Wednesday, April 30, 2008
Niacin drugs
With losses in the billions of dollars emanating from marketing of an unsafe anti-inflammatory drug, Vioxx, the pharmaceutical giant Merck is making it sound like the FDA was unfair in its issuance of a recent disapproval letter for CORDAPTIVE, Merck’s new cholesterol control pill, which is nothing more than a slow-release non-flush niacin pill for management of cholesterol.
Merck’s niacin pill is combined with a statin drug to raise HDL “good” cholesterol levels while driving down LDL “bad” cholesterol. Here’s the big medical breakthrough for Merck --- CORDAPTIVE reduces niacin-induced flushing from 49% to 27% compared to plain slow-release niacin (Niaspan- Abbott Labs- annual sales ~$500 million). [American Journal Cardiology 101: 625-30, 2008] Flushing is the dilation of blood vessels causing redness of the skin coupled with warming or burning on the face and neck.
But will CORDAPTIVE users be any healthier, or lower their mortality risk for coronary heart disease? This is unlikely. Even Merck’s own promotional materials provided a lame rationale for CORDAPTIVE. It is assumed that elevation of HDL cholesterol lowers cardiac risk factors. An experimental Pfizer drug designed to raise HDL cholesterol had to be withdrawn from further clinical study because it increased mortality. But Merck could only say epidemiologic (population) studies have shown that for every 1 milligram/deciliter increase in HDL-C, the risk of developing cardiovascular disease decreases by 2-3 percent. A recent study shows CORDAPTIVE raise HDL levels by 20%.
But that is not direct evidence that Merck’s pill lowers the risk of sudden death heart attack. The problem with niacin, like statin drugs and even natural cholesterol-altering agents like policosanol and red yeast rice, there is no strong evidence they reduce mortality rates. They do alter circulating cholesterol numbers, but the cholesterol that circulates in your arteries is not the cholesterol that accumulates within the arterial wall. Cholesterol is produced in the liver and is needed for transport of antioxidants like vitamin E, lutein, lycopene, to tissues. Cholesterol is needed to produce sex hormones (testosterone, estrogen) and to produce bile for digestion of fats.
A few years ago researchers examine nearly 100 studies and concluded that niacin marginally reduces overall mortality by 4%, compared to 13% for statin drugs and 23% for omega-3 fish oil. [Archives Internal Medicine 165: 735-30, 2005] A broad review of studies involving statin drugs conducted by Harvard research John Abramson (author, Overdosed America) shows statins do not meaningfully reduce cardiac mortality rates. [Lancet. 2007 Jan 20; 369(9557):168-9]
As an aside, it is difficult to locate Dr. Abramson’s report on Medline – the National Library of Medicine’s library of published articles from medical journals. Searching under “statin drugs” and “Abramson” comes up empty. When you do locate the report, no abstract is provided. Investigators have to pay money to access the abstract or full report.
The cholesterol-lowering game is just a charade. Fish oil produces none of the side effects posed by statin drugs, none of the flushing of niacin, and even acts as an anti-inflammatory agent that is far safer than drugs like Vioxx. Fish oil also inhibits blood clots, which is what a heart attack is --- a blockage or clot in a coronary artery that supplies the heart with blood. Fish oil lowers triglycerides, another blood-fat that is considered a risk factor for heart disease. Fish oil makes the heart muscle less irritable and gives the heart muscle a rest by reducing the heart rate by about 6 beats per minute. [J Cardiopulmonary Rehabilitation Prevention 2008 Mar-Apr; 28(2):92-8] Fish oil also lowers blood pressure. [Journal Nutrition 2007 Apr; 137(4):973-8] Statin drugs, niacin, red yeast rice, policosanol? Why even go there when there is omega-3 fish oil? -Copyright 2008 Bill Sardi, Knowledge of Health, Inc.
Labels: cholesterol, fish oil, niacin flush
posted by Knowledge of Health at 4:41 AM
