CardioExchange Archive

CardioExchange, an NEJM practice community for medical professionals dedicated to improving cardiac patient care, was active from 2009 to 2015. CardioExchange fostered discussion between clinicians from across the globe.

October 5th, 2010

Has Subgroup Exuberance Led to Misleading Advertising?

Harlan Krumholz’s latest Journal Club installment, which focuses on subgroup analyses from TRITON-TIMI 38, has generated great comments, including Harlan’s own new observation about how these subgroup data are being misused in advertising. Read what he has to say and share your own thoughts here.

So I am perusing my current issue of JACC and I notice that there is an ad for Effient (prasugrel) that is all about the subgroups in TRITON. And the language is misleading in my opinion. They tout the reductions in thrombotic CV events in diabetes subgroups and state, “The greater reduction in the primary composite endpoint in patients with diabetes treated with Effient plus ASA compared with Plavix plus ASA was consistent with those observed in the overall UA/NSTEMI and STEMI populations.” By saying the ‘greater reduction’ there is the suggestion that there is a signal of great benefit – but the rest of the sentence concedes that the effect in diabetics is no different than non-diabetics. So why the emphasis on the greater reduction – many who are not familiar with the study might think the drug is more effective in diabetics – which the trial does not indicate. And there is more. For bleeding they present a beautiful figure that shows that Effient has a higher risk of non-CABG related major bleeding in the entire study group (2.2% vs 1.7%) — beside it is another bar graph suggesting that the rates in diabetes are similar (2.2% vs 2.3%) – that would be great except that there is no evidence that the bleeding risk in diabetics is different than non-diabetics. And in small font – very small font – under the figures, it says, “P value not provided because the trial was not designed to prospectively evaluate bleeding differences in subgroups.” I wish that were in a larger font. Take a look at the ad and see what you think.

To comment, join in the discussion on the original post here.

Categories: General


You can follow any responses to this entry through the RSS 2.0 feed. Both comments and pings are currently closed.

Comments are closed.