The annual European Society of Cardiology meeting begins this weekend in Barcelona, and here are three key late-stage trials on different anti-clotting agents from big drug makers that are headlining the session:
1) RE-LY: This large study examined the safety and efficacy of Boehringer Ingelheim’s investigational anti-clotting therapy, Prodaxa, against the current gold standard, warfarin, for stroke prevention in atrial fibrillation, a heart condition that affects 2.2 million Americans. Some 18,000 patients with non-valvular AF and at least one other risk factor for stroke, such as a previous stroke, heart failure or high blood pressure were followed for at least one year in this long-term study.
2) PLATO: AstraZeneca will reveal the complete data from this head-to-head comparison between Brilinta, its experimental anti-platelet, anti-clotting drug, and Bristol-Myers’s multi-billion-dollar blockbuster Plavix. In May, AZ announced that Brilinta wasstatistically superior to Plavix in preventing cardiovascular events in patients with acute coronary syndrome, so the safety profile may be more of the focus at the conference, writes Credit Suisse analyst Catherine Arnold in a research note. Good news for AZ could mean pressure on Eli Lilly and Daiichi Sankyo as well, since the FDA approved their anti-platelet medication, Effient, in July. One advantage of Brilinta is that its effects are quickly reversible.
3) OASIS-7: Bristol-Myers is investigating whether higher doses of Plavix early in a treatment regimen, along with a regimen of aspirin, will reduce cardiovascular outcomes and bleeding in patients with acute coronary syndrome who might undergo coronary angioplasty. Arnold thinks the higher dose of Plavix will prove more effective than a lower dose, but notes that the trial doesn’t address the issue of Plavix resistance, which affects 30% of the population.
