SI
SI
discoversearch

We've detected that you're using an ad content blocking browser plug-in or feature. Ads provide a critical source of revenue to the continued operation of Silicon Investor.  We ask that you disable ad blocking while on Silicon Investor in the best interests of our community.  If you are not using an ad blocker but are still receiving this message, make sure your browser's tracking protection is set to the 'standard' level.
Biotech / Medical : Cardiome -- CRME
CRME 2.330-2.1%May 16 4:00 PM EDT
 Public ReplyPrvt ReplyMark as Last ReadFilePrevious 10Next 10PreviousNext  
To: idos who wrote (230)12/14/2007 1:05:54 PM
From: dr.praveen  Read Replies (1) of 285
 
I am not surprised Idos. Their data has a narrow therapeutic range.you know the side effect profile was bad for the higher dosage and lower dose didn't have much of an efficacy.

For quick reference:

RESULTS: Of 175 patients representing the intention-to-treat sample, conversion to NSR was observed in 41% (25/61) of the tedisamil 0.4 mg/kg group, 51% (27 of 53) of the tedisamil 0.6 mg/kg group, and 7% (4/59) of the placebo group (p < 0.001 for both tedisamil groups vs. placebo). Average time to conversion was 35 min in patients receiving tedisamil. There were two instances of self-terminating ventricular tachycardia: one episode of torsade de pointes and one of monomorphic ventricular tachycardia, both in patients receiving 0.6 mg/kg tedisamil.

CONCLUSIONS: Tedisamil at dosages of 0.4 and 0.6 mg/kg was superior to placebo in converting AF or AFL. Tedisamil has a rapid onset of action leading to conversion within 30 to 40 min in the majority of responders.

The following summarizes the fda's opinion "It's almost like throwing a dart to determine what the dose should be," Tom Marciniak, medical team leader at FDA's cardiovascular and renal unit, told the advisory panel. "What will really happen to this drug when it's put out into the real world?"

From prior experience, I sold out my cardiome the first thing that morning post approval and will look into it again mid next yr for the oral cpd.

Cheers,
Praveen
Report TOU ViolationShare This Post
 Public ReplyPrvt ReplyMark as Last ReadFilePrevious 10Next 10PreviousNext  

HomeMailHotSubjectMarksPeopleMarksKeepersSettings
Terms Of UseContact UsCopyright/IP PolicyPrivacy PolicyAbout UsFAQAdvertise on SI
© 2025 Knight Sac Media.  Data provided by Twelve Data, Alpha Vantage, and CityFALCON News