Astrazeneca Presents New Data Demonstrating Crestor(reg) Reduced C-Reactive Protein Levels In African-American Patients

Main Category: Cardiovascular / Cardiology
Article Date: 10 Mar 2005 - 7:00 PDT

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CRESTOR reduced CRP in African-American patients by up to 21 percent -

New ARIES (African American Rosuvastatin Investigation of Efficacy and Safety) data presented today at the American College of Cardiology's Annual Meeting (ACC) show that AstraZeneca's CRESTOR(reg) (rosuvastatin calcium) at 10 and 20 mg reduced levels of C-Reactive Protein (CRP) by 14 and 19 percent respectively while atorvastatin 10 and 20 mg reduced CRP levels by 8 and 15 percent, respectively. In a subgroup analysis performed in patients with elevated CRP, CRESTOR reduced this biomarker of inflammation by 20 and 21 percent at the 10 and 20 mg doses respectively, while atorvastatin reduced CRP by 12 and 20 percent respectively. CRP is a protein in the body whose level increases when there is inflammation of blood vessels.

"An increasing number of cardiologists believe that CRP may be an important, yet often ignored, diagnostic tool," said Dr. Keith C. Ferdinand, clinical cardiologist and medical director of Heartbeats Life Center and the lead investigator for ARIES. "Through the ARIES trial, we have important new information about the changes caused by CRESTOR on this potentially critical biomarker in African-Americans."

The ARIES study was the first-ever large-scale, prospective trial exclusively designed to compare the effects of statins in African-American patients. ARIES was a six-week, randomized, controlled, open-label, multi-center trial designed to evaluate the efficacy of CRESTOR and atorvastatin in African Americans with elevated cholesterol. After a six-week dietary lead-in, 774 African-American adults with hypercholesterolemia were randomized to one of four open-label treatments for six weeks: CRESTOR 10 or 20 mg or atorvastatin 10 or 20 mg. Results showed CRESTOR 10 and 20 mg reduced CRP by 14 and 19 percent (20 mg only; p<0.01 versus baseline) respectively, and 8 and 15 percent (20 mg only; p<0.01 versus baseline) for atorvastatin at the same dosages in patients with elevated LDL or "bad" cholesterol (>160 and <300 mg/dL) and triglyceride levels (<400 mg/dL). The data also showed that in patients with baseline CRP >2.0 mg/L, CRESTOR reduced CRP by 20 and 21 percent (p<0.01 versus baseline) at the 10 and 20 mg doses respectively, 12 and 20 percent (20 mg only; p<0.01 versus baseline) with atorvastatin at the same dosages respectively. Treatments used in the ARIES study were well tolerated.

In addition to ARIES, there are a number of studies underway to examine the effects of statin therapy on patients with elevated CRP. One study, called JUPITER (Justification for the Use of statins in Primary prevention: an InterventionTrial Evaluating Rosuvastatin), is ongoing and will investigate the effect of CRESTOR in the primary prevention of cardiovascular events in patients with normal to low cholesterol levels but elevated CRP.

Additional Studies Presented at ACC:

-- Ezetimibe Added to Rosuvastatin for Severely Hypercholesterolemic Patients: this substudy assessed the effects of CRESTOR on low-density lipoprotein cholesterol and CRP; results showed that the addition of ezetimibe 10 mg to rosuvastatin 40 mg brought 52% of patients to the LDL-C goal of <100 mg/dL. The addition of ezetimibe to rosuvastatin produced further reductions in CRP.

-- NCEP Evaluation ProjecT Utilizing Novel E-Technology (NEPTUNE II): designed to estimate the probability of achieving ATP III cholesterol goals among treated dyslipidemic patients; An analysis was performed to investigate the implications of new recommendations by NCEP, specifically the classification of patients at very high risk and the new optional LDL-C treatment target of <70 mg/dl; results concluded a large proportion of patients with cardiovascular disease would be classified as very high risk, whereas a small minority of this population has a LDL-C level that meets the new optional goal, indicating a need for more aggressive treatment.

About CRESTOR

CRESTOR (rosuvastatin calcium) is a once-daily prescription medication for use as an adjunct to diet in the treatment of various lipid disorders including primary hypercholesterolemia, mixed dyslipidemia and isolated hypertriglyceridemia. It is a member of the statin (HMG-CoA reductase inhibitors) class of drug therapy. CRESTOR has not been determined to prevent heart disease, heart attacks, or strokes. For patients with hypercholesterolemia and mixed dyslipidemia, the usual recommended starting dose of CRESTOR is 10 mg. However, initiation of therapy with 5 mg once daily should be considered for patients requiring less aggressive LDL-C reductions or who have predisposing factors for myopathy, and for special populations such as patients taking cyclosporine, Asian patients, and patients with severe renal insufficiency. For patients with marked hypercholesterolemia (LDL-C >190 mg/dL) and aggressive lipid targets, a 20-mg starting dose may be considered. AstraZeneca licensed worldwide rights to CRESTOR from the Japanese pharmaceutical company Shionogi & Co., Ltd.

Important Safety Information

CRESTOR is contraindicated in patients with active liver disease or unexplained persistent elevations of serum transaminases, in women who are pregnant or may become pregnant, and in nursing mothers. It is recommended that liver function tests be performed before and at 12 weeks following both the initiation of therapy and any elevation of dose, and periodically (e.g., semiannually) thereafter. Rare cases of rhabdomyolysis with acute renal failure secondary to myoglobinuria have been reported with CRESTOR and with other drugs in this class. The 40-mg dose of CRESTOR is reserved only for those patients who have not achieved their LDL-C goal utilizing the 20 mg dose of CRESTOR once daily. When initiating statin therapy or switching from another statin therapy, the appropriate CRESTOR starting dose should first be utilized, and only then titrated according to the patient's individualized goal of therapy. The benefit of further alterations in lipid levels by the combined use of rosuvastatin with fibrates or niacin should be carefully weighed against the potential risks of this combination. Combination therapy with rosuvastatin and gemfibrozil should generally be avoided. CRESTOR should be prescribed with caution in patients with predisposing factors for myopathy, such as renal impairment, advanced age, and inadequately treated hypothyroidism. Patients should be advised to promptly report unexplained muscle pain, tenderness, or weakness, particularly if accompanied by malaise or fever. CRESTOR is generally well-tolerated. Adverse reactions have usually been mild and transient. The most frequent adverse events thought to be related to CRESTOR were myalgia (3.3%), constipation (1.4%), asthenia (1.3%), abdominal pain (1.3%) and nausea (1.3%).

About AstraZeneca

AstraZeneca is a major international healthcare business engaged in the research, development, manufacture and marketing of prescription pharmaceuticals and the supply of healthcare services. It is one of the world's leading pharmaceutical companies with healthcare sales of over $21.4 billion and leading positions in sales of gastrointestinal, cardiovascular, respiratory, oncology and neuroscience products. In the United States, AstraZeneca is a $9.6 billion healthcare business with more than 12,000 employees. AstraZeneca is listed in the Dow Jones Sustainability Index (Global) as well as the FTSE4Good Index. For more information about AstraZeneca, please visit: http://www.astrazeneca-us.com

KEITH C. FERDINAND, MD, FACC
Heartbeats Life Center
New Orleans, Louisiana

Keith C. Ferdinand, MD, FACC, a clinical cardiologist and medical director of Heartbeats Life Center, is also a professor of Clinical Pharmacology at the College of Pharmacy at Xavier University of New Orleans. In addition, Dr. Ferdinand is a clinical instructor at the LSU Medical Center, Section of Cardiology (appointed in 1985) and, since 1991, he has been an assistant professor in the Department of Medicine at Baylor College of Medicine.

Dr. Ferdinand received his medical degree from Howard University College of Medicine (Washington, DC) in 1976 and completed a residency program in internal medicine at the Louisiana State University (LSU) Medical Center in New Orleans in 1979. He also completed two cardiology fellowships, one from LSU Medical Center in 1980 and one from Howard University Hospital in 1981.

In New Orleans, Dr. Ferdinand maintains hospital staff affiliations with several area hospitals including: Columbia Lakeland Medical Center; Memorial Medical Center; Pendleton Memorial Methodist Hospital; Touro Infirmary; St. Claude Medical Center; University Hospital; and Tulane University Hospital and Clinic. He is also host and producer of "Health Issues 2000," a Cox Cable Community TV talk show. He is past-president of the Louisiana State Board of Medical Examiners and, since 1991, he serves as a member of the National Heart, Lung, and Blood Institute's (NHLBI) Committee on Minority Populations and as a national consultant to the NHLBI for the Physician's Health Network, a cardiac risk-reduction program for professionals and the public. (NHLBI is one of the National Institutes of Health in Washington DC.)

Most recently, Dr. Ferdinand has been recognized as one of the top 100 Best Black Physicians in the United States by the magazine, Black Enterprise. Ferdinand is the past president of the Orleans Division of the American Heart Association, Louisiana affiliate and is past chairman of the board of the Association of Black Cardiologists. In 1996, Dr. Ferdinand served as the co-chairman for ISHIB's scientific planning committee for the 11th International Interdisciplinary Conference on Hypertension in Blacks held in New Orleans.