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New Data Demonstrate Rosuvastatin Reduced C-Reactive Protein Levels in African-American Patients

ORLANDO, Fla., March 8 /PRNewswire-FirstCall/ -- 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(R) (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(1).

"An increasing number of cardiologists believe that CRP may be an important, yet often ignored, diagnostic tool(1)," 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; p160 and 2.0 mg/L, CRESTOR reduced CRP by 20 and 21 percent (p 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 Intervention Trial 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 -- 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 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%).

Source: AstraZeneca

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