Jakarta, 20 September 2018 – The full results from the XANAP (RIVAROXABAN for Prevention of Stroke in Patients with Atrial Fibrillation in Asia) study were recently published in the Journal of Arrhythmia, the official publication of the Asia Pacific and Japan Heart Rhythm Societies gives the good news for AF patients in Indonesia.

XANAP, which was conducted across 10 Asian countries involved 2,273 patients – including 126 Indonesian patients - is the first and largest prospective study to date in Asia investigating the use of the non-vitamin K antagonist oral anticoagulant (NOAC) RIVAROXABAN in a broad patient population with the heart rhythm disorder non-valvular atrial fibrillation (AF). The real-world data highlight low bleeding rate (1.5% per year) and low stroke rate (only 1.7% per year) in AF patients treated with RIVAROXABAN, and confirm RIVAROXABAN’s robust safety and efficacy benefit in Asian patients¹.

AF is an abnormal heart rhythm characterized by rapid and irregular beating of the atria, which is often found in the world population including in Indonesia. AF patients have a 5 times higher risk of having a stroke than people without AF³.

“The prevalence of AF is growing in Asia, with an estimated 72 million patients by 2050. These patients will have a five-fold increased risk of stroke due to blood clots. While NOACs offer a new standard of care in preventing AF-related strokes, major bleeding is a key consideration of doctors when prescribing NOACs for AF patients. This data confirms the low bleeding risk of RIVAROXABAN in Asian patients, thus reaffirming its positive benefit/risk profile, and demonstrate its value in preventing the negative impact of stroke on patients and society,” said dr. Daniel Tanubudi, Sp.JP (K) as an investigator. “Indonesia is also facing the aging population. The elderly population was increased from 7.74% in 2000 to 28.68% in 20504. This condition will reflect the increase of AF5-7 and based on gender, AF is more occurred in men compared to women^5-6,” he added.

Related to the importance of XANAP results for patients with FA in Indonesia, Dr. Mohammad Kurniawan,Sp.S(K) as the leader of Indonesia’s investigator explained, ”In XANAP, the major bleeding rate of patients treated with RIVAROXABAN was low at 1.5% per year. Specifically, the rates of gastrointestinal (GI) bleeding and fatal intracranial (skull) bleeding were relatively low at 0.5% and 0.7% per year respectively. Stroke rate was also low at 1.7% per year, firming Rivaroxaban’s effectiveness in preventing AF-related strokes. Over 96% of patients treated with RIVAROXABAN in the study did not experience any major bleeding, stroke/systemic embolism (SE), or all-cause death. The study includes elderly patients across varying levels of stroke risk, with significant medical co-morbidities including heart failure, hypertension, diabetes mellitus, prior stroke/ SE/transient ischemic attack and myocardial infarction¹”.

AF can lead to blood clots and if a clot breaks off, enters the bloodstream and lodges in an artery leading to the brain, a stroke results. Paralysis is a form of disability that is often found in stroke cases with AF. In Indonesia, 37% patient with AF with age less than 75 years old, ischemic stroke is the first symptom to be found10. The number of stroke patients has increased rapidly in this country. Based on Indonesia Health Survey in 1990, the number of stroke patients was 2 per 1.000 populations and increased to 8.3 per 1.000 populations in 2007. RISKESDAS 2013 showed the increasing number 12.1 per 1.000 populations. The increase also occurred in the number of deaths due to stroke. Based on the Indonesia Ministry of Health Survey 2014, 21.1% death caused of stroke and leads this disease as #1 cause of death in Indonesia.

It is important to consider a patient’s individual risk factors to prescribe the right NOAC to the right patient for AF stroke prevention. RIVAROXABAN’s robust experience and evidence in patients across different risk profiles, including those with high stroke risk, will best support doctors and patients in their treatment decision in AF management. The positive data of XANAP further add to this and reaffirm the proven safety profile of RIVAROXABAN in Asian patients including Indonesia.

XANAP is part of the global XANTUS program which comprises three prospective, non-interventional studies, spanning three regions and 47 countries. Results from a large pooled analysis of XANTUS in 11,121 patients were recently published in the Journal of the American College of Cardiology, confirming the global safety profile of RIVAROXABAN in routine clinical practice¹¹.

About XANAP

The Phase III ROCKET AF trial and its East Asian sub-analysis demonstrated that RIVAROXABAN is non-inferior to warfarin for stroke/SE prevention in patients with non-valvular AF, with a favorable benefit–risk profile. XANAP is the first pan-Asian, prospective, single-arm, observational study designed to evaluate the safety and effectiveness of RIVAROXABAN for stroke prevention with non-valvular AF. The study followed 2,273 patients from 435 sites across Asia (Indonesia, Hong Kong SAR, South Korea, Malaysia, Philippines, Singapore, Taiwan, Thailand, Vietnam and Pakistan) in routine clinical practice. Patients were followed at ~3-month intervals for 1 year, or for ≥30 days after permanent discontinuation. Primary outcomes are major bleeding events, adverse events (AEs), serious AEs and all-cause mortality; secondary outcomes included stroke/SE. Major outcomes were adjudicated centrally.

The mean age of patients in XANAP is 70.5 years and 58.1% are male. 49.8% of patients received Rivaroxaban 20 mg once daily (od), 43.8% 15 mg od and 5.9% 10 mg od. Mean treatment duration was 296 days, and 72.8% of patients had received prior anticoagulation therapy. Co-morbidities include heart failure (20.1%), hypertension (73.6%), diabetes mellitus (26.6%), prior stroke/non-central nervous system SE/transient ischemic attack (32.8%) and myocardial infarction (3.8%). Mean CHADS2 score of XANAP is 2.3 and mean CHA2DS2-VASc score is 3.7. This means that patients in XANAP study had high risk of stroke (score >2). The real-world XANAP study demonstrated low rates of stroke and bleeding in patients with non-valvular on Rivaroxaban in Asia Pacific. The results are consistent with the real-world XANTUS study and ROCKET AF.

About Rivaroxaban

Rivaroxaban is the most broadly indicated non-vitamin K antagonist oral anticoagulant (NOAC) and has been marketed in Indonesia since 2009. Globally, since 2008, Rivaroxaban is approved for seven indications, protecting 39 million patients across more venous and arterial thromboembolic conditions than any other NOAC:

• The prevention of stroke and systemic embolism (SE) in adult patients with non-valvular RIVAROXABAN with one or more risk factors.
• The treatment of deep vein thrombosis (DVT) in adults.
• The treatment of pulmonary embolism (PE) in adults.
• The prevention of recurrent DVT and PE in adults.
• The prevention of venous thromboembolism (VTE) in adult patients undergoing.
• Elective hip replacement surgery.
• The prevention of VTE in adult patients undergoing elective knee replacement surgery.
• The prevention of atherothrombotic events (cardiovascular death, myocardial infarction or stroke) after an Acute Coronary Syndrome in adult patients with elevated cardiac biomarkers and no prior stroke or transient ischaemic attack when co-administered with acetylsalicylic acid (ASA) alone or with ASA plus clopidogrel or ticlopidine. 

In Indonesia, Rivaroxaban is approved for four indications:

• Prevention of venous thromboembolism (VTE) in adult patients undergoing elective hip or knee replacement surgery.
• To reduce the risk of stroke and systemic embolism (SE) in adult patients with non-valvular atrial fibrillation:
• Patient with stroke history or transient ischemic attack (TIA)
• Patient with score CHADS2 ≥ 2
• Treatment of deep vein thrombosis (DVT) where the duration of treatment must be based on the underlying disease.
• Treatment of patients with hemodynamically stable pulmonary embolism (PE), which is must be confirmed by spiral CT imaging.

 
NOACs like RIVAROXABAN are recommended as first-line anticoagulants in the prevention of AF-associated stroke in the latest international guidelines for the management of AF published by the European Society of Cardiology in 2017. Whilst regulatory approvals may differ from country to country, across all indications RIVAROXABAN is approved in more than 130 countries.

Anticoagulant medicines are potent therapies used to prevent or treat serious illnesses and potentially life-threatening conditions. Before initiating therapy with anticoagulant medicines, physicians should carefully assess the benefit and risk for the individual patient.

Responsible use of RIVAROXABAN is a very high priority for Bayer.
To learn more about thrombosis, please visit www.thrombosisadviser.com

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References:
_{1.    YH Kim, J Shim, CT Tsai, et al. XANAP: A Real‐world, Prospective, Observational Study of Patients Treated with Rivaroxaban® for Stroke Prevention in Atrial Fibrillation in Asia. Journal of Arrhythmia 2018; 01-10. https://onlinelibrary.wiley.com/doi/epdf/10.1002/joa3.12073. (last accessed: 7 July 2018)
2.    MR Patel, KW MahRivaroxaban®fey, J Garg, et al. Rivaroxaban® versus Warfarin in Non-valvular Atrial Fibrillation. N Engl J Med.2011 Sep 8;365(10):883-91. www.nejm.org/doi/full/10.1056/NEJMoa1009638. (last accessed: 11 May 2018)
3.    Journal PLOS One. Stroke as the first manifestation of Atrial Fibrilation. Available from: https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0168010 ( Last accessed : September 10th,2018)
4.    Gambaran kesehatan usia lanjut di Indonesia. Buletin Jendela Data dan Informasi Kesehatan 2013
5.    Go et al. JAMA 2001;
6.    Heeringa et al. Eur Heart J 2006;
7.    Benjamin et al. JAMA 1994;
8.    Alonso et al. Am Heart J 2009;
9.    Borzecki et al. J Natl Med Assoc 2008
10.    Jaakkola J, Mustonen P, Kiviniemi T, Hartikainen JE, Palomaki A, Hatikainen P, Nuotio I, Yliatalo A dan Airaksinen KE. Stoke as The First Manifestation of Atrial Fibrillation. PloS One. 2016;11:e0168010 
11.    Kirchhof P, Radaideh DM, YH Kim, et al. Global Society Analysis of Rivaroxaban®: A Pooled Analysis of the Global Prospective, Observational XANTUS Program. J Am Coll Cardiol 2018;72:141-153.}