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Lipoatrophy occurrence for MS patients using Copaxone higher than originally thought

The risk of developing lipoatrophy for multiple sclerosis (MS) patients administrated with glatiramer acetate is greater than 60 percent, according to a study developed at the Riverside Medical Clinic that reviewed 73 MS patients. It was already known that the drug could cause the condition, however the rate is higher than what was originally thought, according to the study........... Read More - http://www.ms-uk.org/copaxone

60% is a very high incidence and for years, according to several Copaxone patients who have posted on this forum, the docs who rxd the drug rarely seemed to advise their patients that this was a very possible problem. Then again, Teva probably minimized this with the docs.

Will be interesting now that the patent is coming off Copaxone whether another drug manufacturer will offer the drug for a far cheaper price.

If the choice is between a having less relapses or possibly dealing with lipoatrophy, to me the choice is obvious!

ElliotB wrote:If the choice is between a having less relapses or possibly dealing with lipoatrophy, to me the choice is obvious!

Of course less relapses vs lipoatrophy really isn't a difficult decision for a MS patient to make. What surprised me a number of years ago was the lack of information that Copaxone users had about the lipoatrophy and how Teva kind of dismissed it as being very minor. But as we have learned, the incidence rate is very high and you would have thought that Teva would have addressed it more intensely from the beginning.

I reread the article. They only followed 73 users. I don't know if a study of 73 patients is large enough of a sample to draw any valid conclusions.

I was not one of the 73 patients studied. However, I can attest that lipoatrophy is a significant side effect. I would still choose Copaxone knowing what I know but for Teva to dismiss it as minor is misleading and wrong.

ElliotB wrote:I reread the article. They only followed 73 users. I don't know if a study of 73 patients is large enough of a sample to draw any valid conclusions.

Believe it or not the number of patients in a trial isn't totally important even though we see trials and studies done with hundreds or even a thousand patients. From what I was told a while ago, the number of participants is determined by what the expected outcome may be in the trial. If a probable outcome isn't known at all, then they need a lot of people to ensure enough sampling is done. If they likely know what the outcome may be then they don't need as many to participate. Sounds strange and I thought so but that's what I was told.

In this case, had they not known much about the possible outcome, then only using 73 patients would be a big risk at reaching an end point. Because with only 73 patients, had only 25 suffered from lipoatrophy, then the probability of getting it would only have been about 33%. But they knew the problem existed with Copaxone patients so 73 candidates would likely give them the figures they needed. And that's how they ended up with a high 60% figure.

Ah the world of statistics!

" the number of patients in a trial isn't totally important"

Well, if that is the case, based on my own personal study, 100% of those in my study did not have lipoatrophy.

Obviously a study of 1 is statistically insignificant. Given that many tens of thousands of people, probably hundreds of thousands (anyone care to take a guess) are using the drug, a study of 73 is in my opinion, statistically insignificant as well.

Well, if that is the case, based on my own personal study, 100% of those in my study did not have lipoatrophy.

I guess that's why they go to people who design these studies and not to your study

Seriously, when you do a scientific trial/study, you have to go to the experts who design these things, tell them what you want to do and they in turn plan the trial. And in the medical world, the trial has to be approved beforehand in order for your results to be valid and accepted. They also more or less outline what kind of participants are required and how they should be chosen.

Obviously a study of 1 is statistically insignificant. Given that many tens of thousands of people, probably hundreds of thousands (anyone care to take a guess) are using the drug, a study of 73 is in my opinion, statistically insignificant as well.

You would think that would be the case but it just isn't. You don't need hundreds and hundreds of people to make a trial statistically significant...you need the trial planned properly by those who know what they are doing. In this particular case it must have been correctly done otherwise they would not be allowed to publish it. I know it sounds ridiculous and I initially had your thoughts as well about the entire scenario. But I was told differently, had it explained and accepted what I was told.

ElliotB wrote:" the number of patients in a trial isn't totally important"

Well, if that is the case, based on my own personal study, 100% of those in my study did not have lipoatrophy.

Obviously a study of 1 is statistically insignificant. Given that many tens of thousands of people, probably hundreds of thousands (anyone care to take a guess) are using the drug, a study of 73 is in my opinion, statistically insignificant as well.

Good point, and thus the issue with studies in general, not enough subjects and there are usually dropouts as well. I take Copaxone and have not suffered Lipoatrophy. I have read that it is less prevalent in men and even lower if you have low bodyfat.

Harrys point is valid though, this information should be more widely available. And TEVA has a terrible record when it comes to being open and honest. To me or most people a dent in the flesh may not be a big deal but what about a model? It could have career ending consequences. These studies are important but I can't help but wonder if the "competition" was behind the funding for it. Anytime you inject anything you risk lipoatrophy, vitamins, vaccines, or other MS Meds.

These studies are important but I can't help but wonder if the "competition" was behind the funding for it. Anytime you inject anything you risk lipoatrophy, vitamins, vaccines, or other MS Meds.

It wouldn't be the first time the "competition" did a study like this to try and sway sales away from their competitors!
Happens all the time in the MS med wars because a percent or two change in the market share can result in millions of dollars of gained revenue.

And that is likely one possible reason that only 79 participants were used in the trial. Keep the cost of the trial down and ensure that you have the numbers to meet the criteria for statistical significance. The trial people probably knew what results they were likely to end up with so whether they used 79 or 790, the percentage would be the same. They got the trial approved with 79 participants and went cheap and cheerful ending up with a damaging number for Teva.