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Monday, November 16, 2009

Ezetimibe (Zetia) shown INFERIOR to Niacin (B3)

Expensive Cholesterol Drug Loses Ground To Good Old Niacin (B3)

Zetia Tablets

The battle over expensive lipid lowering prescriptions versus inexpensive safe and effective vitamins took a major turn today. Cable news programs, Newspapers and Radio all broadcasted the latest clinical trial that gave the proverbial big two thumbs down to expensive medications and a grin to Vitamin B3.

One thing disturbs me however, and that is the fact that Vitamin B3 is reported as “Niacin” or “a prescription version of Niacin” or “Niaspan” and it appears that the press (possibly under the thumbscrews of Big Pharma) are trying to belittle the fact that a Vitamin beat out a million-dollar drug. Goliath here has been smitten by a young David. And I must admire the genitals of the researchers and the journal that reported these finding as I am sure the political pressure was enormous not to publish the findings.

Once again critics bash the finding stating that they don’t believe reduction in arterial plaques have an impact on cardiovascular death rates… hogwash! The researchers that don’t want to admit that this is just one of many studies that bash expensive, dangerous and ineffective drugs are just prostitutes for Big Pharma. My 8-year old child can deduce what this study has spelled out. Stay away from costly, often times harmful and in this case ineffective medication and stick with what nature has provided. Vitamin B3 or Niacin is a safe, rather inexpensive option that really makes an impact on cardiovascular health.

Vytorin ® which is a combination of ezetimibe (the drug found in this study to be ineffective) and simvastatin a statin drug will cost you $112 for a 30 day supply at a discount pharmacy. Zetia 10mg is ezetimibe alone and will set you back $111/month at the same pharmacy. Niacin 500mg for a 100 count bottle will only run you about $6. You do the math.

Ironically, as the news spreads today about this Merck drug, Merck stocks rise as Wall Street believes this study is too limited in scope. Are people crazy? Oh, yeah and ObamaCare is spot on for us to embrace as the cure-all and fix-all for our healthcare woes. Dream on. Come on folks, wake up and think for yourselves for a moment. This study was published on the online version of the New England Journal of Medicine and was presented at this year’s American Heart Association scientific meeting in Orlando, Florida, is called ARBITER-6. And even now alongside the studies posting is an editorial by some hired gun (on the Merck payroll) who despite the study’s facts is peddling the line that people should not abandon Zetia just yet… Oh, and what are we waiting for?

Please read my “Beyond Cholesterol” article (below) and power point presentation (link) on this blog.

Beyond Cholesterol

By JP Saleeby, MD (posted April 2005)

Cardiovascular disease the number one killer in America is at the forefront of the battle that steals years away from many Americans. Men are hardest hit, but women are not immune. Postmenopausal women will suffer death from cardiovascular causes at a rate of one in two. Cardiovascular disease kills more Americans than all cancers combined. This goes for women also; heart attacks (acute myocardial infarction or AMI for short) will take the lives of more women than all the lung and breast cancer deaths combined. Researchers are still searching for the right answer and the right medicine. Cholesterol has been in the sights for years and considered the major culprit. But there is more to this story, it does not end with just this one etiology, it is multi-factorial. Other risk factors may have more of an impact on the coronary artery than just cholesterol. For example Homocysteine, Lipoprotein (a), C-Reactive Protein, Fibrinogen and even Apoprotein A-1 and B impact cardiovascular health significantly and may even play a bigger role than "cholesterol." Tackling these other risk factors would go beyond the scope of this article, but I will take apart the Cholesterol issue.

In the past the focus was on reducing total cholesterol and low-density lipoproteins (LDL-C) a subtype of cholesterol. The National Cholesterol Education Program (NCEP) set up guidelines where they recommend Total Cholesterol remain under 200 mg/dL and LDL-C under 100 mg/dL (recently changed from a value of less than 130 mg/dL). Drugs were developed to lower total and LDL-C and thus save lives. Come to find out the true hero is the high-density cholesterol (HDL-C) subunit of cholesterol. This type of cholesterol scavenges the "bad" cholesterol and thus does not allow plaque formation to occur which narrows the coronary arteries and results in AMI. One can even measure the 5 subclasses of HDL-C where H1 & H2 may be harmful while the larger HDL subclasses of H3, H4 & H5 are considered good and reduce risk. The true predictor for cardiac risk is not the total cholesterol or even the LDL-C, but the total cholesterol to HDL-C ration (TC:HDL-C). If this ratio is above 4.8 you are at increased risk to suffer from heart disease. Once a low HDL-C and/or high Total Cholesterol level is diagnosed it is important to implement treatment. Diet alone often fails, since the liver will make up what cholesterol you don’t eat. Several therapies exist, and it is more a matter of how aggressive you need to be and how well tolerated they are as to which you choose.

In a recent case study at the SLI a 36 year old male patient with a total cholesterol of 241 mg/dL, and LDL-C of 159 mg/dL and an HDL-C of 44 mg/dL prior to any therapy was given several regiments in an attempt to control his dyslipidemia. This patient was taking and continued to take a potent multivitamin and mineral supplement and the antioxidant coenzyme Q10 (25 mg daily). First was the very well tolerated and safe Inositol Hexanicotenate (which converts to niacin in the liver) 2000 mg and Garlic 500 mg daily and after 3 months the Total cholesterol was measured at 251, LDL at 150, HDL-C at 43. Not much of an improvement. This is seen in about 50% of subjects started on Inositol Hexanicotenate. The second trial was with Zocor 20 mg at bedtime (again coQ10 was continued at 50 mg per day to offset deficiencies that can occur with this drug) and after 60 days the results were as follows: Total Cholesterol 197, LDL-C 117, and HDL-C of 40. It is interesting to note that a recent study of 153 randomized patients with CAD and low HDL were given low dose Statin and niacin combination with and without antioxidants. The subjects taking antioxidants did not have a rise in HDL-C as did those who did not take an antioxidant cocktail which saw an increase in HDL of 42%. This is of importance when a patient is not responding to statin therapy and on concomitant antioxidant therapy. These were the best results so far.

Finally, because of complaints of muscle pain and the fear of "untoward effects" from the statin drug, the patient was tried on a "new" highly touted lipid-lowering agent called Policosonal (oxycosonal, a derivative of the waxy coating of sugar cane and considered a natural alternative). After 60 days the lipid profile was as follows: Total Cholesterol of 220, LDL-C of 139 and HDL-C of 39. A slight drop in the LDL-C and total, but not good enough. Finally Niacin (in the form of sustained release Niaspan) was attempted, but discontinued after 8 weeks due to constant flushing and pruritis (itching).

While the Inositol Hexinecotinate/Garlic and Policosonal therapies are considered "natural" they certainly were not better at achieving results. Zocor a potent (HMG-CoA reductase inhibitor [Statin] drug (when taken correctly and monitored for liver toxicity and in combination with coQ10 supplementation) is a very aggressive way to lower LDL and raise HDL-C (minimally). There are now low dose statin drugs in combination with niacin (truly the one drug/supplement shown to raise HDL-C the best) that show promise. Factors that may interfere with this may be very high dose antioxidant therapy and one must follow on a case-by-case basis.

Another approach not yet explored with this patient is a combination of herbals and nutrients known to lower cholesterol. This "shot gun" approach may yield better results than any one agent used alone. As this patient is placed on a regiment of lower dose niacin, policosanol, plant sterols, tocotrienols, guggulipid, phosphatidylcholine, oat bran, garlic and antioxidants, time will tell and I will keep you posted. As an integrative physician I use the safest or least harmful therapeutics first, but should they fail, I apply more traditional synthetic drugs to reach an endpoint that is known to save or extend life. Not all that is synthetic is evil as this case study demonstrates; one has to always consider the risk benefit ratio.


For the Beyond Cholesterol Slide Show: PowerPoint Presentation

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Charleston; Myrtle Beach, SC; Raleigh-Durham, NC; Orlando, FL, GA, NC, SC, VA, FL, United States