Posted on 11/18/2008 10:43:32 PM PST by neverdem
New data from the JUPITER study demonstrated that CRESTOR (rosuvastatin calcium) 20 mg significantly reduced major cardiovascular (CV) events (defined in this study as the combined risk of myocardial infarction, stroke, arterial revascularization, hospitalization for unstable angina, or death from CV causes) by a dramatic 44% compared to placebo (p<0.001) among men and women with elevated hsCRP but low to normal cholesterol levels.
Results also showed that for patients in the trial taking rosuvastatin:
These results were accompanied by a median LDL-C reduction of 50% (p<0.001) resulting in an on-treatment median LDL-C of 55 mg/dL.
On the basis of the data, if the results are projected over a period of 5 years, 25 patients would need to be treated to prevent one major cardiovascular event (NNT=25).
The JUPITER results will be presented today at the American Heart Association Scientific Sessions and were simultaneously published online by the New England Journal of Medicine.
"These results provide new information about CRESTOR's effects on CV risk. The JUPITER trial confirmed that CRESTOR dramatically reduces LDL-C cholesterol levels and has now demonstrated a nearly 50% reduction in the risk of heart attack and stroke in a population of patients who had elevated hsCRP but low to normal cholesterol levels," said Howard Hutchinson, Chief Medical Officer for AstraZeneca. "As is appropriate, the medical community, regulators, and guideline committees will now carefully consider these data and any implications for treating patients."
As previously guided, AstraZeneca expects to file a regulatory submission including the JUPITER data in the first half of 2009 and if approved, will begin promotional activities within the approved labeling.
Rosuvastatin is not indicated for the prevention of cardiovascular events. Rosuvastatin should be used according to the prescribing information, which contains recommendations for initiating and titrating therapy according to the individual patient profile. In most countries, the usual recommended starting dose of rosuvastatin is 10 mg.
Rosuvastatin 20 mg was well tolerated in nearly 9,000 patients during the course of the study. There was no difference between treatment groups for major adverse events, including cancer or myopathy. There was a small increase in physician reported diabetes consistent with data from other large placebo controlled statin trials.
Abobut JUPITER
JUPITER (Justification for the Use of statins in Primary prevention: an Intervention Trial Evaluating Rosuvastatin) was a long-term, randomized, double-blind, placebo-controlled, large-scale study of 17,802 patients designed to determine if rosuvastatin 20 mg decreases the risk of heart attack, stroke and other major cardiovascular events in patients with low to normal LDL-C but at increased cardiovascular risk as identified by elevated high-sensitivity C-reactive protein (hsCRP) and age. The majority of patients had at least one other risk factor including hypertension, low HDL-C, family history of premature coronary heart disease (CHD) or smoking. hsCRP is a recognized marker of inflammation which is associated with an increased risk of atherosclerotic cardiovascular events.
JUPITER 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.
About CRESTOR (ROSUVASTATIN CALCIUM)
Studies have previously shown that CRESTOR was the most effective statin at lowering LDL-C, had a significant effect on raising HDL-C and slowed the progression of atherosclerosis, an underlying cause of cardiovascular disease.
CRESTOR has now received regulatory approval in over 95 countries. Nearly 15 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.
Important Safety Information
CRESTOR is indicated as an adjunct to diet to reduce elevated Total-C, LDL-C, ApoB, non-HDL-C, and TG levels and to increase HDL-C in patients with primary hyperlipidemia and mixed dyslipidemia. CRESTOR is also indicated as an adjunct to diet to slow the progression of atherosclerosis in adult patients as part of a treatment strategy to lower Total-C and LDL-C to target levels. CRESTOR is not approved to prevent cardiovascular morbidity and mortality.
CRESTOR is contraindicated in patients with a known hypersensitivity to any component of this product, in patients with active liver disease, which may include unexplained persistent elevations of hepatic transaminase levels, in women who are pregnant or may become pregnant, and in nursing mothers.
Cases of myopathy and rhabdomyolysis with acute renal failure secondary to myoglobinuria have been reported with HMG-CoA reductase inhibitors, including CRESTOR. These risks can occur at any dose level, but are increased at the highest dose (40 mg).
CRESTOR should be prescribed with caution in patients with predisposing factors for myopathy (eg, age greater than or equal to 65 years, inadequately treated hypothyroidism, renal impairment). The risk of myopathy during treatment with CRESTOR may be increased with concurrent administration of some other lipid-lowering therapies (fibrates or niacin), gemfibrozil, cyclosporine, or lopinavir/ritonavir.
Therapy with CRESTOR should be discontinued if markedly elevated CK levels occur or myopathy is diagnosed or suspected. All patients should be advised to promptly report unexplained muscle pain, tenderness, or weakness, particularly if accompanied by malaise or fever. It is recommended that liver enzyme 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. Should an increase in ALT or AST of >3 times ULN persist, reduction of dose or withdrawal of CRESTOR is recommended. CRESTOR should be used with caution in patients who consume substantial quantities of alcohol.
CRESTOR 40 mg should be used only for those patients not achieving their LDL-C goal with 20 mg. Patients initiating CRESTOR therapy or switching from another statin should begin treatment with CRESTOR at the appropriate starting dose.
In the controlled clinical trials database, the most common adverse reactions were headache (3.7%), myalgia (3.1%), abdominal pain (2.6%), asthenia (2.5%), and nausea (2.2%).
Please see accompanying full Prescribing Information.
About AstraZeneca
AstraZeneca is a major international healthcare business engaged in the research, development, manufacturing and marketing of meaningful prescription medicines and supplier for healthcare services. AstraZeneca is one of the world's leading pharmaceutical companies with healthcare sales of $29.55B and is a leader in gastrointestinal, cardiovascular, neuroscience, respiratory, oncology and infectious disease medicines. In the United States, AstraZeneca is a $13.35B dollar healthcare business with 12,200 employees committed to improving people's lives. AstraZeneca is listed in the Dow Jones Sustainability Index (Global) as well as the FTSE4Good Index.
For more information visit www.astrazeneca-us.com.
SOURCE: AstraZeneca
About 5 months ago, my brother suddenly - without warning - collapsed and died of a heart attack. He was only 42 years old. The autopsy report indicated coronary artery disease. I wonder if he had been taking this medication things would be different.
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You have my sincere condolences for the loss of your brother. Does your family have a history of sudden cardiac death? If so, see your doc.
I’m sorry to hear about the loss of your brother; I lost a sister the same way when she was 52 .. no clue, seemingly healthy. Hopefully, this drug will save others the pain we experienced.
I’ve already forwarded to a few friends and will look forward to talking to my own doctor about it.
November 11, 2008
All this hype about the preventative aspects of AstraZeneca’s (AZN) Crestor study published in Sunday’s New England Journal of Medicine. Looking at Table 3 (“Outcomes”) shows only 49 fewer people died on Crestor than taking a placebo in a population of 17,802 study participants. Even less impressive, there were only 109 fewer participants who had a first time cardiac event taking Crestor versus the placebo.
It’s easy to tout percentage differences such as the endlessly reiterated 44% benefit of Crestor versus placebo, but that statistic is meaningless considering the infinitesimal number of actual events. Less than 400 cardiac events (2.2%) and under 450 total deaths (2.5%) were experienced in this extremely large study group. Given the side effects caused by statins which can necessitate additional medical treatment, it’s hard to justify the cost/benefit of medicating when the risks of this population are so low for cardiac events.
It’s fitting that the Crestor study is called Jupiter. Just like the largest planet in our solar system, AstraZeneca has big plans to expand Crestor sales to people with normal cholesterol profiles who have elevated levels of C-reactive protein (CRP) not caused by inflammatory conditions such as arthritis. Since 50% of all heart attacks occur in people with normal cholesterol levels, AstraZeneca believes CRP could be a factor in causing cardiovascular events. The Jupiter trial was fully funded and sponsored by AstraZeneca. 11,001 “apparently healthy” 60+ year old men and 6,801 50+ women with normal cholesterol profiles and no history of cardiovascular disease, but with elevated CRP levels participated. The study was divided equally between those taking Crestor and those taking a placebo. The five year study trial was halted early with a midpoint of 1.9 years of treatment. Crestor comes in 5, 10, 20, and 40 mg dosage levels. Study participants taking Crestor took the 20 mg dosage which according to information on the Crestor website, is for patients “with marked hypercholesterolemia, and aggressive lipid targets.”
This seems a bit extreme for the characteristics of this study group. Dr. Paul Ridker, a cardiologist at Harvard Medical School and Brigham and Women’s Hospital, led the Jupiter study and presented the results at yesterday’s annual scientific meeting of the American Heart Association. Dr. Ridker is an inventor of CRP-related patents held by Brigham. Dr. Ridker and his New England Journal co-authors have received grants and other fees from AstraZeneca. AstraZeneca is hoping the Jupiter study results will influence government- recommended cholesterol guidelines to be expanded next year to increase the number of prescriptions for Crestor.
Marketing Crestor specifically for elevated CRP will require the FDA to approve a label change which is not likely to happen until 2010, if at all. While Pfizer (PFE) is seeing reduced economic value in reinvesting in its cholesterol franchise (Lipitor), AstraZeneca appears to be pumping as much air in the cholesterol bubble as it can muster.
http://seekingalpha.com/article/105274-astrazenecas-crestor-trial-more-hype-than-benefit
What a joke! Read Table 3!! LOL! I guess Astrazeneca is the Pharma Napoleon....still overcompensating for the PR disaster from the 2005 Tufts Study and the FDA health advisory....
Wow! Full blown advertisements disguised as discussion threads! What’s next, V!@gra spam?
Quit griping and get in at the ground level. You’ll be a Double-Diamond Crestor exec in two years.
No doctor will ever get me on a statin drug. I've seen the side effects. This is nothing more than an attempt to spur drug sales. I am not impressed.
These drug pushers do not care about the side effects.
If a statin is taken....PLEASE use at least 100mg of the crystal free CoQ10 a day to counteract the drugs side effects!! What is really interesting is how many Docs poo-poo the CoQ10 when it is cleary written in the drug manufacturers literature that the drug depletes CoQ10 and depending on the overall health of the patient....at a very rapid rate!
“Our office strongly encourages the use of complimentary and alternative solutions to cardiac and cholestrol issues......and discourage statins of any kind.”
Good for you. There are some major side effects from these drugs. As you are probably aware, dementia is another one.
See:
http://seniorjournal.com/NEWS/Health/5-12-21-StateSideEffects.htm
.
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