FDA Approves Roszet (rosuvastatin and ezetimibe) to Reduce LDL-C in Hyperlipidemia and Homozygous Familial Hypercholesterolemia

Althera Pharmaceuticals, a company focused on heart health, announced the FDA approval of Roszet (rosuvastatin and ezetimibe) tablets, as an adjunct to diet, for treatment of elevated low-density lipoprotein cholesterol (LDL-C) in adult patients with primary non-familial hyperlipidemia and in adult patients with homozygous familial hypercholesterolemia. Roszet contains rosuvastatin, a powerful statin for LDL-C reduction, and ezetimibe, an efficacious cholesterol absorption inhibitor. The two components work through distinct but complimentary mechanisms to give Roszet the power to significantly lower LDL-C.

  

“The optimal LDL-C levels in guidelines across the world have been shifting lower and now many patients need to get their LDL-C below 70 mg/dL,” said Dr. Christie Ballantyne, Chief of Cardiology and Cardiovascular Research at Baylor College of Medicine. “These levels can be quite difficult to achieve with just a statin on top of diet and exercise. Rosuvastatin and ezetimibe have been extensively studied in combination therapy and have been shown to significantly reduce LDL cholesterol beyond the statin alone. Combination therapy has been widely used in hypertension to achieve lower blood pressure targets. This new therapy provides a high efficacy statin plus ezetimibe in a single once daily pill which is a powerful new option to help get patients to the desirable LDL goal without increasing pill burden or requiring addition of injectable therapies”

"With Roszet’s approval in the U.S., we reaffirm our commitment to improving cholesterol treatment options for physicians and patients," said Sanjeev Agarwal, CEO of Althera Pharmaceuticals. "We are on a mission to positively impact patients’ health. By making this highly effective medicine available and affordable, we hope to improve the long-term health of patients, including those with prior cardiovascular disease.”

While a patient's out-of-pocket costs will vary depending on insurance status, the Roszet Savings Program aims to reduce co-pays to as little as $20 per month for eligible patients with commercial insurance coverage. Althera is continuing to work with all stakeholders to ensure that Roszet is affordable and accessible to all. Please visit http://www.roszet.com for more information and updates about the Roszet Savings Program and eligibility.

Availability

Roszet will be available in pharmacies in June 2021.

Roszet Indications, Dosage and Other Select Information

Roszet is indicated, as an adjunct to diet, in adults with primary non-familial hyperlipidemia to reduce low-density lipoprotein cholesterol (LDL-C), and alone or as an adjunct to other LDL-C lowering therapies in adults with homozygous familial hypercholesterolemia (HoFH) to reduce LDL-C.

Roszet is available as a once-daily tablet with rosuvastatin/ezetimibe dosages of 5 mg/10 mg, 10 mg/10 mg, 20 mg/10 mg and 40 mg/10 mg.

https://en.wikipedia.org/wiki/Ezetimibe

https://en.wikipedia.org/wiki/Rosuvastatin

Plant flavonols significantly reduce Alzheimer’s risk

A new study published in the journal Neurology in January 2020 concludes that increasing the intake of plant flavonols steeply reduces the risk of Alzheimer’s dementia (AD) by up to a half. In other words, AD could be prevented in many people simply by regularly eating and drinking more foods containing these compounds such as tea, oranges, and broccoli.

Alzheimer’s disease

AD is a progressive brain disorder in which the individual loses cognitive skills, including memory and thinking skills, and the ability to perform simple tasks. It is by far the leading cause of such disorders and affects over 5 million Americans.

One study was carried out on over 900 people, who were part of a community-wide ongoing larger research project called the Rush Memory and Aging (MAP) Project. These participants were assessed yearly for their neurologic health and dietary patterns, for an average of 6 years, but some for as long as 12 years. The average age was 81 years, and 3 out of 4 were female.

The findings

In the first study, 220/921 participants developed AD during the study. The risk of AD fell with a greater intake of flavonols. This finding held good even after the researchers adjusted for other health-associated factors – because those with the highest total flavonol intake were also the best educated, most active and took part in more cognitive activities. They also accounted for genetic factors like the presence of the APOE4 gene, and for cardiovascular risk factors that could influence the risk of AD, such as diabetes mellitus, history of heart attack, or stroke, or hypertension.

When classified into five groups based on decreasing flavonol intake, the participants in the first group (highest intake) consumed over 15 mg of flavonols a day. Compared to those in the lowest fifth (about 5 mg a day), these individuals showed an approximately 50% reduction in AD risk.

In concrete terms, 28 of 186 patients in the highest-intake group developed AD, vs. 54 of 182 in the lowest-intake group.

With respect to individual flavonols, kaempferol intake was linked to a reduction of almost 50%, and both myricetin and isorhamnetin by 40% each. A fourth flavonol, called quercetin, had no noticeable effect on AD risk.

Participants with the highest flavonol intake drank about one cup of black tea a day. Kale, and about a glass of red wine each day, could also supply flavonols.

Sources of flavonols

Kaempferol is richly present in green leafy vegetables, including spinach, broccoli, beans, tea and kale – and also in tea. Isorhamnetin-rich foods include olive oil, red wine, pears and tomato sauce. Myricetin is found in tea, kale, oranges, tomatoes and red wine.

Researcher Thomas Holland says, “More research is needed to confirm these results, but these are promising findings. Eating more fruits and vegetables and drinking more tea could be a fairly inexpensive and easy way for people to help stave off Alzheimer's dementia.”

Implications

Many scientists disagree with the emphasis on flavonols. Though these were thought to have antioxidant activity in the body, this theory was discredited many decades earlier. Antioxidant activity ceases when they are ingested and subjected to the activity of enzymes in the digestive tract.

They point out that flavonols are found in many plants, fruits and vegetables, which have been associated with good health for centuries. Nutritionists say that the AD-delaying effects of such foods are likely due to other plant chemicals which are relatively more abundant. On the other hand, taking flavonol pills or tea extracts is unlikely to produce the same healthful effect, and overdoses could be counterproductive.

This is not to say that eating more flavonol-rich foods or drinking a cup of black tea in the morning would hurt, since any foods containing these chemicals would also contain many more healthful compounds including vitamins, minerals and plant fiber. Holland makes a valid point with his conclusion: “'With the elderly population increasing worldwide, any decrease in the number of people with this devastating disease, or even delaying it for a few years, could have an enormous benefit on public health.”

https://n.neurology.org/content/early/2020/01/29/WNL.0000000000008981

Plant flavonols significantly reduce Alzheimer’s risk

Eating plant-based diet can reduce risk for heart problems in people with type 2 diabetes

Plant-based diets improve glycemic control, lead to weight loss, and improve cholesterol in people with type 2 diabetes, according to a new review published in the journal Clinical Nutrition.

Researchers reviewed nine randomized controlled trials that assessed the effectiveness of vegan and vegetarian diets for diabetes patients. The results show that those who ate a plant-based diet lowered their cholesterol, lost weight, lowered HbA1c levels, and improved other cardiometabolic risk factors when compared to those who ate a nonvegetarian diet.

More than 100 million Americans currently have diabetes or prediabetes. Those with diabetes are two to four times more likely to die from cardiovascular disease than those who do not have diabetes.

"The link between diabetes and cardiovascular disease is strong. Sixty to seventy percent of people who have type 2 diabetes die of heart disease," says study co-author Hana Kahleova, M.D., Ph.D., director of clinical research at the Physicians Committee for Responsible Medicine. "The good news is that this study shows that the same simple prescription--eating a plant-based diet--can reduce our risk for heart problems and improve type 2 diabetes at the same time."

The study authors suggest that plant-based diets, which center on fruits, vegetables, grains, and legumes, benefit both glycemic control and cardiovascular health, because they are low in saturated fat, rich in phytochemicals, high in fiber, and often rich in low-glycemic fruits and vegetables.

Previous controlled trials and prospective cohort studies have shown that a plant-based dietary pattern is associated with a lower risk of coronary heart disease, type 2 diabetes, obesity, hypertension, cardiovascular mortality, and all-cause mortality.

Ref : https://www.elsevier.com/books/vegetarian-and-plant-based-diets-in-health-and-disease-prevention/mariotti/978-0-12-803968-7#

Diet rich in fiber may reduce risk of developing lung disease

A diet rich in fiber may not only protect against diabetes and heart disease, it may reduce the risk of developing lung disease, according to new research published online, ahead of print in the Annals of the American Thoracic Society.

Analyzing data from the National Health and Nutrition Examination Surveys, researchers report in "The Relationship between Dietary Fiber Intake and Lung Function in NHANES," that among adults in the top quartile of fiber intake:

•68.3 percent had normal lung function, compared to 50.1 percent in the bottom quartile.

•14. 8 percent had airway restriction, compared to 29.8 percent in the bottom quartile.

In two important breathing tests, those with the highest fiber intake also performed significantly better than those with the lowest intake. Those in the top quartile had a greater lung capacity (FVC) and could exhale more air in one second (FEV1) than those in the lowest quartile.

"Lung disease is an important public health problem, so it's important to identify modifiable risk factors for prevention," said lead author Corrine Hanson PhD, RD, an associate professor of medical nutrition at the University of Nebraska Medical Center. "However, beyond smoking very few preventative strategies have been identified. Increasing fiber intake may be a practical and effective way for people to have an impact on their risk of lung disease."

Diet rich in fiber may reduce risk of developing lung disease: A diet rich in fiber may not only protect against diabetes and heart disease, it may reduce the risk of developing lung disease, according to new research published online, ahead of print in the Annals of the American Thoracic Society.