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New Data Examines Effects of Crestor Alone or in Combination with Another Therapy in High Risk Patients with Very High Cholesterol

Crestor combined with ezetimibe reduced LDL-C in High-Risk patients by up to 65%

DALLAS, TX -- November 22, 2005 -- New data presented today at the American Heart Association Scientific Sessions show that AstraZeneca's CrestorŽ (rosuvastatin calcium) at 40 mg, when combined with ezetimibe 10 mg, reduced patients' LDL-C or "bad" cholesterol by 65% from their pre-treatment baseline levels.

In the study, nearly 60% of these patients with severe high cholesterol, including those with inherited high cholesterol, treated with this combination achieved target LDL-C goals. In addition, c-reactive protein (CRP) levels were reduced by 54%.

"In line with guidelines, it is always preferable to start patients on the single most effective treatment regimen first, but patients with severe levels of elevated cholesterol often require a combination therapy to successfully manage their condition," said Evan A. Stein, MD PhD, Director of the Metabolic & Atherosclerosis Research Center, Cincinnati and the lead investigator. "Our study provides further evidence that Crestor as a monotherapy, or in combination with ezetimibe, is an important and effective treatment option for this hard-to-treat, high-risk patient population."

The Crestor-ezetimibe add on study was designed to evaluate the additional benefits and tolerability of adding ezetimibe 10 mg to Crestor 40 mg in 109 severely hypercholesterolemic patients (66% men; mean age 53 years) whose low-density lipoprotein cholesterol (LDL-C) remained >100 mg/dL.

Patients had mean LDL-C of 291 mg/dL, triglycerides (TG) of 194 mg/dL, and high-density lipoprotein cholesterol (HDL-C) of 45 mg/dL, prior to any lipid-lowering treatment.

As all subjects had symptomatic coronary heart disease, diabetes or inherited high cholesterol, they were at high risk by current guidelines. In clinical practice, 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.

Results showed the addition of ezetimibe to Crestor resulted in a 29% (P <.001) reduction in LDL-C from their levels on treatment with Crestor alone, which represents a 15% incremental change (P <.001). CRP levels decreased a further 24%. Furthermore, when examining the difference between these patients' LDL-C levels prior to any treatment with a lipid-lowering agent, the combination of ezetimibe and Crestor resulted in a 65% reduction in LDL-C (P <.001), (pooled results). In addition, 59% (63/107) of patients achieved their target LDL-C values <100 mg/dL. The combination of Crestor plus ezetimibe was well tolerated over 12 weeks.

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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