Abbott (NYSE: ABT) has submitted a supplemental new drug application (sNDA) to the U.S. Food and Drug Administration (FDA) for two new dosage strengths of SIMCOR® , a cholesterol medication. SIMCOR is a fixed-dose combination of niacin extended-release and simvastatin. Abbott is seeking FDA approval for the following new dosage strengths of SIMCOR: 500/40 mg and 1000/40 mg (niacin extended-release/simvastatin). SIMCOR was approved by the FDA in February 2008 in the following strengths: 500/20 mg, 750/20 mg and 1000/20 mg. The original FDA approval was supported by results from the SEACOAST trial, which demonstrated efficacy and safety of SIMCOR up to doses of 2000/40 mg daily in patients with mixed dyslipidemia and type II hyperlipidemia. SIMCOR is a prescription medicine used along with diet in people who cannot control their cholesterol levels by diet and exercise alone. SIMCOR is approved to lower levels of elevated total cholesterol, LDL "bad" cholesterol and triglycerides, and to raise HDL "good" cholesterol.
SDI Reports: Prescriptions For Patients New To Niaspan Rise 41 In Week Following Release Of Arbiter 6-HALTS Study Results
In the week ending Friday, Nov. 20 - after the American Heart Association and New England Journal of Medicine released results of the Arbiter 6-HALTS study on Saturday, Nov. 14 - patients new to Niaspan filled 13, 255 prescriptions for the cholesterol therapy, an increase of 41% from the week ending Nov. 13. This data comes from Vector One® : National (VONA), SDI's national-level prescription and patient tracking service. VONA provides a comprehensive overview of the national performance of all prescription drugs dispensed by retail pharmacies. Niaspan prescriptions rose for patients who had never before taken a cholesterol therapy, as well as patients adding Niaspan to their current cholesterol treatment or switching from a different cholesterol medicine to Niaspan. Niaspan prescriptions filled by patients who had not filled a script for a cholesterol therapy during the previous 12 months grew 34% in the week ending Nov. 20 compared with the prior week. Prescriptions dispensed to patients adding Niaspan to their current treatment or switching to Niaspan from a different cholesterol medicine increased 46%.
Risk factors for metabolic syndrome, such as obesity, high blood pressure, and elevated blood lipid levels, can increase a person's healthcare costs nearly 1.6-fold, or about $2, 000 per year. For each additional risk factor those costs rise an average of 24%, according to an illuminating article in a recent issue of Metabolic Syndrome and Related Disorders, a peer-reviewed journal published by Mary Ann Liebert, Inc. The article is available free online at http://www.liebertpub.com/met A two-year study that compared annual healthcare costs for people with and without diabetes found both higher healthcare utilization and significantly greater expenses ($5, 732 versus $3, 581 per year) for those who had risk factors for metabolic syndrome. A group of researchers from the Center for Health Studies (Seattle, WA); United BioSource Corp. (Bethesda, MD); University of Arizona, Tucson; Kaiser Permanente's Colorado Clinical Research Unit in Denver and Northwest Center for Health Research in Portland, Oregon;
Since the introduction of statins to treat high cholesterol, the decline in lipid levels experienced by the wealthy has been double that experienced by the poor. While statins are highly effective in reducing cholesterol and improving heart health, their use may have contributed to expanding social disparities in the treatment of cardiovascular disease, according to research by Virginia W. Chang, MD, PhD, of the Philadelphia Veterans Affairs Medical Center and the University of Pennsylvania, and Diane S. Lauderdale, PhD, of the University of Chicago, published in the September issue of Journal of Health and Social Behavior. "Income disparities in lipid levels have reversed over the past three decades, " according to Dr. Chang, lead author and Assistant Professor of Medicine and Sociology at the University of Pennsylvania. "High cholesterol was once known as a rich man's disease, because the wealthy had easier access to high fat foods (e.g., red meat). Now wealthy Americans are least likely to have high cholesterol, because they are more likely to be treated with statins, an expensive but highly effective pharmaceutical treatment to lower lipid levels.
Resverlogix RVX-208 Second Clinical Trial Demonstrates Success On Key Reverse Cholesterol Transport Markers
Resverlogix Corp. ("Resverlogix" or the "Company") (TSX:RVX) announced that results from the Company's Phase 1b/2a clinical trial have met and exceeded expectations by successfully concluding the drug, RVX-208, is safe and tolerable. Most importantly RVX-208 has met its primary endpoint to increase the production of plasma ApoA-I, the key cardioprotective protein in high-density lipoprotein (HDL), often referred to as "good" cholesterol. ApoA-I is generally endorsed as a key protective factor against atherosclerosis and cardiovascular disease with 40% of all first heart attack patients having low ApoA-I. Resverlogix's Phase 1b/2a study tested RVX-208 for 28 days in three different dosing arms. The most pronounced results were demonstrated among those subjects with low HDL cholesterol levels. Low HDL is an important risk factor in coronary and cardiovascular disease patients. Resverlogix will continue to build upon its world leading position in development of novel small molecules that increase ApoA-l production and reverse cholesterol transport (RCT) markers in patients with high vascular risk profiles.
A derivative of cholesterol is necessary for the formation of brain cells, according to a study from the Swedish medical university Karolinska Institutet. The results, which are published in the journal Cell Stem Cell, can help scientists to cultivate dopamine-producing cells outside the body. The study was led by Professor Ernest Arenas and demonstrates that the formation of dopamine-producing neurons during brain development in mice is dependent on the activation of a specific receptor in the brain by an oxidised form of cholesterol called oxysterol. Dopamine-producing nerve cells play an important part in many brain functions and processes, from motor skills to reward systems and dependency. They are also the type of cell that dies in Parkinson's disease. The scientists have also shown that embryonic stem cells cultivated in the laboratory, form more dopamine-producing nerve cells if they are treated with oxidised cholesterol. The same treatment also reduced the tendency of the stem cells to show uncontrolled growth.
A new study by an international team of researchers found that cholesterol is important for the formation of brain cells, and they hope the findings will help scientists cultivate dopamine-producing cells outside the body. The study, which is published in the 2 October issue of the journal Cell Stem Cell, was the work of researchers from Sweden, the US, Australia and the UK and was led by Professor Ernest Arenas of the Center for Developmental Biology and Regenerative Medicine at Karolinska Institute in Stockholm, Sweden. One of the many challenges of using stem cells in medicine and research is how to control them so cell growth and proliferation does not get out of hand. Stem cell therapies have great potential as treatments for brain-wasting diseases such as Parkinson's disease, where motor function diminshes in line with decline in specialist brain cells that make the neurochemical dopamine which is essential for many brain processes, including motor skills and reward systems.
Teaming Up For Heart Disease: ASU's Biodesign Institute And Singapore's National University Health System
In a new international partnership, Dr. Randy Nelson, a researcher at Arizona State University's Biodesign Institute, and Dr. Tai E-Shyong, associate professor at Singapore's National University Hospital, National University Health System (NUHS), have teamed up to assess the risk of heart disease in diabetics with greater accuracy. The new study, funded by Singapore's National Medical Research Council, will focus on patients in Singapore with and without diabetes, a known risk factor of cardiovascular disease. The research team will examine blood samples from individuals, providing an early glimpse into the key role of a cholesterol component, the so-called 'good cholesterol, ' known as high-density lipoprotein, or HDL. The team's goal is to identify more accurate HDL biomarkers - tell-tale protein signatures - that have the potential to be earlier and more accurate predictors of cardiovascular disease risk. The stakes could hardly be higher. Heart disease has reliably ranked as the number one killer of both men and women, with more than 7 million deaths per year worldwide.
A new study shows uninsured American adults with chronic illnesses like diabetes or high cholesterol often go undiagnosed and undertreated, leading to an increased risk of costly, disabling and even lethal complications of their disease. The study, published online in Health Affairs, analyzed data from a recent national survey conducted by the Centers for Disease Control and Prevention (CDC). The researchers, based at Harvard Medical School and the affiliated Cambridge Health Alliance, analyzed data on 15, 976 U.S. non-elderly adults from the National Health and Nutrition Examination Survey (NHANES), a CDC program, between 1999 and 2006. Respondents answered detailed questions about their health and economic circumstances. Then doctors examined them and ordered laboratory tests. The study found that about half of all uninsured people with diabetes (46 percent) or high cholesterol (52 percent) did not know they had these diseases. In contrast, about one-quarter of those with insurance were unaware of their illnesses (23 percent for diabetes, 29.
New Phase III data published in "Current Medical Research and Opinion" highlight that the recommended starting dose of 2 mg of LIVALO (pitavastatin), a novel synthetic statin, was statistically superior to simvastatin at a dose of 20 mg over 12 weeks in reducing low-density lipoprotein cholesterol (LDL-C), non-high-density lipoprotein cholesterol (non-HDL-C) and total cholesterol (TC) in patients with primary hypercholesterolemia and combined dyslipidemia. With respect to LDL-C goal attainment, treatment with LIVALO was comparable to simvastatin according to the National Cholesterol Education Program (NCEP) Adult Treatment Panel (ATP) III guidelines, but was superior based on European Atherosclerosis Society (EAS) guidelines. Although statins are proven to reduce LDL-C levels, many patients treated with statins fail to reach or maintain recommended LDL-C goals. As many as six out of ten patients stop taking statins during the first twelve months, often due to poor compliance and/or side effects.