Posted by JLM on May 23, 2003, at 2:57:49
In reply to Re: %'s/see bottom » pharmrep, posted by dr dave on November 25, 2002, at 5:49:32
> > > > > Dear Pharmrep,
> > > > >
> > > > > Good to see you back! The idea that Lexapro has fewer side-effects than Celexa seems to be floating around again. I presented the most recent and accurate data on this a while back and invited your comments. I may have missed them so forgive me if I am needlessly repeating myself, but it would be good to be clear about your views on this.
> > > > >
> > > > > > The relative side-effects of Lexapro and Celexa are as follows
> > > > > >
> > > > > >
> > > > > > Side effect..........................Lexapro..............Celexa
> > > > > >
> > > > > > Headache............................15.8%..............19.9%
> > > > > > Nausea................................15.0%..............17.2%
> > > > > > Ejaculation disorder..............9.3%(of men)...8.8%
> > > > > > Insomnia..............................9.2%................8.6%
> > > > > > Diarrhoea.............................8.0%...............10.8%
> > > > > > Somnolence.........................6.9%................4.7%
> > > > > > Mouth dry............................6.2%...............8.1%
> > > > > > Upper resp tract infection.....6.2%...............3.9%
> > > > > > Dizziness..............................6.0%...............5.6%
> > > > > > Flu-like symptoms................5.0%...............6.1%
> > > > > > Rhinitis.................................4.9%...............5.6%
> > > > > > Sinusitis................................4.3%...............5.1%
> > > > > >
> > > > > >
> > > > > > 'Overall, the type and frequency of TEAEs (treatment-emergent adverse events) reported with escitalopram and citalopram were very similar, and are in line with AEs reported for citalopram previously. For the TEAEs listed (above) there were no statistically significant differences for incidences of these events between the escitalopram and citalopram treatment groups.'
> > > > > >
> > > > > >
> > > > > > This is the official information from Lundbeck about relative side-effects. I wonder if you still stand by the comments that Lexapro has fewer side-effects than Celexa, and that Celexa causes somnolence while Lexapro does not?
> > > > > >
> > > > > >
> > > > >***** I'm not sure i agree with all those %'s...i need to get my package inserts for both and will post (ie...Celexa nausea was 21%, not 17, and I know somnolence for celexa was 18%, not 4...but I will post what the U.S. P.I's state)...as for Lundbeck...the European studies and #'s are done separately from the U.S....I dont think they should be much different, it depends on the parameters of the study.
> > > >
> > > =====================================================================
> > >
> > >
> > > You can't really compare package inserts (is that what P.I.s are?) as they are measuring incidences of side-effects in different populations. The best way to get an accurate comparison is to compare incidences in the same population, as I have described above.
> > >
> > > Whether you personally agree with the percentages is arguably not the issue - the issue is what is the most accurate scientific data. I don't mean to offend by that, but it is really important that we rely on scientific data rather than personal opinions.
> > >
> > > As an employee of Forest, I assume you will have access to full safety data - could you let us see it?
> >
> > ************* Where did those %'s come from...(they look like P.I. #'s) If they are from a study...can you cite it?...otherwise it looks like it is your opinion...which is why I gave mine.
> > What "full safety" data are you talking about? I doubt I am privy to any material you aren't able to get.
>
> ================================================================
>
> In the UK a drug company has to present data on the incidence of side-effects in clinical trials. This is sometimes referred to as 'safety data'. What I am asking for is the data that is available comparing side-effects from Lexapro and Celexa in direct comparisons. Some of these have been done outside the US and therefore seem, for some reason I don't fully understand, not to count. But some studies directly comparing the two have been done in the US, by Forest, and we should be able to see the results of these trials. If you cannot provide this information that Forest holds, could you explain why it is being withheld?
>
> The data is from the Gorman meta-analysis, the source is Lundbeck. Check with them if you want to be sure.
>
>Speaking of the Gorman meta analysis, is there anywhere I can read the full text online?
Much appreciated!
poster:JLM
thread:109458
URL: http://www.dr-bob.org/babble/20030520/msgs/228517.html