Last Friday, Genzyme and Isis Pharmaceuticals disclosed that the FDA wants them to gather more data in order to win approval for a novel cholesterol drug. Specifically, the agency indicated that lowering cholesterol is an “acceptable surrogate endpoint” for using their mipomersen in patients with a rare, inherited form of high cholesterol. But an outcomes trial will be needed to win approval for other patients with high cholesterol. Such a trial can prove valuable if the outcome is achieved, but it’s also expensive and time-consuming because many more patients are needed to enroll.
Interestingly, Zetia was approved six years ago on its ability to lower cholesterol, but actual outcomes data for Vytorin still isn’t available. We mention both drugs in the same breath because Zetia, of course, is one part of the Vytorin cholesterol combo sold by Merck and Schering-Plough; the other part is Zocor. And the results of a study that is designed to show that Vytorin can outperform Zocor alone in preventing deaths, heart attacks and strokes won’t be released until 2012, at the earliest.
You may recall that the controversial Enhance study used a surrogate endpoint - carotid intima-media thickness (IMT) - because people with thicker IMT in the carotid artery have a higher risk of cardiovascular events. But the Enhance trial found that Vytorin failed to show any benefit over the much cheaper Zocor in reduce the plaque in the carotid artery, and even showed a statistically insignificant buildup, although it did a better job of lowering LDL in a small group of patients with inherited high cholesterol.
In a recent commentary in the Journal of the American Medical Association, Bruce Psaty and Tom Lumley of the University of Washington wrote that “the public health advantages of rapid approval for drugs that turn out to be safe and effective need to be balanced against harms that might occur when drugs approved on the basis of surrogate end points turn out later either to have significant safety problems or to lack efficacy.” 
Given the concerns over how widely marketed Vytorin and Zetia were over the past few years, the FDA response to Genzyme and Isis raises an interesting thought - whether the agency is no longer willing to approve new drugs for wide use based solely on the ability to improve cholesterol.  What do you think?
Note: There is a poll embedded within this post, please visit the site to participate in this post’s poll.
 
  (Source: Pharmalot)

Here are some Friday links for you…
Novel Way to Prevent Cardiac Fibrosis Identified- In a study that points to a new strategy for preventing or possibly reversing fibrosis — the scarring that can lead to organ and tissue damage — researchers at the University of California, San Diego School of Medicine have determined that a molecule called Epac (Exchange protein activated by cAMP1), plays a key role in integrating the body’s pro- and anti-fibrotic response.
Chocolate Bar Shown To Lower Cholesterol- “Eating two CocoaVia dark chocolate bars a day not only lowered cholesterol, it had the unexpected effect of also lowering systolic blood pressure,” said John Erdman, a U. of I. professor of food science and human nutrition.
Heart Derived Stem Cells Develop Into Heart Muscle- Dutch researchers at University Medical Center Utrecht and the Hubrecht Institute have succeeded in growing large numbers of stem cells from adult human hearts into new heart muscle cells.
Tags: cardiac fibrosis, cardiac links, chocolate bar, cholesterol. heart disease, heart muscle, stem-cellsShare This (Source: A Hearty Life)

Administration of the popular anti-inflammatory drug Celebrex (celecoxib, a nonsteroidal anti-inflammatory drug) in combination with Lipitor (atorvastatin, a cholesterol lowering drug or statin) halts the transition of early prostate cancer to its more aggressive and potentially deadly stage.
“Anti-androgen therapy slows the prostate cancer but eventually the cancer becomes androgen-independent, the therapy becomes ineffective and the cancer cells become more aggressive,” said Xi Zheng, assistant research professor at Rutgers, The State University of New Jersey, who conducted the study.
“Treatments available for the later stage cancers are not very good,” said Allan Conney, director of Rutgers’ Susan Lehman Cullman Laboratory for Cancer Research, another researcher on the project. “Oncologists employ classical chemotherapy drugs which are very toxic and don’t work all that well.”
Such excitingly good news were the findings of researchers at the Rutgers’ Ernest Mario School of Pharmacy.
A combination of low doses of Lipitor and Celebrex had a more potent inhibiting effect on the formation of later stage tumors than a higher dose of either agent alone,” Zheng reported.
“The results from our study indicate that a combination of Lipitor and Celebrex may be an effective strategy for the prevention of prostate cancer progression from the first to the second stage.”
Clinical trial are being planned in the hope that same results will be generated.
Read more from Rutgers University.
Tags: androgen hormone, anti-inflammatory drugs, Celebrex, cholesterol-lowering-drugs, Lipitor, prostate-cancer, statinShare This (Source: Cancer Commentary)

Here is some good news, especially for me who looovvvees any type of nut. Macadamia nuts are now being given the thumbs up and should be included among other nuts that have qualified health claims.
Included in a heart healthy diet, macadamia nuts did reduce total cholesterol, low-density lipoprotein and triglyceride levels.
Up to this point, macadamia nuts as well as Brazil nuts and cashews were not included in the U.S. Food and Drug Administration’s list of nuts with qualified health claims due to their saturated fat level of 6g per 50 grams of nuts and the cut off being 4 g per 50 grams of nuts.
Now go eat some nuts!

Tags: cholesterol, heart-health, Hearty Diet, lipids, macadamia nuts, nutritionShare This (Source: A Hearty Life)

“The strength of reduction of incidence of dementia with simvastatin (Zocor) is striking”.

When I read this article in July, 2007, I asked the doctor to switch my mother from Lovastatin to Zocor. At that time, Zocor was more expensive but now it is also a generic.

In the previous article on this blog I mentioned this decision. You can read…

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This is a classic example of the Alzheimer’s CareGiver conundrum. I switched my mother from Lovastatin to Zocor after reading a similar article pointing out the benefits of statins.

I’ll put the article up on Zocor soon. Zocor did improve her cholesterol numbers.
clipped from www.medicalnewstoday.comHigh cholesterol levels are considered to be…

[[ This is a content summary only. Visit my website for full links, other content, and more! ]] (Source: I am an Alzheimer’s Caregiver)

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That’s right! According to a recent article in Woman’s World magazine (April 7th edition), red grapefruit can help lower your “bad” (aka LDL) cholesterol levels by as much as 20%. This seems to be the case whether or not your high cholesterol is responsive to statin drugs or whether you make any diet or lifestyle changes.
So what’s behind this little Wonder Fruit? Experts claim the antioxidants in red grapefruit have the power to inhibit the liver’s tendency to overproduce LDLs. Wow, who knew?
So I guess it’s not a bad idea to cast aside that dandy Sausage Mc Muffin with Egg and replace it with a little citrusy goodness then, hm? Darn. There go my Friday breakfast plans. Heh.
Tags: Bad Cholesterol, Cholesterol, Grapefruit, Grapefruit Antioxidants, LDL Cholesterol, Red Grapefruit BenefitsShare This (Source: Healthbolt)

Most people know that foods containing trans fats are bad, which is good. But not everyone realizes that foods containing no trans fats are not necessarily good, which is bad. You can hardly walk through the supermarket without being bombarded with product messages announcing “No Trans Fats,” as if that fact automatically rendered them healthful. In fact, a product could contain no trans fats and actually be 100 percent pure fat! That’s because there are two main types of fats; namely, saturated and unsaturated fats. And while avoiding trans fats is a good idea, equally, if not more important, is monitoring and limiting saturated fat intake because saturated fat (along with trans fat and cholesterol) raise the bad LDL form of cholesterol and lower the good HDL form.
The way this works is that typically we think of saturated fats as being “bad,” and unsaturated fats as being “good,” but just to make things complicated, trans fats are unsaturated fats that are “bad.” This made them doubly bad because, before the food labels changed, they were “hidden” in with the “good” unsaturated fats and you had no way to know they were even there. So the food labels were changed to require trans fats to be specifically identified. But since everyone knows that trans fats are bad, no marketer wants to have a product that clearly says “I’ve got trans fats.”
If you were that marketer, what would you do? Obviously you’d eliminate the trans fats and advertise that fact prominently. But since fat tastes good and certain fat free products are tasteless, you might also up the saturated fat content of your product to compensate for the loss of trans fats. Of course, you wouldn’t advertise that fact at all. I call that a scam. Fortunately, you the consumer can see through this ruse, if you pay attention. That’s because the food label still has to disclose total fat, saturated fat, unsaturated fat and trans fat. You just have to read the label. And while you should always look at the food label for fat content (along with calories, cholesterol and sodium [salt]), this is especially true if the product is promoted as being trans fat free.
This is what you should do. As soon as you see a product that you’re interested in that says its trans fat free, immediately say to yourself “That’s interesting, but I wonder if this is a scam? I wonder if it’s trans fat free, but loaded with saturated fat?” Then you look at the label and see how many grams of saturated fat there are per serving and what percent of the Daily Value you’re getting from every serving. While you’re at it you should also look at the serving size and try to estimate whether this is realistic for you (I find that serving sizes are often much smaller than the amount people really eat at one time). For example, if one serving is 10 percent of the Daily Value for saturated fat but the serving size is 12 chips and you’ve never eaten fewer than 25 at a time, then you would be getting at least 20 percent of the Daily Value for your serving size.
Remember too that you won’t be eating the product in a vacuum, meaning that it is just one part of your daily diet. You might also be eating a variety of other saturated fat-containing foods like baked goods, fried foods, snack foods, dairy products, meat, etc. The key is awareness coupled with moderation. You need to be aware of what you’re eating and what it contains (by looking at the label) and, you need to limit the total amount of saturated fat (and cholesterol, which comes from animal products) you’re consuming each day. It’s difficult to give exact numbers because everyone eats a wide variety of different foods and for one person, eating a handful of chips high in saturated fat might be the only high fat food they eat that day, while for another, that same handful of chips might be just one part of a diet that consists nearly entirely of high fat food.
Now, I’m not suggesting that you slavishly examine every food you buy and assiduously count up the grams of fat you eat or exactly calculate what percent of calories you’re getting from bad fat. That would be onerous and you’d never do it. What I am suggesting is that you recognize that trans fat free doesn’t mean fat free (and could mean quite the opposite) and that you be mindful of the amount of saturated fat that’s in the products you buy and consume (trying to keep it as low as possible). Here are some dietary guidelines from the American Heart Association:
• Eat a diet rich in vegetables and fruits.
• Choose whole-grain, high-fiber foods.
• Eat fish at least twice a week.
• Limit how much saturated fat, trans fat and cholesterol you eat.
• Select fat-free, 1 percent fat, and low-fat dairy products.
• Cut back on foods containing partially hydrogenated vegetable oils to reduce trans fat in your diet.
• Cut back on beverages and foods high in calories and low in nutrition, such as soft drinks and foods with added sugar.
• Choose and prepare foods with little or no salt.
• If you drink alcohol, drink in moderation.
If you want to read more about trans fats please see my prior posting on this topic. The FDA also has a variety of information on this subject. (Source: Dr. Z’s Medical Report)

By Dov Michaeli MD, Ph.D So you don’t exercise. And you like your six pack. And you have a bit of a pot belly. But you are not overweight. In fact, your BMI is in the normal range. Do you feel pretty smug? Read on, and I think you’ll get shaken up a bit, as you should. Central Obesity The correlation between obesity and diabetes and heart disease is well known. In fact, we now know that people should be concerned not only about body fat, but importantly: where this fat is located. Waistline fat is a major risk factor of diabetes and heart disease, deceptively cute names like “love handles” not withstanding. But did you know that being a Michelin Man may end up in dementia? The Kaiser study I certainly did not suspect it. And I dare say,I don’t know anybody in the medical community who has. Now comes a wonderful study, led by Rachel A. Whitmer of the famed Research Division of Kaiser Permanente in Oakland , CA , and tells us a very disturbing tale. The investigators took advantage of the extensive medical records kept by Kaiser about their members. They conducted a longitudinal study of 6,583 members of Kaiser Permanente of Northern California who had their sagittal abdominal diameter (SAD) measured in 1964 to 1973. Diagnoses of dementia were from medical records an average of 36 years later (!), January 1, 1994 , to June 16, 2006 . Where else, with the possible exception of the Scandinavian countries, could you get such a long follow-up? And who else would pay for sagittal sections of the abdomen to carry out such a study? Only Kaiser Permanente, which is a non-profit HMO, with “non-profit” being the operative word. Before I go on, sagittal sections divide the body into left and right portions. Rather than waste a thousand words, check out this picture. Bottom line: sagittal sections allow the determination of a pot belly size with great accuracy. And the surprising resuls A total of 1,049 participants (15.9%) were diagnosed with dementia. Compared with those in the lowest quintile of SAD, those in the highest had nearly a threefold increased risk of dementia (hazard ratio, 2.72). Now, you’d think that obesity in general could explain this astonishing finding. But when the BMI (body mass index) was taken into account the hazard ratio, or risk of dementia, was 1.92, or about twofold.Those with high SAD (>25 cm, or 10 inch) and normal BMI had an increased risk (hazard ratio, 1.89) vs those with low SAD (<25 cm) and normal BMI (18.5–24.9 kg/m2), whereas those both obese (BMI >30 kg/m2) and with high SAD had the highest risk of dementia (HR, 3.60). In other words, if you are not obese, but have those cute love handles, your risk is double that of “normal”, and if you are obese and blessed with central obesity, than your risk of developing dementia increases 4 fold! Food for thought, while you still can. Even more alarming: these subjects had central obesity since middle age. And you can’t find refuge in your good numbers; the association held after correcting for high cholesterol, high blood pressure, diabetes, heart disease, stroke, and other variables. And if you think that your sex will shield you, it won’t: the results were the same for men and women. As far as I know, this is the first time that anybody studied the correlation between central obesity and dementia. Nobody has a clue how this works on the physiological or molecular level, but rest assured: researchers will rush in to investigate this surprising finding. But for now, all I can say is: thank you Kaiser Permanente for this great study. (Source: The Doctor Weighs In)

Some Japanese are questioning standards for cholesterol care after learning that university docs involved in drawing up guidelines received donations from some of the same drugmakers that make and sell meds for metabolic syndrome and high cholesterol, The Daily Yomiuri reports. In fact, the docs received far more cash than other docs. The issue is raising questions about whether researchers who have received corporate donations can remain impartial.
Meanwhile, the paper adds that some experts are skeptical about the guidelines due to their low thresholds, which are capable of categorizing healthy people as being sick and in need of medication. The standard for determining whether a person has high cholesterol is set in line with Japan Atherosclerosis Society guidelines, which defines a total cholesterol count of over 220 as being high. This compares to the U.S. level of 240. Compared with this higher level, patient levels double if the figure of 220 is used.
Tomohito Hamazaki, a professor at Toyama University’s Faculty of Medicine, says that if the lower figure is used, half of all middle-aged and elderly women would be diagnosed as having high cholesterol. “The number of patients has been increased unnecessarily, which resulted in an excessive use of drugs,” he tells the paper.
(more…) (Source: Pharmalot)