Fidest – Agenzia giornalistica/press agency

Quotidiano di informazione – Anno 31 n° 259

Posts Tagged ‘cholesterol’

Inclisiran Results in Persistent Lowering of LDL Cholesterol with No Material Safety Observations Out to Three Years

Posted by fidest press agency su lunedì, 20 maggio 2019

The Medicines Company (NASDAQ: MDCO) today announced interim results from the ongoing ORION-3 open-label extension study (Group 1, n=290) which showed that twice-a-year dosing with inclisiran sodium 300 mg resulted in consistent lowering of low density lipoprotein cholesterol (LDL-C) by more than 50 percent with overall follow-up of up to three years. Inclisiran was well tolerated, and no material safety issues were observed in the study. These results were presented today during a late-breaking clinical trial session at the National Lipid Association (NLA) Scientific Sessions in Miami.Inclisiran, the first cholesterol-lowering therapy in the siRNA class, is in Phase 3 clinical development to evaluate its ability to lower LDL-C through twice-a-year dosing. Pivotal Phase 3 readouts for inclisiran are expected in the third quarter. ORION-3 (n=382) is an open-label extension study of the Phase 2 ORION-1 trial to assess the efficacy, safety and tolerability of long-term dosing of inclisiran.“The cumulative effects of elevated LDL-C over time continue to place millions of people with atherosclerosis at increased cardiovascular risk, despite the widespread use of LDL cholesterol-lowering treatments,” said John J.P. Kastelein, M.D., Ph.D., ORION-3 study chair and Professor of Medicine at the Department of Vascular Medicine at the Academic Medical Center of the University of Amsterdam, The Netherlands. “These new data from ORION-3 provide further evidence of inclisiran’s unprecedented ability to deliver persistent LDL-C reductions over a prolonged period, which can help more patients reliably achieve LDL-C goals. Inclisiran also demonstrated a favorable safety profile, an important consideration given the long duration of LDL-C treatment.” In this interim analysis of ORION-3, inclisiran demonstrated a 51 percent (64.0 mg/dL, p<0.001) reduction in LDL-C levels through day 210, which was the study’s primary endpoint. The time-averaged absolute LDL-C reduction with inclisiran was 59.4 mg/dL (p<0.001). These effects were independent of dose level and number of doses of inclisiran previously given in the ORION-1 study.With overall follow-up of approximately three years from the first dose in ORION-1, no change in the overall safety profile was observed in this interim analysis of ORION-3 compared to the one-year follow-up in ORION-1. Inclisiran was well tolerated and no material safety issues were observed, including no elevations of liver enzymes or changes in renal function considered related to study medication. Clinically relevant injection site reactions were infrequent, mild or moderate, and transient, in line with observations in ORION-1. More than 3,000 patient-years of inclisiran safety data have been accumulated to date in the ORION program. The data from ORION-3, as well as ongoing review of blinded data to date from the Phase 3 trials, show no material safety issues; data are at least as favorable as those generated and published from the ORION-1 Phase 2 trial.

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Statin side effects are strongest predictor of failure to meet cholesterol targets

Posted by fidest press agency su sabato, 18 febbraio 2017

cardiologiaSophia Antipolis. Statin side effects are the strongest predictor of failure to meet low-density lipoprotein (LDL) cholesterol targets, according to research published today in the European Journal of Preventive Cardiology.1 Other predictors were statin non-adherence and use of weaker statins.“The beneficial effect of reducing LDL cholesterol on slowing the progression of coronary heart disease is overwhelmingly documented today in epidemiologic and randomised controlled studies,” said lead author Dr John Munkhaugen, a cardiology trainee and post-doctoral researcher at Drammen Hospital, Norway.“European guidelines2 recommend a blood LDL cholesterol goal of less than 1.8 mmol/l but just one in five cardiac patients taking lipid-lowering drugs achieve this,”3 he added.The NORwegian COR (NOR-COR) prevention project originates from the Department of Medicine at Drammen Hospital and is a collaboration between Drammen and Vestfold hospitals, and the Department of Behavioural Sciences in Medicine and Institute of Clinical Medicine, University of Oslo. It is investigating why patients fail to control risk factors including lipids and blood pressure after they have a cardiovascular event. This analysis examined the reasons why cardiac patients do not achieve the LDL cholesterol target.The study included 1,095 patients hospitalised with a first or recurrent coronary event or treatment (heart attack, coronary artery bypass graft, or coronary stent) who were identified from medical records at two Norwegian hospitals (Drammen and Vestfold). Sociodemographic, medical and psychosocial information was collected from medical records, an interdisciplinary self-report questionnaire, clinical examinations, and blood samples while patients were in hospital and at follow-up after two to 36 months.
The researchers found that 57% of patients were not meeting the LDL target of 1.8 mmol/l at follow-up. Statin specific side effects (mainly muscle complaints), low statin adherence, and moderate- or low-intensity statin therapy were the main reasons for failing to meet the target.Patients with side effects were more than three times more likely to miss the cholesterol target than those without side effects. Those who did not take their statins were three times more likely to miss the target than patients who did take them. Patients prescribed moderate- or low-intensity statins were 62% more likely to miss the target than those prescribed high-intensity statins.“We found the same three reasons for not meeting the target when LDL was analysed as a dichotomous or continous variable which confirms the strength of the associations,” said Dr Munkhaugen. “Surprisingly, low socioeconomic status and psychosocial factors did not predict failure to control LDL cholesterol.” “The findings show that the focus for interventions to improve LDL cholesterol control are statin side effects, and adherence to and prescription of sufficiently potent statins,” he continued.Dr Munkhaugen said more research was needed on why side effects of statins had such a big effect on meeting cholesterol goals. “Patients who experience side effects are probably more likely to reduce or terminate statin use, or their doctor may prescribe a weaker drug or take them off statins altogether,” he said. “Individual variations in how the body reacts to and uses the drug may also play a role.”The links between non-adherence and intensity of statin therapy on LDL cholesterol are likely explained by the pharmacological effects of the drug. “Not taking the prescribed amount of statins or being prescribed a weaker statin means there is less drug in the body to act and lower LDL,” said Dr Munkhaugen.“The reasons for statin non-adherence are a complex interaction between factors related to the patient and the healthcare system,” he added. “Interventions aiming to improve statin adherence have been a priority in recent years, but the success has been modest and short-lived.”
The study found that the use of high-intensity statins was significantly more frequent in patients who achieved the cholesterol target. But Dr Munkhaugen said: “The relationship with adherence and side effects needs to be clarified before advice can be given about the potency of statins that should be prescribed. Our findings point to the need for more research on ways to ensure adherence and prescription of sufficiently potent statins, while at the same time addressing side effects.”

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Myanmar warned against unhealthy lifestyles as hypertension and high cholesterol rise

Posted by fidest press agency su sabato, 15 ottobre 2016

ipertensione2Yangon, Myanmar Myanmar’s leading heart doctors have warned against unhealthy lifestyles as nearly one in three citizens are reported to have hypertension and half have high cholesterol. The call comes as the ASEAN Federation of Cardiology Congress 2016 (AFCC 2016) is held in the nation’s capital of Yangon from 14 to 16 October.“Poor lifestyle choices are unfortunately becoming the norm in Myanmar,” said Dr Nwe Nwe, scientific chair of AFCC 2016 and head of cardiology at Yangon General Hospital. “The result is that more people have coronary artery disease, stroke and renal failure than ever before.”Hypertension affects 25–30% of people over the age of 40 in Myanmar. Half of adults have high cholesterol, 12% have diabetes, and 15% are smokers. Risk factors are higher among patients with hypertension, of whom 30% have diabetes and 60% have high cholesterol.“Consumption of salt is high in Myanmar, with people preferring to eat preserved food with a high salt content,” said Dr Nwe Nwe. “People do not exercise regularly, and the intake of fruits and vegetables is low even though they are readily available in Myanmar.” She continued: “On top of that, many patients do not take their hypertensive medication or keep their diabetes under control by keeping an eye on blood sugar levels.” The most up-to-date evidence for the management of hypertension and high cholesterol will be discussed at AFCC 2016. Experts will present the latest information on how to prevent initial and recurrent heart attacks. Current management and surgical interventions of heart diseases including valve disease, heart failure and arrhythmias will be examined. Sessions will be held on congenital heart diseases in children.Leading figures from the European Society of Cardiology (ESC) will present a special programme which includes highlights from the European cardiovascular prevention guidelines.1,2 Professor Michel Komajda, a past president of the ESC and course director of the ESC programme in Myanmar, said: “Cardiovascular disease is the world’s number one killer and many deaths could be prevented with healthy lifestyles and adherence to medical treatment.” He continued: “The best way to stop heart disease is to quit smoking, do regular physical activity, eat healthy food, and take prescribed medications to control blood pressure and cholesterol.” The theme of AFCC 2016 is “Working Together for Heart Health”. Dr Nwe Nwe said: “ASEAN countries are working together to improve the prevention and management of cardiovascular disease through advocacy and research.”

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Detailed positive results from ODYSSEY ESCAPE

Posted by fidest press agency su martedì, 30 agosto 2016

Paris-antenne-vue-eiffel-tourParis, France and Tarrytown, New York Sanofi and Regeneron Pharmaceuticals, Inc. announced detailed positive results from ODYSSEY ESCAPE, a Phase 3 trial which evaluated Praluent® (alirocumab) Injection in patients with an inherited form of high cholesterol known as heterozygous familial hypercholesterolemia (HeFH) who require regular weekly or bi-weekly apheresis treatment. The trial demonstrated that adding Praluent to existing therapy reduced LDL cholesterol by approximately 50 percent from baseline (compared to 2 percent increase for placebo). Praluent significantly reduced the need for apheresis treatment by 75 percent compared to placebo (p<0.0001), the primary endpoint of the study. Results will be presented today at a Hot Line session at the ESC Congress 2016 in Rome, Italy. Apheresis is a procedure similar to kidney dialysis where bad (LDL) cholesterol is removed from the blood, and is usually reserved for high-risk patients with very high cholesterol unable to achieve their cholesterol-lowering goals on any other therapy. Despite being treated with apheresis and entering ODYSSEY ESCAPE with very high LDL cholesterol levels (4.7 millimoles/liter [mmol/L] or 181 milligrams/deciliter [mg/dL]), nearly two-thirds (63 percent) of patients treated with Praluent no longer required apheresis therapy after six weeks of receiving Praluent. At this same time point, the average LDL cholesterol level among the Praluent-treated group was 2.3 mmol/L (90 mg/dL), compared to 4.8 mmol/L (185 mg/dL) in the placebo group. European guidelines recommend LDL cholesterol target levels between 1.8-3.0 mmol/L (70-115 mg/dL), depending on cardiovascular risk. “Findings from ODYSSEY ESCAPE suggest a role for Praluent in the overall management of patients with HeFH undergoing regular apheresis therapy, with the potential to reduce the need for burdensome apheresis treatments,” said Patrick M Moriarty, MD, Professor, Department of Internal Medicine; Director, Atherosclerosis and Lipoprotein Apheresis Center, University of Kansas Medical Center, United States. “This is a significant development in the continued investigation of this drug in HeFH patients, because it is the first clinical trial to demonstrate that Praluent reduced the frequency of apheresis therapy.” Apheresis therapy is an invasive, time-consuming and expensive treatment for some of the most difficult-to-treat patients. Treatment may cost up to $100,000 for each patient per year in the U.S. or up to €60,000 in Germany, where there are 200 centers and LDL apheresis is more frequently used. In the U.S. there are only approximately 60 apheresis centers and many patients must travel significant distances for the procedure. Other key results from ODYSSEY ESCAPE, which will be concurrently published in the European Heart Journal, include: Ninety-three percent of patients treated with Praluent experienced at least a 50 percent reduction in their apheresis procedures (p>0.0001).Throughout the trial, patients treated with Praluent experienced significant reductions in their LDL cholesterol starting at week 6 (55 percent greater reduction compared to placebo), and lasting until the trial ended, at week 18 (46 percent greater reduction compared to placebo) (p<0.0001).A similar proportion of patients experienced adverse events (AEs) in both the Praluent and placebo groups (76 percent both groups). The most common AEs (occurring in at least 5 percent of the Praluent group) were: fatigue (15 percent Praluent; 10 percent placebo), nasopharyngitis (10 percent Praluent; 10 percent placebo), diarrhea (10 percent Praluent; 0 percent placebo), myalgia (10 percent Praluent; 5 percent placebo), upper respiratory infection (7 percent Praluent; 19 percent placebo), headache (7 percent Praluent; 5 percent placebo), arthralgia (7 percent Praluent; 10 percent placebo), and back pain (5 percent Praluent; 10 percent placebo).

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Low control for high cholesterol

Posted by fidest press agency su mercoledì, 2 febbraio 2011

The largest ever study – representing 147 million people – shows that most people with high cholesterol levels are not getting the treatment they need to reduce their risk of cardiovascular disease such as heart attack and stroke. Many of these people – living in England, Germany, Japan, Jordan, Mexico, Scotland, Thailand and the United States of America – are unaware that they need treatment, which is easily accessible in the form of low-cost medicines. This study, published today in the international public health journal, the Bulletin of the World Health Organization, is the first to show the extent of the treatment gap for high cholesterol – a common risk factor for early cardiovascular deaths. In Thailand, for example, 78% of adults surveyed had not been diagnosed, while in Japan, 53% of adults were diagnosed but remained untreated.
http://www.who.int/bulletin/volumes/89/02/10-079947.pdf
The Bulletin of the World Health Organization is one of the world’s leading public health journals. It is the flagship periodical of WHO, with a special focus on developing countries. Articles are peer-reviewed and are independent of WHO guidelines. Abstracts are now available in the six official languages of the United Nations. Further items in this month’s issue include:
•    What is the ideal weight gain during pregnancy? A study from Viet Nam
•    Modern contraceptive use in Africa stagnates
•    Radio programme helps combat food insecurity
•    Why so slow to develop new antibiotics?
•    Diabetes – a product of modern technology

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Chronic diseases

Posted by fidest press agency su martedì, 14 aprile 2009

Loma Linda University research just published in the American Journal of Clinical Nutrition compares the effects of walnuts and fatty fish in the fight against heart disease, demonstrating that in healthy individuals, walnuts lower cholesterol more than fish, while fatty fish lower triglycerides. Both can reduce the overall risk of coronary heart disease. Following the qualified health claim issued by the Food and Drug Administration, researchers found that incorporating approximately 1.5 ounces of walnuts (42 grams, a handful of whole nuts or about three tablespoons of chopped nuts) into the daily diet lowered serum total cholesterol by 5.4 percent and LDL (bad) cholesterol by 9.3 percent compared to a control diet based on USDA recommendations. Using American Heart Association guidelines, the researchers also found that a diet including two servings of fatty fish per week (roughly four ounces each as recommended by the AHA for individuals without heart disease) decreased triglyceride levels by 11.4 percent. Additionally, it increased HDL (good) cholesterol by 4 percent, but also slightly increased LDL (bad) cholesterol compared to the control diet. The fish used in this study was salmon. Dr. Rajaram adds, “Individuals should strive to include a plant source of omega-3 fat in their diet, like walnuts, and also a marine source of omega-3 fat. If fatty fish is not a preferred option for marine-derived omega-3 fat, other options include microalgae oil or DHA-enriched eggs.” The department of nutrition has significant experience conducting tightly controlled feeding studies among varying populations. This one, conducted with a healthy population, is the fifth study testing the health and nutrition properties of walnuts. This study differs from the previous studies in that it compared a plant source of the omega-3 fatty acid with a marine source, the first study to make this comparison. Subjects were randomly assigned to each of the three diets for eight weeks over a 24-week feeding schedule. This gave the researchers a chance to compare the effect of each diet on each participant. Loma Linda University is a health-science university in Southern California known for its nutrition and lifestyle research in relation to chronic diseases. For more information about the University please visit the website http://www.llu.edu. To access the American Journal of Clinical Nutrition. (manuscript reference doi: 10.3945/ajcn.2009.26736S on the Internet)

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