I will try to convince you once again PGS :-)
There are 2.2 million americans with AF and it is responsible for 15% of the strokes in US. It is a huge market and a chance for many players.
1)I agree Cardioversion( talking about external here) is the most effective treatment for converting atrial fibrillation, but it does nothing to prevent recurrence.Restoration of sinus rhythm with direct current or pharmacological cardioversion improves symptoms, cardiac output, and exercise tolerance and is initially successful in up to 90% of patients, but the rate of recurrence after a year can be as high as 60%.
2)there is reduced efficacy of external cardioversion in those patients with a high body-mass index and an increased transthoracic diameter
3)An oral drug, even with efficacy lower than cardioversion, could avoid the risks and unpleasantness of deep sedation for an external cardioversion and a shock applied to the chest.
4)The efficiency of electrical cardioversion is high. A drug will be easier to give, but cardioversion is not the issue, it is maintaining sinus rhythm and preventing reccurance.
5)Compared to AZD-7009 from the competitor Astra zeneca, RSD-1235 has a shorter infusion time. The conversion rate was 52% with a median infusion time of 11 minutes. Infusions are continued until patients cardiovert. Most important RSD-1235 hasn’t seen any QTc prolongation so far, no TdP, and no proarrhythmic effects.
6)From AZN, The oral version of AZD-7009 is on hold “because of noncardiac side effects that were not seen with the IV formulation – fever reaction thought to be tied to the extended release formulation.” An AstraZeneca official said, “We need to
understand that.”
7)Regarding oral RSD1235 of Cardiome,I see that there are no repeat dose safety issues which is an very imp thing in cv drugs. 70% of bioavailability is good. Regd Efficacy we have to wait for the results.
Regards,
Praveen
From Cardiome:
"In August 2005, Cardiome announced the successful completion of a series of Phase 1 studies evaluating the pharmacokinetics, safety and tolerability of orally-administered RSD1235, which was found to be safe and well-tolerated across all dose levels explored. The maximum dose given for 7 days was 900mg twice daily (1,800mg/day), yielding blood levels of RSD1235 approaching peak blood levels seen in IV dosing. The formulation provided sustained high blood levels of drug over an interval deemed suitable for chronic-use oral therapy. No clinically relevant changes were found in clinical laboratory, vital signs or ECG measurements, and there were no serious adverse events." |
