LEARN MORE ABOUT
| Millions More Americans Might Be Placed on Statins |
 |
 |
 |
|
Thursday, 12 February 2009 If doctors start taking results of a recent drug company-sponsored trial seriously, 11 million more older Americans might be taking cholesterol-lowering statin medications, experts say. Results from the JUPITER trial were first reported in November 2008. The study was cut short, because treatment with Crestor (rosuvastatin) -- the statin marketed by AstraZeneca, sponsor of the trial -- was found to reduce heart attack and stroke by 44% among participants who had normal levels of "bad" LDL cholesterol but elevated levels of an inflammatory marker called C-reactive protein (CRP). If that finding becomes an important element in medical practice, researchers at Yale University estimated that the use of statins will be expanded widely. They published their findings Jan. 13 in the journal Circulation: Cardiovascular Quality and Outcomes. High levels of LDL cholesterol can lead to high blood pressure and heart woes, and today about 33.5 million older Americans (men 50 and older, women 60 and older) now either take a statin drug or should be taking one to lower their cholesterol levels, the report said. Statins include blockbuster medications such as Crestor, Lipitor, Pravachol and Zocor. But what about people who have normal levels of LDL cholesterol, but higher concentrations of the inflammatory marker CRP? Adding those people into the mix would greatly expand the pool of potential statin users, the researchers said. "Based on our analysis, more than 44.7 million older Americans might have an indication for statin therapy when you consider those who already meet current guidelines for statin therapy and those who might be eligible based on the criteria proposed in JUPITER," lead author Dr. Erica S. Spatz, an internist and fellow in the Robert Wood Johnson Clinical Scholars program at Yale, said in an American Heart Association (AHA) news release. But while the new analysis "provides important information about the size of the population that might be affected if the JUPITER findings get into clinical practice, it raises more question than it answers," Spatz added. "There are questions about CRP and questions about whether it would be cost-effective to treat that many people with statins." Current guidelines do not include CRP levels as indicators for statin treatment, noted Dr. Timothy J. Gardner, AHA president and medical director of the Center for Heart and Vascular Health at the Christiana Health Care System in Delaware. The guidelines of the U.S. Heart, Lung, and Blood Institute regarding statin use probably will be updated "in the next year or so," Gardner said, and the JUPITER results "will be carefully considered" when they are. "Information from the JUPITER trial has certainly alerted us to the possibility that measuring CRP as a biomarker might indicate that some older patients might benefit from statin therapy who are not on it, because they have LDL levels in the normal range," Gardner said. "It particularly might be worth looking at older men and women who have other risk factors, such as obesity, high blood pressure and metabolic syndrome." Metabolic syndrome is a constellation of risk factors that can include insulin resistance and elevated CRP levels in addition to high blood pressure and obesity. Still, "most cardiologists do not use CRP levels, because they have not been conclusively established as a reliable indicator of risk," Gardner said. "Because of the JUPITER trial, many are considering using it in older patients," he said. But the heart association has taken no stand on the issue, he said. A physician must consider more than CRP and LDL levels when making a decision about statin treatment, said Dr. Suzanne Steinbaum, director of women and heart disease at Lenox Hill Hospital in New York City. High blood pressure and obesity, even at borderline levels, can tip the scale, she said. "What we can glean from this kind of study is that patients we might consider to be at borderline risk, if they have inflammation, we should classify them at a higher risk factor status, she said. "If there is evidence of inflammation, I will start them on a statin." One major issue noted in the analysis is that a large number of older Americans who are eligible for statin therapy on the basis of LDL cholesterol readings are not taking the medications, Spatz said. "If we are to adopt the findings of the JUPITER trial, physicians will be challenged to reach that segment of the population that will benefit from statins," she said. SourceHealthDay News / MedicineNet CommentsHigh LDL cholesterol levels are already being blamed for heart attacks and are therefore a potential target to take medications. With a recent study published in the journal Circulation: Cardiovascular Quality and Outcomes, people with normal LDL cholesterol levels but high C-reactive protein (CRP) levels will also become the candidates for statin therapy. Currently 33.5 million Americans are taking different classes of statins, and if the high CRP group people are added to this, the numbers could rise as high as 44.7 million or more. Current guidelines for statin therapy do not include high CRP levels, but these guidelines are due for renewal within a year. Although some physicians question the efficacy of statins in people who have normal LDL levels, it is very likely that it will be included in the therapy very soon. One of the physicians is reported to have said, "It particularly might be worth looking at older men and women who have other risk factors, such as obesity, high blood pressure and metabolic syndrome." Statins are a group of medications which have a specific action to block one step in cholesterol production in the body through an enzyme called HMG CoA reductase. Yet, these medications are supposed to treat high blood pressure, metabolic syndrome, and high CRP levels (C-reactive protein indicates inflammation in the body and sometimes is used to diagnose a few of the diseases and is considered a cardiovascular risk factor). On the other hand, one of the statins, Lipitor, is going to lose patent protection in 2011. Lipitor brings more than $48 billion to Pfizer constituting a quarter of its revenue. Is it too much of a coincidence that this study, extending the use of statins to millions more, comes at a point when such giant pharmaceutical corporations are struggling to survive? According to Dr. Rath's research, cholesterol is not the cause but a symptom of already existing heart disease. Artificial reduction of cholesterol levels does not address the root cause of heart disease. Extensive laboratory and clinical research conducted by Dr. Rath's Research Institute has proven that synergistic nutrient combination of specific nutrients can safely and effectively reduce various factors in the lipid profile, and control markers of inflammation while strengthening the blood vessels. You can read more about this explanation in the book "Why animals don't get heart attacks...but people do!" as well as at www.drrathresearch.org |