Clinicaltrials gov symptoms and conditions

I have been doing a trial and error thing w/ all my meds and I suspect that Singulair may be the culprit in my insomnia. Since I went down on Cymbalta, it has helped but last night I did not sleep a wink. I took xanax even and was up all night. Finally got up at 4.

Singulair has some ingredients that are the same as anti-histamines which have always affected my sleep but I have copd and am afraid to not take it.It is supposed to open your airways and I use Advair which has a steroid in it and I have no appetite. I still gain weight even though I'm not eating much.Dont know what to do. jo

"Montelukast (Merck brand name Singulair) is a selective Cys-LT1 receptor antagonist that is used to control asthma symptoms in children and adults. Although safe and effective, the inter-patient variability in response is substantial (25-60% response rate), which is due in part to genetic variability. For example, we recently reported that polymorphisms in candidate genes that encode proteins in the LT pathway influence responsiveness to the drug."

Co-sponsored by Merck

http://clinicaltrials.gov/ct2/show/record/NCT00513760

Clinical trial of montelukast in the Netherlands.

I noticed two things:

1. The researcher states that sides effects are 10%.
2. The researcher will not allow patients to also take drugs which are metabolized by CYP2C8 because montelukast inhibits that as proved by in vitro (test tube) studies. American studies in vitro said yes montelukast is an inhibitor but in vivo (in people) that it didn't happen. I was always confused by that and would still like to know more
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I noticed that the FDA turned down approval for Merck's Cordaptive. That was the niacin cholesterol drug that came with it's own chemical to control the side effect of facial flushing.

I noticed that they were in clinical trials for montelukast's effect on preventing heart disease. So I guess that Merck is trying to capitalize on the "inflammation" angle that is mentioned below. Who shows up for these clinical trials?

http://clinicaltrials.gov/ct2/show/NCT00379808?term=%22montelukast%22+and+%22heart%22&rank=1

The surgeons can do liver and kidney transplants but there won't be enough organs to go around for all of us who get sold all of these drugs. But nobody does brain transplants. What are the people on montelukast long term going to do? And there will be many, many more of them if Merck gets approval for preventing heart disease.
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http://blog.pharmexec.com/2008/05/01/mercks-cordaptive-a-nasty-surprise/

"The Merck drug was a nice piece of innovation: Kim’s elves figured out what causes niacin’s worst side effect, facial flushing, and developed a spanking new chemical, laropiprant, to control it. But since the cholesterol market is not exactly under served by pharma, you could also surmise that FDA is getting bearish on innovation there (more about that later).’s John Carey, apparently the only reporter not to be surprised, offers a must-read analysis of the situation.
http://www.businessweek.com/bwdaily/dnflash/content/apr2008/db20080429_182260.htm

“Add it all up and the FDA’s decision shouldn’t be seen as coming out of the blue. Cordaptive offers no big improvement over niacin alone—while introducing a new, unknown risk. And even the benefits of niacin’s effect on cholesterol may not be that big.”

“The decision also comes at a time when the very idea of cholesterol-lowering is under increasing scientific attack. Yes, doctors know that the statin class of cholesterol-lowering drugs, like Lipitor, do prevent heart disease and heart attacks. But there’s growing evidence that a big chunk of the benefits of statins comes from reducing inflammation,” writes John Carey.

Merck is experimenting on premature babies giving them montelukast as we speak. Does anyone believe that they care about these side effects that are posted here?

Here is the clinical trial. Write your congressman.

http://clinicaltrials.gov/ct2/show/NCT00492102?term=montelukast&rank=2

I just want to make another post about studying Singulair in premature babies. There is a person who is very dear to me that I remind practically every day that a scientist proves what is NOT true just the same as a scientist proves what is true. I have read hundreds of Merck studies on montelukast. Does anybody ever say - NO - not true? So with all those YES men behind them, Merck experiments on premature babies. Oh, my God. Where does this end?

I would like other people's opinion of Merck's study about using Singulair (montelukast) on neo-nates - premature babies. This absolutely freaks me out. http://clinicaltrials.gov/ct2/show/NCT00492102?intr=%22Montelukast%22&rank=7

I would like other people's opinion of Merck's study about using Singulair (montelukast) on neo-nates - premature babies. This absolutely freaks me out.

http://clinicaltrials.gov/ct2/show/NCT00492102?intr=%22Montelukast%22&rank=7

Some of you who are following this site may remember that I posted that when I was following the pathways of the leukeotriene receptor antagonist Singulair that I got to a point where I concluded that there has to be a genetic component (meaning that there are different gene groups of people) and that the efficacy of Singulair (and possibly safety) can vary depending upon what gene group people are in. So I took a little time to see if anybody else was already studying that issue. And YES, they are -- including Merck.

quote:

" However, logically one might predict that it will be the combination of the polymorphisms in these different key regulatory enzymes and receptors that may ultimately determine treatment response. There have been some attempts to tease out the possible contribution of different genes important in this pathway for treatment response to a Cys leukotriene receptor 1 antagonist.18 However, because of the number of potential gene variants that may contribute to efficacy, large studies will be needed to fully evaluate the potential contribution of pharmacogenetic variability in this pathway to treatment response to Cys leukotriene receptor 1 antagonists. Work in the cardiovascular field has demonstrated the potential importance of genetic variants in this pathway to disease risk and also to treatment response,19 suggesting the potential for important effects to be defined in asthma."

(Chest. 2006;130:1873-1878.)
© 2006 American College of Chest Physicians

Pharmacogenetics of Asthma
Ian P. Hall, DM
* From the Division of Therapeutics and Molecular Medicine, University Hospital of Nottingham, Nottingham, UK.
Correspondence to: Ian P. Hall, DM, Division of Therapeutics and Molecular Medicine, University Hospital of Nottingham, Nottingham NG7 2UH, UK; e-mail: Ian.Hall@nottingham.ac.uk

http://www.chestjournal.org/cgi/content/full/130/6/1873

And Merck sponsored a study on this which is now completed.

http://clinicaltrials.gov/ct2/show/NCT00116324?intr=%22Montelukast%22&rank=79

Of course, it was sponsored by Merck and paid for by Merck.

I don't know if the study discovered anything but I believe this is an indication that Merck acknowledges genetic differences in populations that may predict the success of montelukast.

I am not any where close to being an expert in this field. I have another background but I believe that there are experts who can tell you exactly why you had side effects from Singulair.

If any one is following what research is being done, here is the description of the new study in children.

http://clinicaltrials.gov/ct2/show/NCT00540839?intr=%22Montelukast%22&rank=19