Should healthy people with low cholesterol take a pill to lower their cholesterol even more in hopes of preventing heart problems? The question is dividing heart doctors and confusing patients.
An analysis published Monday questions research that led federal regulators to allow the statin drug Crestor (rosuvastatin calcium is a cholesterol-lowering agent) wider use for prevention. The Food and Drug Administration broadened Crestor's market to millions more people in February, partly because of a study reported in 2008 by Crestor's maker.
Consequently, more doctors are putting healthy people on statin drugs, sometimes inappropriately, heart doctors say. And they say too little attention is paid to potential risks, such as developing diabetes.
The earlier Crestor study funded by AstraZeneca PLC was controversial from the start. Its findings: Crestor cut the risk of certain heart problems in half for the middle-aged and older men and women in the study, who had normal levels of LDL, or "bad" cholesterol (below 130), and high levels of a measure of inflammation called C-reactive protein, CRP. It not only suggested a new use for Crestor, but a new blood test for CRP.
Critics suggested the dramatic results might be exaggerated because the experiment was stopped after two years instead of the planned five. They questioned why the authors didn't report the rates of death from heart attack and stroke, which when teased out of the data turned out to be unaffected by Crestor.
The new analysis, appearing in Monday's Archives of Internal Medicine, raises those questions again. A second paper in the same journal finds no justification from the earlier results for using a test for CRP to make treatment decisions. And a third paper, an analysis of 11 published studies including the 2008 study, finds no evidence that statins help high-risk people without heart disease live longer.
"Why take a medicine that hasn't been shown to make you feel better or live longer? Yet that's what millions of Americans are doing," said Archives of Internal Medicine editor Dr. Rita Redberg, a cardiologist at University of California San Francisco.
Cholesterol-lowering drugs, including statins, are among top sellers nationally and globally. More than 238 million prescriptions for cholesterol-lowering drugs were dispensed by retail pharmacies in 2009, with more than $17 billion in sales, according to the health industry data firm IMS Health.
Statins, which work to clear LDL or "bad" cholesterol from the bloodstream, are widely prescribed for people with existing heart disease. Most experts agree the drugs reduce the risk of death in those patients. What's not clear is how much they help people who may be at risk because they smoke or have high blood pressure, but have no history of heart disease.
If the AstraZeneca findings were incorporated into treatment guidelines, roughly 6 million more people could be put on statins at a cost of $9 billion a year.
Dr. Michel de Lorgeril of Grenoble University in France, co-author of the new analysis, said the review showed the earlier results weren't clinically and scientifically consistent and that the study should have continued the full five years.
Dr. Paul Ridker of Harvard-affiliated Brigham and Women's Hospital in Boston, who led the 2008 study, said the study was stopped because the drug was clearly benefiting people in the study. He said the FDA’s independent analysis and its approval for Crestor's new use backed up the decision to stop the research early.
Speaking of the critical new analysis, Ridker said: "In the face of overwhelming evidence, the lengths some people will go to avoid dealing with new ideas that unsettle them is quite striking."
An outside expert, Dr. Lisa Schwartz of the Dartmouth Institute for Health Policy and Clinical Practice, said the bottom line for patients is to pay attention to what's still unknown about long-term use of Crestor in healthy people.
"The people in this study only took the drug for under two years. We just don't know what the balance of benefits and harms are for people who are going to take this for a lifetime," Schwartz said.
Source: Carla K Johnson - Associated Press, June 28, 2010
Where Do You Stand as the Patient?
Let’s leave it to the experts to sort out whether healthy people with low cholesterol should take a pill to lower their cholesterol even more in hopes of preventing heart problems.
You should continue to take your antihypertensive medication(s) at the same time each day. Monitor your blood pressure levels regularly and discuss these readings with your health care provider during the scheduled appointments.
In the meantime, you will be pleased to know that diet and behavioral interventions have been shown to reduce both CRP levels and the associated risk of cardiovascular acute events (1).
CRP levels have been correlated to the degree and the distribution of adiposity. Furthermore, weight loss due to caloric restriction has been shown to reduce CRP levels in obese subjects.
These evidences strongly support life style as a key determinant in CRP-mediated cardiovascular risk.
Regular physical activity, smoking cessation and light alcohol intake have been shown to lower CRP levels in several studies.
Dietary factors also modulated CRP levels. A possible direct anti-inflammatory activity induced by Omega-3 polyunsaturated fatty acid intake has been suggested. Low-fat, low cholesterol or low glycaemic diets seem to play a role in lowering CRP levels.
Recently, studies have shown that vitamin have E and vitamin C supplementation reduced the increase of CRP levels after meal. Further studies are needed to clarify the role of Omega-3 and vitamin supplementation as a therapeutic strategy to reduce CRP levels.
You can actually do something to control your CRP level. It is also important that you be mindful of your level of stress.
DO IT NOW!
Journal Reference
Fabrizio Montecucco and François Mach. Therapeutic Approaches for Reducing C-Reactive Protein (CRP) Levels and the Associated Cardiovascular Risk. Current Chemical Biology, 2009, 3, 380-384
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