![[dr. bob]](/dr-bob-sm.gif)
Dr. Bob is Robert Hsiung, MD,
bob@dr-bob.orgShown: posts 208 to 232 of 8406. Go back in thread:
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.
Posted by pharmrep on September 1, 2002, at 10:12:25
In reply to Re: Raines et al, posted by dr dave on September 1, 2002, at 8:23:59
> 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?
> >
>Here is the actual link to what Dr. Dave is referring...Raines did a study checking for people switching from the less powerful 20mg of celexa to the stronger 10mg of Lexapro...as well as other mg switches...the last 2 paragraphs says it all (thanks for the post Dr. Dave) But it sounds like you again dont agree with the findings.
http://www.docguide.com/news/content.nsf/news/8525697700573E1885256C240051630B?OpenDocument&id=48DDE4A73E09A969852568880078C249&c=Depression&count=10&highlight=0,
Posted by pharmrep on September 1, 2002, at 10:42:58
In reply to Re: Lexapro side-effects » pharmrep, posted by dr dave on September 1, 2002, at 8:46:58
Here are other findings from Dr Dave's recommended website from another author(globaly) since Dr Dave "feels" Dr Gorman is "biased."
http://www.docguide.com/news/content.nsf/news/DD86D17DF771760785256A80004D4D42?OpenDocument&id=48DDE4A73E09A969852568880078C249&c=Depression&count=10&highlight=0,
Posted by pharmrep on September 1, 2002, at 12:08:26
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?
The benefits of sustained pharmacological therapy lasting several months or longer are generally agreed to be essential to the long-term treatment of major depressive disorder. Although controlled, not all of the long-term trials of Lexapro have not yet been completed, systematic evaluation of the racemic compound, citalopram, has demonstrated the benefit of maintaining treatment after an initial response in the first 6-8 wks of therapy. The efficacy of citalopram in maintaining an AD response in patients with recurrent depression who had responded and continued to be improved during an initial 22-25 wks of treatment was demonstrated in 1 trial. The subjects were subsequently observed for relapse for an additional period of up to 76 wks....those results took longer to analyse, and therefore a longer period before presented to the FDA...they have now approved/agreed with those findings.
Posted by moxy1000 on September 1, 2002, at 14:14:07
In reply to lexapro (P.I.) dose dependant adverse events, posted by pharmrep on September 1, 2002, at 0:00:38
Seems there is a lot of talk about generic Celexa again, and I think there a couple of things to think about. One, no Celexa generic will be available in the U.S. until approx mid 2005. I think Celexa's patent/exclusivity runs through the end of 2004 and they just received another 6 month patent extension for some studies they did in pediatrics. (I assume generic Celexa/Cipralex formulations are available now in Europe?) Second, Lexapro will be priced Cheaper then Celexa, and thus all other SSRI's. Therefore, if you think about the fact that the folks that run HMOs and formularies usually choose the least expensive agents to make available to their customers, it's probably safe to assume that Lexapro will replace Celexa/or other AD's on a lot of formularies. (Another thing to think about is that very soon the company that makes both drugs will no longer be making much $ on Celexa anymore.) In the case of Lexapro being introduced to the states, one thing is clear - this was Not an invention/product release that came about due to a "patent emergency."
So why is Lexapro being released here? It has been said that it is "basically the same as Celexa." Why would a company introduce a drug that is effectively the same as a drug they have three years left to make money off of? Yes, the two drugs are the same in regards to their mechanism of action - both are SSRI's. But saying they are the same is effectively like saying Lexapro is the same as Prozac. It's like saying an apple is the same as an orange. They are two different molecules, thus having different effects on the body. A couple of things to consider - in vitro data shows Lexapro as being 100 times more potent then Celexa for the inhibition of serotonin reuptake - this means simply that Lexapro will increase serotonin levels at a much higher rate then Celexa. (Does anyone want to hear a disertation about receptor binding of Celexa, the R-enantiomer, and the S-enantiomer? I didn't think so - but I can give the sources and further data if necessary.) However, That is one important difference. The second difference is that in every study I've seen to date - authored by many different physicians - the onset of Lexapro in improving depression occured in 1-2 weeks. This is also a difference, as Celexa and all the other SSRI's claim onset at 4-6 weeks. Also, Lexapro's high life is a bit shorter, and protein binding is less. The side effect profile is cleaner, and Lexapro has the less potential for drug interactions then even Celexa does. I wont go into detail here about the significance of those things, however, it furthers the argument that Lexapro is NOT the same as Celexa.
How does one pose an argument based on this: The authors of a study give their findings on Lexapro. The data looks encouraging. The only argument against the data is that the authors cannot be trusted because the studies were sponsored by a drug company. Funny, when Prozac was introduced, all of their studies were sponsored by the parent drug company, yet physicians through "caution to the wind" and began prescribing it anyway. Thankfully, this brought about a revolution in AD treatment and the patients that finally ditched their irritating Tricyclic meds gave a round of applause for a better tolerated medication.
I still don't think anyone has explained successfully why the company that makes celexa would abandon it's marketing and sampling of Celexa in the U.S. when the patent is good for three more years. And why they would introduce the "same drug under a different name" as some claim requires an explanation also. There seems to be only one school of thought that makes sense - they looked at both Celexa and Lexapro, examined all the relevant studies for both agents, and decided to introduce a superior agent, rather then sit on Celexa until it's patent ran out in a few years. (Can you imagine the backlash against the company if they said, "Yeah, we knew about Lexapro back in 2002, but gee, we had Celexa and were making money hand over fist, so we just tucked Lexapro away for a rainy day." People would be furious if they then tried to market Lexapro as being superior.) Heck, they probably even did some research and believe in the long haul they'll make even more money on Lexapro, if we stick with the "drug companies are fundamentally concerned only with their bottom line and really don't care about patients" approach.What other feasible explanation could there be for Lexapro's release in the U.S.? I'd love to hear any feedback on this...as I have been noodling this concept for several weeks and have been unable to arrive at any other conclusion. If there's another explanation that factually makes sense, I'd probably change my mind completely on Lexapro. But so far, the only argument against Lexapro that I've heard is one based on the authors of every study being dishonest. Is it a conspiracy?
Sorry about the long post. I was banned for a week (apologies Dr. Dave) so I had a lot of thoughts to share.
Posted by Simcha on September 1, 2002, at 15:33:19
In reply to Cheap, Generic Celexa, posted by moxy1000 on September 1, 2002, at 14:14:07
I'm concerned by the growing debate over Lexapro. I am not saying that we should not allow Drug Reps to provide information on this new drug.
However..... I think that Pharmrep is more than zealous about Lexapro. Of course he would be. His job depends on it. I think we need to remind ourselves that drug reps and drug companies in general are for profit institutions and as such the profit is the ONLY GOAL of said institutions.
Remember Enron, Worldcom, and all the rest of the corporate scandals lately. These big companies really have so much control over our lives.
As they make Celexa impossible to get because it will be knocked off of the formulary of most insurance companies due to the pricing of their new drug Lexapro, Forest introduces "New and Improved Celexa" in the form of Lexapro. Now, those of us who do just fine on Celexa may not do as well on Lexapro. I see no convincing evidence that Lexapro will be better for me than Celexa. Most med changes have been very difficult for me.
Knocking the waning Celexa off of insurance formularies by making Lexapro cheaper Forest has made certain that no one but Forest will make profit off of Citalopram. The old drug "citalopram" will die an early death at the hands of the insurance companies so that by the time Forest loses its patent no one will bother marketing generic citalopram because there would be no profit. Thus Forest retains its patent on Lexapro and remains the sole provider of this allegedly superior form of its most successful drug (removing the r-isomer of course).
I do not buy into their claims that this is not a profit driven plan for the reasons above. It will insure a continued monopoly on the s-isomer at the very least and it will kill any incentive for any other company to make a generic citalopram thus keeping Lexapro on top of the market.
Just My Opinion,
Simcha
Posted by pharmrep on September 1, 2002, at 16:59:45
In reply to Cheap, Generic Celexa Won't Happen: Here's Why: » moxy1000, posted by Simcha on September 1, 2002, at 15:33:19
> I'm concerned by the growing debate over Lexapro. I am not saying that we should not allow Drug Reps to provide information on this new drug.
>
> However..... I think that Pharmrep is more than zealous about Lexapro. Of course he would be. His job depends on it. I think we need to remind ourselves that drug reps and drug companies in general are for profit institutions and as such the profit is the ONLY GOAL of said institutions.
>
> Remember Enron, Worldcom, and all the rest of the corporate scandals lately. These big companies really have so much control over our lives.
>
> As they make Celexa impossible to get because it will be knocked off of the formulary of most insurance companies due to the pricing of their new drug Lexapro, Forest introduces "New and Improved Celexa" in the form of Lexapro. Now, those of us who do just fine on Celexa may not do as well on Lexapro. I see no convincing evidence that Lexapro will be better for me than Celexa. Most med changes have been very difficult for me.
>
> Knocking the waning Celexa off of insurance formularies by making Lexapro cheaper Forest has made certain that no one but Forest will make profit off of Citalopram. The old drug "citalopram" will die an early death at the hands of the insurance companies so that by the time Forest loses its patent no one will bother marketing generic citalopram because there would be no profit. Thus Forest retains its patent on Lexapro and remains the sole provider of this allegedly superior form of its most successful drug (removing the r-isomer of course).
>
> I do not buy into their claims that this is not a profit driven plan for the reasons above. It will insure a continued monopoly on the s-isomer at the very least and it will kill any incentive for any other company to make a generic citalopram thus keeping Lexapro on top of the market.
>
> Just My Opinion,
> Simcha*** where do you get your info on Celexa being "knocked off" formulary? I dont think that will happen...Forest is not trying to have "happy" Celexa patients switch to Lexapro...just those who "need" to for adverse event reasons. And to concur..generic Celexa not in US til late 2005....
PS Will somebody tell Simcha about Howard Soloman and his story (and his son) so maybe this way Simcha might see Forest in a different light. (PPS...the above point about waiting til patent out is what GlaxoSmithKline did with Paxil...Paxil CR was approved by FDA 3 years ago, but only came out this year...when the original Paxil expires...the public and Dr's are learning this and are not happy....sorry it happens Simcha...but really...Forest isnt a bad cookie and is trying to do the right thing...by promoting the better med.)
Posted by LostBoyinNC1 on September 1, 2002, at 17:31:47
In reply to Cheap, Generic Celexa, posted by moxy1000 on September 1, 2002, at 14:14:07
Generic Celexa will be better, cheaper than Lexapro. Why shell out your hard earned cash to Forest Labs for Lexapro and make yourself poorer and Forest Labs richer, when you can just buy generic Celexa?
Somethings make absolutely no logic whatsoever. This Lexapro thing is one of them.
LostBoyinNC
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