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Biotech / Medical : Cardiome -- CRME -- Ignore unavailable to you. Want to Upgrade?

To: kenhott who wrote (98)	11/22/2006 3:05:59 AM
From: dr.praveen	Read Replies (2) \| Respond to of 285

"On the 3Q conference call, Cardiome provided details on the design of the phase IIb trial, which is expected to begin 4Q06/1Q07. The trial will test 3 doses of oral vernakalant, 150mg, 300mg, and 500mg, 2x/day vs placebo. 600 patients will be randomized 1:1:1:1, for 150 patients per arm. The entry criteria and trial design will be similar to the phase IIa trial, except that the duration of the trial will be 90 days. Upon entry, patients will be hospitalized for a 3-day run-in with drug or placebo, electrically cardioverted, and then dosed with vernakalant or placebo for the next 87 days. The primary endpoint of the study will most likely be time to recurrence of a-fib. Cardiome will enroll patients at 150 European sites. Powering of the study assumes that about 40% of patients on placebo will maintain normal sinus rhythm, which is the rate observed in the shorter phase IIa study. An interim safety and efficacy analysis will take place around mid-2007" <I like the dosage and the trial design...way to go>

To: kenhott who wrote (98)	7/11/2007 2:22:08 AM
From: tuck	Read Replies (2) \| Respond to of 285

You still follow this pup? Dug up a medscape CME on this: medscape.com Not sure if it tells you anything you didn't know even after the computer ate your homework; doesn't mention the interaction issues you raise, for example. But also shows other competition (AVE0118 doesn't seem to have the QTc problem, but I think it's a long ways from market). Doesn't have a date, but seems pretty recent. Cheers, Tuck

To: kenhott who wrote (98)	10/5/2007 9:28:29 AM
From: tuck	Read Replies (2) \| Respond to of 285

>>Dronedarone for maintenance of sinus rhythm in atrial fibrillation or flutter. N Engl J Med. 2007; 357(10):987-99 (ISSN: 1533-4406) Singh BN ; Connolly SJ ; Crijns HJ ; Roy D ; Kowey PR ; Capucci A ; Radzik D ; Aliot EM ; Hohnloser SH ; Cardiology Division, Veterans Affairs Greater Los Angeles Healthcare System and the David Geffen School of Medicine at UCLA, Los Angeles, CA 90073, USA. bsingh@ucla.edu BACKGROUND: Amiodarone is effective in maintaining sinus rhythm in atrial fibrillation but is associated with potentially serious toxic effects. Dronedarone is a new antiarrhythmic agent pharmacologically related to amiodarone but developed to reduce the risk of side effects. METHODS: In two identical multicenter, double-blind, randomized trials, one conducted in Europe (ClinicalTrials.gov number, NCT00259428 [ClinicalTrials.gov] ) and one conducted in the United States, Canada, Australia, South Africa, and Argentina (termed the non-European trial, NCT00259376 [ClinicalTrials.gov] ), we evaluated the efficacy of dronedarone, with 828 patients receiving 400 mg of the drug twice daily and 409 patients receiving placebo. Rhythm was monitored transtelephonically on days 2, 3, and 5; at 3, 5, 7, and 10 months; during recurrence of arrhythmia; and at nine scheduled visits during a 12-month period. The primary end point was the time to the first recurrence of atrial fibrillation or flutter. RESULTS: In the European trial, the median times to the recurrence of arrhythmia were 41 days in the placebo group and 96 days in the dronedarone group (P=0.01). The corresponding durations in the non-European trial were 59 and 158 days (P=0.002). At the recurrence of arrhythmia in the European trial, the mean (+/-SD) ventricular rate was 117.5+/-29.1 beats per minute in the placebo group and 102.3+/-24.7 beats per minute in the dronedarone group (P<0.001); the corresponding rates in the non-European trial were 116.6+/-31.9 and 104.6+/-27.1 beats per minute (P<0.001). Rates of pulmonary toxic effects and of thyroid and liver dysfunction were not significantly increased in the dronedarone group. CONCLUSIONS: Dronedarone was significantly more effective than placebo in maintaining sinus rhythm and in reducing the ventricular rate during recurrence of arrhythmia.<< Cheers, Tuck