ErinPharm Gazette June 2008
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Progress continues on reversing atherosclerosis with a statin/fenofibrate to increase HDL-cholesterol. Super-centenarian Henrikje van Andel-Schipper reached 115 years of age in good cognitive health. Increasing emphasis is being placed on the alarming inadequate treatment of those with high blood pressure both in the developed world and the developing world. The need for Vitamin D3 supplementation in all age groups globally to reduce the risk of cancer, cardiovascular disease and osteoporosis is supported by recent published studies. Studies suggest statins are reducing the risk of cancer occurrence. The developing world is now facing the same staggering incidence of chronic non-communicable diseases that afflict the developed countries. Sirtris has been acquired by GlaxoSmithKline. Work continues on urging the general population to adopt a healthy lifestyle with exercise, sensible nutrition, lowering high blood pressure and reducing obesity. Dr. Francis Collins is about to step down from his ten year leadership of the Human Genome Project. He has led us in an astounding period of human endeavor; the beginning of wonders yet to come.
A review of June 2008. A selection of topics.
This web page is one of a number of ErinPharm web pages designed by me as a synopsis of topics that interest me as well as being a quick reference page for my newsletter subscribers and myself. I have no affiliation of any kind to any pharmaceutical company or medical group. The opinions expressed are my own. I welcome communication and debate. I am an optimist. I look forward to the future with wonder.
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The first comprehensive map of Genomic copy number variations has been developed. Such copy numbers influence genetic diversity and susceptibility to disease.
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Are you trying to lose weight and have been misled by the multi-billion dollar industry selling pills, potions, and 'magic cures'? You are not alone. A survey backed by a commercial drug company reports that approximately 70% of American dieters have tried scientifically unproven methods to lose weight. That's an astounding number of people who have tried dietary supplements in the form of pills and powders. About half of survey respondents incorrectly think supplements are approved by the federal Food and Drug Administration, while about two-thirds believe such products must carry warning labels for side effects. All that happens is maybe temporary loss of weight and the emptying of your pocket. Resist the temptation to believe in those seductive commercials. The only way you can lose weight and keep it off is by a commitment to a change in lifestyle. I recommend lifestyle changes.
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Readers of ErinPharm Gazettes are among those aware, motivated, and seeking to take advantage of knowledge generated on the expanding frontiers of medical/scientific research. It is important to recognise that while we are privileged to be part of this future coming rapidly toward us we also live on a planet where the majority of our fellow human beings suffer under a burden of disease overwhelming and horrifying. One such disease is malaria. It threatens half the world's population, will strike up to half a billion people this year, at least a million will die, most of them under age 5, the vast majority living in Africa.
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As of March 31, 2008, Abbott Laboratories has already submitted an NDA (New Drug Application) to the US FDA for TriLipix as monotherapy and in combination with a statin.
As Trilipix, from Abbott Laboratories, the new formulation of fenonofibric acid, is under review by the FDA, raising hopes of a medication that will safely raise HDL-cholesterol levels by about 20% when used in conjunction with a statin, research on other methods of raising HDL-cholesterol by inhibiting cholesteryl ester transfer protein (CETP) continue. The first clinical trials with anacetrapib, Merck's CETP inhibitor, have shown impressive effects in raising HDL-cholesterol. Merck researchers report a maximum elevation of 129% for HDL-cholesterol and reduction of 38% in LDL-cholesterol levels. This indicates we are near a pivotal point in atherosclerosis reversal. An NDA approval by the FDA for Trilipix will give immediate access to many of those who have a lower than optimal HDL-cholesterol level to boost HDL-cholesterol above 40 mg/dL as an interim measure for the years between now and a CETP inhibitor reaching the market. For those intent on strategies to reverse arterial plaque this is good news.
In a very interesting development GlaxoSmithKline, a major pharmaceutical company, has acquired Sirtris, a biopharmaceutical company leading in sirtuin research and development, for $720 million. Sirtris has been exploring orally available small molecule compounds with the potential to mimic the health benefits of calorie restriction of which extended lifespan has attracted research attention. That a company the size of GlaxoSmithKline has made such an acquisition is a step forward for sirtuin research. The company has the financial clout and clinical research trial expertise to fully explore the potential of such molecules.
Super-centenarian Henrikje van Andel-Schipper was sharp and joking right up to the end of her life at the age of 115. She survived surgery for breast cancer at age 100 but finally died from stomach cancer. She must have been a wonderful woman to know. At age 82 and then at age 111 she called the University of Groningen in Holland in order to donate her body to science. Thank you Henrikje for that gift you gave us. A post-mortem analysis of her brain showed few signs of diseases we have associated with old age thus establishing that such damage to an aging brain is not inevitable. Her life gives reason and support to those who believe that the elderly should receive medical attention, including surgery, equivalent to that received by much younger people.
A viewpoint presentation at the June 2008 International Society of Hypertension in Berlin, Germany, brought focus to those over 50 years of age. Drs Bryan Williams (Leicester Royal Infirmary, UK), Lars Lindholm (Umeå University Hospital, Sweden), and Peter Sever (Imperial College London, UK) believe that systolic blood pressure should become the sole defining feature of hypertension and key treatment target for people over 50 years of age. They note the rationale for this is that while systolic blood pressure rises with age the diastolic blood pressure begins to fall after age 50; thus targeting systolic blood pressure is more logical since control of systolic pressure will inevitably control diastolic pressure for most people over 50. With recent publication of data indicating that less than 50% of patients with hypertension are treated adequately for systolic blood pressure and not reaching below 140 mm Hg (130 mm Hg for diabetics and those at cardiovascular risk), when a systolic blood pressure of 115 mm Hg is believed to be optimal, when desired blood pressure levels can be reached with dietary modification, exercise, stress reduction techniques, an ACE inhibitor and, if necessary, addition of an angiotensin receptor inhibitor, it is incumbent on all those in the health care professions and patients educated and aware to reach out to those over 50 with advice, counselling, and support to enable this increasing population of over 50 years of age take advantage of this knowledge and bring their systolic blood pressure down to those levels we know reduce cardiovascular risk.
In a troubling finding for healthy middle-aged adults an article in the June 26 online edition of Stroke, by Dr. Sudha Seshadri, Boston University School of Medicine, provides evidence that about 10% of apparently healthy middle-aged adults have experience silent cerebral infarcts (SCI). This is distressing information since silent infarcts increase the risk of clinical stroke and cognitive impairment. A significant association for SCI was found with hypertension, elevated plasma homocysteine, carotid stenosis and concurrent atrial fibrillation. This provides strong reason for treating cardiovascular risk factors even in those apparently healthy.
Now that it is well established that aggressive statin treatment to lower LDL-cholesterol levels are of benefit in reducing cardiovascular risk, and that ever lower levels of LDL-cholesterol are under clinical investigation, and clinical trials are under way on methods to increase HDL-cholesterol levels for additional benefit, attention is shifting toward management of other targets; the sum of all the cholesterol in the proatherogenic lipoproteins and apolipoprotein B, the major apolipoprotein of very low density lipoprotein (VLDL), intermediate-density lipoprotein, and LDL particles. Elevated levels of this sum non-HDL-cholesterol total have been found to be associated with cardiovascular risk. The lead investigator, Dr. John Kastelein, of the Academic Medical Center, Amsterdam, the Netherlands, states in the publication, in the June 10, 2008, issue of Circulation, that future guidelines should favor the use of these levels as a primary treatment target. Dr. John LaRosa, State University of New York Health Science Center, Brooklyn, NY, a coauthor of the study, says that practically speaking a measurement of total cholesterol minus HDL-cholesterol gives a number that can be associated with cardiovascular risk. Since these intermediate particles carry lower amounts of cholesterol along with substantial quantities of triglycerides it makes sense that reduction of triglyceride levels be an important factor in reducing cardiovascular risk. For those already taking a statin the means of reducing triglycerides are available; dietary modification, exercise, omega-3 fish oils, and fenofibrate (but not gemfibrozol).
Every diabetes 2 patient should receive blood pressure lowering agents to reach blood pressure well below target levels; according to Dr. John Chalmers and colleagues at The George Institute for International Health at the University of Sydney, Australia. They drew their conclusions from the latest findings in the ADVANCE trial. The benefits of active treatment, even for those who started with normal blood pressure, were so dramatic that Dr. Chalmers was emphatic in his belief that all patients with diabetes 2 should immediately be started on blood pressure lowering medications.
Dr. Roshney Jacob-Isaac, of George Washington University Hospital and the VA Medical Center in Washington,DC, presented data at the 90th Annual Meeting of the Endocrine Society, ENDO 2008, showing that higher levels of physical fitness confer a survival advantage for men with type 2 diabetes irrespective of whether the patient is obese, overweight, or normal weight. These findings emphasise the importance of moderate levels of activity, say brisk walking 130 minutes a week, to significantly reduce the risk of mortality even if weight loss is not achieved.
Yet another review, covering all papers published between 1985 and 2006 on the safety, efficacy, and side effects of statins, shows that statins used at their usual doses are a remarkably safe and beneficial group of drugs.
There is a general prevalence of Vitamin D3 deficiency in the population of the United States and other countries. It has become a matter of concern among respected medical experts. Dr. Isadore Rosenfeld expressed his concern in a recent Fox News broadcast saying that despite his reluctance to recommend vitamin supplements rather than sensible eating habits he does recommend everyone in the population to supplement with 800 IU of Vitamin D3 daily. The issue is that Vitamin D3 deficiency in a person's blood plasma is associated with a much increased risk of various cancers, cardiovascular disease, osteoporosis, and other disorders. Since deficiency is so prevalent it is prudent that everyone take a daily supplement. Since Vitamin D3 supplements are very inexpensive it is an easy and sensible addition to a daily diet. There are estimates that supplementation in the entire population would reduce the national cancer incidence by up to 50%. Of course Vitamin D3 supplementation has a long history, dating back to the days of rickets in children and subsequent federal legislation mandating the addition of Vitamin D3 to milk and other commonly consumed foods. Many older people will remember the emphasis on taking cod liver oil and some still do. However a troubling study by Dr. Catherine Gordon, of the Children's Hospital in Boston, commented on by Dr. James Taylor, of the University of Washington in Seattle, reveals that not only is Vitamin D3 deficiency common but that it may be even more common, and deleterious, in children. Since correcting this general heath problem is so simple these facts should be widely known.
In a study published by Joyce Malalouf, of the American University of Beirut in Lebanon, in the online edition of the Journal of Clinical Endocrinology & Metabolism, April 29, it was found that Vitamin D3 at a dose of 2,000 IU daily, is safe and produces desirable Vitamin D3 levels in adolescents. The compelling point is made that since Vitamin D3 deficiency in all age groups worldwide has been found to exist, and that many diseases of adults are rooted in childhood, it is important that supplementation become a standard of health care for all.
In a retrospective study presented by Dr. Harinder Singh, at the American Association of Clinical Endocrinologists 17th Annual Meeting and Clinical Congress, it was pointed out that Vitamin D3 deficiency is much more prevalent in patients with osteoporosis than has been believed up until now, and that deficiency should be treated aggressively. Dr. Singh says the data is alarming. Other medical experts at the meeting pointed out that Vitamin D3 deficiency is common across all age groups including children.
The benefits of taking a statin beyond the known benefit of lowering LDL-cholesterol continues to expand. A case control study published in the May issue of Chest suggests that patients taking a statin for more than six months reduced their risk of lung cancer by 55%. The authors, Dr. Vikas Khurana and colleagues, of the Overton Brooks VA Medical Center at Louisiana State University Sciences Center in Shreveport, prospectively collected data from 483,733 VA patients from 1998 to 2004. This protective effect occurred across different age and racial groups, and was independent of the presence of diabetes, smoking status, or alcohol use. The authors urge that this provocative finding be the subject of further study.
The first study to suggest a dose-response effect of statins on cancer occurrence was published in the April issue of the American Journal of Medicine. In a retrospective observational study ot 30,000 patients discharged from hospital after admission for acute heart attack in the province of Quebec, published by Dr. Loise Pilote, of McGill University, Montreal, Canada, cancer incidence was found to be (per 1000 person years) 13.9, 17.2, and 20.6 among statin high dose users, low dose users, and non-users respectively. This is an addition to the accumulating evidence that statin usage reduces the risk of cancer and is a sound basis for more studies to explore this benefit and define the potential.
The World Health Organisation has reported that chronic conditions such as heart disease and stroke have become the chief causes of death globally and are expected to continue to rise up to 2030. WHO Director-General Margaret Chan voiced concern at the rising rate of cardiovascular disease, cancer, diabetes, asthma, obesity and tobacco related death in the developing countries. With extension of lifespan comes these alarming predictions of future health problems around the world.
A new study has found that 80% of deaths connected to high blood pressure now occur in the developing world. This is a staggering problem. Experts have made harsh commentaries about the lack of substantive sustained efforts to address this problem.
There is progress. Clinical testing is imminent for a low cost 'polypill' containing ingredients to lower blood pressure and LDL-cholesterol and thus combat cardiovascular risk factors. There will be controversy over this but there is a real need for drastic measures to help our distant cousins in the developing world.
We sadly announce that Dr. Francis Collins will step down from his leadership of the Human Genome Project August 1, 2008. His leadership has been exemplary.
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