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Rivaroxaban reduces combined risk of cardiovascular death, myocardial infarction, or stroke in ACS patients
An estimated 1.2 million Americans are discharged from a hospital with a diagnosis of acute coronary syndrome (ACS) each year. Now, a new randomized controlled trial dubbed "ATLAS ACS 2" (Anti-Xa Therapy to Lower Cardiovascular Events in Addition to aspirin with/without thienopyridine therapy in Subjects with Acute Coronary Syndrome), is suggesting rivaroxaban may reduce the risk of the composite end point of death from cardiovascular causes, myocardial infarction, or stroke in patients with a recent ACS, but at a cost of increased major bleeding.
An estimated 1.2 million Americans are discharged from a hospital with a diagnosis of acute coronary syndrome (ACS) each year. Now, a new randomized controlled trial dubbed "ATLAS ACS 2" (Anti-Xa Therapy to Lower Cardiovascular Events in Addition to aspirin with/without thienopyridine therapy in Subjects with Acute Coronary Syndrome), is suggesting rivaroxaban may reduce the risk of the composite end point of death from cardiovascular causes, myocardial infarction, or stroke in patients with a recent ACS, but at a cost of increased major bleeding.
The results of ATLAS ACS 2 were recently presented as a late breaker at the American Heart Association's 2011 Scientific Sessions, Orlando, Fla., and published in the January 5, 2012, edition of the New England Journal of Medicine.
According to Formulary Editorial Board Advisor Craig I. Coleman, PharmD, associate professor at the University of Connecticut School of Pharmacy in Storrs, Conn., "Even with the use of long-term dual antiplatelet therapy with aspirin and thienopyridines, ACS patients continue to be at high risk for repeat cardiovascular events." He continued, "While warfarin and investigational anticoagulants have been evaluated for their potential to reduce cardiovascular events following ACS, for numerous reasons, their accepted use in this setting has not come to fruition."
Perhaps not unexpectedly, rivaroxaban did increase both the rates of major bleeding not related to coronary-artery bypass grafting (2.1% vs 0.6%, P<.001) and intracranial hemorrhage (0.6% vs 0.2%, P=.009) compared to placebo.
Dr Coleman noted, "While serious bleeding was increased with rivaroxaban, it is reassuring to see that fatal bleeding was no higher in the rivaroxaban groups compared to placebo."
"It appears that the cardiovascular event reduction benefits outweigh the bleeding risks in this population, based upon the fact that the 2.5-mg dose of rivaroxaban reduced both the rates of death from cardiovascular and any cause," he continued.
Fueled by the results of ATLAS ACS 2, Janssen Pharmaceuticals has submitted a supplemental new drug application to FDA for the approval of rivaroxaban to reduce the risk of thrombotic cardiovascular events in ACS patients. FDA has granted the drug "fast-track" designation for this supplemental ACS indication.
SOURCE
Mega JL, Braunwald E, Wiviott SD, et al; ATLAS ACS 2–TIMI 51 Investigators. Rivaroxaban in patients with a recent acute coronary syndrome. N Engl J Med. 2012;366(1):9–19.
Coalition promotes important acetaminophen dosing reminders
November 18th 2014It may come as a surprise that each year Americans catch approximately 1 billion colds, and the Centers for Disease Control and Prevention estimates that as many as 20% get the flu. This cold and flu season, 7 in 10 patients will reach for an over-the-counter (OTC) medicine to treat their coughs, stuffy noses, and sniffles. It’s an important time of the year to remind patients to double check their medicine labels so they don’t double up on medicines containing acetaminophen.
Support consumer access to specialty medications through value-based insurance design
June 30th 2014The driving force behind consumer cost-sharing provisions for specialty medications is the acquisition cost and not clinical value. This appears to be true for almost all public and private health plans, says a new report from researchers at the University of Michigan Center for Value-Based Insurance Design (V-BID Center) and the National Pharmaceutical Council (NPC).
Management of antipsychotic medication polypharmacy
June 13th 2013Within our healthcare-driven society, the increase in the identification and diagnosis of mental illnesses has led to a proportional increase in the prescribing of psychotropic medications. The prevalence of mental illnesses and subsequent treatment approaches may employ monotherapy as first-line treatment, but in many cases the use of combination of therapy can occur, leading to polypharmacy.1 Polypharmacy can be defined in several ways but it generally recognized as the use of multiple medications by one patient and the most common definition is the concurrent use of five more medications. The presence of polyharmacy has the potential to contribute to non-compliance, drug-drug interactions, medication errors, adverse events, or poor quality of life.
Medical innovation improves outcomes
June 12th 2013I have been diagnosed with stage 4 cancer of the pancreas, a disease that’s long been considered not just incurable, but almost impossible to treat-a recalcitrant disease that some practitioners feel has given oncology a bad name. I was told my life would be measured in weeks.
