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From: LindyBill12/6/2008 4:36:02 PM
1 Recommendation   of 27161
 
Zetia and Vytorin: Let's Look at the Facts
WEB MD - JAN 15, 2008
By Michael Richman, MD, FACS

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.

"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.

blogs.webmd.com 

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From: LindyBill12/6/2008 5:13:53 PM
   of 27161
 
Vitamin D Deficiency

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In my last posting, we discussed the importance of vitamin D in cardiovascular disease. I want to now talk about treatment of vitamin D deficiency. I had previously stated that serum 25(OH)D is the best functional measure of vitamin D status. Most experts agree that a serum level less than 20 ng/ml indicates deficiency and 21-29 ng/ml is considered insufficiency. The optimal range is still debated but most experts consider a level between 32-50 ng/ml to be normal.

The current recommended daily allowance for vitamin D in US is 200 IU/day for children and adults up to 50 years, 400 IU/day for age 51-70, and 600 IU/day over age 70. New research on the non-skeletal benefits of vitamin D has made these guidelines obsolete. Various studies have shown that the greatest physiologic effects have occurred in daily doses of 2000 IU or higher. Doses between 100-200 IU daily for adults are likely needed in absence of sun exposure to maintain levels of 30-50 ng/ml 25(OH)D. Vitamin D3 (cholecalciferol) is the form photosynthesized in mammals. Skin exposure without sunscreen can provide adequate amounts of vitamin D3. Vitamin D does not naturally exist in significant amounts in the human food chain. Milk is fortified with 400IU/quart. It is extremely difficult to consume adequate amounts of vitamin D from the diet unless one consumes oily fish frequently such as sockeye salmon. Cod liver oil and O3FA do not provide adequate amounts.

Vitamin D2 (ergocalciferol) is the plant-based form and is added to certain foods and multiple vitamins and is the only form available by prescription in the US. Toxicity and overdose have been related to vitamin D2 intake but not D3 intake. Doses of more than 50,000 IU daily of vitamin D2 were associated with high calcium and low phosphorous levels in the blood whereas doses up to 10,000 IU daily of D3 for 5 months do not cause toxicity. Symptoms of toxicity include weakness, loss of appetite, itching, thirst, excessive urination, and weakness.

In my own practice I treat patients only after drawing a 25(OH)D level. If the patient is deficient, I have managed them with over-the-counter vitamin D3, 5000 IU daily for 8 weeks and continue an additional 8 weeks if levels do not rise above 30 ng/ml. Once this is achieved, 1000-2000 IU each day is used for maintenance therapy. Doses are adjusted for obese patients and those with darker skin pigmentation. Ideally, levels should stay between 35-90 ng/dl. As levels normalize, many patients have a reduction in fatigue and also less muscle pain and cramping.

blogs.webmd.com 

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From: LindyBill12/6/2008 5:31:41 PM
2 Recommendations   of 27161
 
I am glad I found Dr Richman's blog. Another post.


Advanced Cholesterol Testing

I was originally planning on starting to talk about medicines used to lower Triglycerides but due to the untimely death of Tim Russert, I wanted to discuss Advanced Cholesterol Testing. Last week I had the great pleasure of being interviewed on a nationally syndicated radio show. I was asked what I believed could be done to bring more awareness to physicians and the public about the epidemic of Cardiovascular morbidity and mortality? The entire podcast is available on my website and the feedback that I have received from my patients was that I took a difficult topic and made it so easy to understand for the average person. I hope that after listening and reading this posting you will see the need to perform this special type of cholesterol testing.

Over three years ago, I opened The Center for Cholesterol Management as the only free standing lipid clinic in the Los Angeles area dedicated to Advanced Lipoprotein Particle Testing. As a board certified Cardiothoracic surgeon, I feel I have a unique perspective about coronary artery disease in that I am able to clinically correlate angiographic findings with actual operative findings which in so many incidences are discordant. Coronary artery disease is a largely misunderstood entity.

Hyperlipidemia is the most modifiable risk factor leading to Atherosclerosis, yet traditional lipid testing may miss up to 50% of people who have abnormal lipids. Prevention includes identifying people at risk and providing the best treatment individualized to their specific problem.

It is with this background that I will discuss Advanced Lipid Testing and its role in identifying all patients at lipid related risk and as a tool for management of abnormal lipid levels. I often ask myself how come health care providers do not understand this type of testing? I honestly believe that if all people are identified as being at risk, and then if treated appropriately, we would significantly change the face of Cardiovascular morbidity and mortality.

As physicians, we are taught in medical school that it is all about Total Cholesterol, HDL-C, LDL-C, and Triglycerides, yet few really understand the limitations of traditional lipid testing. I hear everyday physicians say that if it is so important why isn't everyone doing it? I believe the answer is that one does not want to change from old patterns of thinking, and according to other physicians, it is too much trouble to learn and understand. Recently, the ADA/ACC released a Joint Concession Statement on Lipoprotein Management in patients with Cardiometabolic Risk(CMR). The full text is available on my website. I believe it is mandatory reading and states that patients with CMR in the moderately high, high, and very high risk groups, it is now the standard of of care to quantify lipoproteins by performing ApoB or LDL-P on all patients to ascertain risk and as a goal of therapy.

As we all know that since sterols are insoluble in the blood, they need to be driven around the body in Lipoproteins. These include HDL-P, VLDL-P, and LDL-P among others. HDL particles are also known as ApoA and all the particles that cause atherosclerosis are known as ApoB. Although NCEP( National Cholesterol Education Panel) recommends calculating the non-HDL cholesterol, this value only can alert the physician that there may too many lipoprotein particles despite having a normal LDL-C. Approximately 90-95% pf the circulating ApoB particles are LDL-P which have a half-life of around 3 days. As varying amounts of Triglycerides and Cholesterol are driven around the body, in what I tell my patients are "cars", the ApoB particles enter the arterial wall if there are too many of the "cars" circulating in the bloodstream.

By simple diffusion, all the bad particles flow from inside the artery and move into its wall and are "eaten" by macrophages which become foam cells and are the hallmark of Atherosclerosis. In eight published studies of over 11,000 subjects using LDL-P and other Lipoprotein concentrations remained the most significant and independent predictor of cardiovascular morbidity and mortality over any other lipid parameter including the usual ratio that all physicians and patients talk about. . In a nutshell, it is the number of LDL particles that matter most... it is the number of cars that cause a traffic jam, not the people in the cars. For example, what if a person with moderate risk has met NCEP guidelines and has a LDL-C of 110mg/dl.

How do I know that there are not 100 cars with one person driving or two big buses with 55 people? The answer is that I do not unless I measure LDL-P directly by using NMR or as a second option measuring ApoB with Gel Electrophoresis. Traditional testing measures the passengers and lipoprotein testing measures the cars, and it is the number of cars(LDL-P) measured by NMR (Nuclear Magnetic Resonance) that are the most numerous ApoB particles in the body and matter most in the development of Atherosclerosis.

Although a comprehensive review of each of the methodologies to perform Lipoprotein Testing is beyond the scope of this post, I feel that measuring LDL particles directly using NMR is the best way to ascertain someone's true risk and then use that number as a guide to management. As I said in my posting about Alex Trebek, the CDC states that 50% of people who have heart attacks have "normal" cholesterol. I hope you now understand why this can happens, having a normal LDL-C but high LDL-P, and be proactive and ask that your physician performs Advanced Cholesterol Testing.

blogs.webmd.com 

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To: LindyBill who wrote (2411)12/6/2008 8:41:40 PM
From: mistermj
   of 27161
 
Good article from Dr. Richman. He is going right into my Google Reader.

I noticed in the comments section of that blog post that he doesn't think much of calcium scoring.

I've always thought Dr.Davis explanation made a lot of sense regarding calcium scores and the 30% growth factor ect....have to look into Dr. Richmans's view more thoroughly when I get some time.

Michael Richman, MD, FACS said...
Thank you for your kind words Joe. In regard to calcium scoring, you are exactly right. It provides me with no information and exposes people to unnecessary radiation. I also think many physicians have bought them and need to use it. CIMT is a good surrogate for generalized Cardiovascular disease but the problem is that insurance and Medicare do not pay for "screening". I use it in patients that have borderline NMRs as a way to assess how aggressive I will be with treatment.


blogs.webmd.com 

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To: mistermj who wrote (2412)12/6/2008 8:52:38 PM
From: LindyBill
   of 27161
 
It provides me with no information and exposes people to unnecessary radiation.

I think Davis's reasoning makes much more sense. He goes way off base with the "unnecessary radiation." A Chest X-ray is about 2mr. An EBT heart scan is the same. A CT Heart scan is about 8 to 10. That's nothing. I will get 580 during my lung CT next week and 540 on the Kidney one.

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To: LindyBill who wrote (2413)12/6/2008 9:09:17 PM
From: Joe NYC
   of 27161
 
I am looking at this Reverse Osmosis unit:


freedrinkingwater.com 

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To: Joe NYC who wrote (2414)12/6/2008 10:32:36 PM
From: FUBHO
   of 27161
 
You can just put a filter on your tap. This system is way overboard.

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To: Joe NYC who wrote (2414)12/6/2008 11:03:44 PM
From: LindyBill
   of 27161
 
Looks exactly like the unit I used to own. My three filters were in clear plastic so I could see their condition. No big deal.

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To: FUBHO who wrote (2415)12/7/2008 1:50:55 AM
From: mistermj
   of 27161
 
I love my $14 Brita water pitcher. ;-)

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To: LindyBill who wrote (2411)12/7/2008 12:39:44 PM
From: LindyBill
1 Recommendation   of 27161
 
A comment from a TYP Poster:


Dr. Richman's views re: heart scans are indeed troubling but not an enormous surprise, since his background is as a cardiac/thoracic surgeon. He and I have exchanged our perspectives several times on his WebMD message forum (the "Cholesterol Forum" at WebMD), and he's almost militantly against scanning, has called it useless, worthless, and a procedure without merit. He believes that there is nothing of clinical benefit that can be derived from measuring calcium because, in his words, "it's the soft plaques that are dangerous, not the calcified ones." He believes that his surgical knowledge and experience (based largely on autopsy findings) demonstrates that plaques which rupture are not those that are calcified and he is not sold that there's any real relationship between calcific deposits and soft plaques at all.

Dr. Richman runs the "Center for Cholesterol Management" in West LA, where he treats lipid disorders. He also runs another clinic in Beverly Hills called the "Varicose Vein Treatment Clinic" which I think is largely devoted to peripheral vascular disease and, since it's in BH, cosmetic procedures. The guy is very good a self-promotion (not, as they used to say on Seinfeld, that there's anything wrong with that).

Several months back, another TYP member (I can't recall his name) was looking for a cardiologist who might be open to TYP concepts and I recommended that he check out Dr. Richman based on an interview he did on ReachMD radio on XM satellite radio. During that interview, Dr. Richman was portrayed as a huge proponent of NMR and particle testing. I actually have no idea how things turned out for the other TYP member who was treated by him, but after several written exchanges with him, I don't think I'd ever use him. If you search "Richman" in the search engine at TYP's forum, you may find the thread.

His views on Vitamin D3 are not surprising. Many docs here in Los Angeles are now on the Vitamin D3 bandwagon, and are recommending it heavily and testing for it very aggressively with their patients. Dr. Richman's position in this regard, while encouraging, isn't all that different from what many other gp's and internists are doing in Los Angeles.

He's also a HUGE user of Crestor. On the Reach MD interview he bragged that he's probably the largest single prescriber of Crestor in the Southern California area. He probably feels pretty good about the JUPITER study.

While the WebMD message forum on Cholesterol Management bears his name and likeness and its supposed to be "his" board to respond to questions, he rarely writes there any longer. I think he got tired of people like me peppering him with questions. LOL.

There is some useful information at his Cholesterol Managment website (the one promoting his clinic, not at WebMD) that is worth checking out, notwithstanding his antipathy toward scanning.

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