CVRRUSA’s scientific and economical pathway to durable affordable real heart attack prevention with value

The vast majority of physicians when treating cardiovascular risk obtain the standard lipid panel and then treat according to the ACC/AHA guidelines with a Statin attempting to lower the LDL cholesterol by greater than 50% but not necessarily to a specific goal. They may or may not add a cholesterol absorption inhibitor, which is not endorsed by the FDA. The problem is that most cardiac patients happen to be have FCH Familial Combined Hyperlipidemia and despite a Statin almost all retain significant residual risk.

Most if not all patients are under the impression that with their medical insurance they are all paying and receiving heart attack prevention. Not true! Even with a Statin (only 1 in 4 events are  prevented). With advancing years, if one is lucky and survive an initial cardiac event, one is passed on to the US hospitals with its interventional cardiovascular disease or surgical re-vascularization procedures. It appears in the U.S, preventive cardiology forces exist along with interventional cardiology working hand-in-hand to extract as much money as the public and insurance companies can bear. Physicians like to have their patients affection, but they prefer the hospital to like them even more

With one’s first cardiovascular event, all is downhill. One’s body changes permanently both physically and psychologically and most never return to work and thereafter develop subsequent significant social problems. Loosing one’s employment or medical insurance is a formula for bankruptcy. In my opinion our present system has potential financial catastrophe for any US citizen.

Most people’s response would be a hopeless “what can you do?”. With regard to atherosclerosis and heart attacks, the answer is the approach of clients of CVRRUSA. As an illustration, a well-to-do 50-year-old with a family of 4 and without a history of symptomatic ASHD pays $2700/month for a high deductible medical insurance plan $5000/individual. He was under the care of a cardiologist because of hypercholesterolemia. Initially he had a LDL-C > 190 mg/dL with a vascular age by CAC score of a 78-year-old when he was in his 40s. He at least once, possessing doubts, had discontinued  the statin for about a year. He was inquisitive and became aware of LDL particle numbers. His physician and others physicians acquaintances were not very informative.

He expresses his vexation to a retired cardiologist, a classmate of mine at P&S, who states “I know a guy who can help you”. This individual contacted me and agreed to an evaluation and treatment, outside of his insurance coverage for which he would have been totally responsible anyway because of his high deductible. After receiving his previous records and his Advanced Lipid Blood tests, this individual despite being on high intensity statin Lipitor 40 mg/day still had significant residual risk. His LDL-C was 92 mg/dL around the 15th percentile and particle number of 1231 nmole /L, the 30th percentile, demonstrating a mild discordance. His HDL was 71 mg/dL From my observations for a primary prevention candidate most physicians really would not add or alter this drug regimen. They might point to his high HDL as being cardio protective. Do not buy that? HDL-C in this range is in reality is a risk factor either secondary to dysfunctional HDL or cholesterol hyper-absorption, possibly the results of Statin induced compensatory mechanisms or a genetic abnormality involving the NPC1L1 receptor. In fact individuals with hyper-absorption have a higher incidence of cardiovascular events.

Since cholesterol absorption parameters were included in his studies, it was determined that he was hyper absorbing cholesterol. Appropriate therapy was applied and his LDL-C dropped 37 mg/dL to 55 mg/dL, at least below the 2nd percentile and probably the 1st. His LDL-P  had decreased to 882 nmol/L, the 6th percentile. What percentage of physicians would have discovered his hyper absorption problem or instituted therapy?

Now these results are pretty decent and for 80% of similar patients would suffice. However, he also has one of my lipoprotein nemesis. 20%, 1 in 5 of similar individuals would have significantly elevated LPa (mine is elevated also) which is one of the reasons I still continue to be intensely interested in preventive cardiology. His significantly elevated LPa which in addition to his hyper-absorption is associated with significant residual risk.

What does one do for elevated LPa? Niaspan has been trashed or as one of my colleagues states “has been defamed”. This individual was offered an alternative (a PCSK9 inhibitor)  for which I was slightly tentative because of the cost $1000-$1500/Month(to be borne by him) and also the present cloudy PCSK9 indications picture. However, his Cleveland Clinic cardiologist was more authoritative stating that the expense of this additional medication was far less than the total cost of a heart attack. Fortunately this gentleman could afford it.

With the addition of PCSK9 inhibitor his total cholesterol decreased to 92 mg/dl, LDL-C to 19 mg/dl, LDL-P to 442 and his LPa decreased greater than 55% 209 nmol/L to 99 nmol/Lr

Let us analyze the economics, costs and value of this individual’s work up, treatment and medically indicated medications, which was more costly than usual because of his high deductible. He was self purchasing, generic Lipitor and costing $100 somewhere/Month. CVRRUSA could have and eventually did place him on brand Lipitor for $0.40 per day or $12 per month or an alternate high intensity brand Statin for about $0.25 day or $7.50/mo, easily saving over $100 per month. His local pharmacist was charging him $10 per pill for the medically necessary hyper-absorption inhibitor (CAI) which with CVRRUSA’s input is now costing $3 per pill, a $210 savings per month. This approximate $300 per month savings on medically necessary medicines for the first year was more than double the fee he paid for CVRRUSA’s services. He considered these prices a medical bargain but most importantly is assured maximum treatment with regard to his cardiovascular risk factors. CVRRUSA has identified all treatable cardiovascular risk factors and minimized his cardiovascular risk as much as possible considering what was available with today’s drug armamentarium. thus enabling the greatest benefit he could obtain. Hopefully, in the future the new and improved indications will be developed for PCSK9 inhibitors.

He has also been apprised of possible future medications targeting LPa. An ASO for LPa is in the offing with a probable huge price tag. Now remember elevated LPa is present in 20% 1 in 5 of the population and as opposed to FH which is most recently reputed to be 1 in 250. If  the ASO LPa had the same price tag or more than the PCSK9 inhibitor, it could only be maximum distributed as is the PCSK9 inhibitor through insurance coverage and at those prices the potential to bankrupt our present medical system exists.

His therapeutic goals were achieved within months which could have been sooner except that medications have to be added sequentially to obviate confusion. Compare months with CVRRUSA to attain superior goals as opposed years of incomplete treatment with a statin only and significant undetected residual risk.

A major disappointment was that it would have been advantageous for him to have contacted CVRRUSA 10 years earlier with earlier treatment probably greatly delaying progression of his ASHD for that time lapse. Unfortunately, delay in treating cardiovascular risk factors as well as other areas is inherent in our medical delivery system.

Most importantly with regard to the the overall lifetime economics (i.e.value), except for the( PCSK9 inhibitors), this medical regimen is for the vast majority of Americans affordable even without depending upon insurance drug plans and can be adhered to for years without financially draining or infringing upon other essential life necessities, provided other omni-present negative self-serving societal advertisements or input are resisted.

Surely with this approach for a compliant group, interventional procedures and their cost can be avoided with decreased lifetime medical costs. Hopefully his PCSK9 inhibitor and soon to appear Blockbuster priced ASO for LPa could become more reasonable and be brought into the medication Insurance fold. Do not hold your breath.

The take-home message: most of us can be optimally treated with years of affordable proven medications without reliance on insurance but we do not know where to look because we are bombarded with advertisements from multiple self-interest groups. CVRRUSA is an alternative that should be on everyone’s lips.

Real Combination Lipid Rx

During my medical training rather than consider a third year as a chief medical resident I elected to do a year of hematology-oncology. I thought hematology- oncology would expand my experience and better prepare me for a career in medicine and in retrospect I was correct. Those were the years chemotherapy for cancer and hematological disorders switched from single drug to combination therapy (MOPP COPP etc) with amazingly improved mortality. Thus I did not develop a mental set against expansion of combination therapy.

In the year 2000 with the availability of Advanced Lipid Testing and before the appearance of multiple medical organizational guidelines, which I find confusing and less then definitive, I treated the most common cause for heart attacks in my and any similar cardiology practice Familial Combined Hyperlipidemia (FCH) very aggressively with multiple medications directed at correction of undesirable biochemical abnormalities and lipoproteins by favorably altering gene expression

In February 2016 I attended a continuing medical education course. During the CME course, a case was presented which was an extreme incompletely treated case of FCH (Familial Combined Hyperlipidemia)or in my opinion the Metabolic Syndrome. My initial response was the treatment of this problem would be a piece of cake. This male patient on a statin had an LDL-C of 63 mg/dL(best 1-2 %) with an HDL of 32 mg/dL and a TG of 300 mg/dL. No other lipid parameters were obtained. Well, this case happened to be the prominent TV commentator Tim Russet and as you may know he met his demise shortly thereafter.

HIs untimely death caused an uproar which with time has been repressed and forgotten and little really learned, as are most untoward events. My FCH experience as documented by my websites includes innumerable successful treatments of severe metabolic syndromes e.g. My Metabolic Syndrome Journey.(A 50 minute presentation) because I have and continue to Incorporate the principles of combination (three or greater medications) therapy initiated by that one year of hematology-oncology

The organizer of the above CMR course mentioned that the news media was calling into question the LDL hypothesis and in my opinion was well they should.The attending faculty was then polled as well as the participants. Most of the faculty emphasized therapeutic lifestyle changes which I am sure the patient had been attempting for years and which would not have come close to correcting his metabolic abnormalities. Most of the course participants would have added to this patient’s single statin regimen, a single medication, the flavor of the month treatment at the present time, Omega-3 fatty acids, not my first choice. One panelist, a retired prominent researcher, amazingly dismissed both the AIM-HIGH trial and HP2-Thrive by recommending Niaspan.

I was stunned by the vacillation, variation and lack of assertiveness of the panel, except for the retired researcher. I was tempted to initiate a more in depth discussion but had second thoughts about possibly disrupting the meeting about a topic that would most certainly have exceeded the time allowed, but should have been discussed more in detail with greater audience input.

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Recently in preparation for a successful recertification examination in Clinical Lipidology I was required to become familiar with the many National and International Cardiovascular Guidelines and I must say if I did not rely upon my experience predating the large onslaught of consensus panel guidelines, I also would have similar thoughts like most individuals on that panel.

Contrary to the approach with Tim Russert i.e. a single Statin, we need to look at alternatives that WORK for each individual and not rely upon exceedingly variable guidelines from different National and International Consensus Groups who apply one- size-fits-all and now rely only upon Mega-Trials allowing a clear advantage to the big- money interests in medicine.

Just look around you, we are far from all biochemically and genetically similar. So, how can one-size-fits-all? Answer: it doesn’t