Dr. Mickle's Advice to Patients
Regarding the NIH Niacin Study

(May 28, 2011) On May 26, 2011 the NIH terminated the AIM-HIGH study designed to ascertain the advantage of raising HDL-cholesterol (“good cholesterol”) in patients with already very low LDL-cholesterol (“bad cholesterol”).  Although niacin (nicotinic acid) raised HDL-cholesterol by the expected 20%, the study concluded that “high-dose, extended release niacin offered no benefits beyond statin therapy alone in reducing cardio-vascular complications,” and the research was terminated prematurely.

The news media has underscored a perceived failure of niacin.  Patients are considering discarding their niacin supplements (or Niaspan prescriptions) and physicians are considering discarding three decades of research supporting niacin. It’s difficult for health care providers, let alone patients, to make sense of information presented in staccato bursts of near sensationalism.

As a lipidologist with a longstanding habit of reading medical literature and studies critically, I have a number of questions about the relevance of the NIH study to every day practice, where we see patients with a wide variety of conditions and use supplements in conjunction with prescription medicines. For example, perhaps the study was not continued long enough (initially intended as a 5-year study, it was discontinued after three-and-a-half years). Perhaps the numbers of test subjects was inadequate. But, perhaps most importantly, I wonder if the segment of the patient population treated was too narrow for us to be able to draw general conclusions. The study treated subjects whose LDL-cholesteral was already very low: their average LDL-cholesterol was only 71mg (mean population level is 130mg). Perhaps these patients had no further “room” for improvement.  There are other studies in the research pipeline which look at the effects of niacin on other patient populations, and I look forward to them.

Another reservation that I have about the NIH study was that it did not address the multiple salutary effects of niacin in addition to raising HDL-cholesterol:

        --Niacin reduces Lp(a), a particularly pathologic subtype of LDL-cholesterol
        --Niacin increases the size and reduces the number of LDL particles, changes which reduce cholesterol penetration into the artery wall
        --Niacin reduces inflammation (which contributes to artery disease)
        --Niacin provides anti-oxidant protection to arteries

At Cholesterol Studies and Treatment, we respect these benefits and recommend niacin, as well as fish oil and red yeast rice, to more naturally treat artery disease, to reduce or even avoid statin prescriptions. Because the patients in the NIH study began with very low levels of LDL-cholesterol, the study does not tell us about the effects of niacin on patients with more typical, average, or high levels of LDL-cholesterol.

Just 19 months ago, research saluted niacin for a perceived advantage over ezetimibe (Zetia) when added to statins, and we are reminded that the path of medical research remains bumpy, with 3 steps forward and 1 step backward.

I encourage patients to be curious, to ask questions, and to be active partners in making their healthcare decisions.

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Press Releases

National Institute of Health Prematurely Halts HDL-Cholesterol Study
Dr. James Mickle Advises Patients Not To Drop Their Niacin

Santa Fe, New Mexico (May 27, 2011): Yesterday the National Institute of Health terminated the AIM HIGH research study. This study was designed to learn if raising HDL-cholesterol ("good" cholesterol) with nicotinic acid (niacin) reduced artery disease in patients who already have very low LDL-cholesterol ("bad" cholesterol) levels. The test was stopped prematurely when trends indicated that increasing HDL-cholesterol provided no extra advantage over aggressive lowering of LDL-cholesterol.

This new information is surprising, and doctors are wondering if they should dismiss three decades of research supporting niacin. Patients currently taking niacin might be tempted to discontinue its use.

“What are we all to think?” asks cholesterol specialist, James D. Mickle, Jr. MD, of Cholesterol Studies and Treatment in Santa Fe. “After reviewers dissect the research and extract details to accept or challenge, the effort to increase HDL-cholesterol will have lost some of its appeal, at least for patients with very low LDL-cholesterol. There will be questions about the brevity of the study, the numbers of patients tested, the miniscule increase in strokes in patients treated with niacin, and so on. I believe that patients shouldn't be discouraged and discard their niacin. Niacin is not a one-dimensional supplement in cholesterol care, and has several other benefits in addition to raising HDL.”

Dr Mickle also notes, “I believe that the big picture question raised by this study is whether or not an aggressive effort to raise HDL is beneficial for patients. We know that patients who start out with high HDL have a better chance of avoiding arterial disease, heart attack and stroke. Should raising HDL in other patients be a target of our treatment? We know that positive life-style changes such as increased exercise provide real benefits in preventing heart attack and stroke. These lifestyle changes can also raise HDL. Is that increase in HDL just ‘going along for the ride’ as the lifestyle changes improve a patient’s prospects? Or does the increase in HDL itself improve health? These are the kinds of fine-tuned questions that can get lost when a major study yields surprising results. We should all recognize that the path of medical progress is bumpy, and that research redirects us gradually, sometimes with 3 steps forward and one step backward."

James D. Mickle, MD, is a board-certified lipidologist, and operates Cholesterol Studies and Treatment, a private practice dedicated to diagnosing, halting, and reversing vascular disease. Dr. Mickle serves on the Society of Atherosclerosis Imaging and Prevention’s Advisory Council for IMT (intima-media thickness) Ultrasound in Clinical Practice. This international group is formulating new recommendations for the use of carotid artery ultrasound in assessing the state of a patient’s vascular system.
For more information, contact:
James D. Mickle, Jr., MD
doctorj49@aol.com
505-699-1172

James D. Mickle, Jr, MD, Internationally Recognized Cholesterol Specialist Opens Practice in Santa Fe

Santa Fe (March 23, 2011) - There are only about 600 physicians board-certified in the new medical specialty of lipidology in the US and Canada, and one of them now practices in Santa Fe. James D. Mickle, Jr., MD has opened a private practice, Cholesterol Studies and Treatment, dedicated to diagnosing, halting, and reversing vascular disease. Dr. Mickle is an internationally recognized expert on advanced techniques for diagnosing and treating artery disease, the cause of the number one and number three killers of adults in the United States: heart attack and stroke.

Dr. Mickle is a graduate of the Hershey Medical School in Pennsylvania, and was practicing family medicine in the Philadelphia area when he became increasingly puzzled by inconsistencies between the standard medical approach to high cholesterol numbers and the lives of some patients. “As my patients aged, I saw how many diseases stem from cholesterol problems, and I was intrigued by some mysteries—the ninety-year-old who has high cholesterol numbers but excellent health, or the forty-year-old with good numbers who suffers a heart attack. I delved into cholesterol research, and fine-tuned care of my patients.” In 2008 Dr. Mickle became board-certified as a Clinical Lipidologist. “That’s a new specialty—a big word for someone who specializes in artery disease caused by lipids--fats such as cholesterol and triglycerides.” Dr. Mickle currently serves on the Society of Atherosclerosis Imaging and Prevention’s Advisory Council for IMT (intima-media thickness) Ultrasound in Clinical Practice. This international group is formulating new recommendations for the use of carotid artery ultrasound in assessing the state of a patient’s vascular system.

Dr. Mickle believes that the standard diagnostic and treatment protocols are far behind the latest research. For instance, “the lab test that best predicts artery disease is not the familiar LDL (‘bad’) cholesterol test, but rather a tragically under-used test called ApoB. Another underused test is the carotid artery ultrasound, which enables us to visualize the arteries and determine whether or not there is disease, not just guess at the state of patients’ arteries from their lab tests.” He has found that natural supplements, as well as diet and lifestyle changes, can be crucial to artery health. He also believes that statins (prescription cholesterol-lowering medications) are over-prescribed to some patients whose arteries prove healthy, no matter what their basic lab tests say.

Dr. Mickle has opened a practice in Santa Fe for reasons both personal and professional. “Like so many people, I have long loved New Mexico for its natural beauty, diversity, and cultural richness. I have family here, and I think that this is a community that is health-conscious, and receptive to new ideas and natural approaches, while wanting world-class health care.”

 
James D. Mickle, Jr. MD, Santa Fe Cholesterol Expert, 
Speaks to International Physicians and Researchers in Bethesda, Maryland 

Santa Fe, NM, March 23, 2011 -  James D. Mickle, Jr. MD, of Cholesterol Studies and Treatment in Santa Fe, will be a speaker at the Society for Atherosclerosis Imaging and Prevention Training Academy in Bethesda, Maryland, April 14-15, 2011. These training sessions for physicians and cardiac care specialists precede the annual meeting of the Society for Atherosclerosis Imaging and Prevention in Bethesda, April 15-17.

Dr. Mickle is an internationally recognized expert in the use of carotid artery ultrasound to diagnose the presence and progression of arterial disease caused by cholesterol buildup in the arteries. Dr. Mickle says, “Ultra-sound imaging of the carotid artery enables us to visualize the actual state of a patient’s arteries, and not just guess based on cholesterol numbers. Sometimes it reveals that a patient’s arteries are plaque-free and healthy, and suggests that, even in the face of abnormal lab tests, doctors might recommend natural treatments only—supplements, diet, and exercise. When a patient does have plaque in the arteries, imaging can help guide treatment. When we see halting or reversal of disease, we know that our treatment is working.”

Dr. Mickle currently serves on the Society of Atherosclerosis Imaging and Prevention’s Council for IMT (intima-media thickness) Ultrasound in Clinical Practice.  This international group is formulating new recommendations for the use of carotid artery ultrasound in assessing the state of a patient’s vascular system.

Dr. Mickle explains, “I am one of a few full-time clinicians—doctors seeing patients every day--on that panel. Other members are distinguished researchers from around the world. I was invited to participate because I have been doing carotid artery ultrasound in my office for 11 years, and had a body of experience to share with research-oriented physicians and scientists.”

Dr. Mickle is a board-certified lipidologist (cholesterol specialist) and has recently opened Cholesterol Studies and Treatment in Santa Fe, where he employs carotid artery ultrasound and advanced lab tests to assess the state of a patient’s arteries.

Cholesterol Studies and Treatment is located at 4 Calle Medico, Suite C, Santa Fe, 87505. 
Call 505-699-1172, or email us at doctorj49@aol.com