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Effient superior to Plavix in trial

Effient associated with a 26 per cent relative risk reduction of cardiovascular death, myocardial infarction or stroke, compared with Plavix

A new post-hoc sub-analysis of the core clinical cohort of patients from the TRITON-TIMI 38 study demonstrated that treatment with prasugrel combined with aspirin was associated with a 26 per cent relative reduction in risk of cardiovascular death, myocardial infarction or stroke, compared to treatment with clopidogrel (8.3 per cent versus 11.0 per cent, respectively). This corresponds to an absolute risk reduction of 2.7 per cent for patients treated with prasugrel.

The TRITON-TIMI 38 study was a head-to-head study comparing prasugrel plus aspirin with clopidogrel plus aspirin in 13,608 patients with Acute Coronary Syndrome (ACS) managed with percutaneous coronary intervention.

In the core clinical cohort, patients treated with prasugrel experienced higher bleeding rates compared with patients treated with clopidogrel. Based on this post-hoc analysis, the difference in bleeding rates was reduced, without an associated impact on the efficacy of prasugrel versus clopidogrel.

“This analysis showed that the use of prasugrel in a clinically identifiable population of ACS patients significantly improved cardiovascular outcomes,” said Dr Stephen D Wiviott of the TIMI Study Group, Cardiovascular Division, Brigham and Women's Hospital and Harvard Medical School, Boston.

Prasugrel, which was developed by Daiichi Sankyo, is available in more than 65 countries worldwide. The drug has been marketed as Effient in the EU since February 2009 by Eli Lilly and in the US since July 2009. Ranbaxy has marketed a generic prasugrel under the name of Prasita in India since June 2010.

Despite initially being touted as Lilly's great white hope, however, Effient had a slow launch and was widely considered a failure, until promising trial data began to emerge. Sales reached just $27m in 2009 but are now predicted to reach $1bn by 2016, giving Effient blockbuster status.

The US Food and Drug Administration (FDA) approved Clopidogrel, which is marketed by sanofi-aventis and Bristol-Myers Squibb as Plavix and Iscover, for use in 1997. Plavix had sales of $6.2bn in 2009 (down from $9.8bn the previous year), but is due for patent expiry in 2012.

Both drugs may be rivalled by AstraZeneca's Brilinta/Brilique (ticagrelor), which has a broad label (covering all patients with ACS) and a shorter half-life than either Effient or Plavix. Brilinta was approved only last month, but has had data demonstrating its superiority to Plavix on record for more than two years.

16th August 2011

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