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Taranabant is coming?  My story.
Posted: 05 September 2007 11:44 AM   [ Ignore ]
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I have been part of the Merck, Taranabant, trial for the past two years. I am a male in my mid 50’s and began at about 250 pounds. With minimal additional exercise, and closely counting calories, I lost 50 pounds in the first 10-12 months, or so. Since then, I have hit a brick wall. (My dosage was changed with a misleading explanation at the 12 month mark. Which I will discuss below.)

During the second year of the trial, I initially gained 12 pounds and with substantial exercise, I have now lost seven of the 12. At the 12 month point, Merck re-randomized us to test to see what the best maintenance dose is. I was told from the beginning that if I was on a “therapeutic” dose, that it would not change during the course of the study. Consequently, when I hit the brick wall I assumed that the drug had lost its effectiveness. But, now knowing that my dose may have been changed, the wall may have been a result of too small of a dose to maintain the loss.

For the last six months or so I have been stuck within five pounds, seemingly no matter what I do. The harder I exercise the more I crave. The less I eat the less I feel like doing…...anything. Hence, my weight, on average, has gone nowhere. (For the record, I jog 4.5 miles in 45 minutes, 5 times per week and walk at least two rounds of golf each week.)

I still need to lose another 20 pounds to get down to what the government chart says that I should weigh but I have little hope of getting there while on this study.

The positives about Taranabant are first that I am unaware of any side effect that I have incurred while on the drug. Of course, my gizzard may be turning to silly putty as I type, but I am unaware of the change. Second, my co morbidity factors have fallen through the floor. Everything is normal or low normal. The negative is that I do think I hit the wall before I was re-randomized. I think it was at the 10 month check-up. And, if so, something will have to change for the drug to be used long term. Because, it was like a light switch when I got to that point. Appetite was back, cravings were back, the ability to feel full after a reasonable meal was gone. You get the picture….I was back to being on my own to fight my fat demons and the drug has been of little use since.

Anyway, I have great hope that the FDA will see the benefits of Taranabant and that it will not have all of the adverse problems that Acomplia did. Even if it lost all effectiveness at the 10 month mark, it got me to a point that I could physically exercise and mentally think that I can beat this fat thing.

Merck will end the trial in November or December and it is reported that they will apply for FDA approval in 2008. I hope for all of us that can benefit from a drug like this that it gets approved and marketed at a price that folks can afford.

I hope this information helps.

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Posted: 05 September 2007 01:04 PM   [ Ignore ]   [ # 1 ]
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John,

Thank you for your very informative story.

Regarding your plauteau…

You said your appetite returned when you were re-randomized.

Is it possible that you are now getting a placebo?

I am going to post your story so that more people will see it.

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Posted: 05 September 2007 01:33 PM   [ Ignore ]   [ # 2 ]
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Your story is posted here as well:

http://fatnews.com/index.php/weblog/comments/2581/

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Posted: 05 September 2007 01:47 PM   [ Ignore ]   [ # 3 ]
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John,

Most people hit the wall with most diet drugs.

That is why the FDA originally approved phentermine for only 3 months of use.

The studies showed that appetite decreased dramatically during the first 1.5 months, but then returned more to normal.

So way back in 1959, the FDA said something like, “Well, the drug only works for the first couple months, so there is no reason for us to approve it for more than 3 months use.”

After it was discovered that fenfluramine caused heart valve damage, the FDA tried to rewrite history and say, “That’s the reason that we only approved phentermine for 3 months of use, because we weren’t sure about its long-term safety.”

Nonsense. I’ve read the old studies. That was not their reasoning at the time.

Anyway, diet drugs do continue to reduce appetite although the effect is not as great as it was at first, however, many people fail to realize this.

This is true of many drugs.

I have heard of people on antipsychotic medicine who, after taking it for months or years, say, “Well, I don’t think I need this drug any more because I feel fine.”

However, when they stop the drug, they find out that it was still working and that they feel much different without it.

The same is true with diet drugs.

In 1989, I had a roommate who, while in high school weighed 195 lbs. He had gained weight through the year and gotten up to 245 lbs.

With diet and exercise, he had gotten down to 225 lbs but could not seem to go below that.

I told him about the research showing that ephedrine and caffeine caused weight loss.

So he tried one of the herbal products containing ephedra and caffeine and lost 30 lbs, returning to his high school weight of 195 lbs.

He was in his mid-30’s at the time.

But after several months he felt like the ephedrine and caffeine was not working any more and said something like, “Well, I don’t think I need it anymore because it doesn’t seem to be working any more and, besides, I am eating healthier and exercising regularly. I think I can maintain my weight without it.”

So he stopped taking it and, over the next several months, proceeded to regain the 30 pounds he had lost.

It was still working, but he was used to the effects and it felt normal to him after having taking it for a while.

Weight loss doctors can tell you this better than anybody.

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Posted: 05 September 2007 03:40 PM   [ Ignore ]   [ # 4 ]
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Larry,
What I meant to say is that I am not certain when I hit the plateau.  We were re-randomized at the 12 month point.  And, at first I recalled hitting the wall at about that time.  Changing to a new dose would explain the difference.

But, I did some digging and it looks like I hit my low weight point before my ten month check-up and had gained weight at both the 11 and 12 month check-ups…before I was re-randomized.  And, a third possibility is that I am describing a compound effect of plateau and being re-randomized.

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Posted: 05 September 2007 07:08 PM   [ Ignore ]   [ # 5 ]
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John,

Typical weight loss in diet drug studies that also employ diet and exercise is weight loss for the first 6 months—sometimes 9 months if they are really strict and monitor people and have group therapies to help them with behavioral changes—followed by some weight gain.

Studies never seem to show that patients lose 50 lbs and them keep it off for as long as they keep taking the drug. They usually gain some back even when continuing to take the drug, but then if they get off the drug, they often gain all their weight back.

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Posted: 09 October 2007 06:38 PM   [ Ignore ]   [ # 6 ]
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John…. I also have been in the Merck study…. My story is remarkably similar to yours.  I am 54 years old, I started out at 270 lbs.  I lost 60 lbs in 10 months while playing tennis and counting calories (1200 to 1800). Like you all my numbers improved as well…I felt great and had zero side effects..Then at month 10 I was abruptly re-randomized with the reason given, that side effects at the higher doses were of concern.  Well just as you said, it was like a light switch being turned on…. Suddenly cravings returned , satiety decreased and I felt for the first time in 10 months that I was swimming in mud!...  While on the medication, I would get hungry, but was satisfied with reasonable meals. For the first time in memory, I stopped obsessing about food… I don’t know if this makes sense to you, but I stopped craving the good feeling I used to get after eating…a craving that would soon drive me to eat more and more… I guess it blocks the abnormal level of pleasure I would get from eating….thus decreasing my craving for that level of pleasure.

Well I soon gained 15 lbs then lost 5, then gained another 10…now I yo yo this 5 lbs… and currently I am really struggling… I hope the drug is approved soon…I am just eying to hang on until it is available….but I really do have hope now….after almost 40 years of constant struggle..During those 10 months I think I felt like “normal” people feel like… I was able to plan meals follow the plan and it just became a matter of choice not a struggle of trying to fight compulsions…

Let’s hope… Thanks for sharing your story….MJ

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Posted: 10 October 2007 05:33 AM   [ Ignore ]   [ # 7 ]
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MJ,

Thank you very much for sharing your story. Very interesting.

I posted your story as an article so more people would see it.

It is posted here:

http://fatnews.com/index.php/weblog/comments/2682/

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Posted: 01 November 2007 09:30 AM   [ Ignore ]   [ # 8 ]
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MJ have you tried other medications?  What about trying other meds while awaiting for Taranabant.

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Posted: 23 November 2007 02:35 PM   [ Ignore ]   [ # 9 ]
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Yes I have tried a few and each has caused side effects that made it difficult to continue….  I really do not want to keep trying different medications…. As I said..just trying to hang in as best I can until the medication is available…MJ

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Posted: 17 January 2008 04:35 PM   [ Ignore ]   [ # 10 ]
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I participated in the Taranabant trial for 8 months and lost 95 pounds with no additional exercise. However, I was very careful about the calorie count and averaged 1900 calories per day. Since stopping the study one month ago, I have lost another 5 pounds for a total loss of 100 pounds. The drug had a very obvious effect on my urge to overeat, and I also credit it with helping me stop drinking alcohol, which was a lifelong struggle. The 100 pound weight loss cured my high blood pressure, severe obstructive sleep apnea, and diabetes.

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Posted: 18 January 2008 09:17 AM   [ Ignore ]   [ # 11 ]
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Doug,

Thank you for sharing your story.

Congratulations on your incredible weight loss.

I posted your story as an article so that more people will see it.

Your story is posted here:

http://fatnews.com/index.php/weblog/comments/2886/

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Posted: 24 February 2008 07:52 AM   [ Ignore ]   [ # 12 ]
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Hi all,
I am very new to posting messages, but thought I would tell you a little about my weight problems and Taranabant.  I am a woman in her 50’s and have been overweight my entire life.  I have been as heavy as 280 (on my wedding day….19 years ago).  I have been on countless diets in my life, two of the most stupid was once in my teens my mother took me to a doctor that gave me dozens of pills to take everyday.  To get up, to not eat, and to sleep.  I lost a lot of weight, but stopped that and gained it back (plus some).  The other was a diet I did to myself.  I ate only 500 or less calories a day….I lost 60+ pounds but once I almost fainted, I knew it was time to stop…....FORWARD TO November 2006. 

Someone (don’t know who) gave my name to a Clincal Research office.  They called me in for a visit, I signed up for MK-0364 and started at 240 pounds.  In a year I was down to 179.  I felt great.  I could finally shop for clothes that were not in the large section!  Shopping now is my problem.  On December 6, 2007 I went back in for the extension of Taranabant and at that time they said they did not have the pills for me!  I was crazy!!!! I felt like a drug addict.  Everytime the phone rang after that, I was hoping they would call and say come back in.  During this time I decided that I would buy Acompia from the internet, knowing that it is a lot like Taranabant.  FINALLY I had an appointment on Feb 20th (I had also called them 3 times).  BUT…..after my appointment, still no pills.  I had climbed the scale to 188 pounds.  They told me they would call me when the pills would be in.

Taranabant seems to good to be true.  I still have to watch what I eat, and often I am hungry, but I DON’T THINK ABOUT FOOD ALL THE TIME!

Anyway, I would be happy to hear about others expericenes and thank you for letting me share.

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Posted: 24 February 2008 01:40 PM   [ Ignore ]   [ # 13 ]
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Rosie,

Thank you very much for your interesting story.

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Posted: 24 February 2008 02:21 PM   [ Ignore ]   [ # 14 ]
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Rosie,

I posted your story here so that more people would see it.

http://fatnews.com/index.php/weblog/comments/2945/

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Posted: 09 March 2008 08:00 PM   [ Ignore ]   [ # 15 ]
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Larry, from reading this string of posts it seems that Taranabant holds great promise.  As someone who treats overweight / obese patients it’s exciting to hear about new meds in the pipeline.  However, I recently read in Business Week that Merck released preliminary results from a 12 week trial using Taranabant that showed 30% of patients (vs 18% placebo) that experienced psychiatric side effects including depression.  Have you heard any official or personal reports about this drug?

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