Lipitor Significantly Reduced HsCRP Levels In Patients With Stable Coronary Artery Disease, According To New Study
Main Category: Cardiovascular / CardiologyAlso Included In: Heart Disease
Article Date: 04 Feb 2009 - 0:00 PST
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Patients treated with Lipitor® (atorvastatin calcium) 80 mg had a significant 55 percent reduction in levels of high-sensitivity C-reactive protein (hsCRP), while those taking Lipitor 10 mg had a significant 21 percent reduction in hsCRP levels at the end of 26 weeks compared to baseline, according to the results from the primary endpoint of a new study. Patients in this study had stable coronary artery disease, normal to mildly elevated cholesterol levels and chronic low-grade inflammation as indicated by elevated levels of hsCRP, which studies suggest may play a role in determining cardiovascular risk. The findings, from the Comparative Atorvastatin Pleiotropic effects (CAP) study, were recently published in Clinical Therapeutics.
"These findings support results from prior clinical trials suggesting that, in addition to lowering LDL cholesterol levels, Lipitor may help reduce hsCRP, which reflects the systemic inflammation that might contribute to increased risk for cardiovascular events," said Dr. Jean Davignon, director of the hyperlipidemia and atherosclerosis research group at the Clinical Research Institute of Montreal and a principal investigator of the trial. "Even more encouraging was the fact that further reductions in hsCRP were observed with intensive Lipitor therapy versus a lower dose."
The CAP trial was a prospective, randomized, double-blind, 26-week study designed to examine the effects of low-dose versus high-dose Lipitor on hsCRP levels in men and women under the age of 80 with stable coronary artery disease, normal to mildly elevated cholesterol levels and chronic low-grade inflammation as indicated by elevated levels of hsCRP. The mean baseline hsCRP concentration was 3.1 mg/L and 3.6 mg/L in the Lipitor 10 mg and Lipitor 80 mg treatment groups, respectively. Coronary artery disease was defined by at least one of the following: history of heart attack, stable angina, coronary narrowing of at least 50 percent, history of unstable angina and history of coronary artery bypass grafting or coronary angioplasty.
A total of 340 patients were treated with either low-dose Lipitor 10 mg or intensive Lipitor 80 mg therapy. The primary endpoint of the study was the percent change in hsCRP after 26 weeks of treatment with Lipitor 10 mg or 80 mg. Comparisons of hsCRP levels at five weeks were pre-determined secondary endpoints.
After five weeks of therapy, patients treated with Lipitor 10 mg had a significant 25 percent reduction in hsCRP levels compared to baseline, and hsCRP levels remained stable at study end (21 percent reduction). Patients treated with Lipitor 80 mg for five weeks had a significant 36 percent reduction in hsCRP levels compared to baseline. These levels were reduced further at study end to a total reduction of 55 percent. The effects of Lipitor on changes in hsCRP levels were dose dependent; high-dose Lipitor was associated with significantly greater reductions.
Both doses of Lipitor (10 mg and 80 mg) were generally well tolerated.
The prevalence of adverse events considered by the investigators to be treatment-related was 8.2 percent in the 10 mg group and 11.8 percent in the 80 mg group. The most common adverse events, reported with an incidence greater than 1 percent in either the 10 mg or 80 mg group, were asthenia (1.8 percent and 1.8 percent, respectively), increased creatinine kinase (1.8 percent and 0.6 percent), myalgia (1.2 percent and 2.4 percent), constipation (1.2 percent and 1.8 percent), increased aspartate aminotransferase (0 percent and 1.2 percent) and insomnia (0 percent and 1.2 percent). The majority of adverse events in both treatment groups were mild to moderate in intensity, with only 1.2 percent of patients in each group reporting severe side effects.
The study was sponsored by Pfizer and led by a joint Canadian/French steering committee. Patients were recruited from 65 sites in seven countries.
Important U.S. Prescribing Information
Lipitor is a prescription medication. It is used in patients with multiple risk factors for heart disease such as family history, high blood pressure, age, low HDL ("good" cholesterol) or smoking to reduce the risk of a heart attack, stroke, certain types of heart surgery and chest pain.
Lipitor is also used in patients with type 2 diabetes and at least one other risk factor for heart disease such as high blood pressure, smoking or complications of diabetes, including eye disease and protein in urine, to reduce the risk of heart attack and stroke.
Lipitor is used in patients with existing coronary heart disease to reduce the risk of heart attack, stroke, certain kinds of heart surgery, hospitalization for heart failure, and chest pain.
When diet and exercise alone are not enough, Lipitor is used along with a low-fat diet and exercise to lower cholesterol.
Lipitor is not for everyone. It is not for those with liver problems. And it is not for women who are nursing, pregnant or may become pregnant.
Patients taking Lipitor should tell their doctors if they feel any new muscle pain or weakness. This could be a sign of rare but serious muscle side effects. Patients should tell their doctors about all medications they take. This may help avoid serious drug interactions. Doctors should do blood tests to check liver function before and during treatment and may adjust the dose. The most common side effects are gas, constipation, stomach pain and heartburn. They tend to be mild and often go away.
http://www.Lipitor.com
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HMG CO-a Reductase Inhibitor
posted by Dan on 4 Feb 2009 at 5:19 amFacts Believed to be Associated With 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 a blood test to measure these parameters.
There are about 6 available statins to choose for lipid management as needed- with three that are combination drugs that have a statin along with another cholsterol enhancing drug in such combination medications.
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 cornorary plaques in the cornorary arteries.
If these plaques break off of the arterial wall, this leads to a myocardial infarction. Statins are believed to stabalize 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.
However, since this class of drugs has existed for use for over 20 years, statins are considered 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.
This class of drugs also has the ability to raise their HDL lipid parameter as well as lower to their benefit their triglycerol 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 is considered reasonable and necessary if the LDL in their patients need to be reduced, and 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 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, 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.
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,
Dan Abshear
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