Getting into the guidelines can be a slow and laborious process. Some critics complain that it takes too long for new therapies to receive the guideline seal of approval. But with the new guidelines released at the ESC it’s unlikely that anyone will complain about such dawdling.
With unprecedented speed, dronedarone and ticagrelor have achieved class 1 recommendations in the new ESC guidelines released in Stockholm this week. Dronedarone (Multaq, Sanofi) gained a class 1 recommendation for the first line treatment of AF patients who do not have heart failure in the ESC guidelines for the management of atrial fibrillation, while ticagrelor (Brilinta, Astra-Zeneca) which has not yet received regulatory approval anywhere in the world, received a class 1 indication for the treatment of NSTE-ACS and STEMI in the new ESC guideliens for myocardial revascularization. But not everyone is convinced that such haste is warranted.
Former AHA president Clyde Yancy told CardioBrief that he was concerned about the potential dangers of wide usage of dronedarone and that he felt the data probably did not warrant a class 1 recommendation. Yancy was less concerned about the appearance of ticagrelor in the guidelines, though he acknowledged that it was unusual if not unprecedented for a drug to gain a guideline recommendation before receiving regulatory approval.
Sanjay Kaul also expressed concern about the endorsement of dronedarone in the ESC guidelines:
The ESC guidelines overstate the case for dronedarone. Given it’s modest efficacy as an antiarrhythmic agent, lack of clear-cut advantage in tolerability over amiodarone, and a huge cost disadvantage compared with generic alternatives, it is hard to envision dronedarone as a first line option for the management of atrial fibrillation. In contrast to these guidelines, the recent NICE recommendations appear to be more faithful to the evidence.