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Our Editorial on Jupiter Published in Circulation
Mrs. Bremner and mine (and Mary Kelley) editorial on the famous JUPITER study (in which statin medications were used to prevent heart disease in healthy people who had an elevation of the marker of inflammation C Reactive Protein (CRP) which has been linked to heart disease risk) just came out here in the journal Circulation, in which we argue that the results of the study do not dictate that such large numbers of people should start taking statin drugs for the prevention of heart disease based on the marker of inflammation C-Reactive Protein (CRP). I mean CRP can go up with a number of things, like not exercising, or being overweight, etc. There was a response written by the lead author of JUPITER, Paul M. Ridker MD MPH which I read but cannot put online yet, which basically states that it was justified to stop the study early (which incidentally was used to hype the results of the trial) and that the apparent increase in markers of diabetes with statin treatment was not a big deal. I reprint the conclusion of our editorial here:
We believe that the treatment benefits achieved in the JUPITER trial are not large enough to advocate an expansion in the clinical indications for statins. The potential implications of this trial for a change in clinical practice are further limited by a lack of information on the long-term risks and benefits of statin therapy in predominantly healthy individuals. Unfortunately, it is unlikely that we will be able to gather these data in the future. Because sponsorship of major treatment trials is almost exclusively left to the pharmaceutical industry, it is doubtful that another trial will be carried out, with sufficient sample size and proper follow-up, to study the effects of statin treatment in such healthy individuals.
And we go on:
Perhaps the most important lesson to be learned from this trial is that extreme caution should be placed in deciding to terminate early an industry-sponsored trial, such as JUPITER. At the current status of knowledge, behavioral prevention strategies remain the best investment for the prevention of cardiovascular disease and its risk factors in predominantly healthy individuals.
Tagged with: cardiology • cardiovascular disease • Doug Bremner • Heart attack • Heart Disease • Jupiter • Mary Kelley • Prevention • Viola Vaccarino
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I totally agree with you and Dr.Mrs.B. Amazing changes can occur through diligent practice of lifestyle changes. The logic that is used to discredit lifestyle change frequently goes like this: There was a government RECOMMENDATION to reduce fat in the diet, yet people got fatter and other factors got worse, therefore the recommendation was wrong. It’s irrelevant that the American public did not FOLLOW the recommendation and that fat consumption increased in the time period.
It certainly is not EASY to make lifestyle changes, but it can be done with determination. A friend of mine went on a near fat-free diet, very little salts and no manufactured foods following bypass surgery. He’s been hiking 5 or more miles a day and is thin, trim, fit and has no signs of cardiac problems now. Well-managed food intake and exercise work for those who do it. It’s also worked for me personally, though the converse is true also. If I let down on my vigilance I backslide with BP rising and weight coming back on. The new lifestyle must be maintained and consistently followed. It’s not a one-shot deal, but a forever commitment.
Good for you!
The statins are a good and beneficial class of medications- if only others would stop trying to expand the market. Bozos:
Treating Dyslipidemia: What Is Believed To Be Qualities Of All Statin Medications:
Statins are a class of medications specifically prescribed to lower LDL- one of five lipid parameters of a person’s lipid profile, which is alto the name of the blood test to measure these parameters. They are beneficial for those patients with dyslipidemia and cardiovascular disease, as several studies have concluded..
There are about 6 available statins to choose for lipid management as needed- with three that are combination drugs that have a statin included in these drugs.
There are other classes of medications for lipid management, such as bile acid sequestrants and nicotinic acid, which is known as niacin. Yet the side effect profile is more unfavorable of these classes of medications compared with the statin class of drugs.
One’s cholesterol level is primarily due to how they produce cholesterol in their liver, which is overall genetically determined. This level is also determined by one’s lifestyle and diet as well. If a person has too much cholesterol in their blood, it can lead to hardening and narrowing of their arteries as well as the formation of coronary plaques in the coronary arteries.
If these plaques break off of the arterial wall, this leads to a myocardial infarction, or heart attack. Statins are believed to stabilize coronary plaques so this does not occur.
To measure one’s cholesterol, a blood test called a lipid profile is obtained from a person after they have fasted for at least 12 hours. The test should also be performed only if the person is free of any acute illness, as this may affect true lipid measures.
If the results prove to be abnormal, lipid altering medicinal therapy may be initiated- according to the discretion of the person’s health care provider. This therapy usually involves a statin medication.
Adverse events associated with the statin class of pharmaceuticals are thought to occur more often than they are reported- with high doses of statins prescribed to patients in particular at times that may not be necessary to control their dyslipidemia based on their lipid profile. Side effects may include muscle pain, or possible damage to the patient’s liver.
However, since this class of statin drugs has existed for use for over 20 years, statins are considered to be overall safe and effective for enhancing the clearance of LDL noted to be elevated in the lipid profiles of patients.
Also, they have proven to reduce cardiovascular mortality with one who is treated with a statin that has dyslipidemia. In addition to lowering LDL by up to about 60 percent- depending on the choice of the statin prescribed for the patient, and how high the LDL cholesterol is in a patient.
This class of drugs also has the ability to raise their HDL lipid parameter as well as lower to their benefit their triglyceride parameter of their lipid profile. Both of these additional effects in addition to lowering the LDL parameter from taking a statin drug is ultimately beneficial for the patient on a statin drug for lipid management.
Statin therapy is also recommended for those patients who have a greater than twenty percent risk of developing cardiovascular disease, or those patients that have clinical evidence of this disease.
Additionally, there appears to be no comparable reduction in cardiovascular morbidity or mortality, as well as a difference in the increase of one’s lifespan, if one is on any particular statin medication for their lipid management over another, others have concluded. So caution should perhaps be considered if one chooses to prescribe a statin for a patient if they are absent of, or have only mild dyslipidemia to a significant degree.
Furthermore, research should be done by the health care provider if they are under the belief that one statin medication provides a greater cardiovascular benefit over another. In other words, the health care provider should be assured that any choice of statin therapy for their patients should be considered reasonable and necessary if the LDL in their patients need to be reduced.
Furthermore, the statin selection should be determined by the results that have been shown with a particular statin.
There exist abstract etiologies for health care providers at times to choose to prescribe statin drugs on occasion for reasons not indicated with the medicinal treatment of these statin drugs. Examples include the speculated benefits associated with statins- such as reducing CRP levels, or for Alzheimer’s treatment, or other reasons not directly related to cholesterol management.
Statin therapy for such patients may not be considered appropriate, reasonable, or necessary prophylaxis at this point for any patient who does not have the indications for which statins are approved for to treat patients with dyslipidemia.
All other benefits that appear to have favorable effects in such areas not involved with a patient’s cholesterol are suggested at this point due to minimal research in these other variables aside from lipid management.
Other reasons for placing a patient on a statin drug at this time require further research for these disease states and dysfunctions that may exist with a patient aside from dyslipidemia.
Statins as a class of drugs repeatedly seem to in fact decrease the risk of cardiovascular events significantly, it has been proven. Statins also decrease thrombus formation as well as modulate inflammatory responses (CRP) as additional benefits of the medication.
For those patients with dyslipidemia who are placed on a statin, the effects of that statin on reducing a patient’s LDL level can be measured after about five weeks of therapy on a particular statin drug.
Liver Function blood tests are recommended for those patients on continued statin therapy, and most are chronically taking statins for the rest of their lives to manage their lipid profile in regards to maintaining the suitable LDL level for a particular patient presently. Patients should be made aware of potential additional side effects as well, such as myopathy and muscular dysfunctions that occur on occasion when one is on statin therapy.
Yet some have said that about half of all strokes and heart attacks that do occur are not because of increased cholesterol levels of these patients. So it appears clear that high cholesterol may not be an absolute for cardiovascular events for them to occur.
Others believe that it is oxidized cholesterol that causes vulnerable plaques to form on coronary arterial walls, which is the catalyst for a heart attack, and that there is no medicinal treatment for the formation or stabilization of these plaques to prevent heart attacks or strokes.
Some who support statin medicinal therapy for their clinically appropriate patients claim that these drugs, do, in fact, stabilize these plaques as an added benefit, and therefore are beneficial.
As stated previously, in regards to other uses of statins besides just primarily LDL reduction, there is some evidence to suggest that statins have other benefits besides lowering LDL, but not enough evidence yet.
These other disease states include aside from what has been stated already, such as those patients with neurological disease, as well as statins being beneficial for certain cancer patients. Some have suggested that statins interfere with cancer treatment with bladder cancer patients as well. Yet again, these other roles for statin therapy have only been minimally explored and researched, comparatively speaking.
Because of the limited evidence regarding additional benefits of statin medications, the drug should again be prescribed for those with dyslipidemia only at this time involving elevated LDL levels as detected in the patient’s bloodstream.
Yet overall, the existing cholesterol lowering recommendations or guidelines should possibly be re-evaluated. The cholesterol guidelines that presently exist may be over-exaggerated possibly due to tacit suggestions from the makers of statins to those who create these current lipid lowering guidelines.
This is notable if one chooses to compare these cholesterol guidelines with the other guidelines that have existed in the past. The cholesterol guidelines that exist now are considered by many health care providers and experts to be rather unreasonable and unnecessary, as well as possibly have the potential to be detrimental to a patient’s health.
Yet statins are beneficial medications for those many people that exist with elevated LDL levels that can cause cardiovascular events to occur because of this abnormality. What that ideal LDL level is may have yet to be empirically determined.
Finally, a focus on children and their lifestyles should be amplified so their arteries do not become those of one who is middle-aged, and this may prevent them from being candidates for statin therapy now and in the future, regarding the high cholesterol issue. Treating children with a statin drug for dyslipidemia is controversial presently. Dietary management should be the first consideration in regards to correcting lipid dysfunctions that may exist in patients.
http://www.americanheart.org
Dan Abshear
The editorials are in Circulation: Cardiovascular Quality and Outcomes. Circulation is a different journal.
http://circoutcomes.ahajournals.org/cgi/content/extract/2/3/286?etoc
http://circoutcomes.ahajournals.org/cgi/content/extract/2/3/279
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