IMPROVE-IT Proves that with LDL, Lower is Most Definitely Better

The IMPROVE-IT verdict is in and it will change the practice of cardiovascular disease prevention. For the first time, a non-statin medication has been shown to reduce cardiovascular events (including stroke and MI) when added to a statin. Achieving an LDL level of 53 vs 70 by the end of the trial’s first year translated into a significant ASCVD risk reduction. The risk reduction is so substantial that in this patient population the “number needed to teat” was only 50. That means that for every 50 patients treated with Zetia on top of a statin, a serious/life-threatening event was prevented. And, there were no safety issues associated with adding Zetia. Thus, a downside was not present. There are so many ramifications of this trial; I will highlight a few:

  • As believed by most lipid (cholesterol) specialists, lower LDL is definitely better.
  • Ezetimibe should be added to statins in appropriate patients.
  • The hotly debated 2013 ACC/AHA Cholesterol Guidelines now require an addendum adding Ezetimibe to front line therapy.
  • Many insurance companies will have to revisit their denials of Zetia – it has now been shown to be highly effective and must be a part of doctors’ armamentaria.
  • Other emerging medications that dramatically lower cholesterol – the PCSK9 inhibitors and possibly the CETP inhibitors – will likely lower ASCVD events in the right patients.
  • In patients with severe genetically caused high cholesterol – specifically those with Familial Hypercholesterolemia – doctors will try even harder to use varied tools to lower LDL as much as possible. This includes using LDL apheresis, a procedure that has frequently been denied coverage by many insurance carriers, even after experts have testified about its efficacy.
  • We have learned that an understanding of biology and pathophysiology, in the context of clinical experience and careful observation, should not be dismissed solely because of the absence of a large randomized controlled trial (RCT). Though it took an RCT to prove this point, those of us who have been using Zetia religiously for many years have borne witness to its efficacy. We did not need this trial to tell us how important the medication is in the management of ASCVD, but it surely makes us feel better (and a bit vindicated as well). Most consequentially, it is heartwarming to consider the vast numbers of patients we’ve helped avoid experiencing heart attacks and strokes as a result of our well-considered and steadfast convictions.
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IMPROVE-IT Trial: the Day of Reckoning Approaches

Tomorrow morning a large crowd will gather here at the AHA meetings in frigid Chicago to learn the findings of the long-awaited IMPROVE-IT trial. The trial will demonstrate whether or not Ezetamibe (Zetia) added to a Simvastatin (Zocor) successfully decreased cardiovascular events in high-risk patients.

Many lipid specialists and cardiologists, myself included, have used Ezetamibe in combination with statins since the drug’s release. We believe wholeheartedly in the “lower LDL is better” hypothesis. Our clinical results, though anecdotal, have been uniformly exceptional. We fully anticipate that – barring confounding circumstances – the trial will be a winner.

Making this prospect even more impactful is the current NEJM publication by Dr. S. Kathiresan, (a brilliant Harvard Cardiologist/Geneticist) describing a novel genetic mutation that decreases LDL cholesterol, and concomitantly reduces ASCVD events. Where is this mutation you might ask: In the same receptor that is blocked by the drug Ezetamibe. Essentially individuals bearing such a mutation are born with the equivalent of continual Zetia use. This experiment of nature surely supports the speculation that Ezetimibe effectively lowers heart disease, even on top of statin therapy.

For now, we can only speculate about IMPROVE-IT’s findings. Tomorrow will bring some hard facts along with an assessment of how the findings will impact not only doctors’ use of Ezetamibe, but equally importantly, how health insurance companies will view the matter as well. Until tomorrow my admittedly unbiased fingers will be tightly crossed.

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IT’S A MAD WORLD

Last week’s The Voice brought us a superb rendition of the timeless song Mad World which emotionally depicts collective adolescent angst. Mad World to me however conjures feelings about our modern world, besieged by increasing racial and ethnic strife, both of which are continually fueled by those who should instead be squelching the consuming conflagration. Writing a blog limits my ability to comprehensively analyze this issue so I will mention just two problems that clearly are being fueled by either the ignorant or the malevolent.

The first is racial division. No one can honestly deny the growth of this destructive force. Many examples could be cited and hypotheses rendered but watching the news last evening I was struck by a single worrisome observation. Apparently the upcoming senatorial elections are not only consequential, but also nail-bitingly close. So both sides are doing whatever they can to mobilize their troops to vote. It certainly makes sense to do so. What struck me though was listening to African American Democrats at all levels of power emphasize the need to mobilize the black voters. The black vote they say is nearly uniformly Democrat and therefore they must encourage them to vote. What strikes me is the notion that African Americans are being bundled into a singular stereotyped group by those Blacks currently holding elected office. Are ALL Blacks really the same? Shouldn’t Blacks be recognized to have disparate views independent of their skin color? I know Black doctors, lawyers, engineers, scientists etc. Are we to believe they all hold the same political stance? The answer of course is no; they do not. Imagine if you heard the white politicians calling Whites out to vote – the notion would not only offend Blacks and Whites alike; it would also be terribly misguided. So, how do the African American politicians calling for Blacks to vote not see they are marginalizing the Black Race? If I were Black, I would be appalled by their supplications. I would also recognize their actions to foster, not fix racial divisiveness.

The second issue concerns growing Anti-Semitism. Recently a relative called me to express her concern about a bumper sticker saying “Boycott Israel”. There are so many examples of Anti-Semitism here and abroad, some restricted to verbal abuse, others physical. Let’s just look at the Boycott Israel notion. I would suggest that anyone supporting such a stance should lead by example. That would mean you couldn’t have a colonoscopy as the Israeli’s invented the camera used in that procedure. You couldn’t have a capsule endoscopy – they invented that too. If you have Multiple Sclerosis you’d probably have to abandon your medication and if you were a paraplegic you’d have to abandon your device that helps you walk. Yes, the Israeli’s invented those medical marvels too. If you like your flash drive; oops, that’s got to go; and if you like text messaging, sorry you better stop – Israeli’s again. The list of Israeli inventions is nearly endless and if you add Jewish inventions you might as well stay home and raise your own food and build your own appliances. In fact, you won’t be able to go shopping at all because a Jew invented the barcode. The point is that before you spew racial or ethnic derision, get educated. Know what you’re talking about and if what you’re saying is based solely on bigotry; try staying silent.

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The 2014 FH Global Summit – An International Meeting of Minds and Hearts

On October 13th the world’s “who’s who” in FH research and patient care convened in an oddly elongated New York City hotel meeting room. For two days the group shared novel information, spontaneous ideas, well-conceived proposals for future research, and even heart wrenching stories from a handful of brave and resilient FH patients.  Windowless room notwithstanding, leaders from the Netherlands, South Africa, Australia, Chile, Russia, France, Sweden, Oman and the US uniformly basked in the bliss of a mutual goal, raising awareness and improving treatment for this far too common and oft-unrecognized disease.

Some of the highlights included a one-year review of the FH Foundation’s CASCADE FH Registry. We were all pleased and proud to learn that the Registry had surpassed its forecast goal by over 30% (Actually by over 400% of a more modest prediction). We travelled the world identifying FH “Gaps Across the Globe.” During this session leaders from diverse nations compared and contrasted barriers to care, offering useful methods to hurdle such obstacles. We heard from a continuum of clinicians – internists, lipid specialists, endocrinologists, cardiologists, and gastroenterologists – as well as PhDs occupying a wide range of disciplines. To say the conference was comprehensive fails to express its exceptionality. It was a time apart from other times, a transcendent growth opportunity for all those fortunate enough to be in attendance. It will surely serve as a solid springboard for meaningful clinical collaborations throughout the next year.

In sum, the 2014 FH Global Summit was so spectacular it will be hard to surpass in 2015. However, considering the passion and energy shared by members of the FH Foundation and colleagues across the globe, I feel safe in predicting that 2015 will exceed even the extraordinariness of this year’s event.

Learn more about preventive cardiology at www.preventivecardiologyinc.com.

For more information more about essential vitamins and supplements visit www.vitalremedymd.com.

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September 24th is National FH Awareness Day

the FH Foundation

Join us for the FH Foundation Tweetathon @ #KnowFH 2PM EST September 24th

    • Familial Hypercholesterolemia (FH) is a genetic disorder
    • FH results in very high LDL cholesterol levels
    • FH results in a 20x increased risk of heart attack
    • FH causes premature heart disease
    • FH begins in utero (before birth)
    • FH is woefully underdiagnosed: < 10% of FH patients diagnosed in US
    • About 1 in 200 people have FH
    • FH can be diagnosed by your HCP
    • If you think you have FH, go to www.thefhfoundation.org to learn more
    • Find an FH expert at the FH Foundation
    • Diagnosis is the first step toward treatment
    • Treatment can stop heart attacks
    • Treatments are available
    • Learn more about FH: Join us on September 24 at 2PM EST

Learn more about preventive cardiology at www.preventivecardiologyinc.com.

For more information more about essential vitamins and supplements visit www.vitalremedymd.com.

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A Warning During National Cholesterol Education Month

The Internet teems with self-proclaimed experts in every discipline. They exercise free speech saying whatever they choose, ignoring all consequences. The freedom to speak one’s mind is a right that can never be eroded; yet it must be wielded with responsibility and intellectual honesty. And herein lies a pervasive problem. People who know very little are saying an awful lot. In the case of cholesterol, erroneous information can lead to unnecessarily dire consequences – heart attacks, strokes, and even death. Let’s look at LDL, what we know to be true and what we also know to be false.

LDL is a lipoprotein particle that carries cholesterol in our blood. Cholesterol requires such a transporter, as it would crystalize without it. (Knife-like crystals would then literally tear apart the linings of our blood vessels. Not a pretty image!) LDL’s main purpose is to deliver its cargo, leftover cholesterol, to our liver for disposal. It does not – I repeat, it does NOT – carry cholesterol to any other part of our body to be used for beneficial purposes. But many on the Internet say otherwise. They use our body’s undeniable need for cholesterol as evidence that LDL is necessary for brain health, hormone production, and optimal cellular function. And yet there is absolutely no evidence to support their claim. They state that lowering LDL with medications like the statins can lead to dementia and general cellular dysfunction (among countless other things). Their contention is that lowering LDL will leave our cells starving for cholesterol. Again, there is no evidence to support this. And, what they neglect to tell their readers is that every cell in our body has the capacity to make its own cholesterol. So if levels become too low, cells turn up their cholesterol-manufacturing system and create as much as they need. These charlatan fear-mongers also fail to let their information-craving audience know two essential facts. First, LDL undeniably causes vascular disease. And second, statins have unequivocally been shown to reduce heart attacks, strokes, and death.

Supporting the first fact are century-old trials that validate the causal relationship between LDL and cardiovascular disease. But the most compelling information has come on the scene only just recently. Proof positive (to the best of our current scientific capacity) comes in the form of Mendelian Randomization studies (MR studies). These studies use the random assortment of genes during the process of reproduction to eliminate what we call “confounders”, conditions that falsely produce findings while oftentimes going unrecognized. MR studies are actually nature’s superior form of Randomized Controlled Trials (RCT), the bedrock of modern science. And, to date, every LDL MR study has consistently shown that LDL is more than simply associated with cardiovascular disease; it is a major cause. Patients with genetically low LDL are protected from disease, while those with genetically high LDL, such as Familial Hypercholesterolemia (FH) patients, are besieged by disease.  In sum, high LDL is bad. Don’t let anyone tell you otherwise.

The second fact is also backed by innumerable studies and clinical trials. Statins – when given to the right patients – decrease heart attacks, strokes, and death. Statins save lives. Again, please don’t let anyone try to convince you otherwise. As to who are the “right” people to receive statins, we have guidelines to help us decide, but the ultimate decision is one that should be made between patient and physician.

The bottom line, whether it is with LDL or any other serious issue we strive to understand, we must all be very careful about our sources. My credo is to always find a primary resource. In the case of LDL, read and listen to the real experts, those who spend their lives understanding the issues with the sole goal of helping patients become healthier and live longer, better lives.

Learn more about preventive cardiology at www.preventivecardiologyinc.com.

For more information more about essential vitamins and supplements visit www.vitalremedymd.com.

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The Joyful Luxury of Bringing Home a Puppy

The world is under siege.  Muslim extremists in Iraq are “cleansing” the hijacked country of the world’s most ancient Christians. Men, women, and children are being slaughtered, after they’ve been tortured and raped. Jewish teenagers are being kidnapped and executed by similar extremists; people are being beheaded in city streets. These are the same missionaries of terror that pierced our false sense of security, destroying our towers and the thousands of innocents within. Our civilized world is unequivocally in peril. A return to the dark ages is at our doorstep.  Some say there is nothing to fear; it’s a minority who are at the source of this evil. Yet a minority can create catastrophic consequences. Witness the horror of Nazi Germany. And, a “minority” in the world of Muslims is likely well upwards of 200 million people. This is a minority in truth, but one demanding our unwavering attention and concern.  So how does a puppy fit in this story?

Yesterday my wife fell in love with a nine-week-old puppy. We had recently lost a dog to a sudden splenic rupture from cancer and in truth I believed it would be a long time coming before my wife would open herself up to another similar love. But I was mistaken. She informed me of her find and I immediately knew another dog would be coming home. I was sold on this notion with a simple question, “Isn’t this what life is supposed to be about?” Irrefutable. Life should be about love and puppies and the luxury and freedom to enjoy both. As a Preventive Cardiologist I couldn’t deny both the emotional and physical salutary impact of smiles and laughter engendered by the presence of a simple pup. Then I considered those in other parts of the world; Christians, Jews and non-radicalized Muslims fleeing and dying at the hands of terrorists. These individuals cannot enjoy the American luxuries of which I speak. We are a nation of fortune; but this fortune was built on the selfless sacrifices of our fathers and forefathers. Freedom is not an easy thing to gain but I fear it is quite easy to lose. Understanding this, we must be hyper-vigilant about safeguarding it. Yet its nemesis nips at our heels. Political correctness aside, when critically and honestly examining the world one must acknowledge there is but a single group that seeks to dominate all others. Yes, a minority threatens us, and most of the world abhors the actions of this minority. The minority, however, is fierce, brutal, enormous, powerful, determined, and patient. They will have their way if we do not face and stop them. If we fail, love and puppies, and other often-unappreciated freedoms will become our memories, and the dreams of future generations.

Learn more about preventive cardiology at www.preventivecardiologyinc.com.

For more information more about essential vitamins and supplements visit www.vitalremedymd.com.

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The FH Foundation, Turning Hope into Reality

I spent Thursday and Friday in California. No, I wasn’t strolling on the beach or sipping local wines. Instead, I was engaged in strategic conversations during our FH Foundation Board of Directors Annual meeting. FH (Familial Hypercholesterolemia), as you know from prior posts, (if you don’t, please visit www.thefhfoundation.org or see my older blogs and FH/cholesterol articles at www.preventivecardiologyinc.com) is a common yet terribly underdiagnosed genetic disorder that elevates LDL cholesterol which in turn causes early and life-threatening heart disease. Affected patients cover a wide spectrum, having disease from before age ten to as late as 70 or 80 years old. We spent some time examining last year’s accomplishments, but more importantly we determined how to continue the process of converting dreams into reality. I’ve chosen to share this story with you for two reasons: First, FH must be conquered. Second and no less important, the Foundation epitomizes the power of a small group driven by unfettered passion, enthusiasm, and commitment.

Katherine Wilemon, the group’s founder, CEO, and tireless leader, suffered her heart attack shortly after the birth of her daughter. Though she had lifelong high cholesterol, and had experienced symptoms before the event, her genetic disease was initially unrecognized. And, in medicine, to be able to provide appropriate care we usually must know what it is we’re treating. Fortunately for Katherine – and her family -  she survived. Subsequently, wishing to turn a terrible event into a hopeful future, Katherine started the FH Foundation. That was just three years back. Since then, Katherine has not only surrounded herself with a growing group of highly effective and devoted patients, doctors, and businesspeople, she has travelled the world building awareness and interacting with every true FH expert. The FH Foundation has established a National FH Awareness Day. It has created the first and only Registry for FH patients in the US (Cascade FH). The FH Foundation spearheaded the establishment of ICD 10 codes for this disease, and it has initiated protocols to identify every single FH patient in our nation.

Our second Global FH Summit will take place this October in New York City. An array of nations will be represented. The list goes on and on. I recount this litany of achievements not to boast, but to demonstrate how the visions of an individual can burgeon, ultimately impacting the reality of so many. Coming away from two days of inspiring meetings I am certain the Foundation will continue to succeed. In short order FH will entirely emerge from the shadows. FH will become a disease on the tip of every doctor’s tongue, and consequently afflicted patients of all ages will no longer suffer and even die unnecessarily. Millions of people’s lives will be changed for the better. At the risk of being mawkish, I must state that my experience with the FH Foundation illuminated the fact that if more of us would only act with similar commitment and intention, we might just find ourselves in a peaceful and unified world. It’s a tall order I know, but the FH Foundation has given me a glimpse of the possibilities that can be born of the seemingly impossible.

Learn more about preventive cardiology at www.preventivecardiologyinc.com.

For more information more about essential vitamins and supplements visit www.vitalremedymd.com.

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An Update From the 2014 American Society for Preventive Cardiology (ASPC) Annual Meetings

Two weeks ago was the ASPC’s Annual meeting in Boca Raton, FL. The event was superb. Internationally recognized experts in a variety of disciplines convened in Boca Raton for the three–day-event. Nearly 200 healthcare practitioners from around the country came to listen to Professors from Northwestern, Harvard, NYU, The Mayo, Columbia University, The Miami Miller School of Medicine, Emory, Ohio State, UCLA…  Topics such as the somewhat controversial 2013 ACC/AHA Cholesterol and Obesity Guidelines, the enormously under-recognized disorder Familial Hypercholesterolemia, and the vast sex differences in CVD presentation and treatment were discussed.

My lecture was entitled, “The Omega-3 Fatty Acids DHA and EPA: Caution when interpreting the Trials. It’s time to get back to the basics.”  The talk highlighted enormous limitations inherent in recent omega-3 studies. It is not only clinicians and laypeople who must understand such issues, but the press as well. Too many reporters – and even physicians in the news – misinterpret clinical studies, oftentimes sending not just misleading messages to the pubic, but potentially damaging ones as well.

DHA and EPA are the essential fatty acids found in fish, NOT flax, Chia, or olive/canola oil. These fatty acids have been studied in a variety of disorders ranging from heart attacks to dementias, ADHD, eye disease, inflammatory bowel disorders, and Rheumatologic ailments. The list is actually even more extensive than this. Their benefits are legion – anti-inflammatory, anti-oxidant, anti-arrhythmic, and anti-thrombotic to name a few. Scientists across the globe are spending their entire careers evaluating the myriad biological effects of these fatty acids. Although we still do not know precisely how DHA and EPA will fit into our medicinal armamentarium, we do know that they have an important role to play. More studies and clinical trials are needed. One thing is clear however. DHA and EPA are here to stay. They represent a component in our diets that should be emphasized, not neglected. Nearly daily fatty fish or fish oils should be a part of most people’s dietary habits.

Beyond the value of DHA and EPA is an even more important message though. The media, in their unbridled attempt to produce quick and enticing stories, often critically misses the mark. Consequently we all must be very careful about how we interpret what we read or hear. We must always be vigilant when drawing conclusions about our health as well as other consequential matters.

Learn more about preventive cardiology at www.preventivecardiologyinc.com.

For more information more about essential vitamins and supplements visit www.vitalremedymd.com.

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The Glory of Gum – A Smoker’s Tale

Recently, on a medical sojourn, I was met at the airport by a garrulous woman driver. She was a young-appearing fifty year old who as it turns out had recently sustained a TIA, or “mini-stroke.” Although my first thought was atrial fibrillation, she actually had developed a near occlusion of her left carotid artery. Her right carotid artery, she informed me, had a mere 40% stenosis. Our discussion continued and I gleaned that she had a very strong family history of early onset vascular disease, several close relatives even dying quite young from their events. So my next thought was Familial Hypercholesterolemia. But no, her LDL was apparently normal. Then she fessed up. She had been – and continued to be – a smoker. Just like everyone else in her family! Shocking.

To smoke cigarettes nowadays is something I simply cannot wrap my head around. Cancer, stroke, heart disease, lung disease, wrinkles… Tobacco is devoid of any redeeming quality. It’s just plain bad. So why would anyone smoke in the first place? But, once an individual has experienced a near death event that is a direct consequence of tobacco, how in the world could she continue to smoke. My 40-minute drive took on a mission. I was going to get her to quit. I asked about her children and even grandchildren. We spoke about loss of limbs, dependence upon an oxygen tank, facial cancers and their attendant disfigurement, another stroke – the next one of course placing her in a wheel chair, unable to speak or care for herself. Then she dropped me at my destination. She was to pick me up several hours later. Before stepping out of the car I told her with stern authority that a cigarette should never again cross her lips. Chew gum I said. Gain weight if you must, but please don’t ever come near another cigarette. (I must confess; my tone was intentionally severe and perhaps even paternal. The impact I hoped would justify my behavior.)

I went through my day, completed my tasks, and eagerly awaited her return. Upon her arrival she stepped from the car and proudly and loudly through a mouthful of gum intoned that she had done it. She quit smoking. I am not certain whether her resolution will last an hour or a lifetime. For that moment though she was no longer a smoker. A gum chewer yes, but not a smoker.

Learn more about preventive cardiology at www.preventivecardiologyinc.com.

For more information more about essential vitamins and supplements visit www.vitalremedymd.com.

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