The FDA has approved the anticoagulant apixaban (Eliquis) as prophylaxis for stroke and systemic embolism in patients with nonvalvular atrial fibrillation (NVAF).
The agency’s decision is based on results of the ARISTOTLE trial, in which NVAF patients taking apixaban experienced fewer strokes than those on warfarin.
Apixaban use also resulted in lower rates of major bleeding and treatment discontinuation than warfarin.
The FDA had previously put off making a decision about apixaban, first last March and then in June, pending the receipt of additional data from the ARISTOTLE trial.
Though initial results of that study were promising, in other trials, apixaban produced mixed results.
In the APPRAISE-2 study, apixaban increased major bleeding in patients with acute coronary syndrome, without reducing recurrent ischemic events.
And although results of the ADVANCE-2 study suggested apixaban was superior to enoxaparin for the prevention of venous thromboembolism (VTE), the earlier ADVANCE study indicated the drugs were comparable in efficacy.
In the more recent AMPLIFY-EXTENSION study, apixaban reduced the incidence of VTE, VTE-related events, and death, when compared to placebo.
And in the AVERROES trial, apixaban proved superior to aspirin at preventing stroke in patients with atrial fibrillation who could not use vitamin K agonists.
Now, apixaban is approved for use in NVAF patients to reduce the risk of stroke and systemic embolism. The recommended dose for most patients is 5 mg orally twice daily.
But patients with at least 2 of the following characteristics—age of 80 years or older, weight of 60 kg or less, or serum creatinine of 1.5 mg/dL or greater—should receive 2.5 mg orally twice daily.
Patients with prosthetic heart valves should not take apixaban, nor should patients with atrial fibrillation caused by a heart valve problem. These patients have not been studied in clinical trials.
Bleeding, including life-threatening and fatal bleeding, is the most serious risk with apixaban. Additionally, the drug’s anticoagulant effects are irreversible.
Apixaban has also been approved in Japan, Canada, and the European Union. The drug is manufactured by Bristol-Myers Squibb Company of Princeton, New Jersey, and marketed by BMS and Pfizer Inc., of New York.
For additional information on apixaban, see the package insert.
