The Clot Thickens: Lilly’s Prasugrel Performs Well

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blood1.jpgPatients who were given Lilly’s blood thinner after a coronary stent was performed had fewer stent-related clots than those on standard drug therapy, according to an analysis published online by The Lancet. The upshot - Prasugrel could offer better protection against heart attack, stroke and death from cardiovascular events than standard treatment with Plavix, according to the researchers.

Among 12,844 patients treated with stents, clots that formed less than one month after a procedure occurred in 0.6 percent of those given Prasugrel, compared with 1.6 percent of those given Plavix. Prasugrel also caused fewer serious complications, such as stent thrombosis, which is a stent-related blood clot, regardless of the type of stent used. There was a 58 percent reduction in stent thrombosis seen with Prasugrel compared with Plavix.

The results of the TRITON-TIMI 38 trial were presented today at the American College of Cardiology meeting in Chicago, and will, no doubt, make life more difficult for Bristol-Myers Squibb and Sanofi-Aventis, which market Plavix. Prasugrel last month was given a priority review by the FDA, which surprised some on Wall Street and in the medical community. Now, though, docs may eventually have more reason to consider Prasugrel and it will be interesting to watch how Bristol and Sanofi respond.

You may recall that, last November, Lilly released a study that found Prasugrel can lower the risk of cardiovascular death, non-fatal heart attacks or non-fatal strokes when compared with Plavix. But the med also caused some patients to experience a statistically significant increase in major bleeding compared to those treated with Plavix, the $7 billion gorilla of blood thinners. Overall, for every 1,000 people treated with prasugrel compared to Plavix, there were 23 fewer heart attacks and an additional six major bleeding complications.

The trial, by the way, was supported by a research grant from Lilly and Daiichi Sankyo, its partner. Several researchers disclosed they have received consulting or advisory board fees, or grants from Lilly, Daiichi or others. Here is the study

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  1. I’ll take the fewer heart attacks and you can have the increased major bleeding, that sounds fair. Now the question is, how do you identify those two populations, so you use the correct antiplatelet in each?

  2. I believe that these results are very good for prasugrel and could signal some real difficulty for Plavix. Although Plavix has done quite well on the market, it does not provide the degree or the consistency of prasugrel. The FDA also appears to be impressed if they are putting the review on the fast track. I think that once the companies sort out the groups that handle the drug somewhat differently and add this additional information to the database, they should be in good shape.

  3. Don’t hold your breath waiting for me to ever take a Lilly drug. Or any drug, if I could possibly help it. Drugs kill, and people like Lilly execs don’t tell. They hide the side effects, doctor the clinical trial, and put pablum articles in medical journals.

    No thanks.

  4. This was not new data. The stent thrombosis data was rehashed because Lilly sees it as a desperate way to up the risk/reward decision. Prasugrel massively increases the risk for death and serious bleeding. So Lilly is using this new serious problem cause by stents as a niche market where the benefit might outweigh the risk. The comparator was Plavix at too low a dose so that gave prasugrel this inflated efficacy.

  5. It is a scam alright, lots of talk about big relative risk reductions, but little on bleeding - hmmmmmm.

  6. [...] according to a stent analysis from the head-to-head TRITON-TIMI 38 trial…more. And, more here from [...]

  7. lauren, what ARE you doing on a blog called pharmalot? arent there tin foil hat forums aimed more at your crowd?

  8. nipsey,
    Careful, you’ll get sat on hard with that kind of talk! (I know, I’ve been there; I’m still squashed.)

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