Wednesday, 20 November 2013
Data presented at the 2013 American Heart Association (AHA) Scientific Sessions underscore AstraZeneca’s commitment to cardiovascular disease risk factor management
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
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.
Elizabeth Renz 302-885-1936 Elizabeth.Renz@AstraZeneca.com