![[dr. bob]](/dr-bob-sm.gif)
Dr. Bob is Robert Hsiung, MD,
bob@dr-bob.orgShown: posts 218 to 242 of 8406. Go back in thread:
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
Posted by Winger on September 1, 2002, at 17:37:42
In reply to Re: 20%?, posted by Phil on August 1, 2002, at 6:15:48
Posted by Winger on September 1, 2002, at 17:38:13
In reply to Re: 20%?, posted by Phil on August 1, 2002, at 6:15:48
Posted by Winger on September 1, 2002, at 17:43:10
In reply to Re: sex. s/e, posted by pharmrep on August 1, 2002, at 10:54:11
I have read that small doses of Buspar seem to negate the side effects of SSRI's.
I have GAD and took Buspar. It worked great for a while, then it started giving me panic attacks, something I never had... and because of it's short half life, if I missed a does, it was bad... anxiety, chest pain, etc....
I got the buspar from my internest, but finally found a psych doc for help.. she put me on a very small does of zoloft to help me get off the Buspar.. I have to admit, while I was taking a low dose of BOTH, I felt the best I have ever felt.. I slowly stopped the buspar, then the Zoloft started making me edgy and giving me stomach problems.. and so I slowly stopped that as well... I am now trying a low 37.5 mg does of effexor XR.. not bad, fewer side effects, but not as good at the anxiety.. I want to try lexapro... and I may try a small single daily dose of Buspar to get rid of SSRI side effects...
I found a great web site for this kind of research
http://www.biopsychiatry.com/venbus.html
follow the links at the bottom... they're great...
anyone else heard of this buspar/SSRI thing?
Good luck and Thanks!
Posted by dr. dave on September 1, 2002, at 17:52:45
In reply to Cheap, Generic Celexa, posted by moxy1000 on September 1, 2002, at 14:14:07
Let's look at the 'patent emergency' question. It is undeniable that Lundbeck, who developed Celexa, are facing a patent emergency - 81% of their revenue in 2001 was from citalopram, the patent ran out in January of this year, and generic citalopram is available in many European countries. They have had no choice but to launch something new, and escitalopram was all they realistically had. Forest are not in the same position - but what would have happened had they not launched escitalopram when it has been launched in Europe? A 'new, improved' citalopram is being heavily marketed in Europe and they don't launch it too? There would have been uproar in the US, not least on this website. People would believe they were being denied a better drug. So Forest have really had no choice.
I think moxy1000 hasn't quite got the pharmacology here - Celexa is a combination of s-citalopram and r-citalopram, and lexapro is s-citalopram alone. So the active molecules are, in fact, exactly the same molecules, thereby having exactly identical effects on the body. In vitro data show Lexapro to be about twice, not 100 times, the potency of Celexa (Sanchez et al, at http://www.cipralex.ch/pdf/poster/sanch19_500.pdf ). If you think about it, this is only logical. Only half of Celexa is active, so you need twice the weight of it to get the same amount of s-citalopram as you do Lexapro, so half the potency. What does this potency mean? Potency is not related to rate of increase of serotonin levels. It merely describes the relative doses of two substances required to get the same effect. If being more potent means a drug works better, this would mean haloperidol would be a much much more effective drug than quetiapine, as it is tens of times more potent.If there is data to support the claim that escitalopram causes a higher rate of increase of serotonin levels I would be glad to see it.
I don't know what to say further about the claim of a cleaner 'side-effect profile' for Lexapro than Celexa. I've given the research data in detail in a previous post and no-one has provided anything new to contradict what that data says, which is that no difference in rates of side-effects has been found. Again, any data to back up the claim, I'd be glad to see it.
At the risk of being repetitive, we have to look closely at the data here and see what it is saying. It's important to make our own minds up from an informed perspective.
> 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 pharmrep on September 1, 2002, at 18:01:10
In reply to Re: Generic Celexa will be better than Lexapro, posted by LostBoyinNC1 on September 1, 2002, at 17:31:47
> 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*** First of all, no generic available til 2005, 2nd...what do you base this on? Nothing...I didnt think so. If there werent advances in treatment...everybody would still be taking tricyclics...would you rather have that?
Posted by dr. dave on September 1, 2002, at 18:10:49
In reply to other findings, posted by pharmrep on September 1, 2002, at 10:42:58
I'm sorry if what I am saying is annoying you. I don't disagree with the findings, which are that switching from citalopram to escitalopram does not cause an increase in side-effects, and that escitalopram (like citalopram) is superior to placebo in treating GAD and as maintenance treatment in depression. None of these papers contribute any evidence to support any claim that escitalopram is superior to citalopram; no comparisons have been made.
Please let's stick to a careful analysis of the data. To reiterate my position - I believe escitalopram is effectively identical to citalopram (a good antidepressant which I continue to prescribe widely). There's nothing wrong with it particularly; but I cannot see convincing evidence that it contributes anything new, nor can I see how it could even hypothetically be better given the pharmacology.
> 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,
>
> http://www.docguide.com/news/content.nsf/news/7F27EF97B338460A852569B400610AE8?OpenDocument&id=48DDE4A73E09A969852568880078C249&c=Depression&count=10&highlight=0,
>
>
>
>
>
>
Posted by pharmrep on September 1, 2002, at 18:19:09
In reply to Re: sex. s/e (let's try this one more time -newby) » pharmrep, posted by Winger on September 1, 2002, at 17:43:10
> I have read that small doses of Buspar seem to negate the side effects of SSRI's.
> I have GAD and took Buspar. It worked great for a while, then it started giving me panic attacks, something I never had... and because of it's short half life, if I missed a does, it was bad... anxiety, chest pain, etc....
> I got the buspar from my internest, but finally found a psych doc for help.. she put me on a very small does of zoloft to help me get off the Buspar.. I have to admit, while I was taking a low dose of BOTH, I felt the best I have ever felt.. I slowly stopped the buspar, then the Zoloft started making me edgy and giving me stomach problems.. and so I slowly stopped that as well... I am now trying a low 37.5 mg does of effexor XR.. not bad, fewer side effects, but not as good at the anxiety.. I want to try lexapro... and I may try a small single daily dose of Buspar to get rid of SSRI side effects...
> I found a great web site for this kind of research
> http://www.biopsychiatry.com/venbus.html
> follow the links at the bottom... they're great...
> anyone else heard of this buspar/SSRI thing?
> Good luck and Thanks!** No joke...sexual s/e can be tough with SSRI's...I know it is a tough trade for some...treating the depressive componants vs sex s/e. I have heard of the buspar..and others like wellbutrin added on to SSRI's. It seems that your dose can be low enough for you and that the AD still works. Effexor is usually an SNRI, but at doses below 150 it is still an SSRI. How are you doing with the s/e? Are you experiencing increased sweating, increased blood pressure (you have to check your blood pressure with Effexor), dizziness, nausea, somnolence, insomnia, ejac disorder, or anything else? Most of all...like Paxil, you need to be aware of discontinuation s/e with Effexor...this is an AD you cant just stop and switch with..if you do...you might experience agitation, anorexia, anxiety, confusion, impaired coordination, fatigue, vertigo, vomiting,dry mouth, nervousness, and the earlier mentioned s/e. If you do try Lexapro...try it without the Buspar 1st to see if you even need it...you might not.
Posted by LostBoyinNC1 on September 1, 2002, at 18:20:45
In reply to what? » LostBoyinNC1, posted by pharmrep on September 1, 2002, at 18:01:10
> > 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
>
> *** First of all, no generic available til >2005, 2nd...what do you base this on? >Nothing...I didnt think so.WRONG. I base what I say upon solid and basic pharmacology knowledge. Its a hard fact Lexapro is just another SSRI. Its no better than Prozac, Zoloft, Paxil, Luvox or the currently available Celexa. You know it...I know it. So do most psychiatrists and most of the posters on this board. One SSRI is as good as another SSRI.
Dont let your salesman mentality get in the way of logical thinkng Pharmrep. I realize you want to sell as much Lexapro as poosible...thats your job. You work for Forest Labs. When I read your posts, I think "who is this person who is writing this?" And I realize you are a DRUG SALESMAN for the company that makes Lexapro. DUH. Thus you are going to brag about your drug in order to try to sell more of it.
Lexapro is no more effective than currently available antidepressants, pharmrep.
It comes down to this one, basic simple fact pharmrep. Lexapro is nothing but another "me too" selective serotonin type antidepressant. Thus it is no better than anything else. In fact, its not AS EFFECTIVE as some antidepressants which hit multiple neurotransmitters like high dosage Effexor or the MAOIs.
And actually, yeah tricyclics hit more neurotransmitters than Lexapro.
> If there werent advances in treatment...everybody would still be taking tricyclics...would you rather have that?
Dont try to use emotion to sway people pharmrep. Stick to the hard facts when you make claims about your beloved Lexapro. Lexapro is just another SSRI. Id rather take generic Prozac, Zoloft or Paxil than make your company richer.
Generic Celexa will be here soon enough. 2005 is not that far off...just a few years. Once that happens no insurance company will want to pay for Lexapro, they will want to pay for the generic Celexa. As soon as a drug becomes generic, many insurance companies will ONLY pay for the generic version of the drug.
LostBoyinNC
PS: dont argue with me, you will never win.
Posted by Dinah on September 1, 2002, at 18:28:22
In reply to Re: what?, posted by LostBoyinNC1 on September 1, 2002, at 18:20:45
> Dont let your salesman mentality get in the way of logical thinkng Pharmrep. I realize you want to sell as much Lexapro as poosible...thats your job. You work for Forest Labs. When I read your posts, I think "who is this person who is writing this?" And I realize you are a DRUG SALESMAN for the company that makes Lexapro. DUH. Thus you are going to brag about your drug in order to try to sell more of it.
>
> LostBoyinNC
>
> PS: dont argue with me, you will never win.
>
Lost Boy,
Dinah here again, filling in for Dr. Bob.
Please see my civility warning on the thread below.
I'd like to keep this discussion focused on issues rather than on other posters.
Thank you,
Dinah
Posted by pharmrep on September 1, 2002, at 18:30:40
In reply to Re: Cheap, Generic Celexa » moxy1000, posted by dr. dave on September 1, 2002, at 17:52:45
You site the same studies that have opposite conclusions from what you are saying. The Sanchez study showed that s-citalopram is acutally being inhibited from r-citalopram in the microdialysis study. that 2mg of s-cit/Lexapro was more effective than 4mg of Celexa (2mg of s-cit + 2mg of r-cit). Therefore indicating that the r-cit does not help the racemic mixture at all.....and you said "s-citalopram is all that they realistically had." Did you know that the technology used to separate the isomers is so new that the scientists that invented it won the Nobel prize for chemistry for 2001? Lundbeck and Forest are not sitting and waiting, but being proactive and trying to develop better medicine....why dont you try it instead of being Dr. Theory all the time. Afterall, you are in Europe and have had the opportunity where we in the US have not.
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