Healthcare Industry News: rosuvastatin
News Release - November 5, 2007
New Data Examines the Effect of Adding a Statin to Optimized Treatment for Patients with Advanced Heart FailureORLANDO, Fla., Nov. 5 (HSMN NewsFeed) -- New data from the CORONA study presented today at the American Heart Association 2007 Scientific Sessions showed that adding a statin to optimized heart failure treatment did not significantly improve the prognosis for patients with advanced heart failure because it could not reverse or prevent the deterioration of a failing heart.
Patients taking AstraZeneca's CRESTORŽ (rosuvastatin calcium) 10 mg experienced an 8 percent reduction in the combined primary endpoint of cardiovascular death, myocardial infarction or stroke, which was not statistically significant (p=0.12). This reduction was primarily driven by a decrease in atherosclerotic events, i.e. stroke and myocardial infarctions (post hoc analysis, nominal p=0.05), where statins have been proven to have benefit. In this study the majority of deaths were due to sudden death, or non-ischemic causes, which did not appear to be impacted by statin therapy. In addition, significantly fewer hospitalizations occurred in patients on CRESTOR compared to placebo, whether due to any cause (p=0.007), cardiovascular causes (p<0.001), or for worsening heart failure (p=0.01).
"The CORONA results represent a major advancement in medical research and understanding of patients with advanced heart failure, as it appears they clearly differ from patients without heart failure in their response to statin treatment," said lead investigator Prof. John Kjekshus, Department of Cardiology, Rikshospitalet University Hospital, Oslo, Norway. "We added a highly effective statin on top of an optimal treatment regimen. Our findings suggest the major cause of death in these patients was likely not to be related to atherosclerotic events, where benefit with statins in non-heart failure patients has been demonstrated, but instead may have been caused by the deterioration of failing heart muscle damaged beyond repair. CORONA underscores the need for early intervention in the progression of atherosclerosis to prevent one of its worst consequences, heart failure."
"The CORONA study was a novel and challenging study and demonstrates our commitment to advancing medical knowledge by investigating the effects of CRESTOR in challenging patient populations with unmet medical need. The CORONA study included patients with advanced heart failure on optimal treatment who were not candidates for statin therapy in the view of the investigators and which sought to answer the question of whether or not statins provide additional benefit or might even be harmful in this population. As a result of this study, AstraZeneca has provided new scientific information to help answer these important questions", said Elisabeth Bjork, Global Medical Science Director for CRESTOR.
CORONA (COntrolled rosuvastatin MultiNAtional Study in Heart Failure) was a long-term, randomized, placebo-controlled study of more than 5,000 patients with chronic, symptomatic, systolic heart failure (NYHA II-IV) of ischemic origin, whom investigators felt did not need lipid-lowering therapy. The study was designed to evaluate the effects of adding CRESTOR 10 mg to optimized treatment for heart failure on cardiovascular mortality and morbidity and overall survival.
CRESTOR 10 mg was well tolerated in over 2,500 patients during the study, with a safety profile similar to placebo. The frequency and type of adverse events were comparable in all treatment groups throughout the study. CORONA was conducted in 21 countries.
CORONA is a part of AstraZeneca's extensive GALAXY clinical trials program, designed to address important unanswered questions in statin research. Currently, more than 69,000 patients have been recruited from 55 countries worldwide to participate in the GALAXY Program.
CRESTOR has now received regulatory approvals in over 90 countries. Over 11 million patients have been prescribed CRESTOR worldwide. Data from clinical trials and real world use shows that the safety profile for CRESTOR is in line with other marketed statins.
CRESTOR is a once-daily prescription statin medication indicated for use as an adjunct to diet in the treatment of various lipid disorders including primary hypercholesterolemia, mixed dyslipidemia and isolated hypertriglyceridemia, available in a 5-, 10-, 20-, and 40-mg dose. 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. For more complete prescribing information, please visit: www.crestor.com.
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%).
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 $26.47 billion and leading positions in sales of gastrointestinal, cardiovascular, neuroscience, respiratory, oncology and infection products. AstraZeneca is listed in the Dow Jones Sustainability Index (Global) as well as the FTSE4Good Index.
In the United States, AstraZeneca is a $12.44 billion healthcare business with more than 12,000 employees. For nearly three decades, AstraZeneca has offered drug assistance programs side by side with its medicines, and over the past five years, has provided over $3 billion in savings to more than 1 million patients throughout the US and Puerto Rico. AstraZeneca has been named one of the "100 Best Companies for Working Mothers" by Working Mother magazine and is the only large pharmaceutical company named to FORTUNE magazine's 2007 list of "100 Best Companies to Work For." In 2006, for the fifth consecutive year, Science magazine named AstraZeneca a "Top Employer" on its ranking of the world's most respected biopharmaceutical employers.
For more information about AstraZeneca, please visit: www.astrazeneca-us.com.
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