NIASPAN (or niacin): Should You Stop This Cholesterol Medicine?

The Study: The AIM-HIGH trial (Atherothrombosis Intervention in Metabolic Syndrome with Low HDL/High Triglycerides)

On May 26, 2011,  (NHLBI) 

The AIM-HIGH trial was the first large-scale outcomes study to evaluate the impact of adding extended-release niacin (NIASPAN) to statin therapy (simvastatin) in patients with established coronary disease. The study was designed to test whether or not increasing HDL cholesterol and lowering triglycerides in patients with low HDL cholesterol and high triglycerides will reduce the risk of recurrent cardiovascular events in patients whose LDL cholesterol was already within a desirable range with statin therapy.

The patients of AIM-HIGH:  3,414 patients that entered the study and were randomized to statin or to statin plus niacin therapy. The age was 64 ± 9 years, 85% were men and all had documented arteriosclerotic vascular disease. Statin therapy had been used in 94% for some period of time before enrollment. The mean LDL-C was 71 mg/dL, HDL-C 34.9 mg/dL and triglycerides 161 mg/dL at randomization to the treatment regimens. will require careful study to determine if there are specific reasons for the failure of niacin to provide incremental risk reduction in this population of patients.

The results: The incidence of cardiac events was almost identical in those taking additional niacin vs those just on a statin (about 5.6%) The observed higher incidence of stroke (28 vs 12) in the niacin arm will need further investigation.

   The AIM-HIGH trial was halted 18 months early since the researchers flet that the study goal of reducing cardiac events by 25% in those taking niacin would not be reached.

    A number of prior studies used extended-release niacin to treat patients with low HDL-C since niacin has demonstrated benefit in earlier reported studies in conjunction with statins and other drugs, as observed in the HDL-Atherosclerosis Treatment Study (HATS) and the Cholesterol Lowering Atherosclerosis Study (CLAS) and  In the Coronary Drug Project niacin alone was shown to reduce myocardial infarction, stroke, and the need for coronary bypass surgery. However,  none of these trials compared statin therapy to niacin plus statin therapy.          A much larger study with a similar design and measured outcomes is underway (i.e., HPS-2 THRIVE). 

Bottom Line:

Patients should not stop niacin unless advised by their doctors. Vast clinical experience and the studies mentioned above (HATS, CLAS,CDP as well as imaging studies) have shown the significant benefit of niacin. In addition, the AIM-HIGH TRIAL was stopped prematurely because it could not statisically attain the 25% reduction in events in the following 18 months. But could it have attained a 5% in 18 more months and 20% in 5 yrs total? We will never know. Furthermore, the findings presented should be interpreted with caution until the full study details are available and additional studies are completed that should provide insight into the effect of niacin in other populations.

Airport body scans- are they safe?

Airport body scans have created a great deal of anxiety about the safety of such devices due to the potential exposure to radiation. This discussion will only about the safety of such scans, not about the effectiveness of these scanner as an antiterrorist tool.

Background:
After 9/11, airport anti-terrorist measures were in part directed to screening carry-on luggage and checked baggage with xray scanners. Passengers were not exposed to the radiation nor were the airport workers. Passengers were and are asked to walk through metal detectors with the thought that metallic items like guns, knives and explosive devices could be easily identified. Several years ago, especially after the "shoe bomber" was able to smuggle an incendiary device in his shoe, and the availability of plastic explosives and non-metallic weapons, it was felt that the passenger needed to have a full body pat- down or have a body scan to detect such devices.

What are airport body scanners?
There are two types of body scanners:

1. Millimeter wave unit body scanners: One type emits a radiofrequency wave ove the body, reaching just below the clothing and over the surface of the skin to create an image of the surface of the body, just below the clothing, but not through the body itself. There is no radiation at all from this scanner.

2. Xray body scanner backscatter unit: This type of scanner emits a very low amount of radiation that penetrates the clothing, and slightly into the body cavity, like the rectum and vagina. The scanner reconstructs an image of the body beneath the clothing and detects any foreign objects, whether they be metal or non metallic.The ability to penetrate the body cavities is probably limited and variable based on the passengers weight and body shape. This type of scanner does expose the patient to radiation and is the scanner of concern.

What is radiation?
Basically radiation is an energy force that comes in various degrees of strength, from infrared light, ultraviolet light, radio waves and others. Ionizing radiation is the more pwerful type of radiation that can actually interact and change human cells. This is the type of radiation used in medical Xray devices such as chest xrays, CT scans, mammograms etc..The radiation in medical applications can be very powerful such that they penetrate the body and create images of the inside of the body, unlike ariport scanners which only cover the surface of the body. At extremely high and concentrated form of Xray beams are used to actually treat and destroy certain types of cancers.

How much radiation is safe?
It is generally recommended to limit ones Xray exposure to the bare minnum possible. We are constantly exposed to radiation which comes from the enviroment from radioactive decay in rocks and from the atmosphere. People who live at high altitudes such as Denver, Colorado receive more radiation from the atmosphere than those at sea level. Flyng in a plane going cross country at 30,000 ft exposes one to radiation. In truth it is not known for sure what dose can cause cancer and in whom. We do know that certain body parts are more sensitive to radiation, for instance, the breast tissue and thyroid are much more sensitive than the heart to the effects of radiation.

How much radiation dose the airport scanner release to the passanger?
Think of it like this: chest xrays, mammograms and dental Xrays all expose us to much higher doses of radiation than the airport body scan, and none of these medical tests have been shown to cause cancer.

To equal the radiation from:

1. Mammogram: you would have to go through the body scanner 1,300 times
2. Chest Xray: you would have to go throught the body scanner 1,000 times
3. Dental xray: you would need to go through the body scanner 200 times
4. Airline flight: you need to be flying at 35,000 ft for one minute to get the radiation of one body scan


Bottom line:
It is my feeling that the airport body scanners pose no safety risk and I would not hestiate going through it many tens of times. However, it makes common sense that if you are a pilot or stewardess, there are other means to screen  to avoid repeated exposure to the scanner, however small the risk.

Chelation Therapy: Hype or Hope?

THE ISSUE:

October 2010: The FDA today warned eight companies that their over-the-counter chelation products are unapproved drugs and devices and that it is a violation of federal law to make unproven claims about these products.

The companies claim their products treat a range of diseases; including autism spectrum disorder, cardiovascular diseases, Parkinson’s disease, Alzheimer’s disease, macular degeneration, and other serious conditions; by removing toxic metals from the body.  

THE BACKGROUND:

The National Heart, Lung, and Blood Institute (NHLBI) and the National Center for Complementary and Alternative Medicine (NCCAM), both components of the National Institutes of Health (NIH), are sponsoring the Trial To Assess Chelation Therapy (TACT). TACT is the first large-scale, multicenter study to determine the safety and efficacy of EDTA chelation therapy for individuals with coronary artery disease.

What is chelation therapy?

Chelation is a  process in which a substance is used to bind molecules, so that they can be removed from the body. For example, a person who has lead poisoning may be given chelation therapy in order to bind and remove excess lead, or in other cases, iron, copper, and calcium, from the body before it can cause damage. EDTA chelation therapy, (ethylene diamine tetra-acetic acid), is administered through the veins.   Some physicians and alternative medicine practitioners have recommended disodium EDTA chelation as a way to treat coronary artery plaque (hardening of the arteries). The TACT study uses  disodium EDTA,  as an investigational new drug (IND). Disodium EDTA it is not yet approved by the FDA to treat CAD,

The possible side effects:

A common side effect is a burning sensation at the vein insertion site. Rare side effects can include fever, headache, nausea, vomiting, permanent kidney damage,  bone marrow supression, heart failure,  blood pressure dropping acutely, and dangerously low  levels of calcium in the blood.

How might chelation work?

No one knows how or if chelation works. Some theories are that it removes the calcium that is part of the plaque in the walls of the coronary arteries. Other thoughts are that it reduces inflammation of the artery wall. A less plausible theory is that it causes the lowering of cholesterol or induces hormones that remove the calcium from the plaque.

What is the scientific evidence that chelation works?

No significant scientific studies have been done to verify EDTA chelation therapy's safety and effectiveness for coronary disease, most are just anecdotal reports that a scattered patient or so had a reduction in chest pain episodes.  There are only  5 randomized controlled clinical trials regarding the use of EDTA chelation for coronary disease, three trials involved very few people, that only a dramatic improvement could have been detected.  The fourth study reported that EDTA chelation was associated with an improvement in ability to exercise in only 10 patients. and the fifth study was never published in completed format.  Twelve uncontrolled published descriptive studies reported a reduction in angina. These types of studies are the least scientific type of studies and use clinical observations or review past data.


The Bottom Line:
There is no evidence that chelation works, none at all to date. I believe it should be avoided at this point until the evidence from the TACT study is complete. It is foolish to forgo proven treatments for coronary artery disease. If there is significant chest pain of cardiac origin (angina) there are many options available. Save your money for now and avoid chelation therapy unless there are no other options available:


The Hope:
I hope chelation is proven to work. What doctor would not want to administer it in his/her office? It requires no doctor time, it can be administered by a nurse and it is quite lucrative, certainly more lucrative than the administration of the standard treatments such as cholesterol medications and stents.


As a side:
Thirty years ago when I first started private practice in Orange County, California, I went on a local cable TV show to debate/discuss chelation therapy with a doctor using it to treat heart disease. How some 3 decades later we still do not have a definitive answer and it is not supported by the FDA or any medical society. In fact, The FDA has recently sued manufactures for selling it. I do hope it is proven to work!

The End Of Health Care As We Know It: Obamacare

The end of medical care as we know it?
         The present health care changes being instituted by Obamacare (Patient Protection & Affordable Care Act), when fully implemented, will have disastrous effects on our health care system. The unintended consequences are already being felt. The perfect storm for a healthcare disaster is emerging. We have a rapidly aging and long-living population that depends on extremely complex technologies, medicines and infrastructure. This requires more highly trained primary care and subspecialty physicians. Yet we have a health care bill that is not only poorly funded for theses challenges, but provides disincentives for innovation and hard work. More regulations for physicians, reduced reimbursements and no tort reform, will dramatically limit access to doctors. Physicians are leaving practice, curtailing hours, dropping Medicare patients, retiring early, or refusing to see more patients. Patients will have longer waits to see doctors, they will be sicker when they are seen, there will be more emergency room visits and costs will go up dramatically

         Our present health care is the best in the world, and Orange County is a leader in health care quality, technology and innovation. Even so, we all agree that aspects of our health care delivery do need improvement. However, a targeted, evolutionary change is needed to preserve what we do best, not this massive overhaul burdened with new regulations and some 159 new federal programs and bureaucracies. It is simple as this: every new regulation, takes money and time from direct patient care.

            To make matters worse, a single payer system and rationing of care is evolving, unless the present health care bill is withdrawn and revised. Today many independent medical practices are financially unsustainable. Hospital reimbursement is many times higher for the same test done in the hospital that can be done cheaper and better in a doctor’s office. Hospitals are buying doctor practices through a Foundation model, which has a non-profit status and tax advantages. Obamacare requires the formation of ACOs (Accountable Care Organizations), which are hospital and physician organizations. If the hospital has acquired a critical mass of doctors, the money goes to the hospital (the ACO), which then has the power to decide how much doctors are paid and the type of services they may provide. The patient’s health care decision will be in the hands of bureaucrats. This is essentially a single payer system. Doctors and patients will be at the bottom of the health care system, in terms of control of health care decisions. Less money for patient care, less doctors to administer the care. Patient care is going to suffer dramatically, and yes, care will be rationed. This is what we must do now:

1.    Repeal the present health care plan now by electing the appropriate politicians.

2.    Adopt common sense changes: any individual can buy health care, across state lines, carry that insurance from job to job, choose a high deductible, and use your health care expenditures as tax credits through a health savings account.

3.    Tort reform is essential. Require two additional medical experts to agree that the malpractice lawsuit has merit. Require that the plaintiff’s attorney pay all attorney fees if they lose. Limit the attorney settlement fees, e.g., the plaintiff’s attorney gets up to 3 times the patient’s award.

4.    New medical schools to meet the doctor shortage.

5.    Prescription policy revision: Uniform formularies so all brand name drugs are available on all insurance plans at similar prices. At least 90 day supply per prescription. This will save many millions of dollars in lost productivity for patients, pharmacists and doctors.

6.    Prevent a single payer system.  There has to be a level playing field to encourage doctors to remain independent by providing equal tax advantages and reimbursements for independent doctors, similar to those afforded for foundation model practices.

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FISH OIL NOT HELPFUL IN TREATING HEART DISEASE?

THE STUDY:

Reported on in the LA Times, August 27, 2010 edition mentions a study published in the New England Journal of Medicine concerning the benefits of fish oil. 

The study showed that fish consumption (thus fish oils or omega 3 fatty acids) were not very beneficial in patients who  already suffered heart attacks. Fish did not significantly reduce their risk of heart attack, stroke, heart failure and other cardiovascular events by eating about 400 mg of fish fatty acids per day. However, the supplement did help those patients who had  a past heart attack and were also diabetic. So are all the benefits of fish oil just hype? Is it worth taking fish oil? 


THE BOTTOM LINE:
Fish oil  (omega 3 oil or flaxseed oil) is the one supplement you should take, and these supplements will benefit just about anyone and should be taken by most people. The problem with the reults of the study is more the design of the study. These patients already had coronary heart disease and prior heart attacks. Most patients after a heart attack are placed on multple risk altering drugs like statins, niacin, aspirin, beta blockers, aspirin and perhaps Plavix. With this vigorous regimen, the additional benefits from fish oil may be hard to see but are definitelty there.

Substantial research prove  fish oil may prevent cardiovascular disease through various mechanisms:

Clinical studies have shown that omega-3 fatty acids:

  Reduce the rate at which atherosclerotic plaque developes

Helps to prevent thrombosis (blood clotting in blood vessels). 

 

  Lower triglyceride levels. Raise HDL cholesterol slightly.

  

  Lower blood pressure 

  Reduce the risk of arrhythmias which increase the risk of cardiac arrest.

  Improves endothelial function which supports the growth of new blood cells. 

Although omega-3 fatty acids can be obtained from sources other than fish oil,  the most beneficial forms are only available in fish oil. Docosehexaenoic (DHA) and eicosapentaenoic (EPA) are long chained fatty acids which cannot be found in any other source.
Omega-3 can be included in the diet by eating fatty fish (such as salmon) three times a week.

Fish oil supplements, starting 2,000mg day would be benficial for most people if no contraindications.

HEART BYPASS SURGERY BETTER THAN STENTS?

THE STUDY:
THE SYNTAX STUDY reported in the LA Times, Sept 12, 2010, suggested that patients who got coronary stents were 28% more likely to suffer a heart attack, 46% more likely to need a repeat procedure, and 22% more likey to die than patients who had coronary bypass surgery (CABG). The study followed 1.800 patients in Europe or the United States who had a Taxus drug coated stent or underwent CABG.
The results were for those with severe diesase. What is severe disease? The heart has four major coronary arteries: the Left Main, the Left Anterior Descending, the Circumflex, and the Right Coronary Artery. The latter three can also have large branch arteries that may be big enough to require repair. These arteries can be repaired by bypass surgery, hence the possibility of double, triple, quadruple or even quintuple (five way) bypass grafts, or stents in as many arteries as needed. This study shows, and it has generally been known that usually the need for 3 arteries requiring fixing, tends to favor bypass surgery rather than stenting in 3 or 4 arteries.

THE BOTTOM LINE:
If you need one or two arteries fixed, and the arteries are of good size, meaning 2.5mm to 3mm or more in diameter, and the narrowed segment in the artery is short, stents are preferable in most cases to coronary bypass surgery, in my opinion. Drug coated or so called drug eluting stents (DES) have been the most significant advance in treating advanced coronary artery disease (blockages). When I first starting performing coronary balloon angioplasty (PTCA) in 1984, there was a 30% chance or more that the artery would renarrow in 6 months. Now with drug eluting stents (DES), less than 5% will narrow, and if so it is in one year. After one year then stent has <1% chance of narrowing. With bypass surgery, each graft deteriorates over time at about 4% per year risk of closing, so by 10 years about 60% of grafts are closed or closing and probably a repeat bypass surgery is needed.

Diet Pill Causes Increased Heart Attack Risk

The Study:

An FDA advisory panel has voted to recommend that the FDA either severely restrict access to the weight-loss drug sibutramine (Meridia, Abbott Laboratories) and add tougher warnings or pull the plug on it altogether, due to its increased CV risk profile. Only two of the agency's Endocrinologic and Metabolic Drugs Advisory Committee, which spent Wednesday reviewing the results of the Sibutramine Cardiovascular Outcomes Trial (SCOUT), concluded that the drug should remain on the market with a boxed warning only, and no members thought the drug could stay on the market with no labeling changes.

The Bottom Line:

Meridia is one of only three drugs available for weight loss, the other two are: Alli which prevents fat absorption and has the unpleasant side effect of bloating, gas and diarrhea, and Phentermine which can cause an increase in heart rate, jitters and insomnia. All three cause only mild to modest weight reductions. Meridia in a recent study posed an increase in heart attack risk compared to placebo, in a range, that when considering it is only modestly effective in causing weight loss, makes it an unacceptable drug. 

What to do:

If you have serious obesity issues, with a body mass index (BMI) more than 30, or if you have more than 25lbs to lose, any of the popular diet programs are acceptable: Jenny Craig, Weight Watchers, NutriSystem or Optifast. 

My Recommendation:

Optifast has a 35 year track record of rapid, safe and effective weight loss that has a high probablity of being sustained over five years. In the late 1979 and 1980 i studied the effect of Optifast on heart function and rhythm in masively obese patients on an Optifast diet. The heart responded by returning to normal size and function and a normalization of heart beats. My present experience as a cardilogist dealing with morbidly obese patients has shown that Optifast has had been amazingly effective in causing signifcant, safe weight loss. Please see OC-OPTIFAST.COM if you are in need of fast, safe and effective weight loss