Healthcare Industry News: rosuvastatin
News Release - March 24, 2006
First-Ever Large-Scale Prospective Study in Hispanic Patients With Elevated Cholesterol Demonstrates Significant Cholesterol Reductions With CRESTOR(R)WASHINGTON, March 24 (HSMN NewsFeed) -- New data presented today at the National Hispanic Medical Association (NHMA) annual meeting showed that AstraZeneca's CRESTORŽ (rosuvastatin calcium) at 10 and 20 mg reduced LDL-C or "bad" cholesterol by 45.2 and 50.0 percent, compared to 35.9 and 42.4 percent with atorvastatin at milligram-equivalent doses in Hispanic patients with elevated cholesterol (p<0.017 vs. milligram-equivalent doses of atorvastatin). STARSHIP (STudy Assessing rosuvastatin in HIspanic Population) is the first-ever large-scale, prospective trial exclusively designed to compare the effects of statins in Hispanic patients, who have generally been underrepresented in clinical trials.
"STARSHIP is the first trial to demonstrate significantly greater efficacy in lowering LDL-cholesterol in Hispanic patients using milligram equivalent doses of CRESTOR compared to atorvastatin," said Dr. Ramon Lloret, STARSHIP lead investigator and president of the Cardiovascular Center of South Florida in Miami. "As a Hispanic physician who treats this traditionally underserved population, I see firsthand the importance of this study. The STARSHIP trial represents an important opportunity to demonstrate the efficacy and safety of statins in this population."
STARSHIP was a six-week, randomized, controlled, open-label, multi-center trial designed to evaluate the efficacy of CRESTOR and atorvastatin in Hispanic patients with elevated cholesterol. After a six-week dietary lead- in, 696 Hispanic adults predominantly medium and high-risk patients as defined by NCEP ATP III guidelines, with a history of coronary heart disease (CHD), CHD risk equivalent, or 10-yr Framingham CHD risk event equal or greater than 10 percent, were randomized to one of four open-label treatments for six weeks: CRESTOR 10 or 20 mg or atorvastatin 10 or 20 mg. The overall safety experience was similar for all treatments in the STARSHIP study.
Additional data from STARSHIP demonstrated:
* Total cholesterol reduction by 32.4 and 34.9 percent with CRESTOR 10 and 20 mg compared with 25.6 and 30.9 percent for atorvastatin 10 and 20 mg (p<0.017 vs. milligram-equivalent doses of atorvastatin)
* Reduction of non-HDL-C by 40.9 and 44.6 percent with CRESTOR 10 and 20 mg compared with 32.6 and 39.2 percent for atorvastatin at the same dosages (p<0.017 vs. milligram equivalent doses of atorvastatin)
* Increase of HDL-C by 5.5 and 5.7 percent with CRESTOR at 10 and 20 mg compared with 3.5 and 4.3 percent with atorvastatin at milligram-equivalent doses
These data were also recently presented at the American College of Cardiology (ACC) annual meeting. A sub-study from STARSHIP focusing on C- reactive protein (CRP) was recently presented at the 46th Annual Conference on Cardiovascular Disease Epidemiology and Prevention in association with the Council on Nutrition, Physical Activity, and Metabolism sponsored by the American Heart Association and found that CRESTOR reduced CRP levels from baseline. These results showed an 18.8 and 26.7 percent reduction in median CRP levels with CRESTOR 10 and 20 mg compared to 16.8 and 23.8 percent reduction with atorvastatin at milligram equivalent doses (p<0.01 vs. baseline). CRP is a protein in the body that is a non-specific marker of inflammation.(1)
Hispanics and Elevated Cholesterol
According to the American Heart Association, high cholesterol is a serious health concern for Hispanic adults. Among Hispanic Americans age 20 and older, 51.9 percent of men and 44.8 percent of women have total blood cholesterol levels of 200 mg/dL or higher. Of these, nearly 17 percent of men and nearly 14 percent of women have total cholesterol over 240 mg/dl.(2) Furthermore, Hispanics are 36 percent less likely than Caucasians to have properly controlled cholesterol.(3)
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%).
A full copy of the prescribing information for CRESTOR is available at http://www.astrazeneca-us.com/pi/crestor.pdf, or by calling 1-877-420-7249.
STARSHIP is part of AstraZeneca's GALAXY Program, designed to address important unanswered questions in statin research and to investigate the impact of CRESTOR on cardiovascular risk reduction and patient outcomes.
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 $23.95 billion and leading positions in sales of gastrointestinal, cardiovascular, neuroscience, respiratory, oncology and infection products. In the United States, AstraZeneca is a $10.77 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: www.astrazeneca-us.com
(1)American Heart Association. "Inflammation, Heart Disease and Stroke: The Role of C-Reactive Protein." Online. Internet. 2005. Available: http://www.americanheart.org/presenter.jhtml?identifier=4648.
(2)American Heart Association. Hispanics/Latinos and Cardiovascular - Statistics - 2006 Update. Dallas, TX.; 2006.
(3)American Heart Association. "American Ethnic Groups less likely to have cholesterol controlled." Online. Internet. Available at http://www.americanheart.org/presenter.jhtml?identifier=3026059. Accessed February 15, 2006.
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