• High-intensity statin therapy found to reduce plaque in heart arteries

    April 2006 

    A recent study found high-intensity statin therapy caused a regression of atherosclerosis, which is the accumulation of plaque in the arterial wall-more commonly known as hardening of the arteries.

    This is significant because until now other statin studies had only shown a slowing process or standstill in the growth of atherosclerosis. This study, called the ASTEROID trial (A study to Evaluate the Effect of Rosuvastatin on Intravascular Ultrasound Derived Coronary Atheroma Burden), is the first to show evidence of regression of atherosclerosis.

    “...achieved LDL levels are the lowest values ever to be recorded in a statin atherosclerosis progression trial. The increase in HDL also surpassed reports from previous statin trials.” 

    The trial’s report, which was published on March 13, 2006, in JAMA (Journal of American Medical Association), was performed at 53 community and tertiary care centers in the U.S., Canada, Europe and Australia. A team of researchers lead by Dr. Steven Nissen from the Cleveland Clinic conducted the trial.

    Eligible participants in the trial were required to have at least one heart artery obstruction with more than 20 percent narrowing in the coronary vessel. Each trial participant was also required to be “statin-naïve,” which the trial described as “receiving no statin therapy for more than three months during the previous 12 months.” Individuals with any baseline low-density lipoprotein (LDL) was admitted for the trial. However, those with triglyceride levels greater than or equal to 500 mg/dL or 15.7 mmol/L or with uncontrolled diabetes (glycosylated hemoglobin levels greater than or equal to 10 percent) were excluded.

    Intravascular ultrasound (IVUS) imaging, a technique in which a tiny ultrasound probe is inserted into the artery to measure the plaque, was used to determine the baseline of 349 qualified participants. Each patient received a high-intensity dose of 40 milligrams a day of rosuvastatin, brand name Crestor, versus a normal dosage of 10 milligrams a day.

    Trial results

    After 24 months, patients received a repeat IVUS examination. Regression of atherosclerosis occurred in nearly all subgroups of the trial (men, women, older and younger patients and most lipid-level subgroups). The high intensity dosage of rosuvastatin was found to also reduce LDL by 53 percent and increase the "good" cholesterol, high-density lipoprotein (HDL), by 14.7 percent.

    It is important to note that the achieved LDL levels are the lowest values to ever be recorded in a statin atherosclerosis progression trial. The increase in HDL also surpassed reports from previous statin trials.

    Crestor controversy

    While many achievements have been noted for the drug, Crestor has received its fair share of criticism. When the drug was first introduced in the U.S. in August 2003, there were reports of muscle and kidney problems. However, federal regulators dismissed the cases.

    The ASTEROID study itself has also received some criticism since it didn’t include patients taking a placebo pill and was funded by AstraZeneca, which produces Crestor.

    However, the medical community views this as a promising study to help fight against cardiovascular disease, which is the No. 1 cause of death in the United States with more than 50 million Americans experiencing cardiovascular problems.

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Page last updated: 8/7/2015 1:59:53 PM
  • What the news means for you

    Study provides new hope to reverse coronary heart disease

    Debabrata Mukherjee, MD

    Wright, Heather, MDFor the last decade, statins have become one of the standard treatments for patients with established coronary heart disease because of its effect in lowering LDL cholesterol-what your doctor may have referred to as “bad cholesterol.

    LDL works in the blood to carry cholesterol, a soft, fatlike substance, through the body for use by the cells. We consider LDL bad cholesterol since it also carries cholesterol to the arteries. High levels of LDL can accumulate on the walls of the arteries, producing atherosclerotic plaque or atherosclerosis, which can lead to heart attacks and strokes.

    “The recent study...is the most promising news about statins to date...” 

    Previous studies have shown statins can halt or slow down the progression of atherosclerosis. However, the recent study, the ASTEROID trial, is the most promising news about statins to date, showing it has the ability to remove 7 to 9 percent of plaque buildup, which has taken years to accumulate in the artery walls.

    The ASTEROID trial also proves that statins help increase HDL cholesterol, which is considered good cholesterol because it removes LDL out of the artery’s lining and transports it to the liver where it can be turned into bile and excreted.

    New LDL and HDL targets

    Based upon everything we know and the findings from this recent study, I recommend target LDL levels below the current guidelines, aiming for a range of 50 to 60 mg/dL. We continue to strive for high HDL levels with a target of at least 40 mg/dL for men and 50 mg/dL for women.

    Statin side effects

    Studies have proven statin to be a very safe drug. However, as with any medication, statins cause about 5 percent of patients to experience some side effects, such as muscle aches and pains and rarely liver toxicity. Use of statins requires close monitoring by the prescribing physician.

    Before starting statin therapy, a patient should have a baseline check of their liver and muscle enzymes. Liver enzymes should be checked approximately 12 weeks after starting therapy, then annually or more frequently if indicated. If at any time the patient begins to experience symptoms, the levels should be checked.

    “If you have been diagnosed with cardiovascular disease, you should talk to your doctor about statin therapy.” 

    What can you do?

    If you have been diagnosed with cardiovascular disease, you should talk to your doctor about statin therapy. If you are already taking a statin, such as Lipitor, Lescol, Mevacor, Pravachol, Crestor or Zocor, you should discuss your LDL levels with your doctor to determine if a higher dosage would help you reduce your atherosclerosis. It may not be necessary to increase your dosage to 40 mg/dL, as indicated in the study. Some patients may find positive benefits and achieve target LDL level with only 20 mg/dL while others may need a higher dose.

    If you have not been diagnosed with cardiovascular disease but have a history of diabetes, smoking, hypertension, peripheral vascular disease, aortic aneurysm or a first degree relative 55 or younger with diagnosed heart disease, you should consult a doctor.

    Since elevated blood cholesterol is an indicator for a higher risk of heart attack and stroke, it’s important for you to have your cholesterol levels checked regularly and discuss the levels with your physician. You should request a lipid profile, which breaks down your blood cholesterol numbers into HDL, LDL and triglycerides.

    Heart healthy habits for everyone

    Lifestyle choices continue to be one of the strongest ways to turn around cardiovascular disease. Everyone should abide by the following guidelines to have a healthy cardiovascular system.

    • Keep your weight under control. Obesity can lead to type 2 diabetes and many other health conditions that affect the heart.
    • Exercise at least three times a week. Each exercise session should be 20 to 30 minutes in length.
    • Eat a heart-healthy diet. Add more fruits and vegetables to your diet and try to keep your fat intake to less than 10 percent.
    • Stop smoking. Smoking is not only harmful to your lungs but it also affects your heart.

    If you have already been diagnosed with cardiovascular disease, you should adhere to these heart-healthy guidelines in addition to taking statin therapy.

    Dr. Mukherjee is a cardiologist at the UK Gill Heart Institute and associate professor of internal medicine who completed his fellowship in cardiology at the Cleveland Clinic with the principal investigator in charge of the ASTEROID trial.

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