AstraZeneca
(NYSE:AZN) today announced the results of three analyses of data from
the National Health and Nutrition Examination Survey (NHANES), all of
which supported that an unmet treatment need still exists for
dyslipidemia patients, particularly those at high-risk. These data were
presented at the 2013 American Heart Association (AHA) Scientific
Sessions in Dallas, Texas.
Dyslipidemia (an abnormality of serum lipids and lipoproteins in the
blood) is a well-recognized risk factor for cardiovascular disease
(CVD). More than 100 million U.S. adults have dyslipidemia. Around 71
million American adults have high levels of LDL (“bad”) cholesterol and
an estimated 5 million American adults have very high triglyceride
levels (>500 mg/dL). The results of these new analyses suggest that the
proportion of U.S. adults with dyslipidemia who are not meeting
recommended LDL-C and non-HDL-C goals remains high, despite the
availability of effective treatments.
“Although significant steps have been made over the years in
understanding, identifying and developing treatments for dyslipidemia,
these data reinforce the fact that more still needs to be done to raise
awareness of the importance of dyslipidemia management,” said Dr. Philip
de Vane, Executive Director of Medical Affairs and Strategic Development
at AstraZeneca.
Specifically, the following three abstracts sponsored by AstraZeneca
were presented:
-
Failure of Moderately High-Risk Patients to Achieve Recommended
Low-Density Lipoprotein Cholesterol Target: The National Health and
Nutrition Examination Survey 2003–2010 (poster #15945; presented
November 18)
-
The authors of this analysis found that approximately 118.3
million U.S. adults (81%) at moderately-high risk of coronary
heart disease are not meeting an LDL-C target of <130 mg/dL. The
researchers conclude that these data highlight the need for
increased screening of patients for dyslipidemia, greater HCP
education about treatment guidelines, and further patient
education about the importance of dyslipidemia treatment and
adherence.
-
Prevalence of Suboptimal Non-High-Density Lipoprotein Cholesterol
in U.S. Adults with Hypertriglyceridemia: the National Health and
Nutrition Examination Survey 2003–2010(poster #15921; presented
November 18)
-
The authors of this analysis found that approximately 86.6% of
U.S. adults with hypertriglyceridemia (hyperTG) had elevated
non-HDL-C levels (>130 mg/dL) and only an estimated 1.6% of U.S.
adults with hyperTG achieved optimal non-HDL-C levels of less than
100 mg/dL.
-
Lack of Improvement in Low-Density Lipoprotein Cholesterol Goal
Attainment in the United States: A Time-Sensitivity Analysis from the
National Health and Nutrition Examination Survey 2003–2010 (poster
#15889; presented November 20)
-
The authors of this analysis found that LDL-C goal attainment has
not improved over time from 2003-2010, even among moderately
high-risk and high-risk patients. The researchers conclude that in
order to improve goal attainment rates, educational approaches
need to be reassessed and guideline implementation needs to be
improved.
“AstraZeneca is proud to sponsor these abstracts as we understand the
importance of ongoing research into CVD and its risk factors,” said Dr.
de Vane. “We strive for scientific leadership; developing clinical
insights is the foundation of what we do to address the world’s most
critical unmet medical needs—and presently, there are none greater than
in CVD. AstraZeneca is committed to cardiovascular research and we are
enhancing our efforts to educate both patients and HCPs about the
identification, prevention, and management of CVD.”
AstraZeneca is also committed to pioneering innovative treatment options
for management of CVD risk factors. With over a decade of cardiovascular
experience, AstraZeneca has already developed a robust CV portfolio,
including CRESTOR® (rosuvastatin calcium) for the treatment
of patients with high cholesterol or hypertriglyceridemia. Our vision
for the future is to continue our legacy of delivering great medicines
to patients through scientific research, innovation, and excellence.
INDICATIONS for CRESTOR® (rosuvastatin
calcium) Tablets
CRESTOR is indicated as an adjunct to diet to reduce elevated Total-C,
LDL-C, ApoB, non-HDL-C, and triglycerides, and to increase HDL-C in
adult patients with primary hyperlipidemia or mixed dyslipidemia and 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 indicated to reduce the risk of myocardial infarction,
stroke, and arterial revascularization procedures in patients without
clinically evident coronary heart disease but with an increased risk of
cardiovascular disease (CVD) based on age (men ≥50 and women ≥60),
high-sensitivity C-reactive protein (hsCRP) ≥2 mg/L, and the presence of
at least one additional CVD risk factor, such as hypertension, low
HDL-C, smoking, or a family history of premature coronary heart disease.
Important Safety Information about CRESTOR
-
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 statins, 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 ≥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, lopinavir/ritonavir, or atazanavir/ritonavir
-
Therapy with CRESTOR should be discontinued if markedly elevated CK
levels occur or myopathy is diagnosed or suspected. There have been
rare reports of immune-mediated necrotizing myopathy associated with
statin use. All patients should be advised to promptly report
unexplained muscle pain, tenderness, or weakness, particularly if
accompanied by malaise or fever, and if muscle signs and symptoms
persist after discontinuing CRESTOR
-
It is recommended that liver enzyme tests be performed before the
initiation of CRESTOR and if signs or symptoms of liver injury occur.
All patients treated with CRESTOR should be advised to promptly report
any symptoms that may indicate liver injury, including fatigue,
anorexia, right upper abdominal discomfort, dark urine, or jaundice.
There have been rare postmarketing reports of fatal and non-fatal
hepatic failure in patients taking statins, including CRESTOR. If
serious liver injury with clinical symptoms and/or hyperbilirubinemia
or jaundice occurs during treatment with CRESTOR, promptly interrupt
therapy. If an alternate etiology is not found, do not restart CRESTOR
-
CRESTOR should be used with caution in patients who consume
substantial quantities of alcohol and/or have a history of chronic
liver disease
-
Increases in HbA1c and fasting serum glucose levels have been reported
with statins, including CRESTOR. Based on clinical trial data with
CRESTOR, in some instances these increases may exceed the threshold
for the diagnosis of diabetes mellitus
-
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%)
-
Rare postmarketing reports of cognitive impairment (eg, memory loss,
forgetfulness, amnesia, memory impairment, confusion) have been
associated with statin use, including CRESTOR. These reports are
generally nonserious and reversible upon statin discontinuation
-
CRESTOR 40 mg should be used only for those patients not achieving
their LDL-C goal with 20 mg
Please read the full Prescribing
Information.
If you have any questions concerning prescription-only CRESTOR, please
visit CRESTOR.com
or contact AstraZeneca at 1-800-CRESTOR.
NOTES TO EDITORS
About AstraZeneca
AstraZeneca is a global, innovation-driven biopharmaceutical business
with a primary focus on the discovery, development and commercialization
of prescription medicines for gastrointestinal, cardiovascular,
neuroscience, respiratory and inflammation, oncology and infectious
disease. AstraZeneca operates in over 100 countries and its innovative
medicines are used by millions of patients worldwide.
For more information about AstraZeneca in the U.S. or our AZ&Me™
Prescription Savings programs, please visit: www.astrazeneca-us.com
or call 1-800-AZandMe (292-6363).
CRESTOR is a registered trademark, and AZ&Me is a trademark of the
AstraZeneca group of companies.
©2013 AstraZeneca. All rights reserved.
2926710 11/13
Copyright Business Wire 2013