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“Low risk” nurse with normal cholesterol but self-destructive lifestyle ends up with heart transplant after CCTA

Posted by Colin Rose on December 20, 2010

Here in a nutshell is a demonstration of the problem with expecting technology to substitute for good clinical medicine and save us from our self-destructive addictions. If anyone is puzzled about the dichotomy between the exorbitant cost of the US medical system and its relative lack of effect on any measure of health here is the reason.

Below is a story from theheart.org followed by the actual paper in the Archives of Internal Medicine minus the references.

In the absence of any symptoms attributable to coronary artery disease there was no reason to do any more testing but the temptation to use high tech tools without good indication is irresistible to many doctors. CCTA is the latest expensive test to detect coronary atherosclerosis. Patients think that they will never have a heart attack and live longer if the disease is detected and some surgical procedure, like an angioplasty or bypass is done and doctors making $millions from doing them are not about to discourage them and point out the total lack of evidence for any significant benefit from angiography or the surgical procedures in patients with chronic coronary disease.

The authors have labelled this patient “low risk” because her “cholesterol” was normal but clearly she was at high risk based on her obesity and hypertension, both indices generally of  junk food addiction, in spite of her being a nurse.  When she started new exercises she probably got muscle pain from weight lifting. With an obvious self-destructive lifestyle, she should not have been “simply reassured” as recommended by the editors. But instead of encouraging her to make meaningful lifestyle change her doctors ordered tests with no clinical indication.

Framingham scores, lipid profiles and CRPs can be very deceptive because they do not assess LDL modification in the arterial wall, essential to the formation of atherosclerotic plaque. In spite of having “normal” numbers for all the usual “risk factors” she had advanced atherosclerosis in her coronary arteries. Apparently no dietary history was taken and no attempt was made to encourage her to change her lifestyle, an example of gross diagnostic and therapeutic incompetence, all too common in an era of absolute faith in the power of technology to protect us from our self-destructive addictions. Doctors abdicate professionalism by ordering tests instead of dealing with the real problems, like junk food addiction, which take much time for which they are not compensated and risk alienating patients who demand a high-tech fix or reassurance so that they can continue their risky behaviour.

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Case study shows how “just-in-case” CCTA in a low-risk patient may spectacularly backfire

DECEMBER 17, 2010 | Reed Miller

San Francisco, CA – Coronary computed tomographic angiography (CCTA) in patients with a low pretest risk of coronary disease wastes resources and can even lead to horrendous outcomes, a case study published December 13, 2010 in the Archives of Internal Medicine shows. The report tells the story of a 52-year-old white female who initially presented with chest pain and had a CCTA; this was followed by an unfortunate chain of events in which she suffered an aortic dissection during cardiac catheterization and that culminated in her having a heart transplant.

Part of its ongoing “Less is More” series begun last April, the latest case, reviewed by Dr Matthew Becker (St Vincent’s Heart and Vascular Institute, Erie, PA), Dr John Galla (Providence Hospital, Mobile, AL), and Dr Steven Nissen (Cleveland Clinic, OH), describes how the well-meaning attempt to reassure a patient with a low risk of coronary disease backfired spectacularly.

“Perhaps the most important point to be learned from the case described by Becker and colleagues is that there are safer ways to reassure patients,” say journal editors Drs Rita RedbergMitchell Katz, and Deborah Grady (University of California, San Francisco) in an accompanying editorial. “Patients value our advice. Talking with our patients should be our first choice for reassurance.” They add that “applying the ‘less-is-more’ principles prospectively could have avoided this unfortunate case.”

From diagnostic uncertainty to disaster
The 52-year-old nurse had hypertension and mild obesity and had recently begun an exercise and diet regimen to control her weight and blood pressure. She presented to her primary physician with chest pain, but no other symptoms: she had a normal ECG with a normal lipid profile and normal C-reactive-protein level. Her doctor attributed the chest pain to a musculoskeletal cause but performed a CCTA to reassure her that she was not at risk for a coronary event.

The CCTA showed discrete, noncalcified, nonobstructive plaque in the mid and distal segments of the left circumflex and dominant right coronary arteries and diffuse, complex calcification in the proximal left anterior descending (LAD) coronary artery. Because that calcification was difficult to quantify, the physician recommended that she undergo cardiac catheterization to get a clearer look at the LAD.

This exam, performed at the local community hospital, revealed only a mild irregularity in the LAD, but during the procedure, the patient complained of chest pressure, which prompted an aortogram that revealed an aortic root dissection that was compromising the left main coronary artery.

So the patient underwent urgent coronary artery bypass graft (CABG) surgery and stayed in the hospital for two weeks with a residual left ventricular ejection fraction of 35%. The bypass graft soon failed and was treated with multiple drug-eluting stents, but despite her compliance with dual antiplatelet medical therapy, a stent in the vein graft supplying the circumflex artery developed a thrombosis, causing an ST-segment-elevation MI complicated by cardiogenic shock. The thrombosis was successfully treated, but the patient remained in refractory cardiogenic shock and ultimately underwent orthotopic heart transplantation.

Unnecessary testing happening every day
“With few cardiac risk factors and an atypical chest pain presentation, this patient had a low pretest probability for coronary artery disease and should have been reassured and not undergone any further risk stratification,” say the authors. “Lacking randomized data suggesting improvement in clinical outcomes and with clear risks, including contrast load, radiation exposure, and suboptimal diagnostic specificity, CCTA should have a very limited role in the evaluation of patients who present with chest pain.”

They acknowledge the risk of complications associated with cardiac catheterization is low, but catastrophic events are always a possibility. They believe the physicians in this case overestimated the stenosis in this patient’s coronaries because they did not fully appreciate the CCTA’s potential for false-positive findings. Complete visualization of all segments of the coronary tree with CCTA is often hindered by cardiac motion, which can lead to the appearance of “blooming artifacts” of coronary calcification that may cause the observer to overestimate the extent of stenosis.

Becker et al point out that previous studies comparing CCTA with conventional coronary angiography in diverse patient populations show CCTA’s sensitivity is between 79% and 100% for the detection of obstructive coronary disease, but its specificity is only 64% to 85%, corresponding to “an unacceptably high false-positive rate” of up to 81% in some populations.

As reported by heartwire, the recently released professional guidelines on Appropriate Use Criteria for Cardiac Computed Tomography list CCTA as “inappropriate” for detection of CAD patients with a low risk of heart disease, ability to exercise, nonacute symptoms that may be an “ischemic equivalent,” and an interpretable ECG.

Patient could have been simply reassured
“If a test is not sufficiently accurate to change clinical management in a particular setting, it should not be done,” but according to Redberg et al, often these tests are done anyway—sometimes even before the patient sees a physician—because nobody has assessed the patient’s pretest probability of the disease or properly considered how the test result will change the clinical management of the patient.

“There are cases where [the test presents] more risks than benefits, and you really need to consider the risks and benefits and not [assume that] just because you can do the test, you should do the test. And this case highlights that,” Redberg told heartwire.

Cases like this where an inappropriate test leads to many complications and near catastrophe are rare, “but to have a CT or another test that was just done for reassurance, when you could have just told the patient ‘You’re fine,’—I think that’s done every day lots of times.

“You don’t know which [tests] are going to lead to that kind of problem, but you do know which of those is not going to give you any benefit, so if there is no benefit, it’s better not to be taking any risk, even a small one.”

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Left Main Trunk Coronary Artery Dissection as a Consequence of Inaccurate Coronary Computed Tomographic Angiography

Matthew C. Becker, MD; John M. Galla, MD; Steven E. Nissen, MD

Arch Intern Med. Published online December 13, 2010. doi:10.1001/archinternmed.2010.464

ABSTRACT


A 52-year-old woman presented to a community hospital with atypical chest pain. Her low-density lipoprotein cholesterol and high-sensitivity C-reactive protein levels were not elevated. She underwent cardiac computed tomography angiography, which showed both calcified and noncalcified coronary plaques in several locations. Her physicians subsequently performed coronary angiography, which was complicated by dissection of the left main coronary artery, requiring emergency coronary artery bypass graft surgery. Her subsequent clinical course was complicated, but eventually she required orthotropic heart transplantation for refractory heart failure. This case illustrates the hazards of the inappropriate use of cardiac computed tomography angiography in low-risk patients and emphasizes the need for restraint in applying this new technology to the evaluation of patients with atypical chest pain.

REPORT OF A CASE

A 52-year-old white female nurse with a medical history that was notable for hypertension and mild obesity presented to her local primary care physician with the recent onset of chest pain. Further investigation revealed that in an effort to lose weight and assist in the control of her hypertension, she had adopted a new diet and exercise program several weeks earlier. At her initial presentation, she described 48 hours of nonexertional, sharp chest pain that was aggravated by elevation of her right arm and deep inspiration. She denied associated symptoms of shortness of breath, nausea, vomiting, or diaphoresis, and her office electrocardiogram showed no abnormalities.Other than mild hypertension (blood pressure, 142/85 mm Hg), the results of her physical examination were unremarkable except that elevation of her right arm and palpation of the right chest wall reproduced the symptoms with which she presented. With a normal lipid profile and an ultrasensitive C-reactive protein level, she was diagnosed as having atypical chest pain most likely of musculoskeletal origin. Hydrochlorothiazide was used to treat her hypertension, and cardiac computed tomography angiography (CCTA) was performed to exclude the possibility of coronary artery stenosis and to reassure her. Interpretation of the CCTA findings suggested that both the left circumflex and the dominant right coronary arteries had discrete areas of mild, noncalcified, nonobstructive plaque in their mid and distal segments. The large-caliber left anterior descending coronary artery (LAD) was reported to have diffuse and complex calcification of the proximal segment, which made accurate quantification of the luminal stenosis challenging.

Subsequently, the patient’s physician recommended cardiac catheterization to enable more precise assessment of the LAD luminal stenosis. Selective coronary angiography was performed at the local community hospital and revealed only a mild luminal irregularity of the LAD. Shortly after the second injection of contrast, the patient complained of intense chest pressure and was noted to be hypotensive and tachycardic (blood pressure, 78/45 mm Hg; heart rate, 110/min). Mild “staining” of contrast was noted in the left coronary cusp of the aorta, and an ascending aortogram revealed a dissection of the aortic root extending into, and resulting in compromise of, the left main coronary artery. An intra-aortic balloon pump was placed, and the patient underwent urgent coronary arterybypass with saphenous vein grafting of both the LAD and the left circumflex coronary artery.

Following a prolonged, 14-day hospital course and a residual left ventricular ejection fraction of 35%, the patient was discharged home with intensive cardiac rehabilitation. Unfortunately, within 6 months of the bypass, she presented again with escalating chest pain and was noted have premature graft failure that was treated with percutaneous coronary intervention with multiple drug-eluting coronary stents. Despite her compliance with dual antiplatelet medical therapy (aspirin and clopidogrel daily), she presented 8 weeks later with an ST-segment elevation myocardial infarction complicated by cardiogenic shock. Emergent catheterization revealed thrombosis of the stent in the vein graft supplying the circumflex artery that was successfully treated with a catheter-based intervention. However, the patient remained in refractory cardiogenic shock and ultimately required urgent orthotopic heart transplantation.

COMMENT


Emergency department visits for chest pain syndromes represent a large and growing health care burden. Because patients with chest pain require urgent triage and timely management, there are great incentives for developing a new generation of novel, complementary diagnostic strategies. A recent addition to the diagnostic armamentarium, multidetector CCTA, can noninvasively generate reconstructed images of the coronary circulation. However, the brisk expansion and rapid adoption of CCTA over the past decade has outpaced supportive clinical data and has led to the referral of a much larger, and often lower-risk, segment of the population for coronary artery catheterization. We believe that in this case the unwarranted use of advanced diagnostic imaging (false-positive CCTA findings) directly contributed to unnecessary cardiac catheterization that resulted in a tragic complication and significant morbidity.Advanced diagnostic imaging technologies or the latest biomarker cannot, and should not, replace a thorough history and physical examination with subsequent decision making guided by the bestevidence-based practice. The need for testing in patients with chest pain is based on the clinician’s estimation of the pretest probability of coronary disease. In a patient with a low pretest probability (<10%) of having significant coronary disease, the preferred course is to reassure the individual and to focus the treatment plan on primary or secondary prevention strategies. Additional diagnostic testing rarely garners useful information and exposes the patient to unnecessary risk—both from the diagnostic test itself and from subsequent invasive testing because of false-positive results. While the risk of complications associated with cardiac catheterization is low, catastrophic events can occur. As opposed to CCTA, in appropriately selected patients coronary angiography allows the presence, location, and, most importantly, the functional significance (eg, fractional flow reserve, intravascular ultrasonography) of lesions to be determined. Because there is often discordance between luminal stenosis and the physiologic significance of lesions, functional testing has assumed critical importance in the assessment of patients with a moderate pretest probability (10%-90%) of coronary disease.

Therefore, given the possible adverse consequences of the overuse of diagnostic imaging in a broad and uncensored population of patients with chest pain, recent joint professional guidelines emphasize that ” . . . an appropriate imaging study is one in which the expected incremental information, combined with clinical judgment, exceeds the expected negative consequences by a sufficiently wide margin for a specific indication that the procedure is generally considered acceptable care and a reasonable approach for the indication. . . . “Furthermore, because of differences in body habitus, coronary physiology, exercise physiology, symptom presentation, and disease prevalence, the diagnostic accuracy of stress testing may be affected by the female sex. In addition to having a markedly different ST-segment response to exercise from a young age, data suggest that ST-segment depression tends to be less sensitive and specific for coronary artery disease in women. With normal electrocardiographic findings, negative cardiac biomarkers, and a classically atypical presentation, our patient had an age-specific risk level that was below average. She had a low pretest probability of coronary disease (<10% risk of myocardial infarction or death per 10 year interval), making further testing inappropriate and the chance of false-positive study results unacceptably high. However, in an era of rapid advancement in diagnostic imaging strategies, the savvy clinician must not forget the basic tenets of data-driven medicine, patient selection, and risk tolerance and ultimately realize when less may be more. Such is precisely the case with CCTA.

Because CCTA is rapid and noninvasive and has wide availability, it has increasingly been used to detect coronary atherosclerosis in a broad array of patient populations. However, the lack of randomized data suggesting clinical benefit, as well as technical and anatomical limitations, restricts its application in many patients. Studies comparing CCTA with conventional coronary angiography in diverse patient populations suggest that CCTA is highly sensitive (79%-100%) for the detection of obstructive coronary disease, with a positive predictive value ranging from 86% to 91%. However, these same studies report suboptimal specificity (64%-85%) and negative predictive values of 83% to 90% that correspond to an unacceptably high false-positive rate of up to 81% in selected subpopulations. Further limiting the diagnostic accuracy of CCTA is the fact that complete visualization of all segments of the coronary tree is hindered by cardiac motion (heart rate, >70/min), smaller vessel caliber (<2 mm), and tortuousity that may result in portions of a vessel moving in and out of an imaging plane. Furthermore, given its high attenuation coefficient, the presence of coronary calcification commonly produces a “blooming artifact” that makes accurate assessment of adjacent arterial luminal challenging and may result in overestimation of the degree of luminal stenosis, which is likely the case in the patient described herein. Therefore, CCTA often overestimates the presence and severity of coronary atherosclerosis to a degree that is dependent on the study population, the equipment used, and the experience of the interpreting physician, which may lead to unnecessary, higher-risk, and costly invasive procedures.

Nevertheless, the use of CCTA has increased dramatically over the past decade, with some estimates suggesting up to 26% per year. In an era in which comparative efficacy of therapies has assumed critical importance, the unchecked growth of CCTA seems not only unfounded but also irresponsible and unsustainable. Aside from its cost implications, CCTA also exposes the patient to substantial amounts of ionizing radiation. It is estimated that the collective dose received from medical radiation increased by more than 700% between 1980 and 2006, with increases in computed tomography accounting for more than 50%. Furthermore, 64-slice CCTA (without tube current modulation) exposes the patient to an average effective dose of 15 mSv of radiation compared with only 7 mSv for diagnostic coronary angiography. With recent data suggesting that 1.5% to 2.0% of all reported cancers in the United States may be linked to ionizing radiation from computed tomography, there is reason for pause.

In conclusion, our patient suffered a rare but devastating complication from an cardiac catheterization that was the direct result of unnecessary CCTA and false-positive findings. With few cardiac risk factors and an atypical chest pain presentation, this patient had a low pretest probability for coronary artery disease and should have been reassured and not undergone any further risk stratification. Lacking randomized data suggesting improvement in clinical outcomes and with clear risks including contrast load, radiation exposure, and suboptimal diagnostic specificity, CCTA should have a very limited role in the evaluation of patients who present with chest pain.

Posted in atherosclerosis, cardiology, CCTA, cholesterol, coronary artery disease, coronary computed tomographic angiography, diet, ethics, heart transplant, junk food, lifestyle, obesity, professionalism, surgery, technology, waist circumference | 1 Comment »

CHUM hires a new director

Posted by Colin Rose on October 8, 2009

Paire’s waist circumference looks at least 45 inches. Abdominal obesity is a preventable disease resulting from junk food addiction that increases the chances of many other diseases such as Type 2 diabetes. Another example of how the “health care” system is showing you how to care for your health.


CHUM hires a new director
AARON DERFEL GAZETTE HEALTH REPORTER
The Gazette
08 Oct 2009

Hoping to turn the page on years of internal strife, the Centre hospitalier de l’université de Montréal has recruited a top hospital administrator from France to serve as its executive director. But yesterday, in his first appearance before the…read more…

Posted in junk food, obesity, professionalism, waist circumference | Tagged: , , | Leave a Comment »

Keeping the crescent fat

Posted by Colin Rose on February 5, 2009

By stripping down during the Big Jump one source of the water shortage problem is revealed. For a “region in virtual lockdown”  these guys are managing to stay plump. Here is something “practical” and “bottomup” they could do. If those obese mayors and their fellow citizens ate less they would need a lot less water for their gardens, animals, cooking etc. Why should precious water be wasted generating excess human fat?

jordanriver-mayors-obesity


Keeping the crescent fertile
VANESSA FARQUHARSON
National Post
05 Feb 2009

Water doesn’t recognize borders. The Jordan River in the Middle East, for example, runs freely without a passport all the way from the Golan Heights down to the Dead Sea, flowing through Israel, Jordan and Palestine. Despite the river’s inherent…read more…

 

 

 

 

 

Posted in obesity, waist circumference, water | Tagged: , , , | Leave a Comment »

The Atherogenic Football Diet

Posted by Colin Rose on February 1, 2009

Who are the coaches and “nutritionists” that advise football players to eat atherogenic, obesogenic , diabetogenic, hypertensogenic diets just so they can trample the opposing team? They should be banned from the game.
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By Madison Park
CNN

(CNN) — Football players guzzle protein shakes, down steaks and lift weights. They train and gain weight, hoping to build mass under the careful eye of the team’s coaches, nutritionists and gurus.

“It was a scripted lifestyle where they tell you how to eat, how to take care of yourself, how much body fat you should have,” said Chuck Smith, a former defensive end for the Atlanta Falcons and the Carolina Panthers.

But once their glory days are over, they have the same problem as millions of other Americans: They’re fat.

footballobesity

Football Team

“When I trained, they told us to eat all you can eat,” said Smith, who played in Super Bowl XXXIII with the Falcons. “Drink beer, eat peanut butter to gain weight. All those eating habits were great for football. But when I got done, no question I had to make adjustments.”

Without scheduled practices, meals, and games on Sunday, it became tougher to keep in shape.

When players were younger, they had the opposite problem.

Many tried to gain weight, believing that bigger is better. But as they age and retire from football, many are seeing that “big” is causing problems.

Smith, who weighed 274 pounds during his professional days, often had four plates of food in one sitting “to keep my weight up.” After retirement, Smith had to unlearn those habits.

“I had to retrain my thinking,” he said. “I don’t need to be full. I don’t have to stuff myself to feel comfortable. That took a long time. You stuff yourself to gain weight, then you get out of shape.”

Smith learned he had high cholesterol (he had to take Lipitor), and his blood pressure was climbing, too.

“I had to take the bon-bons out of my mouth,” said Smith, 39. “I had to empower myself. Strength coaches, nutritionists aren’t going to take care of me. Guys have to empower themselves to take care of themselves.”

Smith is now a fitness trainer at Defensive Line Incorporated, where he works with football players. Through healthy foods and workouts, he trimmed his body fat, lowered his cholesterol and shed 50 pounds.

Some players understand the risks, said Dr. Archie Roberts, a former National Football League quarterback and retired cardiac surgeon.

“They understand that if they stay 250, 300, 350 pounds as they age, that’s going to shorten their life span and cause them more health problems,” he said. “Others don’t get it and they’re unable — for whatever reason — to lose the weight, and they will suffer the consequences, just like anybody else in the general population carrying too much weight.”

Diabetes, hypertension and high cholesterol are all cardiovascular risks associated with obesity.

Roberts heads the Living Heart Foundation, a nonprofit promoting health for former football players. For five years, he has conducted research to determine whether former football players are at added risk for heart problems (they’re not).

After left tackle Bob Whitfield retired from the New York Giants in 2007, he gained 20 pounds. The 37-year-old Pro-Bowler is trying to lose 40 pounds, which would bring him to 290 pounds, the lowest he has weighed since ninth grade.

“You don’t want to be the person at the buffet and people look at you crazy,” Whitfield said. “Overall, you want to have a healthier lifestyle. It doesn’t mean you want to be muscled up. … I don’t want to be the biggest man in the room anymore.”

Looking back at his career, Whitfield doesn’t think his size made him a better player.

“When that mass gets too heavy, you decline, you can’t accelerate, you don’t have as much force,” he said. “I never felt that being bigger gives you a competitive advantage. I put it on flexibility, the explosive nature of your movements.”

Several decades ago, 300-pound players were a rarity; now, the league has more than 500, Roberts said.

Decades ago, the Washington Redskins’ offensive line was known for its size and dominance.

“They had the largest line in the NFL, called the Hogs, 20 years ago,” said Dr. Ben Levine, director of the Institute for Exercise and Environmental Medicine at Texas Health Presbyterian Hospital in Dallas, and professor of medicine. “If you go back and look at their size, they’re about the size of the running backs today. The impression was these guys were massive, huge. They couldn’t play in the NFL today. They’re too small.”

Smith said he wasn’t forced to gain weight, but perceptions exist on how a player should look based on his position. That “needs to change in the NFL,” he said.

Being faster, stronger and more aggressive is more important than size, Smith said. He drew an analogy to airline stewardesses: “We want her to be tall and slim so she can walk down the aisles. Now is there really a difference between a 135-pound woman and a 150? Well, maybe a little bit different in the hips, but the same effectiveness happens when she does her job.”

He added, “I’m a classic example that size doesn’t matter.”

But that’s not what young, aspiring players think.

Jackie Buell, director of sports nutrition at Ohio State University, said she encounters players who seek to gain as much as 30 pounds by next season and seldom care whether it’s fat or muscle.

Buell’s research examined 70 college linemen and found that nearly half have metabolic syndrome, meaning that the players have at least three of the five risk factors of developing diabetes and heart disease. Her next project is to explore whether junior high and high school football players are developing metabolic syndrome.

“My fear is, these young men have this metabolic profile, what happens when they stop working out intensively?” Buell said. 

Posted in atherosclerosis, athlete, cholesterol, diabetes, Type 2, diet, drugs, football, junk food, lifestyle, obesity, statins, waist circumference | Tagged: , , , | Leave a Comment »

JUPITER is a gas giant

Posted by Colin Rose on November 21, 2008

An excellent article by André Picard in today’s Globe and Mail, the only story on JUPITER I have seen in the lay press that reveals the massive fraud behind the reporting of this “study”.

JUPITER is aptly named. It’s gigantic. Probably the largest, most expensive drug trial in history. When one looks below the surface of the publication in the NEJM, the results are about as exciting as the Jovian composition. A lot of gas. I would conservatively estimate that this “study” cost at least $500 million. But if you are AstraZeneca and stand to sell $many billions worth of Crestor because of this paper that’s small change. And junk food addicts, who comprise most of the subjects of JUPITER have one more excuse, however deceptive, to continue their self-destructive habits.

Here is my opinion posted in the NEJM blog on the paper.

nyt-jupiter-unethical

A more detailed analysis of the marketing driven deception and lack of professionalism in the paper by Sandy Szwarc.

Another perspective by John McDougall similar to mine on the big lie behind the claim that many “healthy” people need Crestor..

When all of these criticisms are considered it turns out that JUPITER is nothing more than a thinly disguised  infomercial for Crestor and should never have been published in a presumably high quality journal like the NEJM. But in being able to make this paper freely available on the web (and not wait 6 months like other papers) the NEJM must have received a large payment from AstraZeneca.

Non-blinded statin trials like JUPITER, have the potential for bias in subjective outcomes like the decision to do an angioplasty or coronary bypass, outcomes that constitute the vast majority of the combined endpoint. Also, it is quite likely that when the JUPITER subjects knew that their blood LDL was low because they were taking Crestor they had less incentive to change self-destructive lifestyles. That is probably why the group treated with Crestor had significantly more diabetes. In light of the JUPITER trial the Therapeutics Initiatives group at the University of British Columbia has updated their recommendations for use of statins in primary prevention, which would include people like those entered into the JUPITER trial, and concluded that “statins do not have a proven net health benefit in primary prevention populations and thus when used in that setting do not represent good use of scarce health care resources.

See a slide show on JUPITER and “dyslipidemia”.

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Lead “investigators” of JUPITER

Paul M Ridker, M.D., Eleanor Danielson, M.I.A., Francisco A.H. Fonseca, M.D., Jacques Genest, M.D., Antonio M. Gotto, Jr., M.D., John J.P. Kastelein, M.D., Wolfgang Koenig, M.D., Peter Libby, M.D., Alberto J. Lorenzatti, M.D., Jean G. MacFadyen, B.A., Børge G. Nordestgaard, M.D., James Shepherd, M.D., James T. Willerson, M.D., Robert J. Glynn, Sc.D., for the JUPITER Study Group

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Dominican Republic

What typical JUPITER subjects would look like. These are "apparently healthy" people? Is it not unethical to prescribe drugs to these people to "treat" the symptoms of their self-destructive lifestyles?

Nowhere in the JUPITER paper will you see it mentioned that CRP can be markedly reduced with cost-free lifestyle change alone, no statins, as shown in this paper in the Journal of Applied Physiology in 2006, results of which are summarized below. The subjects in the JAP paper were just the same as in the JUPITER study, obese people, many with metabolic syndrome but the authors did not call them “apparently healthy”. They had nothing to sell.

jap-diet-crp

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When it comes to statins, don’t believe the hype

November 20, 2008
The Globe and Mail
André Picard”Cholesterol drug causes risk of heart attack to plummet” – Fox News.

“Cholesterol-fighting drugs show wider benefit” – The New York Times.

“Cholesterol drug cuts heart risk in healthy patients” – The Wall Street Journal.

The New York Times article summarized the exciting news in a front-page story saying that “millions more people could benefit from taking the cholesterol-lowering drugs known as statins.”

That’s big medical/business news, because statins are already the bestselling drugs in the world, with sales in excess of $20-billion (U.S.).

Quoting some of the world’s top heart researchers, media reports touted the importance of a blood test for C-reactive protein. That’s because those benefiting from statins had high levels of CRP (a marker for inflammation) rather than high levels of LDL cholesterol, which is usually the criterion for statin prescription.

The news stories were based on research published last week in the prestigious New England Journal of Medicine and presented, with much fanfare, at the annual convention of the American Heart Association.

Like much reporting on medical research (and drug research in particular), however, there is more (or, more accurately, less) to these stories than meets the eye.

The principal finding in this study was that participants who took a statin pill recorded a 50-per-cent reduction in the risk of heart attack, stroke, surgery and death compared with those who took a placebo (a sugar pill).

Who wouldn’t be wowed by those numbers? Who wouldn’t want that miracle drug?

But the benefits are relative risk reductions.

When you look at the raw data in the study, they reveal that 0.9 per cent of statin users had cardiovascular problems. By comparison, 1.8 per cent of those taking a placebo had heart problems.

There were 17,802 participants in the study, yet there were only 83 cardiac events among statin users, compared with 157 in the placebo group. That’s 50 per cent fewer.

Are those really “dramatic” findings? Do statins really make heart attack risk “plummet”?

According to a cautionary editorial in the New England Journal of Medicine (which received virtually no mention in news reports), 120 people in this study needed to be treated with a statin for two years to see a benefit in one person.

That’s a lot of people taking a pricey drug ($3 Canadian a day) for no benefit – not to mention that there are risks.

While researchers (and journalists who report on studies) love to highlight benefits of drugs, they too often gloss over risks.

Like all drugs, statins have side effects. The drug used in the study, rosuvastatin (brand name Crestor), has been associated with muscle deterioration and kidney problems.

In the study, those taking statins had a higher risk of developing Type 2 diabetes – 3 per cent compared with 2.4 per cent of those taking a placebo. That’s a 25 per cent higher relative risk among people with very little heart disease to begin with.

As noted earlier, researchers (and news stories) suggested that, based on the findings, the number of patients taking statins could and should expand dramatically.

But is that really what the research tells us, even in its most optimistic interpretation?

The study involved exclusively men older than 50 and women older than 60 who did not have high cholesterol or histories of heart disease or inflammatory illness. All the people in the study needed to have low cholesterol and high CRP.

Initially, researchers recruited 90,000 people in those age groups, but more than 80 per cent of them were deemed ineligible. This is a very select population.

To say, by extrapolation, that these “dramatic” (read: modest) benefits apply to the general population is erroneous.

Similarly, while it is true that about half of all heart attacks and strokes occur in people whose cholesterol is not considered high, does that mean everyone should get a blood test to measure levels of C-reactive protein? Hardly.

Yes, there is more heart disease among people with high levels of CRP, but the jury is still out on what this means.

Some scientists believe that because CRP – secreted in response to inflammation – is present in plaque, it increases the risk that the plaque will burst, leading to blood clots that cause heart attacks. But other researchers think that CRP levels are, at best, a telltale sign of heart disease, a bit like grey hairs are a sign of aging – not its cause.

The CRP test is expensive at almost $50. And it’s worth noting that one of the principal authors of the new research holds the patent on the test and makes money every time it is used.

When you cut through all the hype and the self-interest, what we know is this: Statins reduce levels of [LDL] cholesterol. This is beneficial to people who have had a heart attack or other serious heart problems.

But for otherwise healthy people, high CRP levels or not, the potential benefits of taking statins are marginal, and the risks are not insignificant.

Hardly the stuff of dramatic newspaper headlines.

Posted in atherosclerosis, cardiology, cholesterol, coronary artery disease, death, diabetes, diabetes, Type 2, drugs, junk food, obesity, professionalism, statins, waist circumference | Tagged: , , , , , , , , , , , , , , , , , , | 2 Comments »

Large Waists Kill

Posted by Colin Rose on November 19, 2008

Visceral ectopic fat is a major risk factor for many chronic diseases and death. Everyone should have a waist circumference at the level of the umbilicus less than half their heights. If everyone did so, we could cut the cost of our “health care” systems by at least 50% in a very short time.

http://content.nejm.org/cgi/content/full/359/20/2105

nejm-epic-waist-abs

nejm-epic-waistcircumference2

Relative risk of death increases by a factor or four from lowest to highest values in this population.

 

Multiple beneficial results of losing visceral fat

 

 

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Obesity weighs heavy on heart

Posted by Colin Rose on September 22, 2008

Bottom line: obese people have heart attacks at least ten years sooner and have much more diabetes than thin people, regardless of their blood cholesterol. So all those who say fat is OK as long as you are happy are wrong. And all those drug dealers say you are OK as long as you take a statin to lower your “bad” cholesterol are selling you a very expensive mirage.


Obesity weighs heavy on heart: study
SHARON KIRKEY CANWEST NEWS SERVICE
The Gazette
22 Sep 2008

Heart attacks are hitting the overweight more than a decade sooner than ?normal? weight people, researchers are reporting. A study of more than 111,000 people is one of the first to put real numbers to the risk of obesity and suggests ?excess…read more…

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