New med shows successful results in prevention of myocardial infarction and stroke
Xarelto (rivaroxaban) is the first and only non-vitamin K antagonist oral anticoagulant. The drug is currently under assessment among high risk patients with coronary or peripheral artery disease. The major news announced by Bayer and Janssen (the developers Xarelto) is that the primary end point of the Phase III COMPASS study of the clinical trial has been met earlier. More importantly, the results are “overwhelmingly” satisfying. The medicine has shown positive safety and efficacy results for the prevention of major adverse cardiac events like cardiovascular death, myocardial infarction and stroke. The complete data analysis is to be announced later this year.
According to the competence of an independent Data Monitoring Committee, which has conducted an earlier analysis of the trial, the study has “reached its prespecified criteria for superiority”. In other words, Xarelto has proven to be more effective than predicted and with superior safety profile. This will allow Bayer and Janssen, and the Population Health Research Institute to offer rivaroxaban to clinical trial participants in an “open-label extension trial”.
The importance of coronary artery disease and peripheral artery disease
Coronary artery disease (CAD) is the cause of 7.3 million deaths annually. It is the most common cause of cardiovascular disease in high income countries. More worrisome is that the number of people with this ailment is rising worldwide.
Peripheral artery disease is an important risk marker of cardiovascular disease, which often stays undiagnosed. More importantly, it affects over 27 million people in Europe and North America, and one fifth of the adults over 55 years. The numbers of affected people are also rising.
About Xarelto (rivaroxaban)
Rivaroxaban is the first and only non-vitamin K antagonist oral anticoagulant, which is used in the treatment of venous and arterial thromboembolic (VAT) conditions. It is approved for treatment of the following seven indications:
- prevention of stroke and systemic embolism in patients with non-valvular atrial fibrillation
- pulmonary embolism (PE)
- deep vein thrombosis (DVT)
- prevention of recurrent DVT and PE in adults
- prevention of venous thromboembolism (VTE) in patients undergoing elective hip replacement surgery or
- elective knee replacement surgery
- prevention of atherothrombotic events after an Acute Coronary Syndrome in adult patients with elevated cardiac biomarkers and no prior stroke or transient ischemic attack (TIA) when co-administered with antiplatelet drugs.
About the clinical trial
The successful COMPASS study is the largest clinical trial of Xarelto and up to date it has enrolled 27,402 patients from more than 600 sites across more than 30 countries globally. The study was randomized, and patients received either rivaroxaban 2.5 mg twice daily in addition to aspirin 100 mg once daily, or rivaroxaban 5 mg twice daily alone, or aspirin 100 mg once daily alone. By the time of its completion, the extensive investigation study is expected to include more than 275,000 patients in both clinical trials and real-world settings.
Such major clinical trial is successfully and earlier completed due to appropriate management of data. Up to date, Bayer is utilizing effectively one of the clinical trial management systems on the market. The latter has shown to be productive in its data organization among the afore mentioned 600 sites and 30 countries worldwide. The system allows for faster gathering of the results, thus allowing breakthroughs like the one of Xarelto. Regardless of the country or site where the trial is being conducted, the use of an appropriate CTMS integrates the entire data and simplifies what has been regarded as complex. In addition, more people globally could benefit of the treatment, since the results it shows are “overwhelming”.
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You can find a PDF version of this article here: Xarelto Completes Phase III
Source of the news: www.bayer.com
