Silver Springs, MD - A new Food and Drug Administration analysis has shown that statins do not increase the risk of amyotrophic lateral sclerosis (ALS), also known as Lou Gehrig's disease [1].
The meta-analysis, which included 41 clinical trials and was published online September 29, 2008 in the journal of Pharmacoepidemiology and Drug Safety, revealed similar rates of ALS in the statin-treated and placebo-treated patients, but the agency says that caution is still needed because of the expansive use of the drugs and the dire consequences of this neurodegenerative disorder.
"People should look at this paper as one bit of evidence," said lead investigator Dr Eric Colman (Food and Drug Administration, Silver Spring, MD). "You have to be a little cautious about how much you make of the results. We just look at this as one bit of information in a much larger puzzle, and we're going to have to see what other data look like."
Speaking with heartwire, Colman said the agency observed a disproportionate number of reports for ALS in association with statin use in the adverse-event databases. In 2006, there were 91 reports of ALS with statins in the agency's adverse-event reporting system (AERS), and these findings prompted internal discussions that eventually led to the meta-analysis.
"It got a point where we thought it would be useful to go back to look at the clinical-trials data to see what kind of numbers there were for ALS in those trials," said Colman. "It's often tough to know what to make of data-mining signals. You really can say very little about most of them, but this was a spark for us to go back and look at the trial data."
The statin manufacturers were requested by the agency to provide data from placebo-controlled trials and the occurrence of ALS in patients during the study or poststudy follow-up. The 41 clinical trials ranged in duration from six months to five years and represented approximately 200 000 patient-years of exposure to statin therapy and 200 000 patient-years of exposure to placebo. Overall, the incidence of ALS was similar in the statin-treated and placebo-treated patients.
Cases of ALS from clinical studies of statins
Therapy
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Patients, n
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Person-years
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ALS cases
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Incidence/100 000 person-years
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Statins
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64 602
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212 775
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9
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4.2
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Placebo
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56 362
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200 078
|
10
|
5.0
|
To download table as a slide, click on slide logo above
Colman said the incidence of ALS in the general population is one to two cases per 100 000 person-years, and the incidence increases with age. He said he is unaware of any biological mechanism whereby statins would cause ALS, but, as has been reported by others, statins might unmask or alter the clinical course of disease.
The agency points out that none of the clinical trials were designed to examine the incidence of ALS, and in the absence of formal adjudication, some of ALS cases might have been misdiagnosed. Also, follow-up after the completion of the studies was short, usually only 30 days, and might lead to some ALS cases being missed.
Colman said there is an ongoing case-control study by Dr Lorene Nelson at Stanford University investigating the possible link between statin therapy and ALS risk. The agency also stressed that the benefits of statins outweigh the risks in individuals with or at high risk for cardiovascular disease.
Source
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Colman E, Szarfman A, Wyeth J, et al. An evaluation of a data mining signal for amyotrophic lateral sclerosis and statins detected in FDA's spontaneous adverse event reporting system. Pharmacoepidemiol Drug Saf 2008; DOI: 10.1002/pds.1643. Available at: http://www3.interscience.wiley.com/journal/5669/home.
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October 3, 2008 07:15 (EDT)
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now that's....
A meta-analysis I can sink my teeth into. When the number studied is over 100,000 - we have find the meta to be credible.
I'm sure this won't get the drama and media attention or the blog space that negative stories get. I can scratch ALS related to my statin use and rx behavior off the list of concerns. mc |
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October 22, 2008 12:36 (EDT)
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YOU ARE MISSING THE LINK TO ALS
It's not the statins that is causing the ALS, It is a metal allergy. YOU CARDIOLOGIST may not be ready to believe it, but you can actually be allergic to your coronary stents. My wife's cardio drop her from his care when I brought the evidence of her allergy. My wife had a blood test done throu the MELISA foundation ( www.MELISA.org they are an excellent place to start)and found out that she is not only allergic to NICKEL (known to cause cancer) but also to MOLYBDENUM. The medical community has always suspected the that nickel and molybdenum cause restinosis (restinosis is scar tissue, scar tissue is what the body makes to cover a wound, or remove an allergen). I got that from PUBMED website. FDA even put out a warning (google "Talk about metal allergy") WEll lets see, from 98 to 04 Tana had 12 heart caths (12 heart caths is 6 years), Tana had 11 stents placed at 4 of the caths (4 in 98, 2 in 2000,3 in 2003, 2 in 04), leaving 8 caths to open up the restinosis (scar tissue not plaque). Think its not an allergy? 4 months after her TAXUS stents went in Tana had a triple by pass because they could not put more stents in. For 7 months my wife lived in agonizing sternal pain after the by pass. It was finally brought to our attention that some people have an allergic reaction to the nickel in the medical grade 316L stainless steel wires. THE EXACT SAME MATERIAL AS THE CORONARY STENTS!!!!! Coronary stents are not exempt from metal allergy. Scientist say that the surface area of the stent is so small that it can't cause an allergy, but one peanut will kill a person if they are allergic to it. A flu virus you can't see but will make you ill. Tana has known about her allergy since childhood (can't wear earing that contain nickel, makes her ear itch, burn, red inflamed, imagine not being able to take them out) Yes it's just that simple, if you can't wear an earring because it contains nickel, you have a nickel allergy and probably should get stents. The manufactures even warn of this. By the way did any of you stent recipient get the manufactures "DIRECTION FOR USE GUIDE"? Tana either, we downloaded it from the internet at the manufactures web site. Apparently Cardiologist are supposed to hand them out with the stent placement. It's an owners manual for you new stent and it has all of the scary things they don't want you to know about (22.1% suffer one or more adverse events in the first 6 months)
I can document the decline of my wifes health per stent placement. The links to metal allergy and chronic diseases is huge (rheumatoid arthritis, Lupus, ALS, IBS, neorlogical disorder, Autism, Bipolar, schizophrenia, sleep apnea, fibromyalgia, temperature regulation problems, Asthma just to name a few. The list is longer than one would imagine.
If you are wondering about the link to ALS, it's already been document that there is a link to metal allergy and ALS. In ALS patients the metal allergy has run rampent for so long the the body turns on itself. If you don't remove the metal you just get more and more toxic (google "Metal Toxicity" )
I challenge anyone to prove me wrong. If you have ALS get metal allergy tested with the MELISA FOUNDATION ( www.MELISA.org ) I would bet everything that this is the link.
Also go to www.angioplasty.org web site and go to the forum section (link in upper right corner of home page) and see just how many people are blogging in on "not feeling well after stenting" and see how many feel crappy. They all seem to be feeling the same symtoms after stents are place.
By the way fevers, flu-like symptoms, nausea, pain, fatigue, vomiting, chills, rashes, itching are all classic signs of rejection.
Good luck and lord bless on your quest for wellness. If you are sure do your own web search. Google is great for answers.
Email me at mogins1@hotmail.com if you want the knowledge I have, I will be more than happy to forward documents for answers.
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