News Release 

Apixaban may be a safer and more effective than rivaroxaban for preventing stroke and blood clots

American College of Physicians

1. Apixaban may be a safer and more effective than rivaroxaban for preventing stroke and blood clots in patients with Afib

Abstract: http://annals.org/aim/article/doi/10.7326/M19-2522

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The blood thinner apixaban may be safer and more effective than rivaroxaban in preventing strokes and systemic blood clots in patients with atrial fibrillation. Findings from a large cohort study are published in Annals of Internal Medicine.

Patients with atrial fibrillation are often prescribed anticoagulants to prevent blood clots or stroke. Apixaban and rivaroxaban are newer blood thinners that are being recommended over warfarin because of their improved safety. Although trials have individually compared apixaban and rivaroxaban with warfarin in patients with atrial fibrillation, few studies have compared the two treatments with each other.

Researchers from Brigham and Women's Hospital and Sinai Health studied a nationwide U.S. commercial insurance claims database to compare the safety and effectiveness of apixaban versus rivaroxaban for patients newly prescribed one of the blood thinners for nonvalvular atrial fibrillation. Two closely matched treatment groups included 39,351 patients who were prescribed apixaban and 39,351 prescribed rivaroxaban. At 290 days follow-up, the rivaroxaban group had a higher rate of stroke or systemic blood clots than the apixaban group, and the apixaban group had a lower rate of gastrointestinal bleeding or bleeding in the brain than the rivaroxaban group. According to the lead author, the results should help to inform decision making when discussing treatment options with patients who have atrial fibrillation.

Media contacts: For an embargoed PDF please contact Lauren Evans at laevans@acponline.org. To speak with the lead author, Michael Fralick, MD, PhD, please contact him directly at mif823@mail.harvard.edu.

2. A single dose of universal flu vaccine, FLU-v, may provide long-lasting protection against influenza

Abstract: http://annals.org/aim/article/doi/10.7326/M19-0735

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A single dose of adjuvanted FLU-v, a synthetic universal flu vaccine, may provide long-lasting protection across a broad spectrum of influenza viruses. Findings from a randomized, double-blind, placebo-controlled trial are published in Annals of Internal Medicine.

Currently, the best available prophylactic treatment against influenza is annual vaccination with inactivated or attenuated influenza virus. However, the short time between publication of WHO recommendations on the strains to include in the annual vaccine and the start of the influenza season, coupled with the lengthy eggs or cell-based manufacturing process, means that the availability of doses is limited, and in addition, the prediction may not be correct or influenza strains may mutate, making the vaccine ineffective. FLU-v is a synthetic vaccine allowing all year round manufacturing and designed to provide cross-protection against A and B influenza strains for a broad patient population.

The primary and secondary endpoints were achieved in a Phase 2b study, done within the UNISEC (Universal Influenza Vaccines Secured, European Union-funded consortium for the advancement of universal influenza vaccines) Consortium and funded by the European Commission under the Seventh Framework Programme for Research and Technological Development (FP7). The researchers randomly assigned 175 healthy adults to either an injection of adjuvanted (1 dose) or nonadjuvanted (2 doses) FLU-v or adjuvanted or nonadjuvanted placebo to compare the safety, immune response, and exploratory efficacy of different formulations and dosing regimens. They found that a single dose of adjuvanted FLU-v elicited a greater immune response compared with placebo. Adverse events were mostly mild to moderate injection site reactions. The authors conclude that a phase 3 trial is warranted to explore efficacy.

Media contacts: For an embargoed PDF please contact Lauren Evans at laevans@acponline.org. To speak with the lead author, Dr. Olga Pleguezuelos please contact her at olga.pleguezuelos@seekacure.com.

3. Alirocumab linked to scleritis with uveal effusion in patient with autoimmune diseases

Abstract: http://annals.org/aim/article/doi/10.7326/L19-0815

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Alirocumab, a newer PCSK9 inhibitor used as a second-line treatment for adults with uncontrolled high cholesterol, may trigger pathologic inflammation in susceptible patients. A case report is published in Annals of Internal Medicine.

Clinicians at Columbia University Irving Medical Center, New York-Presbyterian Hospital report the case of a 63-year-old woman who had several weeks of increasing pain, redness, and loss of vision in her right eye that did not resolve with steroid treatment. The patient had a history of Hashimoto thyroiditis and Ménière disease and had been taking an oral statin for hypercholesterolemia, but started alirocumab treatment about 6 weeks before the eye symptoms began. Suspecting a rare reaction from the alirocumab, the clinicians discontinued the medication and treated the patient's scleritis with uveal effusion with prednisone. Within 1 week, the patient reported dramatic improvement in her ocular and systemic symptoms. By 2 months, all of her symptoms and findings had completely resolved. Alirocumab treatment was not resumed.

According to the authors, newer PCSK9 inhibitors will likely bring significant health benefits to many people; however, because they are monoclonal antibodies with immune system interactions, they may also trigger pathologic inflammation in a subset of susceptible patients. Physicians should be on the lookout for idiosyncratic inflammatory responses to these monoclonal antibodies and continue to take good histories to uncover possible links.

Media contacts: For an embargoed PDF please contact Lauren Evans at laevans@acponline.org. To speak with authors Royce W. Chen, MD (rc2631@cumc.columbia.edu) or Mark P. Breazzano, MD (mb4417@cumc.columbia.edu), please email them directly.

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