Diet and Health FAQ

Tagged As: Zelnorm

Question:
Zelnorm (Tegaserod) is a new drug for women with IBS. The research done for FDA approval did not test enough men, thus the drug is meant for women only. It is made by Novartis Pharm. 1. Have any women out there used Zelnorm and if so, what was your experience with the drug? 2. Have any men used Zelnorm and if so, what was the experience like?

Answer:
Not exactly...EVERY SINGLE drug has to be tested on both genders through Phase II trials (testing on dozens to hundreds of sick people to test for efficacy) The genders you test on is HIGHLY regulated.  It is not done based on marketing strategy, but on the science. A lot of people seem to see some sort of conspiracy that IBS drugs are tested in woman, but they cannot test any drug in phase III where it fails in the phase II trials. At the end of Phase II a gender breakdown HAS to be done and submitted. This is because up until the 1990's men and only men were ever used for drug tests. Most drugs have never been tested on woman at all. Now MOST drugs do not show a gender bias at the phase II clinical trial level.  You have to prove that it is effective for EACH gender in order to be able to go on to Phase III for each gender. When the drug is equally effective, both genders must be included in phase III.  If it only works for one gender then you can only do that gender in phase III.  You do not get to choose. Zelnorm in the Phase II trials (adequate numbers of each gender to see if it is worth doing it on thousands of patients) enough men were tested to try to get approval to do Phase III trials. In the phase II trials men did slightly worse *as a group* on Zelnorm then on placebo.  With numbers like that you are not allowed to do additional testing on men.  If it had been woman it would have been the reverse. Now some individual men may do well on zelnorm (there are some who have tried it, but most of the men I have heard tried it anyway didn't get any relief on it).  But something is different in the genders so that the majority of men get no benefit. Some drugs work better in men than woman, some better in woman than men.  We are just now seeing the drugs coming to market tested under the new rules.  I expect over the coming years we will see many other drugs that are gender specific. Thanks for the clarification. The recent CME course I took revealed that somewhere around 4000 women and about 500 men where in the phase III study. When I called Novartis to ask what their protocols were for men using Zelnorm, they mentioned that Novartis did not recommend Zelnorm for men because there were not satisfactory results in the phase III trials. So, I am not surprised to hear that the men you mentioned did not get results. I'd still like to know how women are doing using Zelnorm. I believe, but am not entirely sure, the recommendations are Zelnorm 6 mg daily for 6 weeks and then evaluate the results. So what happens after 6 weeks? The drug is not a cure as I understand. Can Zelnorm be taken on a continuous basis? Well, I've just started Zelnorm (tegaserod), and I am a man.  I've been taking it for a few days, and I definitely see _some_ improvement.  It's not all better, but some of the bizarreness of my abnormal bowel function seems to be reduced.  If other men had an experience similar to mine, though, I can also imagine why some would say that the symptoms had gotten worse, because it increases peristalsis, so I find that I have to pass gas even more often than before, which is pretty awful (though it doesn't smell most of the time, once I've gotten my bowel basically empty).  But even there, I find an improvement in that I am not constantly suffering from bloating and a sensation of trapped gas that could literally take _hours_ to get out and would simply torment me until that moment.  I sort of wish I hadn't read these postings about the reasons why men are not included in the FDA approval, because I had been feeling pretty optimistic.  So far, this is the only thing that has had any benefit other than what I had been doing until now, which is using sodium phosphate enemas every day to clear my entire bowel out.  That worked, but it hurt, could get exhausting, and could take forever.  I don't know -- I still might have to use that, too.  But I've gotten by without it since starting Zelnorm. I have a question about the Zelnorm dose schedule but will post it separately. From the data on file with Novartis Pharmaceuticals Corporation, they seem to have had such a choice. In their population data on Phase III trials trial B358 (n=1519); was a women only study. They have studies over 5000 people worldwide with a distribution of 89.5% of subjects being women. Patients recruited were mainly women with abdominal pain, bloating, hard stools and straining. There are THREE phases. Phase I and Phase II are NO CHOICE. Phase III isn't BY CHOICE it depends on the gender analysis of the PHASE TWO trials. You can only proceed to the next phase with something that worked in the previous phase. Works for both genders in Phase II MUST do both genders in Phase III Works for ONLY ONE gender in Phase II You can ONLY do that gender in Phase III except for things where you are trying to understand the nature of the gender bias. If it doesn't work for EITHER gender you cannot do any Phase III testing at all. The Phase III gender selection is due to the results of the Phase II trials. If the results had been reversed, no matter how much they want to market it to woman they would have been only allowed to test it and market it to men. The FDA regulates the clinical trials and which phase you are in pretty closely. You cannot proceed to the next level only after approval, and only for the subsets of people that passed the previous phase. I should probably also inform you for what the #'s are for the various Phases. Phase I.  Tens of people who are healthy to determine if the drug is safe to give to anyone and what doses are safe to give anyone. Phase II.  Hundreds of people who have the disease. Initial efficacy and dose that does something that is in the doesn't kill you range. This would be the 10% of the people tested who were men. All in the Phase I and  II. Phase II. Thousands of people who have the disease. Refined efficacy and determine the most common of the side effects and their frequency. AT EACH STAGE you have to have approval to move on AT THE END of PHASE II a gender analysis HAS TO be submitted. With the data the FDA decides if you CAN do phase III and if you have to do it in one or both genders.