"In truth, the gold standard is already a barbarous relic."

Justine Cadet, News Editor

While the early 20th Century British economist John Manyard Keynes was referring to monetary standards, many clinical studies are currently attempting to assess, and even surpass, the current gold standard of oral antiplatelet medication—clopidogrel—with varying degrees of success.

Plavix, which is manufactured and distributed by Bristol-Myers Squibb and AstraZeneca, reaps in approximately $8 billion in annual revenue. The blockbuster drug is set to lose its patent in 2012, but in the meantime, remains unchallenged in the U.S. antiplatelet market. However, while the new antiplatelet agent prasugrel received unanimous support from an FDA panel in February, its makers Eli Lilly and Daiichi Sankyo are still awaiting the FDA's prolonged verdict to confront clopidogrel's place in the U.S. market.

This week, AstraZeneca released new data from a head-to-head phase III PLATO trial for its antiplatelet contender Brilinta (ticagrelor) involving 18,000 patients. The company said its data revealed that in patients with acute coronary syndrome Brilinta was more effective than Plavix in preventing cardiovascular events such as vascular death and non-fatal MI and stroke. The British company said it is on track to begin the U.S. regulatory filing in the fourth quarter of this year. The full PLATO results are scheduled to be released at the European Society of Cardiology (ESC) annual conference in August.

Contrarily, in a surprising turn of events, Medicines Company was forced to terminate the phase III clinical trial for its antiplatelet possibility cangrelor, when the Interim Analysis Review Committee recommended that the drug failed to meet its clinical efficacy endpoints in patients undergoing PCI. Cangrelor, which Medicines licensed from AstraZeneca in 2003, was involved in a head-to-head comparative study with Plavix as well.

Just to flex its gold-standard muscles, a new study was released in today's New England Journal of Medicine, showing that Plavix, when combined with an aspirin regimen, was effective in reducing the risk of major vascular events, especially stroke, for patients with atrial fibrillation for whom vitamin K-antagonist therapy was unsuitable.

While the viable Plavix is far from a "barbarous relic," its position is consistently being challenged and questioned by competitors and clinical investigators seeking to test its limits.

On these topics, or any others, please feel free to contact me.

Justine Cadet, News Editor
jcadet@cardiovascularbusiness.com