The Greek god Dionysos demanded a great deal of attention. When King Pentheus refused to acknowledge the divinity of Dionysos, the god exacted a terrible and bloody revenge, as recounted in the Bacchae, one of the great tragedies of all time. But the new Dionysos is far less demanding. You might even say he’s shy.
This modern Dionysos isn’t a god but a clinical trial comparing the Sanofi drug Multaq (dronedarone) with amiodarone. But you probably haven’t heard much about DIONYSOS and in the view of Sanofi that’s not a tragedy.
The preliminary results of DIONYSOS were released in a Sanofi press release back in December 2008. Subsequently the data was made available to the FDA’s cardiorenal advisory committee and was incorporated in the critical viewpoint and commentary by Sanjay Kaul’s group and published in JACC . Now, finally, the results of DIONYSOS have been published in the Journal of Cardiovascular Electrophysiology along with an accompanying editorial by Jayakumar Sahadevan and Albert Waldo. But don’t look for a press release or any other efforts to disseminate the findings of the trial from Sanofi.
An experienced cardiologist who wishes to remain anonymous informed me about the publication and offered some pungent commentary. Here’s what he had to say:
…many were wondering when or if it would be published. It is the only direct comparison of amiodarone and dronedarone in atrial fibrillation. And dronedarone was very significantly worse in terms of efficacy. The criticism is that had this been a positive trial the drug company would have attempted to get it published in a high-profile journal with a big media splash. Since it was a negative trial I am sure that the company is happy it got absolutely no press.
I’m also guessing you won’t see a lot about DIONYSOS in the CME and other educational and promotional content sponsored by Sanofi. And, I note, with disappointment and sadness, you won’t find anything about it on AFibProfessional.Org, the AF educational website managed by the ACC and the HRS and sponsored by Sanofi.
In the DIONYSOS paper the discussion section emphasizes the limitations of the DIONYSOS trial while making little effort to consider whether it contains any relevant information. (In my experience most authors make an effort to extract useful information from their trials.) Similarly, the editorial dismisses the results of DIONYSOS. But it should be noted that one of the editorialists, Albert Waldo, a very influential figure in the EP world, is a Sanofi consultant who has received honoraria from the company “relevant to this topic.”
It should be noted that this is not the first time unflattering data about dronedarone has gone missing for a long time. The ANDROMEDA trial, which found that treatment with dronedarone in patients with heart failure was associated with a higher rate of death, was stopped early in 2003 but not published until 2008, as noted by reporter John Fauber in his investigation of Multaq in the Journal Sentinel.