{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,5,4]],"date-time":"2026-05-04T20:20:53Z","timestamp":1777926053784,"version":"3.51.4"},"reference-count":27,"publisher":"PeerJ","license":[{"start":{"date-parts":[[2022,9,9]],"date-time":"2022-09-09T00:00:00Z","timestamp":1662681600000},"content-version":"unspecified","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"name":"College of Medicine Research Center, Deanship of Scientific Research, King Saud University, Riyadh, Saudi Arabia"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"abstract":"<jats:sec>\n<jats:title>Background<\/jats:title>\n<jats:p>Real-world evidence on factor Xa inhibitor (rivaroxaban) prescribing patterns, safety, and efficacy in patients with non-valvular atrial fibrillation (NVAF) and venous thromboembolism (VTE) is rare. Herein, we sought to examine the above outcomes in the largest academic center in the Kingdom of Saudi Arabia (KSA).<\/jats:p>\n<\/jats:sec>\n<jats:sec>\n<jats:title>Methods<\/jats:title>\n<jats:p>This is a retrospective observational study designed to examine the prescribing pattern, safety and real-world effectiveness of the factor Xa inhibitor rivaroxaban in patients with NVAF and VTE. Data on rivaroxaban prescriptions were collected and analyzed. Bleeding outcomes were defined as per the International Society on Thrombosis and Hemostasis (ISTH) definition.<\/jats:p>\n<\/jats:sec>\n<jats:sec>\n<jats:title>Results<\/jats:title>\n<jats:p>A total of 2,316 patients taking rivaroxaban recruited through several departments of King Saud University Medical City (KSUMC). The mean age was 61 years (\u00b117.8) with 55% above the age of 60 and 58% were females. Deep vein thrombosis and pulmonary embolism (VTE) was the most prevalent reason for prescribing rivaroxaban, followed by NVAF. A total daily dosage of 15 mg was given to 23% of the patients. The incidence rate of recurrent thrombosis and recurrent stroke was 0.2%. Furthermore, rivaroxaban had a 0.04 percent incidence rate of myocardial infarction. Half of the patients with recurrent thrombosis and stroke were taking 15 mg per day. The incidence rate of major bleeding was 1.1%. More over half of the patients who experienced significant bleeding were taking rivaroxaban at a dosage of 20 mg per day. According to the HAS-BLED Score (&gt;2 score), 48 percent of patients who experienced significant bleeding had a high risk of bleeding. Non-major bleeding occurred in 0.6% of cases. Similarly, 40% of patients with non-major bleeding were taking rivaroxaban at a dosage of 20 mg per day. According to the HAS-BLED Score, just 6.6% of these individuals had a high risk of bleeding. 93.4% of the patients, on the other hand, were at intermediate risk.<\/jats:p>\n<\/jats:sec>\n<jats:sec>\n<jats:title>Conclusion<\/jats:title>\n<jats:p>The prescription of rivaroxaban in this real-life cohort study differs from the prescribing label and the outcomes of a phase 3 randomised clinical trial. However, for individuals with VTE and NVAF, the 20 mg dose looked to be more efficacious than the pivotal trial outcomes. Furthermore, among patients with VTE and NVAF, rivaroxaban was linked to a decreased incidence of safety events such as recurrent thrombosis, recurrent stroke, MI, major bleeding, and non-major haemorrhage in a real-world environment.<\/jats:p>\n<\/jats:sec>","DOI":"10.7717\/peerj.13974","type":"journal-article","created":{"date-parts":[[2022,9,9]],"date-time":"2022-09-09T08:20:01Z","timestamp":1662711601000},"page":"e13974","source":"Crossref","is-referenced-by-count":6,"title":["A retrospective study of real-world effectiveness and safety of rivaroxaban in patients with non-valvular atrial fibrillation and venous thromboembolism in Saudi Arabia"],"prefix":"10.7717","volume":"10","author":[{"given":"Hind M.","family":"Alosaimi","sequence":"first","affiliation":[{"name":"Clinical Pharmacy Department, College of Pharmacy, Riyadh Elm University, Riyadh, Saudi Arabia"},{"name":"Pharmacy Services, King Fahad Medical City, Riyadh Second Health Cluster, Riyadh, Saudi Arabia"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Saeed","family":"Alqahtani","sequence":"additional","affiliation":[{"name":"Department of Clinical Pharmacy, College of Pharmacy, King Saud University, Riyadh, Saudi Arabia"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Bander","family":"Balkhi","sequence":"additional","affiliation":[{"name":"Department of Clinical Pharmacy, College of Pharmacy, King Saud University, Riyadh, Saudi Arabia"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Mishari","family":"Alqahtani","sequence":"additional","affiliation":[{"name":"Department of Clinical Pharmacy, College of Pharmacy, King Saud University, Riyadh, Saudi Arabia"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Faisal","family":"Alzamil","sequence":"additional","affiliation":[{"name":"Department of Clinical Pharmacy, College of Pharmacy, King Saud University, Riyadh, Saudi Arabia"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Abdulaziz","family":"Alhossan","sequence":"additional","affiliation":[{"name":"Department of Clinical Pharmacy, College of Pharmacy, King Saud University, Riyadh, Saudi Arabia"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Fatmah S.","family":"Alqahtany","sequence":"additional","affiliation":[{"name":"Hematopathology Unit, Department of Pathology, College of Medicine, King Saud University, King Saud University Medical City, Riyadh, Saudi Arabia"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Abdullah A.","family":"Alharbi","sequence":"additional","affiliation":[{"name":"College of Medicine, King Saud Bin Abdul Aziz University for Health Sciences, Riyadh, Saudi Arabia"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Nawaf Abdullah","family":"Alqahtani","sequence":"additional","affiliation":[{"name":"College of Medicine, King Saud Bin Abdul Aziz University for Health Sciences, Riyadh, Saudi Arabia"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Hanan","family":"Albackr","sequence":"additional","affiliation":[{"name":"Department of Medicine, College of Medicine, King Saud University Medical City, King Saud University, Riyadh, Saudi Arabia"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Ghada","family":"Elgohary","sequence":"additional","affiliation":[{"name":"Department of Adult Hematology\/Oncology, King Saud University Medical City, King Saud University, Riyadh, Saudi Arabia"},{"name":"Clinical Hematology and Bone Marrow Transplantation Unit, Division of Internal Medicine, Ain Shams University, Cairo, Egypt"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Farjah H.","family":"Algahtani","sequence":"additional","affiliation":[{"name":"Division of Oncology\/Hematology, Department of Medicine, College of Medicine, King Saud University, Kind Saud University Medical City, Riyadh, Saudi Arabia"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"4443","published-online":{"date-parts":[[2022,9,9]]},"reference":[{"issue":"2","key":"10.7717\/peerj.13974\/ref-1","doi-asserted-by":"publisher","first-page":"e44S","DOI":"10.1378\/chest.11-2292","article-title":"Oral anticoagulant therapy: antithrombotic therapy and prevention of thrombosis, 9th ed: American College of Chest Physicians evidence-based clinical practice guidelines","volume":"141","author":"Ageno","year":"2012","journal-title":"Chest"},{"issue":"1","key":"10.7717\/peerj.13974\/ref-2","doi-asserted-by":"publisher","first-page":"7","DOI":"10.1186\/s12959-019-0195-7","article-title":"International longitudinal registry of patients with atrial fibrillation and treated with rivaroxaban: RIVaroxaban evaluation in real life setting (RIVER)","volume":"17","author":"Beyer-Westendorf","year":"2019","journal-title":"Thrombosis Journal"},{"issue":"9","key":"10.7717\/peerj.13974\/ref-3","doi-asserted-by":"publisher","first-page":"2469","DOI":"10.1161\/STROKEAHA.119.025824","article-title":"Effectiveness and safety of rivaroxaban 15 or 20 mg versus vitamin K antagonists in nonvalvular atrial fibrillation","volume":"50","author":"Blin","year":"2019","journal-title":"Stroke"},{"issue":"2","key":"10.7717\/peerj.13974\/ref-4","doi-asserted-by":"publisher","first-page":"243","DOI":"10.1007\/s40265-013-0174-4","article-title":"Rivaroxaban: a review of its use in the treatment of deep vein thrombosis or pulmonary embolism and the prevention of recurrent venous thromboembolism","volume":"74","author":"Burness","year":"2014","journal-title":"Drugs"},{"key":"10.7717\/peerj.13974\/ref-5","doi-asserted-by":"publisher","first-page":"117","DOI":"10.2147\/VHRM.S39726","article-title":"The role of factor Xa inhibitors in venous thromboembolism treatment","volume":"11","author":"Cabral","year":"2015","journal-title":"Vascular Health and Risk Management"},{"issue":"5","key":"10.7717\/peerj.13974\/ref-6","doi-asserted-by":"publisher","first-page":"471","DOI":"10.1093\/humupd\/dmt028","article-title":"Venous thromboembolism in women: a specific reproductive health risk","volume":"19","author":"Eichinger","year":"2013","journal-title":"Human Reproduction Update"},{"issue":"9162","key":"10.7717\/peerj.13974\/ref-7","doi-asserted-by":"publisher","first-page":"1386","DOI":"10.1016\/S0140-6736(98)07534-5","article-title":"Acute pulmonary embolism: clinical outcomes in the international cooperative pulmonary embolism registry (ICOPER)","volume":"353","author":"Goldhaber","year":"1999","journal-title":"Lancet (London, England)"},{"issue":"6","key":"10.7717\/peerj.13974\/ref-8","doi-asserted-by":"publisher","first-page":"1349","DOI":"10.1253\/circj.cj-13-1324","article-title":"Rivaroxaban vs. warfarin in Japanese patients with non-valvular atrial fibrillation in relation to age","volume":"78","author":"Hori","year":"2014","journal-title":"Circulation Journal"},{"issue":"9","key":"10.7717\/peerj.13974\/ref-9","doi-asserted-by":"publisher","first-page":"2104","DOI":"10.1253\/circj.CJ-12-0454","article-title":"Rivaroxaban vs. warfarin in Japanese patients with atrial fibrillation \u2013 the J-ROCKET AF study","volume":"76","author":"Hori","year":"2012","journal-title":"Circulation Journal: Official Journal of the Japanese Circulation Society"},{"issue":"1","key":"10.7717\/peerj.13974\/ref-10","doi-asserted-by":"publisher","first-page":"3451","DOI":"10.1038\/s41598-018-21884-y","article-title":"Effectiveness and safety of different rivaroxaban dosage regimens in patients with non-valvular atrial fibrillation: a nationwide, population-based cohort study","volume":"8","author":"Huang","year":"2018","journal-title":"Scientific Reports"},{"issue":"21","key":"10.7717\/peerj.13974\/ref-11","doi-asserted-by":"publisher","first-page":"2689","DOI":"10.1161\/CIRCULATIONAHA.106.653048","article-title":"Major hemorrhage and tolerability of warfarin in the first year of therapy among elderly patients with atrial fibrillation","volume":"115","author":"Hylek","year":"2007","journal-title":"Circulation"},{"key":"10.7717\/peerj.13974\/ref-12","article-title":"FDA approves XARELTO\u00ae (rivaroxaban tablets) to help prevent deep vein thrombosis in patients undergoing knee or hip replacement surgery","author":"Janssen Pharmaceuticals Inc","year":"2018"},{"issue":"1","key":"10.7717\/peerj.13974\/ref-13","doi-asserted-by":"publisher","first-page":"40","DOI":"10.15420\/ecr.2017:11:2","article-title":"Direct oral anticoagulants: a quick guide","volume":"12","author":"Julia","year":"2017","journal-title":"European Cardiology"},{"issue":"4","key":"10.7717\/peerj.13974\/ref-14","doi-asserted-by":"publisher","first-page":"777","DOI":"10.1111\/cts.12766","article-title":"Rivaroxaban precision dosing strategy for real-world atrial fibrillation patients","volume":"13","author":"Konicki","year":"2020","journal-title":"Clinical and Translational Science"},{"issue":"7","key":"10.7717\/peerj.13974\/ref-15","doi-asserted-by":"publisher","first-page":"1317","DOI":"10.1185\/03007995.2014.907140","article-title":"Real-world comparative effectiveness and safety of rivaroxaban and warfarin in nonvalvular atrial fibrillation patients","volume":"30","author":"Lalibert\u00e9","year":"2014","journal-title":"Current Medical Research and Opinion"},{"issue":"7","key":"10.7717\/peerj.13974\/ref-16","doi-asserted-by":"publisher","first-page":"860","DOI":"10.1161\/CIRCULATIONAHA.111.060061","article-title":"Use of the CHA(2)DS(2)-VASc and HAS-BLED scores to aid decision making for thromboprophylaxis in nonvalvular atrial fibrillation","volume":"126","author":"Lane","year":"2012","journal-title":"Circulation"},{"issue":"3","key":"10.7717\/peerj.13974\/ref-17","doi-asserted-by":"publisher","first-page":"249","DOI":"10.1007\/s11239-011-0555-z","article-title":"Practical issues with vitamin K antagonists: elevated INRs, low time-in-therapeutic range, and warfarin failure","volume":"31","author":"Lee","year":"2011","journal-title":"Journal of Thrombosis and Thrombolysis"},{"issue":"5","key":"10.7717\/peerj.13974\/ref-18","doi-asserted-by":"publisher","first-page":"311","DOI":"10.1046\/j.1525-1497.1998.00096.x","article-title":"Risk of major hemorrhage for outpatients treated with warfarin","volume":"13","author":"McMahan","year":"1998","journal-title":"Journal of General Internal Medicine"},{"issue":"9","key":"10.7717\/peerj.13974\/ref-19","doi-asserted-by":"publisher","first-page":"2494","DOI":"10.1161\/STROKEAHA.117.017549","article-title":"Real-world setting comparison of nonvitamin-K antagonist oral anticoagulants versus vitamin-K antagonists for stroke prevention in atrial fibrillation: a systematic review and meta-analysis","volume":"48","author":"Ntaios","year":"2017","journal-title":"Stroke"},{"issue":"10","key":"10.7717\/peerj.13974\/ref-20","doi-asserted-by":"publisher","first-page":"883","DOI":"10.1056\/NEJMoa1009638","article-title":"Rivaroxaban versus warfarin in nonvalvular atrial fibrillation","volume":"365","author":"Patel","year":"2011","journal-title":"The New England Journal of Medicine"},{"issue":"15","key":"10.7717\/peerj.13974\/ref-21","doi-asserted-by":"publisher","first-page":"2153","DOI":"10.2165\/11538030-000000000-00000","article-title":"Clinical pharmacology of direct and indirect factor Xa inhibitors","volume":"70","author":"Rupprecht","year":"2010","journal-title":"Drugs"},{"issue":"4","key":"10.7717\/peerj.13974\/ref-22","doi-asserted-by":"publisher","first-page":"692","DOI":"10.1111\/j.1538-7836.2005.01204.x","article-title":"Definition of major bleeding in clinical investigations of antihemostatic medicinal products in non-surgical patients","volume":"3","author":"Schulman","year":"2005","journal-title":"Journal of Thrombosis and Haemostasis: JTH"},{"issue":"1","key":"10.7717\/peerj.13974\/ref-23","doi-asserted-by":"publisher","first-page":"32","DOI":"10.1007\/s11239-015-1317-0","article-title":"Guidance for the treatment of deep vein thrombosis and pulmonary embolism","volume":"41","author":"Streiff","year":"2016","journal-title":"Journal of Thrombosis and Thrombolysis"},{"issue":"4","key":"10.7717\/peerj.13974\/ref-24","doi-asserted-by":"publisher","first-page":"447","DOI":"10.1111\/jcpt.12288","article-title":"Evaluation of the appropriateness of dosing, indication and safety of rivaroxaban in a community hospital","volume":"40","author":"Tellor","year":"2015","journal-title":"Journal of Clinical Pharmacy and Therapeutics"},{"issue":"18","key":"10.7717\/peerj.13974\/ref-25","doi-asserted-by":"publisher","first-page":"2276","DOI":"10.1093\/eurheartj\/ehn310","article-title":"Guidelines on the diagnosis and management of acute pulmonary embolism: the task force for the diagnosis and management of acute pulmonary embolism of the european society of cardiology (ESC)","volume":"29","author":"Torbicki","year":"2008","journal-title":"European Heart Journal"},{"issue":"3","key":"10.7717\/peerj.13974\/ref-26","doi-asserted-by":"publisher","first-page":"193","DOI":"10.1055\/s-0031-1273083","article-title":"Gender and the risk of venous thromboembolism","volume":"37","author":"Tormene","year":"2011","journal-title":"Seminars in Thrombosis and Hemostasis"},{"key":"10.7717\/peerj.13974\/ref-27","doi-asserted-by":"publisher","first-page":"13","DOI":"10.2147\/VHRM","article-title":"Role of rivaroxaban in the management of atrial fibrillation: insights from clinical practice","volume":"14","author":"Vimalesvaran","year":"2018","journal-title":"Vascular Health and Risk Management"}],"container-title":["PeerJ"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/peerj.com\/articles\/13974.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/peerj.com\/articles\/13974.xml","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/peerj.com\/articles\/13974.html","content-type":"text\/html","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/peerj.com\/articles\/13974.pdf","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2022,9,9]],"date-time":"2022-09-09T08:20:08Z","timestamp":1662711608000},"score":1,"resource":{"primary":{"URL":"https:\/\/peerj.com\/articles\/13974"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2022,9,9]]},"references-count":27,"alternative-id":["10.7717\/peerj.13974"],"URL":"https:\/\/doi.org\/10.7717\/peerj.13974","archive":["CLOCKSS","LOCKSS","Portico"],"relation":{},"ISSN":["2167-8359"],"issn-type":[{"value":"2167-8359","type":"electronic"}],"subject":[],"published":{"date-parts":[[2022,9,9]]},"article-number":"e13974"}}