![[dr. bob]](/dr-bob-sm.gif)
Dr. Bob is Robert Hsiung, MD,
bob@dr-bob.orgShown: posts 201 to 225 of 8406. Go back in thread:
Posted by pharmrep on August 28, 2002, at 2:34:46
In reply to Re: and that particular link... » IsoM, posted by dr dave on August 28, 2002, at 2:02:47
Hi DR.Dave, Nice site...I noticed is was about 2 years old...any chance of any newer sites that might list more recent findings/or drugs since then? And I'm curious...how do you feel about isomer science in general...do you believe that it's all about money and getting a "new" drug out to replace an old one, or do you believe there can be a benefit to the single isomer/enantiomer over the racemic mixture?
Posted by dr dave on August 28, 2002, at 3:15:33
In reply to dosage/tested improvement » Patson, posted by pharmrep on August 28, 2002, at 1:51:43
It is repeatedly claimed Lexapro has fewer side-effects than Celexa. What does the data show? In the Burke et al trial 85.6% of those on Lexapro 20mg had side-effects compared to 86.4% on Celexa 40mg (not statistically significant). Not impressive, I would suggest. 10.4% of those on Lexapro 20mg discontinued because of side-effects compared to 8.8% of those on Celexa. So in fact more discontinued Lexapro than Celexa. But the result is not statistically significant and therefore likely to be a chance result.
The incidence of discontinuations on Lexapro 10mg a day was 4.2% compared to 2.5% on placebo. Again, not statistically significant. The overall rate of side-effects on Lexapro 10mg was 79.0% compared to 70.5% on placebo (not statistically significant). The comparison between Celexa 20 mg and placebo is not available as this dose was not used.
So the Burke study provides no data to support the claim that Lexapro has fewer side-effects than Celexa.
Gorman gives discontinuation rates for Lexapro in both doses as being 5.9% versus 2.2% for placebo (not statistically significant). No equivalent rate for Celexa is available. No more detail on side-effects is given in this, the most comprehensive analysis of the data currently available. Myself, I ask why not, if this is such a step forward in terms of side-effects.
These results are entirely consistent with the hypothesis that there is no statistically significant difference in side-effects between Lexapro and Celexa, and provide no evidence of the difference that is so widely claimed as being an established fact.
If there is other evidence to fit into this overall picture, this must be considered, but these results seem to suggest very powerfully that there is no significant difference in side-effects.
Decide for yourself on the basis of actual hard facts.
Posted by Kath on August 28, 2002, at 10:15:51
In reply to Re: Lexapro update, posted by pharmrep on July 31, 2002, at 2:04:24
This feels like a stupid question, but I just want to make sure. I have taken Celexa for 2 years & it works well for me. I sure hope it'll continue to be available. Will it have a different name once it "goes generic"?
Kath
> I am a Celexa rep, and will be marketing Lexapro once the FDA gives final approval (sometime in August is what we've been told). I have gone to extra training to know the differences between Celexa and Lexapro, and when the samples go to the Dr's, so will the studies (very impressive.)
> As far as efficacy...yes it will be more effective than Celexa or any antidepressant available...it will also be more tolerable with "side-effects and discontinuation due to adverse events comparable to placebo." That last quote is being allowed by the FDA...awesome. And most importantly...Lexapro is replacing Celexa because the technology to separate the isomers is just now available...so Ritch, you are partially right, but re-patent? Wrong...Celexa will still be available for 3 years before going generic. Dont lump Forest in with some other unethical pharm companies who get FDA approval years in advance, and then don't offer the new drug til the old one goes generic. Forest is moving to Lexapro because studies show Lexapro is better, and all our efforts will be in promoting the better drug. Hard to believe a company is giving up over $5 billion over the next 3 years...I guess the message Forest is sending is that it that sure Lexapro is that good.
Posted by ehb975 on August 28, 2002, at 20:36:02
In reply to Re: Wish I could » JaneB, posted by Ritch on June 11, 2002, at 23:04:41
Lexapro will be available beginning 9/5/02. I would caution you about switching from Celexa to Lexapro immediately. If you are well controlled on Celexa and comfortable with the therapy, you may want to seriously talk it over with your doc. You are altering the reuptake of seratonin in your brain and psychopharmacology is no perfect science. If you switch to Lexapro it's quite possible your seratonin levels will rise considerably due to the potency of this new isomer. No doubt there is much to be excited about with Lexapro. Just don't take this decision lightly.
Much luck to you!
Posted by ehb975 on August 28, 2002, at 21:00:51
In reply to when will lexapro be available?, posted by mopey on June 19, 2002, at 15:40:30
Reps will begin sampling on Thursday 9/5/02
Posted by Mr.Scott on August 28, 2002, at 23:11:45
In reply to Re: Dr. Dave - the Monstrous vs. the Miraculous » dr dave, posted by Ritch on August 28, 2002, at 0:36:42
Posted by dr. dave on August 29, 2002, at 5:34:09
In reply to Re: Lexapro update- Celexa availability?, posted by Kath on August 28, 2002, at 10:15:51
The important name to remember is citalopram - this is the proper name for 'Celexa', and anything generic will be called citalopram, plus possibly another trade name (like 'Celexa').
> This feels like a stupid question, but I just want to make sure. I have taken Celexa for 2 years & it works well for me. I sure hope it'll continue to be available. Will it have a different name once it "goes generic"?
>
> Kath
>
> > I am a Celexa rep, and will be marketing Lexapro once the FDA gives final approval (sometime in August is what we've been told). I have gone to extra training to know the differences between Celexa and Lexapro, and when the samples go to the Dr's, so will the studies (very impressive.)
> > As far as efficacy...yes it will be more effective than Celexa or any antidepressant available...it will also be more tolerable with "side-effects and discontinuation due to adverse events comparable to placebo." That last quote is being allowed by the FDA...awesome. And most importantly...Lexapro is replacing Celexa because the technology to separate the isomers is just now available...so Ritch, you are partially right, but re-patent? Wrong...Celexa will still be available for 3 years before going generic. Dont lump Forest in with some other unethical pharm companies who get FDA approval years in advance, and then don't offer the new drug til the old one goes generic. Forest is moving to Lexapro because studies show Lexapro is better, and all our efforts will be in promoting the better drug. Hard to believe a company is giving up over $5 billion over the next 3 years...I guess the message Forest is sending is that it that sure Lexapro is that good.
>
>
Posted by Simcha on August 30, 2002, at 10:51:17
In reply to Re: Lexapro update- Celexa availability? » Kath, posted by dr. dave on August 29, 2002, at 5:34:09
Gee,
I'm so glad that a drug rep has assured us that Lexapro is a better drug and that Forest is an ethical company. Now we can all relax. *Cough*
Forgive the sarcasm. It's just that we've heard this song and dance before. I'm on Celexa now. It works brilliantly. I'm going to insist that my pdoc wait for about a year or so to pass before even considering a switch to Lexapro. I'll let others be guinea pigs and wait it out.
Everytime I've made med changes my whole world gets upset for a while. I want to see what this transition from Celexa to Lexapro does to others before I allow Forest to experiment with my brain.
Take Care,
Simcha
Posted by Anyuser on August 30, 2002, at 11:18:34
In reply to Re: Lexapro update- Celexa availability? » dr. dave, posted by Simcha on August 30, 2002, at 10:51:38
What is the significance of Lexapro receiving separate FDA approval as a “maintenance treatment” for depression? Aren’t all ADs, including Celexa, used for maintenance as well as initial treatment? Pharmrep, if you’re still out there, will there be new prescribing info for a maintenance dosage, of will the maintenance dosage be the same as the therapeutic dose?
Posted by dr dave on August 31, 2002, at 6:02:25
In reply to dosage/tested improvement » Patson, posted by pharmrep on August 28, 2002, at 1:51:43
Pharmrep - do you have any comments on my presentation of the data about Lexapro's side-effects compared to Celexa's?
I don't think I've ever said Lexapro hasn't been tested - I supplied links to lots of research in a previous post. Incidentally, I've been in touch with Jack Gorman about the conflict between the poster and the paper in terms of end-point LOCF score, and he says the poster is wrong.
> > There seems to be a question here... 10 = 40 This really means that 10 milligrams is equal to the EFFICACY of 40mg of celexa... right? If you can get a greater efficacy with fewer side effects then this would be a benefit... No? Is there such a thing as "too well" or "too much improvement?" This is my interpretation from what I have read so far. SSRIs are usually started low and titrated up to avoid side effects. I guess I'm confused on the 10 = 40....
> >
> > 10mg can not equal 40mg of medication.... But the results of 10 are greater than the results of 40.....
> >
> >
> >
> > Thanks for your answers.
> >
> *** I dont get Dr. Dave...he says Lexapro is not tested. Most new drugs go against placebo...Lexapro went again placebo and Celexa! And did show improved efficacy. (If 10mg of Lex can do at least what 40mg of Celexa does...with fewer side effects, and with a cleaner drug-to-drug interaction profile, and with onset of action in 1-2 weeks...I would say that sounds like improvement.) Also, why are we talking about patent protection again? Lexapro is coming out now...3 years before a generic for Celexa is available...this is because Lex is proving to be better, and that's it...otherwise Forest could "milk" Celexa for awhile longer, then pull out Lexapro at the last minute...again...not what Forest is doing. And as far as marketing...I dont know what Lundbeck is doing in Europe, but in the US...it's like this. If a patient is not seeing the results they/or the DR. desires on any antidepressant (including Celexa), then switch to Lexapro, favorable s/e profile, lack of drug interactions, and rapid onset make Lexapro an attractive SSRI. And for new patients...the previous also applies, and since very tolerable, it's a good first try (only 6% of patients discontinued due to adverse events) If doctors usually switch from one AD to another 25+% of the time...6% would be a great improvement for them and of course the patients.
Posted by Anyuser on August 31, 2002, at 11:33:31
In reply to Lexapro side-effects » pharmrep, posted by dr dave on August 31, 2002, at 6:02:25
I am surprised that someone eager to make a case against escitalopram keeps pressing the Gorman study. If you're depressed and considering Lexapro and you read the Gorman study, you will camp out on the sidewalk of your drugstore to be the first in line on the morning of the 5th. This is the first paragraph of Gorman's conclusion:
"The results of the pooled analyses clearly support the previously reported antidepressant effect of escitalopram. Additionally, these findings suggest that escitalopram may be superior to citalopram, in terms of both speed of onset and magnitude of its clinical effects. The early and sustained antidepressant efficacy observed with escitalopram was achieved with doses of 10-20 mg/day, which have reported to be very well tolerated."
Posted by dr dave on August 31, 2002, at 12:53:17
In reply to Dr. Dave versus Dr. Jack » dr dave, posted by Anyuser on August 31, 2002, at 11:33:31
Let me try to clarify - I am not trying to make a case against escitalopram. I am making a case against the claims that it is any different from citalopram. I think they are effectively identical.
When reading a study you need to understand who's writing it, and look at the actual results. The Gorman et al study was co-authored by two Forest employees, one of whom is a medical writer. It is not surprising it is enthusiastic in its tone. If you were to read an advertisement for a product in a magazine saying it was much much better than other similar products, would you automatically camp outside a store for it, or would you want to know more about whether those claims were justified?
To see whether the claims are justified, we look at the figures. It seems clear, from the figures which I have given in a previous posting, that there is no significant difference in side-effects. Indeed new research presented this week (Raines et al) looking at people switching from citalopram to escitalopram did not show any significant reduction in side-effects.
This leaves the issue of efficacy. Gorman's study shows no significant difference between citalopram and escitalopram at end-point when drop-outs are accounted for (LOCF analysis). While a significant response after one week is reported, this has been previously reported and used as a selling point for citalopram.
I quote the Gorman study (and other studies) because this debate should be about the scientific evidence that is avilable. The important thing is the truth, and I believe that lies more in the research data than in the opinions of those aiming to promote the drug.
Material produced by drug companies needs to be carefully analysed because (and excuse me if you find this shocking or hard to believe) it can sometimes be a little biased.
> I am surprised that someone eager to make a case against escitalopram keeps pressing the Gorman study. If you're depressed and considering Lexapro and you read the Gorman study, you will camp out on the sidewalk of your drugstore to be the first in line on the morning of the 5th. This is the first paragraph of Gorman's conclusion:
>
> "The results of the pooled analyses clearly support the previously reported antidepressant effect of escitalopram. Additionally, these findings suggest that escitalopram may be superior to citalopram, in terms of both speed of onset and magnitude of its clinical effects. The early and sustained antidepressant efficacy observed with escitalopram was achieved with doses of 10-20 mg/day, which have reported to be very well tolerated."
Posted by Anyuser on August 31, 2002, at 13:29:18
In reply to Re: Dr. Dave versus Dr. Jack » Anyuser, posted by dr dave on August 31, 2002, at 12:53:17
"Indeed new research presented this week (Raines et al) looking at people switching from citalopram to escitalopram did not show any significant reduction in side-effects."
That sounds important. Got a link? Or, can you copy and post?
Posted by Anyuser on August 31, 2002, at 15:53:03
In reply to Re: Dr. Dave versus Dr. Jack » Anyuser, posted by dr dave on August 31, 2002, at 12:53:17
What I hear you saying is that Gorman's data do not support his conclusions. Fair enough. I know this is a naive question, but how does he get away with that in what looks on the surface, at least to a non-expert, to be a scientific paper? I know these papers are generated and collected to serve the purposes of the manufacturers, but are they first published in journals that are "peer-reviewed" and offer a venue for criticism? The link you posted was from a manufacturer web site, but the document itself says "academic supplement." How is a lay reader to know if the thing was published in a reputable publication? I mean, if what you say is true, do you have the opportunity to send a letter to an editor and bust his lying ass (arse)?
Posted by pharmrep on August 31, 2002, at 21:33:15
In reply to Re: Lexapro update- Celexa availability? » dr. dave, posted by Simcha on August 30, 2002, at 10:51:17
> Gee,
>
> I'm so glad that a drug rep has assured us that Lexapro is a better drug and that Forest is an ethical company. Now we can all relax. *Cough*
>
> Forgive the sarcasm. It's just that we've heard this song and dance before. I'm on Celexa now. It works brilliantly. I'm going to insist that my pdoc wait for about a year or so to pass before even considering a switch to Lexapro. I'll let others be guinea pigs and wait it out.
>
> Everytime I've made med changes my whole world gets upset for a while. I want to see what this transition from Celexa to Lexapro does to others before I allow Forest to experiment with my brain.
>
> Take Care,
> Simcha*** To use your own term..."brilliant"...if you're doing fine on any SSRI, then don't switch just because something new is out. The message Forest is sending is to switch to Lexapro if you feel you need to (maybe you have unwanted side effects, or drug interactions, or lack of efficacy.) These are the patients Lexapro should be for...or new patients...not just switching for no reason.
Posted by pharmrep on August 31, 2002, at 21:33:56
In reply to Re: Lexapro update- Celexa availability? » dr. dave, posted by Simcha on August 30, 2002, at 10:51:17
> Gee,
>
> I'm so glad that a drug rep has assured us that Lexapro is a better drug and that Forest is an ethical company. Now we can all relax. *Cough*
>
> Forgive the sarcasm. It's just that we've heard this song and dance before. I'm on Celexa now. It works brilliantly. I'm going to insist that my pdoc wait for about a year or so to pass before even considering a switch to Lexapro. I'll let others be guinea pigs and wait it out.
>
> Everytime I've made med changes my whole world gets upset for a while. I want to see what this transition from Celexa to Lexapro does to others before I allow Forest to experiment with my brain.
>
> Take Care,
> Simcha*** To use your own term..."brilliant"...if you're doing fine on any SSRI, then don't switch just because something new is out. The message Forest is sending is to switch to Lexapro if you feel you need to (maybe you have unwanted side effects, or drug interactions, or lack of efficacy.) These are the patients Lexapro should be for...or new patients...not just switching for no reason.
Posted by pharmrep on August 31, 2002, at 21:42:10
In reply to Lexapro maintenance treatment approval?, posted by Anyuser on August 30, 2002, at 11:18:34
> What is the significance of Lexapro receiving separate FDA approval as a “maintenance treatment” for depression? Aren’t all ADs, including Celexa, used for maintenance as well as initial treatment? Pharmrep, if you’re still out there, will there be new prescribing info for a maintenance dosage, of will the maintenance dosage be the same as the therapeutic dose?
** maybe I dont get your question, but here goes...Since only 2 doses..10 and 20 mg...Lexapro has a starting/maintenance dose of 10 (this is so that your Dr doesnt just go up to 20 because its available). Most patients will be ok staying at 10mg. Compare this to Celexa...most are ok starting at 20, then go to 40, and even fewer go higher.
Posted by pharmrep on August 31, 2002, at 22:13:49
In reply to Lexapro side-effects , posted by dr dave on August 28, 2002, at 3:15:33
> It is repeatedly claimed Lexapro has fewer side-effects than Celexa. What does the data show? In the Burke et al trial 85.6% of those on Lexapro 20mg had side-effects compared to 86.4% on Celexa 40mg (not statistically significant). Not impressive, I would suggest. 10.4% of those on Lexapro 20mg discontinued because of side-effects compared to 8.8% of those on Celexa. So in fact more discontinued Lexapro than Celexa. But the result is not statistically significant and therefore likely to be a chance result.
>
> The incidence of discontinuations on Lexapro 10mg a day was 4.2% compared to 2.5% on placebo. Again, not statistically significant. The overall rate of side-effects on Lexapro 10mg was 79.0% compared to 70.5% on placebo (not statistically significant). The comparison between Celexa 20 mg and placebo is not available as this dose was not used.
>
> So the Burke study provides no data to support the claim that Lexapro has fewer side-effects than Celexa.
>
> Gorman gives discontinuation rates for Lexapro in both doses as being 5.9% versus 2.2% for placebo (not statistically significant). No equivalent rate for Celexa is available. No more detail on side-effects is given in this, the most comprehensive analysis of the data currently available. Myself, I ask why not, if this is such a step forward in terms of side-effects.
>
> These results are entirely consistent with the hypothesis that there is no statistically significant difference in side-effects between Lexapro and Celexa, and provide no evidence of the difference that is so widely claimed as being an established fact.
>
> If there is other evidence to fit into this overall picture, this must be considered, but these results seem to suggest very powerfully that there is no significant difference in side-effects.
>
> Decide for yourself on the basis of actual hard facts.** Ok Dr. Dave...I will ask again. Why are you comparing the higher 20mg of Lexapro to 40mg of Celexa when its 10mg of Lexapro that should be your comparing point? Do you normally start your patients at the highest dose? You should compare 10mg Lexapro to 40mg of Celexa since that is where the studies show that "10mg of Lexapro is at least as effective as 40mg of Celexa" Of course if you look at the 20mg of Lex then you will see higher side effects than the 10mg. But as you said...not a statistically significant difference than placebo. That is a good thing, so why the complaint...the FDA even allows the statement in the package insert. Maybe it would have been easier for you if Forest just compared Lexapro to Placebo like most new drugs that come out. Since Celexa and placebo are in the comparison, and Lexapro does show a significant statistical difference ahead of both...you seem to think there isnt. Stop trying to find a reason why you disagree with the studies...and be a little more objective, or better yet...let the folks here in the US have the chance to decide for themselves if they want to try Lexapro...since you arent willing to and have had the chance for some time now.
Posted by pharmrep on September 1, 2002, at 0:00:38
In reply to Re: Lexapro side-effects » dr dave, posted by pharmrep on August 31, 2002, at 22:13:49
Some of the more common adverse events (as listed in the package insert) are as follows:
adverse event......Placebo.(311 patients)/...10mg Lexapro.(310 patients)/...20mg Lexapro (125 patients)
insomnia..............4%.................................7%..........................................14%
diarrhea..............5%.................................6%..........................................14%
dry mouth...........3%.................................4%...........................................9%
somnolence.........1%.................................4%...........................................9%
dizziness..............2%.................................4%...........................................7%
sweating increased1%.................................3%...........................................8%
constipation.........1%.................................3%...........................................6%
fatigue.................2%.................................2%...........................................6%
indigestion...........1%.................................2%...........................................6%The overall incidence rates of adverse events in 10mg Lexapro treated patients (66%) is similar to that of the placebo treated patients (61%), while the incidence rate in 20mg Lexapro treated patients was greater (86%).
Posted by Anyuser on September 1, 2002, at 0:45:58
In reply to Re: Lexapro maintenance dose » Anyuser, posted by pharmrep on August 31, 2002, at 21:42:10
Forest issued two press releases, one on the 15th announcing approval of lexapro for MDD, and a second on the 29th announcing approval of lexapro for maintenance therapy. Why the separate approvals?
Posted by Simcha on September 1, 2002, at 5:35:06
In reply to Re: Lexapro side-effects » dr dave, posted by pharmrep on August 31, 2002, at 22:13:49
I'll chime in here even though I wasn't asked.
Because many of us who take an SSRI for OCD AND MDD need the higher dose.
Sure, Celexa at 20mg had very few side effects. Of course it did not work as well for me as the 40mg dose. At that level Celexa made my teeth grinding worse. The pdoc explained that this was because the SSRIs (all of them) block dopamine receptors in the joints. He gave me clonazepam to help with this. It did the trick.
I have no confidence that Lexapro will be any different in this regard for people like me. More than likely, following the Lexapro dosing guide, I would need 20mg of Lexapro. OK, so it's only the s-isomer. (And do we really know that the r-isomer is inert since we really don't understand just how these drugs really work in the brain?) Even with only the allegedly uniquely active s-isomer we are still dealing with an SSRI. All SSRIs have side effects that include some form of sexual side-effects, sweating, and for me teeth grinding. The sexual side effects are handled nicely by the addition of WellbutrinSR to my mix and over time that side effect has subsided.
Oh, yes, I plan on sticking with Citalopram as long as insurance companies stick by it. Of course, Forest has made Lexapro slightly cheaper therefore it is more attractive to insurance companies. Oh, and Forest has five years left on the patent for Citalopram? Goody, they can make Lexapro look attractive to insurance companies to insure Lexapro's success so that it makes a handsome profit. Forest can rest assured that so long as they hold the patent for citalopram they will continue to make a handsome profit even if people who need it will, most likely, have to jump through extra hoops to get their insurance companies to pay for it.
This is just a business to these huge drug companies. I don't buy the bit that Forest is being benevolent "passing up profits" by making Lexapro cheaper. It's a great strategy business wise. It's not going to convince me that they are the "Mother Theresa" of drug companies.
Simcha
Posted by dr dave on September 1, 2002, at 7:46:21
In reply to Re: Dr. Dave versus Dr. Jack » dr dave, posted by Anyuser on August 31, 2002, at 15:53:03
The editor of the journal the paper is published in is Jack M. Gorman MD. I think he's unlikely to disagree with himself, but the idea of a letter to the journal is a good one and I may well write.
> What I hear you saying is that Gorman's data do not support his conclusions. Fair enough. I know this is a naive question, but how does he get away with that in what looks on the surface, at least to a non-expert, to be a scientific paper? I know these papers are generated and collected to serve the purposes of the manufacturers, but are they first published in journals that are "peer-reviewed" and offer a venue for criticism? The link you posted was from a manufacturer web site, but the document itself says "academic supplement." How is a lay reader to know if the thing was published in a reputable publication? I mean, if what you say is true, do you have the opportunity to send a letter to an editor and bust his lying ass (arse)?
Posted by dr dave on September 1, 2002, at 8:23:59
In reply to Raines et al » dr dave, posted by Anyuser on August 31, 2002, at 13:29:18
You can find a report by going to http://www.docguide.com and searching for 'escitalopram'. There is a news report dated 08/29/02 on the switching study. If there were any difference between citalopram and escitalopram the side-effects would have decreased and this would have been a major finding. It is noticeable by its absence.
> "Indeed new research presented this week (Raines et al) looking at people switching from citalopram to escitalopram did not show any significant reduction in side-effects."
>
> That sounds important. Got a link? Or, can you copy and post?
>
Posted by dr dave on September 1, 2002, at 8:46:58
In reply to Re: Lexapro side-effects » dr dave, posted by pharmrep on August 31, 2002, at 22:13:49
I'll try to explain this again. Lexapro 10mg contains 10mg of s-citalopram. Celexa 20mg contains 10mg of s-citalopram plus 10mg of r-citalopram. They both have the same amount of active ingredient and differ only in the presence or absence of r-citalopram. The value of removing r-citalopram is the issue under discussion here. You have to compare like with like to get meaningful results. If you want to find out whether r-citalopram affects the efficacy of s-citalopram, you have to look at the same amount of s-citalopram with or without the r-citalopram. This is to be sure any differences seen are due to the r-citalopram, and not due to diifering doses of s-citalopram.
You cannot compare side-effects from Lexapro 10mg with those from Celexa 20mg in these study populations because there are no figures for Celexa 20mg. Rates reported in other studies are not directly comparable because they occurred in a different population and may have been measured differently. So the only figures you can properly compare to have any hope of accuracy are the figures I have given, which show no significant difference between Lexapro and Celexa.
As you have brought up the FDA, it is worth repeating that they have concluded Lexapro is not significantly better than Celexa. This is all that I am saying. Are they not objective? Are the other independent authorities which have reviewed this research not objective? There is a very serious debate to be had here, and I repeat that I think it should be the content and quality of the evidence which should be our focus.
> > It is repeatedly claimed Lexapro has fewer side-effects than Celexa. What does the data show? In the Burke et al trial 85.6% of those on Lexapro 20mg had side-effects compared to 86.4% on Celexa 40mg (not statistically significant). Not impressive, I would suggest. 10.4% of those on Lexapro 20mg discontinued because of side-effects compared to 8.8% of those on Celexa. So in fact more discontinued Lexapro than Celexa. But the result is not statistically significant and therefore likely to be a chance result.
> >
> > The incidence of discontinuations on Lexapro 10mg a day was 4.2% compared to 2.5% on placebo. Again, not statistically significant. The overall rate of side-effects on Lexapro 10mg was 79.0% compared to 70.5% on placebo (not statistically significant). The comparison between Celexa 20 mg and placebo is not available as this dose was not used.
> >
> > So the Burke study provides no data to support the claim that Lexapro has fewer side-effects than Celexa.
> >
> > Gorman gives discontinuation rates for Lexapro in both doses as being 5.9% versus 2.2% for placebo (not statistically significant). No equivalent rate for Celexa is available. No more detail on side-effects is given in this, the most comprehensive analysis of the data currently available. Myself, I ask why not, if this is such a step forward in terms of side-effects.
> >
> > These results are entirely consistent with the hypothesis that there is no statistically significant difference in side-effects between Lexapro and Celexa, and provide no evidence of the difference that is so widely claimed as being an established fact.
> >
> > If there is other evidence to fit into this overall picture, this must be considered, but these results seem to suggest very powerfully that there is no significant difference in side-effects.
> >
> > Decide for yourself on the basis of actual hard facts.
>
> ** Ok Dr. Dave...I will ask again. Why are you comparing the higher 20mg of Lexapro to 40mg of Celexa when its 10mg of Lexapro that should be your comparing point? Do you normally start your patients at the highest dose? You should compare 10mg Lexapro to 40mg of Celexa since that is where the studies show that "10mg of Lexapro is at least as effective as 40mg of Celexa" Of course if you look at the 20mg of Lex then you will see higher side effects than the 10mg. But as you said...not a statistically significant difference than placebo. That is a good thing, so why the complaint...the FDA even allows the statement in the package insert. Maybe it would have been easier for you if Forest just compared Lexapro to Placebo like most new drugs that come out. Since Celexa and placebo are in the comparison, and Lexapro does show a significant statistical difference ahead of both...you seem to think there isnt. Stop trying to find a reason why you disagree with the studies...and be a little more objective, or better yet...let the folks here in the US have the chance to decide for themselves if they want to try Lexapro...since you arent willing to and have had the chance for some time now.
Posted by pharmrep on September 1, 2002, at 9:53:57
In reply to Re: Lexapro maintenance dose » pharmrep, posted by Anyuser on September 1, 2002, at 0:45:58
> Forest issued two press releases, one on the 15th announcing approval of lexapro for MDD, and a second on the 29th announcing approval of lexapro for maintenance therapy. Why the separate approvals?
** dont know...I will find out and get you an answer though.
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