Lilly responds to Serebruany attack on TRITON-TIMI 38

In response to Victor Serebruany’s editorial in Cardiology criticizing TRITON-TIMI 38 (see our previous post), a Lilly spokesperson sent the following statement to CardioBrief:

“In response to Dr. Victor Serebruany’s editorial in the June 5 edition of Cardiology, the analysis he refers to is an incomplete assessment of site-reported endpoint events in TRITON-TIMI 38 and does not include all site-reported events.  In addition, the proposition that the statistical significance would be lost in TRITON-TIMI 38 if that primary outcome were based on only investigator-reported events is not correct. Drs. Montalescot and colleagues recently published the complete assessment of site-reported endpoint events as well as an analysis of peri-procedural myocardial infarctions.  The complete assessment clearly demonstrates that prasugrel produced a significant reduction in site-reported primary endpoints when compared with clopidogrel, including a highly significant reduction in site-reported myocardial infarctions.”

The Lilly spokesperson said more information about this issue is available in a letter by Montalescot et al in the Lancet.

Serebruany provided CardioBrief with the following response to Lilly’s statement:

“The Cardiology Editorial does not contain any speculations, rather than describe the facts outlined in the FDA Prasugrel Review. Moreover, the facts are acknowledged by the Agency’s Cardio-renal division leadership.

“1. With regard to “incomplete assessment site reported end point events in TRITON” , as stated in Table 21 on page 332, there were 630 – clopidogrel versus 486 -prasugrel CEC-adjudicated MI’s with a difference of 144 events favoring prasugrel. However, if site-reported events only are counted the difference is 298-226 = 72 MI’s, exactly half of the declared prasugrel benefit. Suggesting that these data are “incomplete” may require some additional clarification with the Agency.

“2. Concerning “…the proposition that the statistical significance would be lost in TRITON-TIMI 38 if that primary outcome were based on only investigator-reported events is not correct”. As stated on page 330 of the FDA review with regard to the whole TRITON population: ” The results for the primary site-reported endpoint are not statistically significant by the Gehan test stratified by ACS type, i.e., UA/NSTEMI vs. STEMI, or by the log rank test stratified or non-stratified”.

“3. With regard to Montalescot, et al. paper: it was already severely criticized in the Lancet. The main issue is that there is no late MI benefit for prasugrel in TRITON if clinically relevant site-reported events will be properly counted, as clearly shown at Figure 17 on page 331 of the FDA document.”

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Trackbacks

  1. […] editorial used data from the FDA briefing document to criticize the TRITON-TIMI 38 trial. We posted a response from Lilly and Serebruany’s rebuttal. We then received an off-the-record communication that was highly critical of the FDA review, […]

  2. […] Lilly responds to Serebruany attack on TRITON-TIMI 38 […]

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