively. During follow-up, the following rates of clinical outcomes were observed: bleeding events (1.7%), transient ischemic attack (1.7%), all-cause mortality (1.7%), stroke (0.6%), myocardial infarction (0.2%), and systemic embolism (0.08%). CONCLUSIONS: This MENA patient population was younger and had lower mean baseline CHA2DS2-VASc and HAS-BLED scores. The rates of clinical outcomes over 1-year in this study were low. Longer follow-up is required to comprehensively assess clinical outcomes in this patient population.

The atrial FibriLlatiOn real World management registry in the Middle East and Africa: design and rationale.

BACKGROUND: Atrial fibrillation is the most common cardiac arrhythmia, affecting 33.5 million patients globally. It is associated with increased morbidity, leading to significant clinical and economic burden. There exist only limited data in the Middle Eastern region from the existing registries. The goal of the FLOW-AF (atrial FibriLlatiOn real World management registry in the Middle East and Africa) registry is to evaluate the characteristics, treatment patterns, and clinical and economic outcomes associated with anticoagulation among patients newly diagnosed with nonvalvular atrial fibrillation in Egypt, Lebanon, the Kingdom of Saudi Arabia, and the United Arab Emirates. METHODS: This study will be a multicountry, multicenter, prospective observational registry aiming to enroll 1446 newly diagnosed nonvalvular atrial fibrillation patients at more than 20 sites across the four countries. During the recruitment period, patients will be included if they were newly diagnosed with nonvalvular atrial fibrillation and had initiated treatment for the prevention of stroke/systemic embolism. Patient data will be assessed prospectively at 6 and 12 months from their enrollment date. Demographics, clinical characteristics, antithrombotic treatments received, clinical outcomes, adverse events, healthcare resource utilization, and direct costs associated with management of nonvalvular atrial fibrillation will be collected and analyzed overall, by country, and by groups created based on treatment, demographics, and clinical characteristics, medical history and risk factors. CONCLUSION: The FLOW-AF registry will provide information on the uptake of oral anticoagulants, treatment patterns, clinical outcomes, and healthcare utilization and costs among newly diagnosed nonvalvular atrial fibrillation patients in the Middle Eastern region.

Cost-effectiveness of apixaban for stroke prevention in non-valvular atrial fibrillation in Saudi Arabia.

BACKGROUND: Apixaban, an oral anticoagulant for stroke and systemic embolism prevention in non-valvular atrial fibrillation (NVAF), was superior to warfarin in prevention of stroke and systemic embolism, bleeding outcomes and mortality (ARISTOTLE trial), and substantially reduced stroke risk, with no significant increase in major or intracranial bleeding risk versus aspirin (AVERROES trial). OBJECTIVE: Estimate cost-effectiveness of apixaban versus other anticoagulants for NVAF treatment in Saudi Arabia. DESIGN: Lifetime Markov model. SETTING: A published model was adapted from the United Kingdom (UK) to the Saudi Arabia setting. PATIENTS AND METHODS: The model enabled pairwise comparisons of apixaban against other anticoagulants, aspirin, and aspirin+clopidogrel. Apart from warfarin and aspirin, comparisons were indirect. Subpopulations included vitamin K antagonist (VKA) suitable and unsuitable patients. Medication and physician visit costs were from published lists. A cost ratio (0.533), from comparison of UK and Saudi physician visit costs, was applied to UK model inputs to estimate local event costs. Background life expectancy was from Saudi life tables. Model structure, treatment comparators, patient characteristics, event rates, and utilities were unchanged. Costs and health benefits were discounted by 3.5% annually. MAIN OUTCOME MEASURE: Incremental cost-effectiveness ratio of cost per quality-adjusted life-year (QALY) gained. SAMPLE SIZE: Model cohort of 1000 NVAF patients, for VKA suitable and VKA unsuitable populations. RESULTS: Apixaban was dominant versus warfarin (VKA suitable) and rivaroxaban (VKA suitable and unsuitable). Compared against dabigatran (110mg, 150 mg, 110/150mg), the cost/QALY gained for apixaban was $5166, $11 143, $10 849 (VKA suitable) and $5 157, $14 424, $14 134 (VKA unsuitable), respectively. Cost/QALY for apixaban versus aspirin and aspirin+clopidogrel was $14 805 and $5784 (VKA suitable); and $10 564 and $4203 (VKA unsuitable), respectively. Sensitivity analyses demonstrated consistency of findings across varying inputs. CONCLUSIONS: Apixaban was found to be cost-effective for stroke prevention among Saudi NVAF patients, when assessed using a US$20 000 willingness-to-pay threshold. LIMITATIONS: Lack of robust local clinical, cost and utility data for model inputs. Lack of head-to-head clinical trial data for rivaroxaban, dabigatran, and clopidogrel plus aspirin comparators. CONFLICT OF INTEREST: Study was funded by Pfizer Inc. and Bristol Myers-Squibb. KO, RS, SAK and AAA received salaries from their respective employers, but did not receive direct financial compensation for participation in or authorship of this study.

Cost-effectiveness of Apixaban for Stroke Prevention in Patients with Atrial Fibrillation in Algeria.

Background: Atrial fibrillation (AF) is a chronic sustained heart rhythm disorder associated with an increased risk of stroke. Apixaban, a new oral anticoagulant, was approved by the European Medicines Agency for prevention of stroke in patients with AF. The efficacy of apixaban has been investigated in randomised controlled trials. Objectives: The objective of this study was to estimate the economic implications of using apixaban compared to other anti-coagulations to reduce the risk of stroke in patients with AF from the perspective of the Algerian payer. Methods: A previously published Markov model was adapted to the Algerian setting. The model included patients for whom vitamin K antagonist (VKA) treatment is suitable and could initiate on acenocoumarol, rivaroxaban or apixaban, and those unsuitable for VKA treatment who could initiate on aspirin or apixaban. Over a lifetime time horizon, costs were estimated in Algerian dinars (DZD) and outcomes included life-years (LYs), quality-adjusted life-years (QALYs) and incremental cost-effectiveness ratios (ICERs). Results: In the VKA suitable population, apixaban was estimated to be a dominant treatment option over rivaroxaban, providing a higher number of QALYs at lower costs, while when compared with acenocoumarol, an ICER of 3 672 059 DZD per QALY gained was estimated. Amongst those unsuitable for VKA therapy, the ICER was 2 061 863 DZD per QALY gained. Conclusion: Apixaban was found to be a cost-effective choice for stroke prevention in patients with AF in Algeria compared to acenocoumarol and rivaroxaban in the VKA suitable population and compared to aspirin in the VKA unsuitable population.

The Cost-effectiveness of Celecoxib versus Non-steroidal Anti-inflammatory Drugs plus Proton-pump Inhibitors for Treating Osteoarthritis in Algeria.

Background: Cyclooxygenase-2 inhibitors such as celecoxib are as effective as non-selective non-steroidal anti-inflammatory drugs (ns-NSAIDs) in the treatment of osteoarthritis (OA), have fewer gastrointestinal side effects, but are more expensive. Objective: To evaluate the incremental cost-effectiveness ratio (ICER) of celecoxib versus ns-NSAIDs, with/without proton-pump inhibitor (PPI) co-therapy, for treating OA in Algeria. Methods: The National Institute for Health and Clinical Excellence (NICE) health economic model from UK, updated with relative risks of adverse events using CONDOR trial data, was adapted for costeffectiveness analysis in OA patients aged ≥65 years. Patients could initiate treatment with celecoxib or ns-NSAIDs with/without omeprazole. Conditional probabilities were obtained from published clinical trials; effectiveness measure was quality-adjusted life years (QALYs) gained/patient. The analysis was conducted from a healthcare payer's perspective. The average daily treatment costs and frequencies of resource use for adverse events were based on data collected in August 2011 from a private clinic located in Cheraga, Algiers, Algeria. Probabilistic sensitivity analysis (PSA) was performed to construct cost-effectiveness acceptability curves (CEACs). Results: QALYs gained/patient over a 6-month horizon were higher with celecoxib (0.368) and celecoxib+PPI (0.40) versus comparators. The lowest expected cost/patient was associated with ibuprofen (US$134.76 versus US$175.67 with celecoxib+PPI, and US$177.57 with celecoxib). Celecoxib+PPI was the most cost-effective drug treatment, with an ICER of US$584.43, versus ibuprofen. Treatment with celecoxib alone showed an ICER of US$1,530.56 versus diclofenac+PPI. These ICERs are <1 gross domestic product per capita in Algeria (US$7,500). Over 1-year, 3-year and 5-year horizons, celecoxib with/without PPI co-therapy showed higher QALYs/patient versus comparators, and decreasing ICERs. The ICER of celecoxib+PPI was lower than that of comparators over all time horizons. These findings were confirmed with CEACs generated via PSA. Conclusion: Using data from a single private clinic in Cheraga, Algiers, Algeria, and after considering new adverse event risks, we showed that celecoxib with/without PPI co therapy is more cost-effective than ns-NSAID+PPI for treating OA patients aged ≥65 years. Celecoxib+PPI remains dominant over a 5-year horizon, making it the most cost-effective treatment option for medium- and long-term use.