Replies to post #55910 on Biotech Values

[rkrw]

From one of the banks today...

Atrial Fibrillation (AF): Rate vs. Rhythm Control. The AF talk was given by Dr. Jamie Beth Conti from the University of Florida. She highlighted the AFFIRM: On Treatment Analysis Study, which found that the presence of normal sinus rhythm was associated with a lower risk of death. However, the beneficial antiarrhythmic effects of drugs used in the study were offset by their toxicities. This suggests that more efficacious/safer drugs/treatment strategies could make rhythm control safer. There is a high lifetime risk for AF that is increasing with the aging population. The current guidelines are too conservative with respect to AF management, in her view. There are evidence-based reasons to aggressively treat atrial fibrillation (restoration and maintenance of sinus rhythm) to prevent progression and decrease mortality, although it is not addressed in the current algorithms. Dr. Conti suspects that future algorithms will change dramatically, with more emphasis on prevention of atrial fibrillation and more aggressive management of rhythm after the initial episode. In our opinion, this is positive for Cardiome's (CRME, Market Outperform) vernakalant program for the conversion and maintenance of AF to normal sinus rhythm.

[genisi]

The efficacy of agents such as beta-blockers for rate control and possibly suppression of AF, is indeed gaining more appreciation. But this class also have major side effects (such as fatigue, breathlessness, and risk for torsades de pointes).

[pi]

to poorgradstudent on vernakalant --

I respectfully disagree with you. It is true that the studies you have cited favor rate control but the studies do not effectively address morbidity and that is a downstream event that is difficult to ascertain. In addition the ease of use of vernakalent would favor it over cardioversion anyday. And there is indication that rhythm sustainability can be in vernakalant's favor. Now IF the oral form is only half as efficacious with the same safety profile there will be no question what the patient will prefer and what the market will be.

[genisi]

Having a high safety profile - especially the fact that no torsade de pointes has reported up to date, and the fact that IV vernakalant studies included patients who had AF recurrences on oral antiarrhythmic agents , I think that vernakalant has a high probability to be the next antiarrhythmic approved for the IV termination of recent onset AF.
As for the rhythem/rate debate: It makes more sense to me to try and handle rhythem first and go for the rate only if that can not be achieved. Since there is a wide range of etiologies for AF onset, and factors such as structural heart disease, risk for thromboembolic events and hypertension, the appropriate rate control and antiarrhythmic drugs are chosen based on the absence or presence of those factors along with anticoagulation treatment and other procedures.