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Published online 10 November 2008 | Nature | doi:10.1038/news.2008.1218
News: Briefing
Should healthy people take statins too?
Rosuvastatin appears to lower the risk of heart disease in healthy people.
The results of a study examining whether a potent cholesterol-lowering drug decreases the risk of heart disease are out1. Rosuvastatin was given to 17,802 seemingly healthy people, and their chance of developing heart problems plummeted.
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Can Nature find a more meaningful or pratical topics to talk about??
Well, I think this is relevant to a lot of people. Here in Europe, statins are ingredients of (somewhat expensive) margarines which are advertised with respect to their cholesterol-lowering properties. So we have something like a big - and probably not really supervised - field trial going on, as there are a lot of people consuming this product. I have heard that in the Netherlands, health insurance companies even rebate the extra cost of this alimentary supplement for the insurance holders. They must be very convinced of its positive effects.
I think this is a landmark study - but I'm surprised that the author missed a key problem with the study, or at least the way it is presented: These are not 'healthy' patients. 40% had metabolic syndrome at baseline; the average BMI was 28-29%. 11% were smokers. Althought the study author stated that the benefit was seen across patient subgroups, its still important to note that these are not, on average, patients that we would consider 'healthy'. That having been said, this is an important result and speaks less to the issue of whether CRP is important, and more to the issue of whether our standards for 'normal' cholesterol are far too high.
This brings up the interesting question of what constitutes normal or healthy. Individuals who are overweight or smoke or have high cholesterol or high C-reactive protein levels may all be relatively healthy, even though these behaviors or conditions may be predictive of eventual heart related problems. The individuals in the study all had high C-reactive protein levels, an indication of underlying inflammation. It has been suspected for at least the last several years that this is the real cause of heart problems, only exacerbated by high cholesterol. It is fortuitous that statins deal with both problems, but maybe the real question to address is what is causing the underlying inflammation?
Ralph Feltens is making a serious mistake. There is no margarine with statins on the market, but margarines containing plant stanols or plant sterols. The dutch product he is referring to, contains plant sterols, mainly sitosterol. The plant sterols reduce absorption of cholesterol from the intestine, hereby reducing LDL-cholesterol. It has nothing, what so ever to do with statins. It is unfortunate to spread this kind of severe misunderstandings/ignorance via Natures web-site. Regarding the referred study, the important point is whether it is correct to term people with increased C-reactive protein levels as healthy. A just as valid interpretation of the result, is that the "classical" cardiovascular risk markers are insufficient, and that the inflammatory risk markers are as important (which also is supported by the literature, for example Ridker et al. (2002) New England J. Medicine 347:1557).
Isn't CRP a risk factor which does not depend on elevated cholesterol? Low CRP levels appears to be associated with low risk, despite high levels of cholesterol. Why not low-dose aspirin with modified diets and exercise? This triad is equally effective and safer alternative to chronically administered statins. And finally is cholesterol-lowering really the right target? Should we not be paying more attention to the growing evidence that 'small dense, oxidized LDL' -- enriched with oxysterol or auto-oxidized cholesterols -- the inflammatory trigger introduced by the consumption of highly processed foods?
There is a fundamental bias in such as research,althoug it has been published in NEJM, which corroborates my definition Middle Ages of today's Medicine (See : http://blogs.nature.com/ Top cited papers. Diet and Risk of Type 2 Diabetes Paper Author: Sergio Stagnaro et al. Paper Posts: Linked to by 1 post AND http://blogs.nature.com/posts?paper=669 A tribute to Dr. Sergio Stagnaro, - consider yourself warned? Date: 05 Nov 2008 Blog: The Sciphu Weblog ; http://sciphu.com/2008/11/middle-ages-of-todays-medicine.html). In fact, this article reveals that biophysical-semeiotic constitutions and related inherited real risk are overlooked, unfortunately (www.semeioticabiofisica.it). As far as CAD is concerned, notoriously coronary inherited real risk, as well as sub-clinical, and consequently very dangerous, coronary heart disease is very prevalent among populations, independently associated with actually known risk of CAD , and substantially increases the risk (presence of newborn-pathological, type I, subtype b) aspecific, Endoarterial Blocking Devices in coronary small arteries, according to Hammersen), among patients with hypertension or diabetes mellitus. In following, I suggest an useful, reliable and easy clinical manoeuvre, I have been suggesting for years,that allows doctor to bedside recognize both CAD Inherited Real Risk and silent CAD (2-4). This manoeuvre proved to be really useful in my 52-year-long clinical experience, also in order to the bed-side recognizing heart ischaemic disease before cardiac pathology occurs. Moreover, it is well known that patients with coronary artery disease (CAD) may have no symptoms at all for many years or decades and that the electrocardiographic features of ischaemia may be induced by exercise without accompaning angina (2). (For further information: See web site http://www.semeioticabiofisica.it, Practical Applications). In other words, we need a clinical tool reliable in rapid detecting CAD, even clinically silent, initiating from CAD ?inherited real risk?, doctor can now utilize in his day-to-day practice (2). I think surely that one method is "Myocardial Ischaemic Biophysical- Semeiotic Preconditioning", described elsewhere(2-4). From the tehnical viewpoint, doctor has to know, at least, the auscultatory percussion of the stomach, described even in old acàdemic books of two last centuries (Rasario IX edition). Briefly, in health, digital pressure of mean intensity, applied upon heart cutaneous projection area, brings about the so-called gastric aspecific reflex (= in the stomach, fundus and body are dilated; on the contrary, antral-pyloric region contracts) after an age-dependent latency time of 8 sec., that lasts less than 4 sec. (= parameter value of paramount significance since it parallels the efficacy of coronary microvessel Microcirculatory Funcional Reserve). A second, successive evaluation after an interval of 5 sec. exactly, provokes the identical reflex, but after lt. of 12 sec. or more: physiological myocardial preconditioning, typeI. On the contrary, in patients involved by CAD, even silent, i.e. subclinical,latency time persists identical in both evaluations, or results clearly lower in the second one, in relation with disease seriousness: type II and respectively type III preconditioning. Of course, biophysical semeiotic preconditioning evaluation, really more complex than it appears in the above brief description, can be applied to all others biological systems, with favourable influences on primary prevention and diagnosis (2-8). Finally, since November 2007, thanks to Quantum Biophysical Semeiotics, based on non local Realm, I demonstrated for the first time, besides the local realm, in biological systems (9-12), in only one second physicians can recognize clinically healthy heart, excluding CAD Congenital Real Risk, even in individuals kilometres away (13-15). References 1) Stagnaro Sergio. New bedside way in Reducing mortality in diabetic men and women. Ann. Int. Med.2007. http://www.annals.org/cgi/eletters/0000605-200708070-00167v1 2)Stagnaro-Neri M., Stagnaro S. Introduzione alla Semeiotica Biofisica. Il Terreno Oncologico. Ed. Travel Factory, Roma, 2004. http://www.travelfactory.it/ semeiotica_biofisica.htm 1) Stagnaro S., Stagnaro-Neri M., Le Costituzioni Semeiotico-Biofisiche.Strumento clinico fondamentale per la prevenzione primaria e la definizione della Single Patient Based Medicine. Travel Factory, Roma, 2004. 4)Stagnaro S. Epidemiological evidence for the non-random clustering of the components of the metabolic syndrome: multicentre study of the Mediterranean Group for the Study of Diabetes. Eur J Clin Nutr. 2007 Feb 7; [Medline] 5) Stagnaro S. Newborn-pathological Endoarteriolar Blocking Devices in Diabetic and Dislipidaemic Constitution and Diabetes Primary Prevention. The Lancet. March 06 2007. http://www.thelancet.com/journals/lancet/article/PIIS0140673607603316/comments?totalcomments=1 6)Stagnaro-Neri M., Stagnaro S., Deterministic Chaos, Preconditioning and Myocardial Oxygenation evaluated clinically with the aid of Biophysical Semeiotics in the Diagnosis of ischaemic Heart Disease even silent. Acta Med. Medit. 13, 109, 1997. 7) Stagnaro Sergio. Biophysical-Semeiotic Bed-Side Detecting CAD, even silent, and Coronary Calcification. 4to Congreso International de Cardiologia por Internet, 2005, http://www.fac.org.ar/ccvc/marcoesp/marcos.php. 8) Stagnaro Sergio. Role of Coronary Endoarterial Blocking Devices in Myocardial Preconditioning - c007i. Lecture, V Virtual International Congress of Cardiology. http://www.fac.org.ar/qcvc/llave/c007i/stagnaros.php 9) Stagnaro Sergio e Paolo Manzelli. Limiti della Medicina Ufficiale. L?Esperimento di Lory www.ilpungolo.com, 03 Gennaio 2008, http://www.ilpungolo.com/leggi-tutto.asp?IDS=13&NWS=NWS5267 10) Stagnaro Sergio e Paolo Manzelli. L?Esperimento di Lory. Scienza e Conoscenza, N° 23, 13 Marzo 2008. http://www.scienzaeconoscenza.it//articolo.php?id=17775 11) Stagnaro Sergio. Il test Semeiotico-Biofisico della Osteocalcina nella prevenzione primaria del diabete mellito. www.fce.it Febbraio 2008. http://www.fcenews.it/index.php?option=com_content&task=view&id=909&Itemid=47 12) Stagnaro Sergio. La Diagnosi Clinica nella Semeiotica Biofisica Quantistica. www.fce.it 02-05-2008, http://www.fcenews.it/index.php?option=com_content&task=view&id=1285&Itemid=47 13) Stagnaro Sergio. Role of NON-LOCAL Realm in Primary Prevention with Quantum Biophysical Semeiotics. www.nature.com, 01 Feb, 2008-05-17 http://www.nature.com/news/2008/080130/full/451511a.html 14) Stagnaro Sergio. Diagnosi clinica di cuore sano in un secondo! 7 Aprile 2008. www.fce.it http://www.fcenews.it/index.php?option=com_content&task=view&id=1218&Itemid=4715) 15) Stagnaro Sergio. Semiotica Biofisica Quantistica: Diagnosi di Cuore sano in un Secondo in paziente distante 200 KM! www.fce.it, 07-05-2008 http://www.fcenews.it/index.php?option=com_content&task=view&id=1316&Itemid=47 16) Stagnaro Sergio. Bedside Evaluation of CAD Biophysical-Semeiotic Inherited Real Risk under NIR-LED treatment. EMLA Congress, Laser Helsinki August 23-24, 2008. "Photodiagnosis and photodynamic therapy", Elsevier, Vol. 5 suppl.1 August 2008 issn, pag s-17. Abstract also in www.melatonina.it, URL http://www.melatonina.es/articulos/55-2008-09-01.html
Before the discovery of statin people with diabetes, ischaemic heart disease, hypertension and obesity survived by changing their life style, taking aspirin and selective betablockers and also reducing free salt intake. If one smokes, does do regular aerobic exercise, eat fatty food and indulge in sedentary life style and or gets stress in life, who else would suffer from ischaemic heart disease? How could we forget the 4S study and the implication of cholesterol lowering? What about should we not remember regarding non-fatal myocardial infarction and statin use? Cholesterol is an important part of the biomolecular amunitions of cells. Ischaemic heart disease or coronary artery disease is an inflammatory disease. The panacea hormone insulin and the evolution of its resistance is involved in the pathogenesis of AIHD or CAD. That is why there is high prevalence of CAD in diabetics and fatality is more in Type 1 as there is almost absolute lack of insulin. What is about the role of kidney in cardiac health? Who could explain the prevalence of CAD in chronic renal failure? It is a fact that we are reviving the 'Middle Age' in the practice of medicine. We are somehow loosing our ethics and sanctity to our greed for money and luxurious life style which could be provided to us by the pharmaceuticals. Many a Harvard Brahmins would be purchased by this manoeuvres but ultimately good sense would prevail and we would revert back to good life style, less animal protein, more exercise and possibly a very low aspirin intake fortified by regular meditation. Udayan Ray-The University of Tasmania, AUSTRALIA.
"Nature News gets to the heart of the matter." Except that it doesn't. What you actually offer is little more than an extended advert for a seriously flawed trial. "those taking the drug rosuvastatin rather than the placebo were 44% less likely to have a major heart attack or heart-related illness and 21% less likely to die from heart disease." But this is just the relative risk! The difference in absolute risk between the statin group and the control group was considerably less impressive. And if you just consider heart attacks alone, and not the rather ambiguous "heart-related illness", then the difference is negligible. "This rosuvastatin study was stopped early ? after just two years ? because the results were already clear." And by doing so, of course, there is no danger of having to report any side effects that manifest only AFTER two years of use. "The two big statin worries ? myopathy (muscle weakness) and cancer ? weren't a problem in this trial." Well of course not. If you carried out a two year trial into cigarette smoking you'd find precious little to worry about, but carry the trial on for another 20 or 30 years and then see what you find. A point which cannot be made strongly enough is that stopping a major trial halfway through - whatever the results - is extremely ill-advised, and highly suspicious given the potential profits now to be reaped from the pharmaceutical company involved. I recommend to everyone Sandy Szwarc's devastating report on her Junkfood Science weblog: that really does get "to the heart of the matter." Do not be mislead by the naive media stories that have championed this study - the truth is far less impressive.
I totally agree with Mathew Iredale!
A study of closely-selected group of people, funded by the pharmaceutical manufacturer who markets the substance which is found to have magical life-extending properties, being run by the patent holder of the simple (but money generating) test, which identifies the healthy humans... who evidently SHOULD be taking statins, if the relative risk of a heart attack is to be reduced. What do we have here? Another advertisement for a statin, rather than any kind of reliable clinical research that actually merits the name, 'scientific research'. ############################################ The earth-shattering news that humans are at risk, if they don't imbibe large numbers of expensive pharmaceuticals is the take-home message which is being pushed onto an unsuspecting public once again. The rapacious drug dealers are evidently determined that every person should take a healthy handful of drugs - their drugs. ############################################ Penalties for peddling drugs are (rightly) very high. How can it be that our legislation does not extend to the pharmaceutical industry? They don't get penalised for the mass peddling of drugs with which they aim to have people get addicted. Creating false anxieties in lay people and blinding clinicians with money, equipment and research grants. The proper business, in this case, is that old story of making money and that endpoint is not especially laudable, particularly when selling the story... 'we can help you to live forever'. Vendors have only one single-minded purpose and that is to sell their products. This is more advertising dressed up to look like the nice drug company (AstraZeneca) wants you to live longer. ############################################ Manufacturing pharmaceuticals should not be dignified with the term, 'industry' because the drug companies and their shareholders, have no interest in whether we live or die. The ideal position is to keep us all just on the verge of being healthy so that we continue to need the drugs. In this respect statins are a big win. We need to take them for life to derive the supposed benefits. ############################################This particular drug trial did not just end early... which is not a good clinical trial if one wanted the date to try to determine the longer term benefits. Can it be that the trial was stopped before the real 'benefits' had made themselves known? An independent data safety monitoring board was involved with the cessation of this trial. It parallels the cessation of the atorvastatin/torcetrapib trial being run by Pfizer, which was halted on December 3rd 2006. ############################################ http://www.fda.gov/bbs/topics/news/2006/new01514.html ############################################ It is entirely unethical that the vendor of a product, should be permitted to fund clinical research into the products they are peddling. It ought to be the case that the subject matter of clinical research is determined by clinicians who see a real and definite clinical rationale, rather than another means of climbing aboard the statin gravy train. ############################################ Any research worker who has ANY kind of pecuniary stake, in the outcome of clinical research, should automatically be disbarred from discussing their 'findings' in clinical journals and gaining peer-reviewed acceptance, through publication, citings and the legitimacy that devolves from publication of this nonsense in journals that purport to further clinical science. ############################################ The medical profession have been slow to stamp out this nonsense of 'sponsored clinical research' and as a result, half of the populations of the developed world believe that they will die, unless they have statins sloshing about in their blood. The clinicians, who are the only means of protecting the lay person, are too busy filling their own needs (as portrayed by the NEJM) to raise a collective voice in protest, at precisely the sleight of hand used in this so-called study, and the public are now facing enforced medication throughout the developed world. ############################################ THIS MADNESS HAS TO STOP! ############################################ Thoughtful evaluation of this ersatz research is to be found at the following links: ############################################ http://www.drmcdougall.com/misc/2008other/news081110crestor.html ############################################ http://junkfoodscience.blogspot.com/2008/11/when-news-sounds-too-good-statins-new.html ############################################ http://www.proteinpower.com/drmike/cardiovascular-disease/1853/ ############################################ http://www.businessweek.com/bwdaily/dnflash/content/nov2008/db2008119_446462.htm?chan=top+news_top+news+index+-+temp_news+%2B+analysis ############################################ http://www.drbriffa.com/blog/2008/11/10/statins-reduce-cardiovascular-disease-in-health-people-and-why-this-study-is-a-poke-in-the-eye-for-the-cholesterol-hypothesis/ ############################################ The inability to use standard html formatting tools has prevented this contribution from being formatted so that it is easily read, hence the use of the hash sign [#] to aid legibility.
As a "Statinised" victim of this medication, I can attest to the potential and real hazards of unbridled distribution (at a cost) of Statins to the general public. Statins are a MODERATE inflammatory medicine; in that lies their benefit (if any). BUT, by inhibiting CoA reductase in the mevalonate pathway (CPY3A4) to decrease the production of cholesterol, statins affect other vital functions utilizing this same essential, internal engine, such as the synthesis of CoQ10, dolichol and selenoprotein and normal Glyceryl-glyceryl phosphorylation; thus producing an environment wherein the mitochondria may become inefficient in their production of ATP and susceptible to compromise. When your plane is going down you don't dump the fuel to lighten the load. This is a dangerous medication, and any results which are in any way funded by or overseen by pharmaceutical firms should be viewed with healthy skepticism.