CRESTOR(R) Reduced Risk of Blood Clots in the Veins
cut the risk of venous thromboembolism (VTE) by 43% (p =0.007) compared to
placebo among men and women with low to normal cholesterol levels and elevated
high-sensitivity C-reactive protein (hsCRP). This analysis was presented today
at the 58th Annual American College of Cardiology Scientific Sessions (ACC) in
Medicine.
Venous thromboembolism, a serious and sometimes fatal condition, occurs
when a blood clot forms in a vein. The most common form of VTE is deep vein
thrombosis (DVT), which occurs in the ‘deep veins’ usually in the legs or
pelvis. An embolism is created if the clot travels through the venous system.
Blood clots lodging in the lungs are known as a pulmonary embolism (PE).
Estimates suggest that at least 350,000 and as many as 600,000 Americans
annually develop DVT/PE, and at least 100,000 deaths are thought to be related
to these diseases each year.
Additional results of this secondary endpoint analysis of
rosuvastatin 20mg produced a significant 55% (p=0.004) reduction in the risk
of DVT and a non-significant 23% reduction in PE (p=0.42).
“This is the first time a statin has been shown to reduce the risk of VTE
in a randomized, prospective study,” said
Clinical Development, AstraZeneca US. “This result is in addition to the
effect on cardiovascular events already demonstrated by CRESTOR in the primary
analysis of
Rosuvastatin 20mg was well tolerated in nearly 9,000 patients during the
course of the
ABOUT
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.
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.
AstraZeneca has previously announced that it expects to file a regulatory
submission including the
approved will begin promotional activities within the approved labeling.
ABOUT CRESTOR (ROSUVASTATIN CALCIUM):
Studies have previously shown that CRESTOR significantly lowered LDL-C,
had a significant effect on raising HDL-C and slowed the progression of
atherosclerosis, the build-up of plaque in the arteries.
CRESTOR has now received regulatory approval in over 90 countries. More
than 13 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 adult patients
with primary hyperlipidemia and mixed dyslipidemia. CRESTOR is also indicated
as an adjunct to diet to slow the progression of atherosclerosis 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. If you have any
questions concerning CRESTOR, please contact AstraZeneca at 1-800-237-8898.
CRESTOR is a registered trademark of the AstraZeneca group of companies.
ABOUT ASTRAZENECA:
AstraZeneca (NYSE: AZN) is engaged in the research, development,
manufacturing and marketing of meaningful prescription medicines and in the
supply of healthcare services. AstraZeneca is one of the world’s leading
pharmaceutical companies with global healthcare sales of
a leader in gastrointestinal, cardiovascular, neuroscience, respiratory,
oncology and infectious disease medicines. In
is a
For more information about AstraZeneca in the US or our AZ&Me(TM)
Prescription Savings programs, please visit: www.astrazeneca-us.com.
SOURCE AstraZeneca