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Google News Psychopath or Sociopath Dysfunctional News Feed: Fark.comCollected LORCASERIN posts in one place. I was looking these over now that lorcaserin is on the verge of either being approved or back to the drawing board.
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lorcaserin
In terms of efficacy, lorcaserin is pretty much a bust. Arena published the phase 3 trial results. The active group lost only 10.6lbs more than the placebo group, 17.9lbs to 7.3lbs. That’s 17.9 pounds in TWO YEARS! PATHETIC! Officially, lorcaserin failed to meet one of the two FDA efficacy requirements. Arena’s stock price plummeted on the news.
However, all is not lost. Why ? Because weight loss is a highly emotional issue and most who seek pharmaceutical assistance don’t pay attention to efficacy, side effects, length of treatment, etc. Irrational optimism, it’s like a form of denial.
If Arena is going to push this drug to market, I’m going to buy stock. I do believe it will be a big seller even if it doesn’t work.
I wonder how Alli is doing these days.
Sandra, thanks for your comment.
My post pretty much zeros in on lorcaserin as the dexfenfluramine only without the cardiac issues. Perfect? No, but put that with phenteramine (i.e., speed) and you have the 1997 sales figures — something like 18MM scripts that year. Emotional or not, people bought it. No doubt there will be off label prescribing.
I just don’t get the negativity. I mean, it works OK. if it is the safe version of dexfenfluramine, it will work much better in combination with phenteramine. Plus, it’s not a two-in-one pill, so you can modulate your own dosing. (Presumably everyone will end up self dosing at some point if obesity is chronic). As far as the placebo effect, I mean, you read the posts — people were dropping out like flies when they didn’t get any weight loss. So that skews the placebo to those who perhaps saw some weight loss.
Again, I’m not saying this drug is the be all and end all (it isn’t) but seriously, if you can keep people from irreversibly turning diabetic because they are at a steady weight, without changing their life one iota, and without side effects, good.
The 17.9 pounds was lost in one year.
Lorcaserin patients who completed 52 weeks of treatment according to the protocol lost an average of 8.2% of body weight, or 17.9 pounds, compared to 3.4%, or 7.3 pounds, in the placebo group (p<0.0001).
I enjoy reading on your site
Thank You
Thank you sauve9 – glad you like the site, and I thought it was only one year and not two as “Sandra” posted above.
I started posting on lorcaserin and some of the other anti-obesity meds about a year or so ago, and have no inside baseball on that one at all. From a drug development point of view, it made perfect sense to me. It will be interesting to see how this market plays out.
BLOOM was the first Phase 3 trial, initiated Sep 2006, 2 years in duration, and it excluded patients with valvulopathy.
BLOSSOM and BLOOM-DM are the second and third trials, initiated Dec 2007, 1 year in duration, no valvulopathy exclusions.
It’s the BLOOM results which Arena just released in Mar 2009. (BLOSSOM and BLOOM-DM will be released later this year, apparently.) I don’t know why they are reporting 1 year weight loss figures when the trial duration was 2 years.
http://arna.client.shareholder.com/releasedetail.cfm?ReleaseID=320295
“The BLOOM trial will evaluate a 20 mg dose (10 mg dosed twice daily) of lorcaserin versus placebo over a two-year treatment period …”
Can anyone explain this?
Here’s the link to clinical trials.gov BLOOM, and here’s the explanation:
Further study details as provided by Arena Pharmaceuticals:
Primary Outcome Measures:
* Year 1: Proportion (%) of patients achieving > or = 5% weight reduction at the end of the first year of treatment (Week 52) [ Designated as safety issue: No ]
* Year 2: Proportion of patients maintaining > or = 5% weight reduction at the end of Year 2 (Week 104) [ Designated as safety issue: No ]
Secondary Outcome Measures:
* Change in body weight at the end of Year 1 [ Designated as safety issue: No ]
* Additional body weight change during Year 2 [ Designated as safety issue: No ]
* Change in waist and hip measurements [ Designated as safety issue: No ]
* Change in cardiovascular risk factors [ Designated as safety issue: No ]
* Change in use of concomitant medications for comorbidities (i.e., hypertension, dyslipidemia) [ Designated as safety issue: No ]
* Change in Quality of Life measures [ Designated as safety issue: No ]
Enrollment: 3182
Study Start Date: September 2006
Estimated Study Completion Date: March 2009
Estimated Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Regarding year 1 and year 2 there are 3 groups-
placebo/placebo
Lorcaserin/placebo
Lorcaserin/Lorcaserin
We were given the 1 year data, and what Arena said about the upcoming 2 year data is–
“During Year 2 of the trial, patients continuing on lorcaserin were better able to maintain more of the Week 52 weight loss than Year 1 lorcaserin patients re-randomized to placebo in Year 2.”
so I am expecting a small weight GAIN in groups 2 and 3 vs 1 year weight loss
============================
3,182 patients
Patients were randomized in a 1:1 ratio to lorcaserin or placebo at baseline. At Week 52, 856 patients taking lorcaserin were re-randomized in a 2:1 ratio to continue lorcaserin or to switch to placebo, and 697 patients on placebo were continued on placebo.
==========================
Thanks swivelchair and sauve9. So for BLOOM, Arena has released the first year data. Presumably they will release the second year data later.
Arena’s comment about year 2 is interesting, “patients continuing on lorcaserin were better able to maintain …”
I’ll bet $50 that there was 2nd year weight gain for ALL three groups. (I’d bet more, but I’m saving up to buy a garage.) Any takers?
I will place my bet alongside yours, there will be weight gain in year 2 for all 3 groups.
Although I am an ARNA shareholder, I do not believe in a “magic pill” for weight loss, so I think we all 3 can agree that diet, exercise and motivation are key.
What I have found most interesting about the BLOOM results, which nobody talks about, is comparing numbers for the 52 week completers vs the “quitters” if I may call them that.
Just look at these numbers
BLOOM trial results
Group . . . .average % body weight loss
Loracaserin completers. .8.2%
Placebo completers . . .3.4%
Lorcaserin quitters . . . .2.8%
Placebo quitters . . . . . . 1.2%
Amazingly, those who stayed on Placebo for the entire trial had more weight loss than those who took Lorcaserin but did not finish the trial.
I think the key to this result is the motivation, diet and exercise of the participant.
This is again reflected in the fact that Lorcaserin patients who finished the trial Had TRIPLE THE WEIGHT LOSS as those who were on Lorcaserin but did not finish.
My take-away is that diet exercise and motivation are the number one thing.
Lorcaserin can triple results for those who employ the number one thing.
With that being the case + a good safety record, I would say that this is a good drug that can help people and will sell very well.
You really can’t compare the lorcaserin completers with the quitters. You need to compare the lorcaserin completers with the placebo completers.
There’s a psychological aftermath when you quit a weight loss trial, not just from adverse effects or other direct reasons for quitting, but guilt and feelings of failure. All of the participants were obese. You know that many if not all of these people had dieted and failed, probably many times, and that’s why they joined the trial. Guilt, feelings of failure, and other stresses will drive a person to overeat. I’m not surprised at all that the quitters lost less than the completers.
The lorcaserin completers lost an average of 17.9 pounds and the placebo completers lost an average of 7.3 pounds. I can tell you that 17.9 pounds lost in a year is nice, but not impressive.
I would like to see if the lorcaserin completers actually lost more but started to regain before the year was over. Why isn’t Arena releasing the data for both years? They released adverse effects data for both years. What about the weight loss? I’ll bet the lorcaserin completers started regaining weight during year 1 and continued to regain during year 2 despite remaining on the drug. The honeymoon was over at some time during the first year. In another thread we saw some comments by a woman who was taking lorcaserin (verified) but said the initial appetite suppressing effects wore off and she was dieting under her own power after that.
Of course, if you’re in the business of making money on a weight loss drug, you really don’t care about long-term efficacy. Weight loss is such an emotional issue, especially with the extreme fat hating going on these days. The companies with weight loss meds in the pipelines are all salivating at the prospect of another winner like fen (after it was combined with phen, that is). Look at Arena’s presentations to investors, you’ll see the dollar signs in their eyes. Make your money and run on the initial weight loss. If the people start regaining, it’s easy to blame the reversal on them, not on the failure of the drug.
And here’s something to consider … any reasonable risk-benefit comparison would indicate that weight loss meds be given only to obese people whose health is compromised by their obesity. (Same is true of bariatric surgery.) And yet you know that this drug will be given to anyone seeking it, even if they only want to lose 10 pounds for purely cosmetic reasons. Arena knows this and knows very well that it will drive up their sales. I can’t wait to see the advertisements. I’ll bet they make more money from non-obese users than obese users. But we should not forget that lorcaserin is a serious SSRI, this is no Alli or herbal supplement, and no phen with a 30 year track record. We should always remember what we learned from fenfluramine, that SSRIs can have unpredictable results, and that pharmaceutical companies can lie about adverse events and get away with it.
“Arena’s drug did not meet the second FDA guideline, which mandates that people on the drug lose 5 percent more weight than those taking a placebo. The average weight loss for those taking the drug was 12.7 pounds, or 5.8 percent of body weight, compared with 4.7 pounds, or 2.2 percent for those in the placebo group. The difference was 3.6 percent.”
I guess they’re forced to combine quitters with completers.
Suave9 do you know if they’ve released reasons for non-completers (drug and placebo)?
I am the one who was on the drug twice a day and quit and it was verified due to me requesting Arna to pay for my ER visit. No worries. I am fine.
I have a problem with eating in the middle of the night. I’ve done this since I was a young child. I woke up with twinkies in my hair. no kidding. I didn’t even remember eating! I still do it.
I can vividly remember awaking while on Lorcaserin and standing in my pantry looking at cookies and saying to myself, “Don’t eat them! You have a weigh-in coming up at the research company. You have to have a good weigh-in.” So I turned myself around and went back to bed.
I believe to some degree that Lorcaserin helped. I was able to lose 20 pounds in 3 months. BUT I exercised consistently 6 days a week and kept at 1500 calories or less a day, but it was harder in months two and three to stay at the lower calories.
Was diet boredom setting in in months two and three? Was the drug wearing off? OR was I so motivated with the upcoming weigh-ins, that that kept me in line?
Take overweight people and make them go weigh in with someone either weekly, every two weeks, or even every month, and see if they maintain? If they are anything like me, they’ll work hard to see a loss so as to not look like a loser.
I think the drug will be successful if it’s approved. Overweight people are looking for help and there’s no good help out there drug-wise.
Hey Sandra,
One,
Verified?? How? If it was in this blog, I have no idea who is for real and who is not, and so please, no one sue me for posting false clinical trial information. Again, the huge disclaimer . . . don’t make any decisions based on what’s here, get all official information from the company.
Two, I don’t understand your point. Is it:
1. The drug doesn’t work, so no one should take it.
Or,
2. The drug works moderately, but no one should take it.
Thank you for your comment Alisa. I would appreciate it Alisa if you gave me permission to re-post your previous comments, that I removed at your request. (I have them saved). I hope you understand that this puts me in a conundrum, because either way, readers could assume that removing your posts, or keeping them up implies validity or whatever. (At this point, I have to respond publicly.)
Readers: this post has not been “verified” on this blog, and I have no way of knowing if what this person says is true or not.
You know, this reminds me of being in a deposition once, and the lawyer would smack his hand down on the table and shout, “Verify this for the Record!!!” and everyone would look like, “Oooo, it’s verrrrifffied. . . .” Later I asked him, “What is that, ‘verified for the record?’” He said he just basically made it up. So when you see the word “verified” it is one of those truthiness kind of sounding words. Is there a word for words that sound official, but are a bunch of baloney?
I know Sandra outside of this site, and so she knows me and knows i was truly on the drug.
Swivelchair, you may post my previous comments if you would like to. There’s nothing in my paperwork from Pivotal Research company that says I can’t talk about my experience, and I verified that — there goes that “verified word again. lol — and so I am free to speak as I wish.
Funny you mention a deposition, I’m a court reporter!! I’ve been in thousands of depositions since 1999 as a reporter, and I’ve never heard an atty say that before.
Thank you Alisa, your comments from earlier are back up.
Alisa, kindly re-direct folks to your own website as I am not comfortable with your posts. I’m leaving up your previous comments, and I’d appreciate your putting up a comment saying that if anyone is interested in your views, please go to your own site.
Seriously, this blog is not to be considered in any kind of financial arrangement pertaining to any stock or anything else. If anyone so dares to put people’s pensions at stake based on the comments here, they need a serious dose of second thoughts at least. So, heaven forbid, please do not consider any of these musings on this message board as any kind of advice to bet anyone’s money on anything.
The point of my prior post was that if lorcaserin works, it might be that it only works temporarily and then its effectiveness wears off. Then what’s the point of taking it at all?
I think we already know that Arena intends lorcaserin to be long-term therapy, because they know that subjects who stopped using the drug start regaining weight. (The mice subjects regained all of their lost weight.) (I so want to see the year 2 BLOOM data!)
But if some number of months into your lorcaserin therapy you find that it’s not longer suppressing your appetite, what do you do? It’s like you stopped taking the drug even though you’re still taking it. In order to keep losing or at least maintain your new lower weight, you MUST do the hard work, restrict your calories and exercise. In other words, you must engage in good old fashioned diet and exercise, the proven no-risk solution. Why not just do that in the first place?
False dichotomy, Sandra. Weight loss meds and diet/exercise are not mutually exclusive.
You missed (or avoided) my point:
What if any appetite-suppressing effect that lorcaserin might have wears off after a couple of months? Then what’s the point of taking it at all?
Is this product designed to help cure the so-called obesity epidemic? Or is it designed to enrich a company and some investors?
Is this product designed to help cure the so-called obesity epidemic?
==============================
Lorcaserin TRIPLES the efforts of the dieter.
There are drugs to help smokers quit.
They do not stop the smoking.
The smoker stops the smoking, and the drug helps achieve the objective.
In the same way, the overweight person loses weight with diet and exercise.
Lorcaserin TRIPLES their efforts in weight loss.
That is the point in taking Lorcaserin.
I think that Lorcaserin’s fate has taken a step in the right direction. News out about a week ago stated that Lorcaserin has a low abuse potential. This is a Big Plus for its potential in being passed by the FDA. News out lately has also stated that Arena is planing on submitting it to the FDA very soon, perhaps within a month. Some food for thought here… What do people think about Lorcaserin potentially being prescribed with Phentermine? And no, it was not Phentermine that was the problem when Phen-Fen was around. It was the Fenfluramine part.
Well this is good and keep posting waiting for more such informative content.