Email a Friend
Print Article
Zetia and Vytorin: Let's Look at the Facts
Let's talk about the current media frenzy about the results of a study that seems to conclude that Zetia may not be effective for treating high cholesterol: the ENHANCE study. After the reports were published, I got a bunch of telephone calls from patients and family who are either on Vytorin or on Zetia in combination with another statin and they want to know about what to do now.
My response to them is to relax, and please read this post. I want to make it perfectly clear that I have absolutely no relationship with Merck in any way but I feel it incumbent upon me to state the facts. As a Cardiothoracic Surgeon, my personal goal is to present my patients with the facts in a clear and concise manner and treat them as I would my own family. I went into medicine to save lives, not to be an alarmist and scare the public. The media seems to do that on a daily basis. It is pretty ironic that the same two or three people always seem to make comments in the media about every study, many of whom were "sponsored" by a drug company, and seem to always put their own spin on things and never calmly state the facts.
I think that it is time for the media to come to us, doctors who actually treat patients on a daily basis, for our thoughts.
I. What Was Studied
The ENHANCE Study results were released in part yesterday. This study is a Vytorin 80 mg, which is a combination pill consisting of Zocor and Zetia, versus Simvistatin (Zocor) on the effects of IMT. IMT is the amount of thickening of the layers of the carotid artery and is assessed using a type of duplex ultrasound.
Increased IMT means the person is at a higher risk of Cardiovascular events. It is often used as a marker for either progression or regression of Atherosclerotic Vascular disease. Whether this thickening represents early atherosclerosis or a change that parallels atherosclerosis is a subject of controversy.
II. What Wasn't Studied
IMT is not a measure of the amount of plaque that can cause a blockage in the artery. The ENHANCE study was performed in people with severe familial hypercholesterolemia, (high cholesterol attributed to genetic causes) -- a group notoriously resistant to treatment, and a group that has nothing in common with most of the patients seen in a clinician's office.
In the ENHANCE study, there was no statistically significant difference between the treatment groups for each of the primary endpoints including the carotid artery, nor did key secondary imaging endpoints show any statistical difference between the treatment groups. There were also no safety issues with the Zocor/Zetia whatsoever.
One must remember that reduction in risk for cardiovascular events is directly related to LDL cholesterol lowering. Lower LDL cholesterol is better than higher and has this been shown to reduce the incidence of cardiovascular deaths and complications. While statins are first line management, if one is unable to bring their patients to the NCEP goal of cholesterol reduction, the majority of clinical events will not be reduced.
What Should We Learn?
So are we supposed to give up on an FDA-approved therapy, statins and ezetimibe (Zetia), to get to the goal and listen to these hysterical rants from some physicians or should those of us who actually treat patients continue down the same course? I personally believe we should do the latter.
I perform LDL particle testing on all my patients (Go to my website to find out more about Advanced Cholesterol Testing.) This test allows me to individualize treatment in all my patients and follow their progress with LDL particle testing. I believe this is the reason why heart disease is increasing while even more conventional lipid testing is being done. Simply put, people are not seeing the entire picture clearly.
Like ENHANCE, five recent major clinical studies have failed to meet their primary endpoints. Due to improvements in cardiovascular care the individuals in trials receive, it is becoming increasingly harder for clinical trials to meet their primary endpoint.
III. Why Outcomes Matter More than Predictions
Dr Robert Harrington from the Duke Clinical Research Institute pointed out on Heartwire yesterday that the ENHANCE study should not provoke such a strong reaction.
There is absolutely no prospective data from clinical trials about how raising HDL levels will lower clinical events. Nobody seems to know this yet everyone seems to think that if there HDL is high that is great and they won't have a heart attack or stoke. They do not know that the CDC says that 50% of people who suffer heart attacks have "normal cholesterol".
I beg to differ and that is why I recommend advanced testing on everyone. Advanced testing misses nobody at risk even when their traditional lipid testing numbers were normal. They forget about the true villains which are LDL particles. All the HDL data is from animal studies or population/epidemiologic studies.
I hope this helps to quell some of the panic in the public. I will continue to prescribe Zetia when my patients are unable to meet their LDL goal on statins alone with no hesitation.
Related Topics: Technorati Tags: zetia, vytorin, cholesterol, lipids, ENHANCE, clinical, trials, studies
My response to them is to relax, and please read this post. I want to make it perfectly clear that I have absolutely no relationship with Merck in any way but I feel it incumbent upon me to state the facts. As a Cardiothoracic Surgeon, my personal goal is to present my patients with the facts in a clear and concise manner and treat them as I would my own family. I went into medicine to save lives, not to be an alarmist and scare the public. The media seems to do that on a daily basis. It is pretty ironic that the same two or three people always seem to make comments in the media about every study, many of whom were "sponsored" by a drug company, and seem to always put their own spin on things and never calmly state the facts.
I think that it is time for the media to come to us, doctors who actually treat patients on a daily basis, for our thoughts.
I. What Was Studied
The ENHANCE Study results were released in part yesterday. This study is a Vytorin 80 mg, which is a combination pill consisting of Zocor and Zetia, versus Simvistatin (Zocor) on the effects of IMT. IMT is the amount of thickening of the layers of the carotid artery and is assessed using a type of duplex ultrasound.
Increased IMT means the person is at a higher risk of Cardiovascular events. It is often used as a marker for either progression or regression of Atherosclerotic Vascular disease. Whether this thickening represents early atherosclerosis or a change that parallels atherosclerosis is a subject of controversy.
II. What Wasn't Studied
IMT is not a measure of the amount of plaque that can cause a blockage in the artery. The ENHANCE study was performed in people with severe familial hypercholesterolemia, (high cholesterol attributed to genetic causes) -- a group notoriously resistant to treatment, and a group that has nothing in common with most of the patients seen in a clinician's office.
In the ENHANCE study, there was no statistically significant difference between the treatment groups for each of the primary endpoints including the carotid artery, nor did key secondary imaging endpoints show any statistical difference between the treatment groups. There were also no safety issues with the Zocor/Zetia whatsoever.
One must remember that reduction in risk for cardiovascular events is directly related to LDL cholesterol lowering. Lower LDL cholesterol is better than higher and has this been shown to reduce the incidence of cardiovascular deaths and complications. While statins are first line management, if one is unable to bring their patients to the NCEP goal of cholesterol reduction, the majority of clinical events will not be reduced.
What Should We Learn?
So are we supposed to give up on an FDA-approved therapy, statins and ezetimibe (Zetia), to get to the goal and listen to these hysterical rants from some physicians or should those of us who actually treat patients continue down the same course? I personally believe we should do the latter.
I perform LDL particle testing on all my patients (Go to my website to find out more about Advanced Cholesterol Testing.) This test allows me to individualize treatment in all my patients and follow their progress with LDL particle testing. I believe this is the reason why heart disease is increasing while even more conventional lipid testing is being done. Simply put, people are not seeing the entire picture clearly.
Like ENHANCE, five recent major clinical studies have failed to meet their primary endpoints. Due to improvements in cardiovascular care the individuals in trials receive, it is becoming increasingly harder for clinical trials to meet their primary endpoint.
III. Why Outcomes Matter More than Predictions
Dr Robert Harrington from the Duke Clinical Research Institute pointed out on Heartwire yesterday that the ENHANCE study should not provoke such a strong reaction.
"Dr. Nissen's suggestion about a moratorium on ezetimibe (Zetia) is rather alarmist, given that this was just an imaging study, an imaging study should not change clinical practice. So for me, whatever way it went. I would not have been blown away by results from this trial".I could not agree with him more. Dr. Harrington is involved with one of the large clinical-outcome trials under way with Zetia.
"Enhance is just a biomarker study. Whatever the results were, even if they had been positive, I would still have said we have to wait for the clinical-outcome trials before making our minds up about this drug. The imaging guys all say these imaging studies are predictive of clinical events, but they would say that, wouldn't they? To prove a biomarker is a true surrogate is actually very difficult, and I do not believe that IMT or IVUS (Intravascular Ultrasound) meet the criteria for surrogate markers in this setting," he said. He added, "So I would say not much has changed. If you liked Zetia before ENHANCE because it lowers LDL, I would think you would carry on using it but if you were of the opinion that you would rather wait for clinical outcome results before prescribing it, the there is nothing in this trial to change your mind about that...To me, these results just raise my interest even more in the clinical outcome studies. They are now going to be even more important."As I have stated repeatedly in my talks as well as on my message board, all these studies are great but without clinical outcome studies, it is impossible to draw conclusions. I want to point out that Lipitor became one the best selling drugs of all time before any shred of outcome data was released. Where were these alarmists then? Maybe they worked for Pfizer at that time? Who knows?
There is absolutely no prospective data from clinical trials about how raising HDL levels will lower clinical events. Nobody seems to know this yet everyone seems to think that if there HDL is high that is great and they won't have a heart attack or stoke. They do not know that the CDC says that 50% of people who suffer heart attacks have "normal cholesterol".
I beg to differ and that is why I recommend advanced testing on everyone. Advanced testing misses nobody at risk even when their traditional lipid testing numbers were normal. They forget about the true villains which are LDL particles. All the HDL data is from animal studies or population/epidemiologic studies.
I hope this helps to quell some of the panic in the public. I will continue to prescribe Zetia when my patients are unable to meet their LDL goal on statins alone with no hesitation.
Related Topics: Technorati Tags: zetia, vytorin, cholesterol, lipids, ENHANCE, clinical, trials, studies
46 Comments:
I want to thank Dr. Richman for this outstanding posting on his blog. This just confirms my attitude about the media and the fact that you never get the true story. I take Zetia and will continue to do so along with my Lipitor.
If this is proven to be true, what should a person take of their liver enzymes increased due to statin use? Zetia was the only option.
Once again, we see that the media runs with half-truths and mis-information instead of getting the facts straight. Thank you to Dr. Richman for taking the time to explain what the study was really about. I called my doctor and he said, "Don't go off Zetia! Don't believe everything you see on the news." And he referred me to Dr. Richman's blog. After reading this, I see what a real cholesterol expert had to say, not a journalist who is feeding the media frenzy fire. Thank you so much for clearing this up!
I've heard a lot about LDL particle studies but my Doctor has never done that test and I don't know if medicare covers it since it is obviously expensive. I understand that dense LDL is much more dangerours than the fluffy stuff but I don't see insurance companies paying the additional money for that test.
From the Zetia WEbsite:
The effects of ZETIA, either alone or in addition to a statin, on the risk of cardiovascular morbidity and mortality have not been established.
Why take it then?
We need to be careful when a "researcher" says he is still involved in tests of any drug that has received media scrutiny,and that we should stay the course of therapy. Keep in mind that he has financial reasons to continue his study. Drug companies pay large bucks to researchers for clinical trials. While Zetia and Vytorin caused no harm, they are grossly overpriced products with questionable benefit. Generic statins are my personal choice, and I have taken both Zetia and Vytorin in the past.
I have been on Zetia for 41/2 years because I was unable to take statins. My cholesterol was not that high,however I had a dissected aorta with no evidence of atheromatous debris. The thought was that Zetia would continue normal coronary arteries,at this point am I doing more damage than good?
I was prescribed Zetia as a first line of defense against borderline high cholesterol (LDL was above recommended levels but HDL was high as well) – presumably there would be fewer side effects with Zetia than with a statin. In fact, my cholesterol is now at a healthy level and I have had no side effects from Zetia. Are there any data or suggestions about using Zetia as a first course of treatment (without a statin) when cholesterol isn't that high?
I understand that Merck and Schering-Plough entered a joint venture to divide the profits on Vytorin. Dr. Richman said he has no connection with Merck...how about Schering-Plough? Also, there was some discussion that plaque buildup was twice as fast with Vytorin as with Zocor, and concern was expressed about possible liver damage? The report I saw said there was no medical benefit for patients taking Vytorin, but a couple of negatives. Still wondering!
Sorry..but I find Dr Richman's posts inconsistant. A few posts ago "I rarely ever ask to have LP(a)tested" and blasted a poster that suggested using a Niacin and Statin combo,to reduce LDL and LP(a)counts. Quoting the latest Chol.Panel study that says only LDL needs to be reduced. My group of 11 Cardiologists do not beleive that & use the Niacin/Statin combo aggressively to reduce both....even to counts around 30 for both....
It is correct to say that outcomes matter more than predictions. Having said that, there have been no outcomes studies published on either Zetia or Vytorin. Outcomes studies have indeed shown that simvastatin prevents heart attacks, as have most other statins. Discerning patients who can tolerate a statin should opt for a generic statin rather than either Zetia or Vytorin unless/until they can show positive outcomes.
Two weeks before the report came out yesterday, I found that I had plaque in my cortoid artery which was not there two years ago before I had Zetia added to the Lipitor. It has surely reduced the Cholesterol readings but wondering if the plaque came from taking Zetia. Getting all kinds of reports from doctors. I hope it works itself out and it is a safe drug. I will see a surgeon on Monday to find out what he is planning on doing. Just makes me wonder who is right and who is wrong. We never learn all the facts anyway about our medicines but would hope that they will not harm us. Undecided now as to what I want to do. My doctor says to keep on taking it. Have a big decision to make.
I am very appreciative of all the comments. I really understand the confusion and the difficulty with understanding what the right thing is to do regarding medications. I also understand the confusion created by the media but that seems to be their role by alarming the public. I have always practiced evidence based medicine although at times the evidence supporting a drug or treatment is scant. I really would like to believe that most doctors always try and do the right thing which I define as how I would care for my immediate family. What I can tell you is that statins have changed the face of cardiovascular disease and without question reduced CV risk dramatically.
I also want to let everyone know that I have absolutely nothing to do with Merck Schering-Plough and never have.
i have been on vytorin for about 2 years. i had a heart cath 1 year ago it showed a 60% blockage which hey just watch. i year later because of chest pain they did another cath and theblockage was 80% and i got a stent. my doctor said it never gets that bad in a year. hmm
I have tried taking 2 statins. Lipitor made me very ill and affected my liver enzymes. I could only take it for a month. It took me two weeks before I was able to eat without feeling like vomitting.
I then tried Crestor. I really didn't notice any side effects, except that I was having trouble with my stomach. I attributed my stomach problems to taking NSAIDS. Crestor worked great and with the medicine plus diet changes my LDL came down to less than 100. However, I still continued to have stomach problems and I really needed to take Celebrex to control arthritis pain.
My doctor and I decided to stop the Crestor to see if that was causing the stomach problems. There was a good chance since the Lipitor did. After about 2 months of being off Crestor, I was able to take Celebrex without any stomach issues and my overall pain levels have decreased dramatically.
I now take Zetia and Lopid to control my cholestrol. My LDL is not as low as it was on the statins, but I am working on lowering with diet and exercise. I have always had good HDL and triglycerides.
I will never take another statin. I don't want to risk having stomach problems or all over body aches again. When I heard the study said Zetia didn't lower cholesterol, I knew that was wrong. It has lowered mine. I also know data can be manipulated to say whatever you want it to say.
I have researched this and a suggestion would be to use WelChol if your worried about the liver enzymes associated with Zetia and statin combo therapy....any opinions?
I have researched this and a suggestion would be to use WelChol if your worried about the liver enzymes associated with Zetia and statin combo therapy....any opinions?
Given the facts that Zetia may not be proven to be effective in lowereing the bad cholesterol and that it blocks the absortion of vitamin D which help develop bone strength, I am feeling that we are paying $120.00 or more a month to the drug companies who are using the public unethically. I have been taking Zetia for over a year now. I have change my diet as well lowing my combined from 289 down to 182 simply by leaving quiting my extremely stressful employer 8 years ago. Zetia has not assisted in lowering my good to bad ratio. The most recent test showed HDL 33 (normal should be above 35) and LDL 125 (normal should be below 100the ratio 5.45 actually has increased. My Triglycerides have alway been great at 115 (normal is lower than 200). I do beleive I am paying for a drug that may be putting my long term life in jeapardy. Shouldn't drug companies disclose all information regarding data that could be a risk and or lack of benifit as well as the benifits? Are the drug companies so desperate they take money from individual that well not benifit? It does lead me to beleive it is safer not to use any of the designer drug that are being pumped to the comsumers until there is a full audit of all the information regarding the new drug. AS WELL there should be a class action suit regarding the deceptive behavior.
My husband has been taking Vytorin for about 2 years. In that time he has had surgery on both carotids and a quadruple bypass. He has bad muscle pain. He can't walk for long periods. Just going to the grocery store tires him out. He is only 53 and it has changed our lives completely. He has had all kinds of tests and they cannot find a cause for the muscle fatigue and pain. He sees his cardiologist and other doctors religiously.
We just cannot get an answer for his muscle problems and yet his plaque build up continues.
I am a victim of Simvastatin where after taking it for two months all my muscules where attacked to the point of being unable to walk.Statins are evil to some and generic drugs are not always a deal moneywise.I have been on Zetia for six months and my total cholesterol has dropped 50 points and my LDL has dropped 30 points.For me the price for Zetia is well worth it compared to using a walker which is what I was sent home with from the hospital.
Dr. Richman, you assert that " statins... have without question reduced CV risk dramatically."
1. Could you quantify what you mean by dramatically and to what population are you referring?
2. Could you please post the journal names, dates, authors, and titles of articles detailing the results of reasonably large, well-controlled, replicated studies that support that assertion? Although I strive to keep my own lipid numbers in the approved range, I am beginning to have doubts about the diet-cholesterol-CVD hypothesis.
Thanks.
With so many other problems, I am glad that I can just trust my longtime dcctor. Having taken Lithium for bipolar for 32 years, my kidneys stopped excreting it and I had a stroke. Having recovered, I was placed on Seroquel which I knew raised blood sugar level, but I have been on it now for 3 years and am so much better. I feel as though I should have never taken Lithium. Anyway, the Seroquel first gave me acid reflux so I get that treated. A couple of weeks ago the doctor checked my cholesterol and it was 325! He put me on Vytorin and I began to immediately feel better. Before I was placed on that I felt weak, tired and had body aches.
I read the report on it but as long as I feel better on what I take I will trust the good Lord to instruct my doctor to make the right decisions for me.
I took Zocorstarting at 5 mg per day and had to increase it until I got to 20 mg. My LDL kept going up as tho the Zocor was causing it to increase. Finally with the addition of Zetia, my LDL dropped until I was back on the lowest dose Zocor I could go-5mg. There I will stay for the Cardioprotective nature of the medication.My whole family is on this combination with success. Thanks.
I was on Lipator for a few years and my cholesterol did not come down at all. I've been on Vytorin 10/40 for 6 months almost to the day. I went for my annual blood test just last week and my LDL dropped from 267 down to 160. I have no ill side effects from this medicene and will continue to take it on my Doctors advise.
The Doc was not able get my cholesterol down, with several other statins. He put me on Zetia and my LDL dropped quickly. I have had by-pass 9 yrs. ago. Since then he has also put me on 5mg. of crestor, my LDL, trigly. and HDL are all in the upper 50's now. and have reamined that way for the past 2-3 yrs. my total is 127 now!
you all have to remember that Zetia is a Systemic drug menaing it is metabolized in the liver and travels the bloodstream. Zetia is a Cholesterol Absorption blocker, meaning it keeps that bacon cheezeburger from being absorbed. You can have elevated liver enzymes on Zetia. Zetia affects your body like a statin but it is an extremely lower dose. I tried both a statin and Zetia but could not tolerate either. Zetia caused elevated liver enzymes like the statin. Now I take a drug called WelChol, it does not enter the bloodstream, the liver, or kidneys. It has lowered my cholesterol by about 22% and my Dr. says with my increasingly better diet and more exercise I could reach my LDL goal. I have read all I can about these drugs we take and WelChol is a safe drug to take if you want an alternative.
I was very disheartened last friday evening when I watched the CBS national news and Katie Couric was interviewing some "expert' who said that statins were not necessary in low risk patients for a Cardiovascular event. First of all I will define low, moderate, high, and very-high risk. This is based on the Framingham Risk Assessment which is made up of 5 variables. I personally believe that it is very antiquated and there are new and emerging risk factors that are not even taken into account. Nonetheless, one does not qualify for scoring unless they have at least 2 of the major risk factors for CAD and it is known to underestimate the risk of a CV event in women. Low risk is defined as 0-10% risk of an event in 10 years, moderate risk 10-20% chance, high risk > 20% chance, and very high risk is > 20% chance with a Coronary Artery Disease equivalent. What about the risk at 20 or 30 years? Framingham does not take that into account. I was happy last night to see that the AHA released statistics showing that stroke and heart attacks were down about 25% since 1999. This is due to improving cardiac care and all the "experts" I heard interviewed said it was due in large measure to the liberal use of statins. I completely agree with this. I will soon continue my series on the safety of lipid lowering drugs. I have already covered the effects on the liver so I encourage everyone to read it cause I am still getting questions regarding the effects of statins on the liver on my message board. Most of the questions should be answered in that post. My next blog post will be on the effects of statins on muscle.
As a family practitioner I have been grateful for the Zetia option in my patients intolerant of statins. I have however noticed a subset of my patients develop dramatically increased triglyceride levels on Zetia, even when chole levels respond. I typically discontinue the med when I find that. Did the ENHANCE study note this? Could this explain the progression in some patients? I would love any feedback on this.
I want to make a few comments regarding your question. First of all, too many physicians are quick to say that patients are intolerant to statins. I do not have any patients that cannot take some statin. I have a few patients who had documented Rhadomyolysis on a statin and they seem to do well on a very low dose every other day or every third day. They just need to be monitored closely. Stains have outcome results and Zetia does not so Zetia should not be used as the first line agent unless all things really do fail which is extremely rare. Zetia should be added first rather then raising the statin dose, as dose escalation leads to increasing problems while each doubling of any statin dose will lower LDL-C around 7%. I personally have not had any patients with elevating Triglycerides while on Zetia but you may want to try one of the agents used to lower Triglycerides. Remember that LDL particles are the villain and need and need to be aggressively removed from the body as they traffic the cholesterol into the arterial wall and cause Atherosclerosis
Dr. Richman-
I was taking gemfibrozil for a number of years for lowing triglycerides. Suddenly in 2004, the drug apparently stopped working and I had a heart attack in Jan. 2005. I was 56 at that time.
I was put on Crestor 10mg for about 2 years and after noticing joint and muscle failures, I was put on a dose of 5 mg and continued taking that dose for about another 6 months. Even at that dose, I was having more and more trouble, but the test results were always great.
Finally the side effect was just to debilitating and my doctors put me on Zetia alone. I have been on it for about 6 months now and I feel much better and the joints and muscles do as well.
Finally, I do have the same problem that the doctor who wrote to you mentioned........increased triglycerides. Where they were at 75 while taking the Crestor, they have now risen to 175. My HDL/LDL and total cholesterol are all fine.
Since you mentioned that you hadn't noticed the increase in triglycerides in your patients taking just Zetia, I thought that I would substantiate the good doctors story with my own account.
I was also interested in your suggestion of taking a very low dose of the statin every few days. I wonder if this would work for me and be able to lower my triglycerides. Perhaps I will mention it to my doctors and see what they make of it. I sure wouldn't want to start the joint and muscle weakening/pain again though.
Allen
I have been on this drug about a year I have less aches and pains on it then lipator my ldl has lowered a lot I trust it and do beleave it is helping me.
I am glad to have found this site. My husband was on 5 mg of Crestor. His blood test in mid-December showed that his LDLs were 180 and Triglycerides were 200. His doctor wanted to bring them down further, and put him on Zetia in combination with the Crestor. His blood test two days ago (mid-February) showed that his LDLs went down to 38, and his triglycerides are now 1239 (this is NOT a typo). They are doing further testing now. The nurse told him that people rarely react to Zetia this way, but it does happen.
As a side note, I would like to add that he is only about 10 pounds overweight and we have not made any changes to our diet in the last two months. He is also not on any other medications, nor does he drink or smoke. Blood pressure and sugar in excellent condition.
As you can imagine, we are both at a loss for words, and quite afraid of him suffering a heart atttack or worse.
I was taking Lipitor for about 8 yrs and was having increased muscle aches to the point I felt I shuld try something else. It as controlling all lipid levels well.
I switched to Vytorin 10/20 from
Lipitor 40mg. After 6 months my lipid levels were still good. The last lipid test after 18 months on Vytorin showed my Tri level shot up from 88 to 182. My muscle ache
seems to be better but now I have
Gerd, somach burn/ache, heart burn, insomnia. I am concerned about the Tri being high...?
I appreciate the posts from the Dr's. and other posters. Hearing the news today on the radio was just another "shock" report for the media.
I have been taking a variety of statins for over 12 years and by themself I couldn't get my numbers where they needed to be and I run 5 days a week, eat right, etc... For the past couple of years I have been using Vytorin 10/40 and it has brought all of my numbers where they need to be.
Numbers don't aways tell the truth.
Are the numbers from Vytorin cometic ??? I am real concerned
when they tell me the plaque is still building even tho my numbers all show they are in the good range. I take Vytorin but have NO
confidence that it is doing the job....
I was going to write a response to try to explain why the Enhance study is very relavent and a negative trial that should change clinical practice, but I thought it much easier to direct you all to view the recommendations straight from the American College of Cardiology(ACC) expert panel that was convened to analyse the results from Enhance w/ Vytorin(Zetia). They were selected by the ACC because they are unbiased experts that could make recommendations at the Annual Scientific session which is a meeting of over 20,000 cardiologist from around the world. All of you who are on Vytorin or Zetia, are considering it, or have family members on it, must watch this short 10 minute video of the actual panel discussion. The panel was made up of national thought leaders who are experts in the field of lipids and clinical research. Go to cardiosource.com/rapidnewssummaries/acc08.asp Once at the web site, scroll down to Sunday March 30. Then look for "Effect of Combination Ezetimibe and High-Dose Simvastatin vs. Simvastatin Alone on the Atherosclerotic Process in Patients With Heterozygous Familial Hypercholesterolemia (ENHANCE) – John Kastelein". It is the second to last listing under Sunday March 30. I highly recommend that you view the "Panel Discussion Video" listed here. If you also have time you can view the presentation of the trial itself listed as "presentation video", however it might be a bit too scientific for some to follow. The panel discussion is more relevant because this is the consensus opinion of ACC national experts in this field. You really must all watch this; including Dr. Richman. Let me know your thought afterwords.
I'd like to put my 2 cents in here.
My doctor put me on Zetia a few years ago due to elevated LDL. I took it for approximately 6 months and then had blood work again. My cholesterol totals including LDL actually shot up nearly 20% while paying out more than $500 for the drug! So I knew Zetia was never effective, but was actually nothing more than an over priced placebo. Knowing that now and seeing the news today, I wish I had suied the Schering Corporation! Since then I've experienced 2 very bad side effects involving severe muscle and joint pain after taking both Lescol and Tricor. Never again will I take another statin!
I was taking Zetia alone with good results until my ldl's shot way up. I then started a regime of Fish oil, and Flaxseed oil caplets twice a day, and in 3 months brought everything back towards a normal range. I am now off of Zetis, but am not sure if I should get back on it. I will call my Dr. tomorrow and ask. I am having leg tightness in both legs and am wondering if this is one of the side affects of discontinuing Zetia?
This is the second time I’m responding to this subject; for some reason, my two cents occasionally are not applied to the blog. Here goes again:
I have been on Lipitor since 1999. In Oct 2006, I had an MRA that revealed my left carotid was about 40-45% blocked, which, I was told, was not cause for alarm. I was put on Vytorin in January of 2007 to further lower my cholesterol, which was about 190 at the time.
In November 2007, another MRA revealed that the left carotid was now more than 90% blocked. I had immediate surgery. The Zetia/Vytorin study broke about a month later, and my family doctor placed me back on Lipitor alone.
Since I’m 63, that means that arithmetically, it took me 62 years to block my left carotid 45%, but only 13 additional months to double that blockage. Or could it have been the Zetia (in the form of Vytorin) that caused the rapid increase?
Was Disraeli right, i.e., that there are three kinds of lies—lies, damn lies, and statistics? Or can there be a connection between my use of Zetia and an increase in artery blockage?
Is very low cholesterol dangerous? My total is 84,
HDL 31, Non HDL 53, Ratio 2.7, triglycerides 69. I have started an exercise program so hopefully my LDL will come down. I was on Vytorin due to a higher ratio, but since the scary report I asked to be switched and now I'm on Crestor which I am concerned about. Thank you
I was a big fan of Vytorin but now I'm not so sure. I was on it all last year and brought my overall number down from 245 to 106. Earlier this year I got my butt into the gym and dropped 30 lbs and reached an near ideal weight of 190 lbs at 6'3". I work out regularly, run, drink water like a champ, and vastly improved diet/food choices, etc. Feeling good about my lifestyle changes, I decided to try to come off Vytorin in April. Blood test in Sept showed my number had gone back up to 190 so I was told to restart. It's been about 3 weeks now and 1-2 times a week, I'm experiencing serious stomach pain (enough to visit CVS at 3am). I did not have any intestinal distress before but since my restart (and 30 lbs lighter with better diet, etc) and experiencing side effects and may have to switch. -thought I'd share...
My husband took Zetia for 7 days and had a severe, uncontrollable emotional reaction to it. He ended up hospitalized. He is unable to take any of the statins due to becoming unable to walk from muscle breakdown. He also can't take niacin as it creates major vision problems. That doesn't leave many options.
Zetia has a very high NNT score that makes it useless in preventing a cardiac event. Even the drug manufacturer admits this.
Your chances of winning the lottery are better.
My expericence seems to parrallel some of the other comments. I have had high cholestrol we think for most of my life however it didn't get identified until 1990's. I experienced a sever stress situation and developed GERD as well as taking Cholestrol medication about the same time. I took Vytroin as a second choice after the first medication did not lower my cholestrol enough. It worked for a year however I reacted to it with sever muscle pain. Was taken off and put on lipitor. Muscle pain stopped but after a couple of years started up again but not as sever. Have now switched to Crestor at a reduced dose. During this process starting with Vytorin I developed arthritus in my big toes. I still have some muscle pain. I can't help but suspect the experience with Vytorin some how instigated my continued issues with muscles and arthritus. I am sure that my GERD medication is some how affecting my bodies ability to use medications and absorb other necessary vital nutritional elements. Just can't get a handle on it. Haven't seen any studies that tie these issues together however it seems from the other comments there might be a thread and a need for a study related to these possible relationships. Thanks
Dr. Richman, my experience with any statin - Zocor, Lipitor, etc has been difficult. While the statins are best for getting rid of cholesterol because it goes straight into the blood stream - these also can cause liver damage / muscle aches rather quickly. I would caution you to not say that these drugs are SAFE. No drug is without its side affects. For those who are on statins and experience leg pain - this is NOT a good sign. Call you doctor if this persists for more than 2 weeks.
Post a Comment