Effient Has Lower Death Risk Than Plavix, But Patients Bleed More: Study

The findings of a recent study appear to indicate that patients given the blood thinner Effient were more likely to survive coronary artery bypass graft surgery (CABG) than patients prescribed Plavix, but may be at a higher risk of serious bleeding events.  

The study, known as TRITON-TIMI 38, was presented on Tuesday at the American Heart Association (AHA) Scientific Sessions annual meeting in Chicago, Illinois. The findings come several months after a study published in the Archives of Internal Medicine raised concerns about a potential increase in the comparative risk of cancer with Effient.

The TRITON-TIMI 38 study looked at 346 patients suffering from acute coronary syndrome who were given either Effient or Plavix before undergoing CABG. Researchers found that only 0.6 percent of patients given Effient died from cardiovascular problems within 30 days of receiving the surgery, compared to 5.8% of patients given Plavix. However, patients given Effient experienced a higher volume of blood loss in the 12 hours following surgery than those given Plavix.

Plavix (clopidogrel) is a blood thinner that prevents blood platelets from sticking together to form clots. It is prescribed to prevent heart attacks, strokes and blood clotting when drug coated stents are used in patients with arteriosclerosis and in other at-risk patients. It is a blockbuster medication, generating annual sales of over $9 billion for Bristol Myers Squibb Co. and Sanofi-Aventis.

Effient (prasugrel) was approved by the FDA in July 2009 to prevent blood clots in people receiving angioplasty for clogged blood vessels. Eli Lilly introduced Effient with high hopes for future sales potential as a direct competitor of Plavix. The medication has been shown to decrease the risk of cardiovascular problems, such as heart attacks, strokes and death, by 19% compared to Plavix. However, some raised questions about the future of Effient amid the concerns about a potential risk of cancer.

In a June 2010 study published in the Archives of Internal Medicine, researchers found that patients given Effient may be 60% more likely to develop certain solid-tumor cancers than those given Plavix. That data was gleaned from a clinical trial involving 13,608 patients, which was actually used to obtain FDA approval for the medication last year.

Eli Lilly, which may face potential Effient lawsuits from users diagnosed with new or worsened solid tumors after taking the medication, has dismissed the potential cancer link and defended Effient’s safety. However, following the June study, some experts called for the FDA to require a black box cancer warning for Effient. They also called on doctors to limit prescriptions of Effient until more data is available, recommending that use be limited to a duration of weeks instead of months.