Fidest – Agenzia giornalistica/press agency

Quotidiano di informazione – Anno 31 n° 275

Posts Tagged ‘patients’

“Patients’ Perceptions and Use of Medical Marijuana”

Posted by fidest press agency su lunedì, 22 luglio 2019

The Global Healthy Living Foundation urges 2020 Presidential candidates to support the rescheduling of marijuana so that it, along with CBD products, can be tested under controlled parameters and with peer review to assess their safety, dosing, and effectiveness, arming both patients and doctors with the best available evidence to make informed treatment decisions. Presently, cannabis remains illegal and classified as a Schedule 1 drug under federal law (defined as being “of no medical use”). Following passage of the 2018 Farm Bill, however, which legalized the regulated production of hemp, along with 33 U.S. states that have legalized the usage of marijuana for medical purposes, many chronic disease patients are trying tetrahydrocannabinol (THC) and cannabidiol (CBD) products to treat serious conditions, such as rheumatic and musculoskeletal disease.
According to the “Patients’ Perceptions and Use of Medical Marijuana” study conducted and presented by CreakyJoints®, a Global Healthy Living Foundation patient community, 57 percent of arthritis patients have reported trying marijuana and/or CBD products for medical purposes. Despite the study finding that 62 percent of those who use marijuana medically regularly use it at least once daily, a third of regularly using participants chose not to tell their healthcare provider about their use of these substances.
It’s time to reschedule marijuana so that it can be studied with the same rigor as other treatments and we urge 2020 Presidential candidates to make this an important objective of their healthcare platform,” he added.To help inform medical decisions, the Global Healthy Living Foundation also asks that the U.S. Food and Drug Administration (FDA) develop and approve clinical trials and conduct proper research to provide doctors and patients with adequate data on the effects of THC and CBD on arthritis and other conditions.

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Treatment of Patients with Acute Graft-Versus-Host Disease

Posted by fidest press agency su domenica, 26 maggio 2019

Incyte Corporation (Nasdaq:INCY) today announced that the U.S. Food and Drug Administration (FDA) has approved Jakafi® (ruxolitinib) for the treatment of steroid-refractory acute GVHD in adult and pediatric patients 12 years and older. Jakafi is the first and only FDA-approved treatment for this indication.The approval was based on data from REACH1, an open-label, single-arm, multicenter study of Jakafi in combination with corticosteroids in patients with steroid-refractory grade II-IV acute GVHD. Of the 71 patients recruited into REACH1, 49 patients were refractory to steroids alone, 12 patients had received two or more prior anti-GVHD therapies and 10 patients did not otherwise meet the FDA definition of steroid-refractory. Jakafi was administered at 5 mg twice daily, and the dose could be increased to 10 mg twice daily after three days in the absence of toxicity.The efficacy of Jakafi was evaluated based upon Day 28 overall response rate (ORR), defined as a complete response (CR), very good partial response or partial response based on the Center for International Blood and Marrow Transplant Research (CIBMTR) criteria. The Day 28 ORR in the 49 patients refractory to steroids alone was 57 percent with a CR rate of 31 percent. The most frequently reported adverse reactions among all 71 study participants were infections (55 percent) and edema (51 percent), and the most common laboratory abnormalities were anemia (75 percent), thrombocytopenia (75 percent) and neutropenia (58 percent).GVHD is a condition that can occur after an allogeneic stem cell transplant (the transfer of stem cells from a donor) where the donated cells initiate an immune response and attack the transplant recipient’s organs, leading to significant morbidity and mortality. There are two major forms of GVHD, acute and chronic, that can affect multiple organ systems including the skin, gastrointestinal (digestive) tract and liver. Patients who develop steroid-refractory acute GVHD can progress to severe disease, with one-year mortality rates of approximately 70 percent. Previously, the FDA granted Jakafi Breakthrough Therapy Designation and Orphan Drug Designation for the treatment of patients with steroid-refractory acute GVHD, and the supplemental New Drug Application (sNDA) was reviewed under the FDA’s Priority Review program.Jakafi will be made available to appropriate patients with steroid-refractory acute GVHD immediately. Incyte is committed to supporting patients and removing barriers to access medicines. Eligible patients in the U.S. who are prescribed Jakafi have access to IncyteCARES (Connecting to Access, Reimbursement, Education and Support), a comprehensive program offering patient support, including financial assistance and ongoing education and resources to eligible patients.

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Dentists Are Often the First to Find Possible Signs of Oral Cancer in Patients

Posted by fidest press agency su domenica, 19 maggio 2019

Dental checkups are critical for healthy and long-lasting teeth, but they can also help with the detection of serious and even life-threatening forms of oral cancer.Dentists are often the first to identify growths or suspicious-looking areas in the mouth of patients that could be the first sign of oral cancer – including oral cavity cancer, such as in the lips or tongue, and oropharyngeal cancer, more commonly referred to as throat cancer.
And early detection and treatment as soon as possible are important for defeating oral cancer, which can also occur in the cheeks, lips, gums, tongue, and floor and roof of the mouth.A dentist recently discovered a growth on Gibbs’ mouth during a routine checkup. Gibbs, 26, was diagnosed with salivary gland cancer – a very rare form of cancer that affects about 1 of every 100,000 people, according to the American Cancer Society.
Gibbs, who advanced to the third round of the U.S. Open in 2014 and the Australian Open in 2017, will have surgery Friday and miss the French Open that starts May 26. But Gibbs plans to participate in the qualifying matches for Wimbledon in late June.Gibbs is the latest well-known athlete or entertainer to be diagnosed with oral cancer. Many celebrities, including actor-producer Michael Douglas and guitarist Eddie Van Halen, have battled and defeated oral cancer, thanks to early diagnosis and treatment.Currently, an estimated 91,000 people in the U.S. are living with oral cancer, and about 39,000 new cases are diagnosed every year, according to the National Institute of Health. About 8,000 deaths are connected to oral cancer every year in the U.S. Many of those deaths could be prevented with early diagnosis, according to many reports. The five-year survival rate for oral cancer diagnosed early is 75 percent, but the rate drops dramatically to 20 percent with a late diagnosis, according to the NIH.

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Phase III CAPTAIN Study of Trelegy Ellipta in Patients with Asthma Meets Primary Endpoint

Posted by fidest press agency su domenica, 5 maggio 2019

GlaxoSmithKline plc (LSE/NYSE: GSK) and Innoviva, Inc. (NASDAQ: INVA) today announced headline results from the pivotal phase III CAPTAIN study of once-daily single inhaler triple therapy Trelegy Ellipta (fluticasone furoate/umeclidinium/vilanterol: FF/UMEC/VI) compared to Relvar/Breo Ellipta (FF/VI), in the treatment of patients living with uncontrolled asthma.The study met its primary endpoint, demonstrating a statistically significant 110mL improvement in lung function (measured by change from baseline in trough FEV1 at 24 weeks of treatment) for FF/UMEC/VI 100/62.5/25mcg (p<0.001, 95% CI: 66-153 mL) compared with Relvar/Breo 100/25mcg and a statistically significant 92mL improvement in trough FEV1 for FF/UMEC/VI 200/62.5/25mcg versus Relvar/Breo 200/25mcg (p<0.001, 95% CI: 49-135 mL).The key secondary endpoint was annualised rate of moderate/severe exacerbations for FF/UMEC/VI (100/62.5/25 and 200/62.5/25) versus Relvar/Breo (100/25 and 200/25) and demonstrated a 13% (95% CI: -5.2 to 28.1) reduction in exacerbations, however this was not statistically significant. Therefore, all subsequent analyses were considered descriptive.
Dr. Hal Barron, Chief Scientific Officer and President, R&D, GSK, said: “We believe a once-daily single inhaler triple therapy that improves lung function is an advance for patients with uncontrolled asthma since this option is not currently available. We plan to submit these data for regulatory review after the full dataset is available.”CAPTAIN was also designed to investigate two further doses of FF/UMEC/VI (100/31.25/25 and 200/31.25/25 mcg) compared to Relvar/Breo (100/25 and 200/25). There were increases in trough FEV1 of a similar magnitude to those of FF/UMEC/VI 100/62.5/25 and 200/62.5/25, with no difference in exacerbation rates.The safety profile of FF/UMEC/VI was consistent with the known profile of the individual components and their combinations. Adverse event rates were similar across all six study arms with the most common adverse events being reported as nasopharyngitis (13-15%), headache (5-9%), upper respiratory tract infection (3-6%) and bronchitis (3-5%).Dr. Paul Meunier, Vice President of Respiratory Medicine at Innoviva noted that: “The CAPTAIN study has shown that triple therapy in a single inhaler provides a potential new treatment option for asthma management in patients uncontrolled on ICS/LABA.”
Full results from CAPTAIN will be submitted for future presentation at upcoming scientific meetings and in peer-reviewed publications.

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Awareness of Fatty Liver Disease Remains Low Among Most At-Risk Patients

Posted by fidest press agency su domenica, 5 maggio 2019

The results of a new survey released last week at the 3rd Annual NASH (nonalcoholic steatohepatitis) Summit in Boston show that even among patients most at-risk for the fatty liver disease, awareness of the condition remains low.Global clinical trial enrollment company Continuum Clinical, which conducted the survey, found that among Americans with co-morbidities most associated with NASH—including type 2 diabetes, obesity, and hypertension—only 6% have ever heard of NASH. In a previous survey Continuum conducted of 1,000 Americans, unaided awareness of NASH was only 2%.”Low public awareness of NASH and fatty liver disease is a barrier to clinical trial enrollment,” said Cathleen Dohrn, Ph.D., Continuum Clinical’s Senior Scientific Director who presented the findings at the Summit. “NASH clinical trial sponsors need thousands of patients in order to find the first treatment for this condition, which will necessitate increased awareness and diagnosis of NASH.”According to the National Institute of Diabetes and Digestive and Kidney Diseases, NASH is an advanced form of nonalcoholic fatty liver disease (NAFLD), a condition in which excess fat is stored in your liver and is not caused by heavy alcohol use. NAFLD is one of the most common causes of liver disease in the United States, and a precursor to NASH. Experts estimate that about 20 percent of people with NAFLD have NASH.Continuum also found that 48% of at-risk Hispanic/Latino respondents were most concerned about liver disease versus 32% of the total population surveyed. In addition, Hispanic/Latino respondents were more significantly more interested in learning about a hypothetical NASH clinical research study (62% versus 49% of the total population).”NASH disproportionately affects the Hispanic/Latino population, so having confirmation that this cohort is interested in clinical research signals to us that a special effort must be made to ensure clinical trial enrollment is inclusive,” Dohrn said.
To help explore strategies on how pharmaceutical companies can tackle this patient enrollment challenge, on May 22 Continuum Clinical will host a webinar on overcoming NASH clinical trial challenges with Wayne Eskridge, CEO of the Fatty Liver Foundation, and Qin Ye, MD, MS, associate principal of ZS Associates.

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Therapies for Patients with Serious Liver Disease

Posted by fidest press agency su sabato, 15 dicembre 2018

Perspectum Diagnostics and the SC Liver Research Consortium (SCLRC) are delighted to announce a collaboration to advance clinical development of investigational therapies. This will focus on patients with serious liver diseases including non-alcoholic steatohepatitis (NASH), primary sclerosing cholangitis (PSC), autoimmune hepatitis (AIH) and hepatocellular carcinoma (HCC).SCLRC is a site management organization consisting of over 85 clinical sites based in the United States with specialized expertise in hepatology. SCLRC has successfully executed phase 1-3 trials in hepatitis C, hepatitis B, NASH, cirrhosis and HCC. SCLRC offers sponsors guidance in clinical development, as well as the recruitment and execution of clinical trials for regulatory approvals.Perspectum are imaging experts in Magnetic Resonance Imaging (MRI) and provide specialized imaging clinical research services in NASH, cholestatic liver disease and HCC. Their products, LiverMultiScanTM (which includes MRI-PDFF) and MRCP+, for quantitative imaging of the liver and biliary tree, and their comprehensive imaging CRO services have been included in over 18 phase 1-3 studies since their launch in 2014.With these complementary offerings, SCLRC and Perspectum will build a major US-based network setting a new standard for sponsors, both Pharmaceutical and Biotech companies. This network will be focused on clinical development of drugs and diagnostics for patients with liver disease. SCLRC currently has 45 clinical sites with access to Perspectum’s imaging-technology, with plans to enable the majority of clinical sites by June 2019.“We believe that this unique partnership will bring together novel technologies with deep clinical development experience to address high unmet medical needs for patients with liver disease,” according to Dr Cathy O’Hare, Head of US operations for Perspectum, based in South San Francisco. Professor Sir Michael Brady, Chairman of the Perspectum Board went further: “Perspectum Diagnostics, with technology that builds on decades of academic research at the University of Oxford, is changing the paradigm for clinical development in liver disease. We have the opportunity to develop drugs for diseases that to date have had no approved therapies, because we have the unique ability to demonstrate the benefits of investigational agents on imaging biomarkers.” Dr. Paul Pockros, Head of SCLRC and the Director of the Liver Disease Center at Scripps Clinic comments: “The collaboration between SC Liver Research Consortium and Perspectum will provide investigators and sites with an important technology to allow breakthroughs in NASH research. We believe this relationship will be beneficial for patients and physicians alike.”

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Patients Search for Information Online

Posted by fidest press agency su lunedì, 10 settembre 2018

Recent research commissioned1 by Teva Pharmaceuticals has shown that patients, especially those with chronic conditions, have a significant need for online information but they question the reliability of some sources.
Today, Teva in Europe announced a series of partnerships and initiatives aimed at directly addressing this unmet need. The first, a partnership with Healint, the developer of the Migraine Buddy© platform, will provide real-world evidence about the many issues and outcomes experienced by migraine patients in Europe. These statistical insights produced by Healint on their platform are based on the contributions of patients, who opt-in to share about their condition anonymously for the purpose of increased migraine awareness, and research. This patient-reported evidence with an unprecedented scale will support the generation of educational and supportive content for doctors, neurologists, health specialists and individuals looking to enhance their understanding of migraine.Recent research in the professional field highlights the growing interest by medical professionals in digital assets to support their continuous education needs and day-to-day work. A 2017 DRG Digital report found that millennial physicians are more reliant on digital sources of information spending as much as three hours consulting external digital resources including websites for healthcare professionals. They source online medical journals and medical reference sites far more frequently than their older peers. To address this professional need Teva is working with Migraine Trust International Symposium (MTIS) to create engaging online interviews with leaders in the field of neurology including Professor of Neurology at King’s College London and Medical Trustee of The Migraine Trust, Peter J. Goadsby on the subject of ‘Recent advances in headache neuroimaging’. These videos and content will be made available through the MTIS website for UK delegates and on NeurologyBytes.com for non-UK delegates.
Neurology Bytes is a European Healthcare Professional portal initiated by Teva Europe that hosts a variety of educational content that complements the busy schedule of a neurologist and addresses the unmet need for reliable and trustworthy information.Teva Head of Digital, Timothy White said: “Teva is committed to empowering patients and professionals around the world through their health journey, especially those living with or treating chronic conditions such as migraine, by providing high quality medicines as well as tools based on human insights. Our partnerships with MTIS and Healint as well as the growth of our Neurologybytes.com platform demonstrate the practical ways of how we are bringing the vision to life.”

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Heart doctors call for permission to provide therapy to stroke patients

Posted by fidest press agency su venerdì, 25 maggio 2018

Paris, France Heart doctors from the European Society of Cardiology (ESC) Council on Stroke are calling on national health authorities for permission to provide stroke patients with mechanical thrombectomy, a life-saving treatment for acute ischaemic stroke, in regions where there is a lack of trained specialists. Details of the proposal are presented today at EuroPCR 2018.1“We have evidence that after a short period of training on the procedure, interventional cardiologists treating acute ischaemic stroke achieve the same results as traditional interventional neuroradiologists,” said Professor Petr Widimsky, Chair of the ESC Council on Stroke.Acute ischaemic stroke is a severe form of the condition where a blood vessel to the brain becomes blocked. It accounts for up to four in five strokes, or over one million cases in Europe each year.Without treatment most patients die or are severely disabled and permanently bedridden. Even with clot-busting drugs, 75% of patients die or are severely disabled. With mechanical thrombectomy, a procedure to physically remove the clot and restore blood flow to the brain, about half of patients survive and function normally. If performed within two to three hours of symptom onset, the rate of survival with normal neurological function rises to more than 70% of patients.In Europe, mechanical thrombectomy is currently provided by interventional neuroradiologists, but there is a severe shortage of these specialists. Even countries with the most specialists, such as Germany, the Netherlands and the Czech Republic, only have sufficient numbers to treat around one-third of acute ischaemic stroke patients. In some other countries, less than 1% of acute ischaemic stroke patients can be treated.Professor Widimsky said: “There are interventional cardiology units in all countries in Europe and the Americas, and in most other continents. The equipment for mechanical thrombectomy is available; it’s the trained specialists to perform the procedure that are lacking. This situation could be solved by training cardiologists to perform mechanical thrombectomy.”The ESC Council on Stroke is proposing that interventional cardiologists receive three months of training on how to do mechanical thrombectomy, rather than the typical two years required for other physicians. “Many interventional cardiologists routinely perform stenting of the carotid arteries so three months of training is sufficient to learn intracranial mechanical thrombectomy,” said Professor Widimsky. “It is up to health authorities in each country to decide if they will allow this.”
The proposals are being put forward by the ESC Council on Stroke and the European Association of Percutaneous Cardiovascular Interventions, a branch of the ESC.

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Faster walking heart patients are hospitalised less

Posted by fidest press agency su sabato, 21 aprile 2018

Ljubljana, Slovenia. Faster walking patients with heart disease are hospitalised less, according to research presented today at EuroPrevent 2018, a European Society of Cardiology congress, and published in the European Journal of Preventive Cardiology.1,2
The three-year study was conducted in 1,078 hypertensive patients, of whom 85% also had coronary heart disease and 15% also had valve disease.Patients were then asked to walk 1 km on a treadmill at what they considered to be a moderate intensity.3 Patients were classified as slow (2.6 km/hour), intermediate (3.9 km/hour) and fast (average 5.1 km/hour). A total of 359 patients were slow walkers, 362 were intermediate and 357 were fast walkers.
The researchers recorded the number of all-cause hospitalisations and length of stay over the next three years. Participants were flagged by the regional Health Service Registry of the Emilia-Romagna Region, which collects data on all-cause hospitalisation.Study author Dr Carlotta Merlo, a researcher at the University of Ferrara, Ferrara, Italy, said: “We did not exclude any causes of death because walking speed has significant consequences for public health. Reduced walking speed is a marker of limited mobility, which is a precursor of disability, disease, and loss of autonomy.” 4,5. During the three year period, 182 of the slow walkers (51%) had at least one hospitalisation, compared to 160 (44%) of the intermediate walkers, and 110 (31%) of the fast walkers.
The slow, intermediate and fast walking groups spent a total of 4,186, 2,240, and 990 days in hospital over the three years, respectively.The average length of hospital stay for each patient was 23, 14, and 9 days for the slow, intermediate and fast walkers, respectively (see figure).
Each 1 km/hour increase in walking speed resulted in a 19% reduction in the likelihood of being hospitalised during the three-year period. Compared to the slow walkers, fast walkers had a 37% lower likelihood of hospitalisation in three years.Dr Merlo said: “The faster the walking speed, the lower the risk of hospitalisation and the shorter the length of hospital stay. Since reduced walking speed is a marker of limited mobility, which has been linked to decreased physical activity,4 we assume that fast walkers in the study are also fast walkers in real life.”
She continued: “Walking is the most popular type of exercise in adults. It is free, does not require special training, and can be done almost anywhere. Even short, but regular, walks have substantial health benefits. Our study shows that the benefits are even greater when the pace of walking is increased.”

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Stroke prevention drugs may help reduce dementia risk for atrial fibrillation patients

Posted by fidest press agency su domenica, 18 marzo 2018

Barcelona, Spain – Patients with atrial fibrillation could reduce the risk of dementia by taking stroke prevention medications, according to recommendations published online today in EP Europace1, a European Society of Cardiology journal, and presented at EHRA 2018.2 The international consensus document was also published in HeartRhythm, the official journal of the Heart Rhythm Society (HRS), and Journal of Arrhythmia, the official journal of the Japanese Heart Rhythm Society (JHRS) and the Asia Pacific Heart Rhythm Society (APHRS).The expert consensus statement on arrhythmias and cognitive function was developed by the European Heart Rhythm Association (EHRA), a branch of the European Society of Cardiology (ESC); the Heart Rhythm Society (HRS); the Asia Pacific Heart Rhythm Society (APHRS); and the Latin American Heart Rhythm Society (LAHRS).Heart rhythm disorders (arrhythmias), as well as some procedures undertaken to treat them, can increase the risk of cognitive decline and dementia. The international consensus document was written for doctors specialising in arrhythmias and aims to raise awareness of the risks of cognitive impairment and dementia and how to reduce them.The document states that atrial fibrillation is associated with a higher risk for cognitive impairment and dementia, even in the absence of apparent stroke. This may be because atrial fibrillation is linked with a more than two-fold risk of silent strokes. The accumulation of silent strokes and the associated brain injuries over time may contribute to cognitive impairment.Stroke prevention with oral anticoagulant drugs is the main priority in the management of patients with atrial fibrillation. The consensus document says that oral anticoagulation may reduce the risk of dementia.Adopting a healthy lifestyle may also reduce the risk of cognitive decline in patients with atrial fibrillation. This includes not smoking and preventing or controlling hypertension, obesity, diabetes, and sleep apnoea.“Patients with atrial fibrillation may be able to reduce their risk of cognitive impairment and dementia by taking their oral anticoagulation medication and having a healthy lifestyle,” said Dr Nikolaos Dagres, lead author and consultant, Department of Electrophysiology, Heart Centre Leipzig, Germany.The document also reviews the association between other arrhythmias and cognitive dysfunction, including post-cardiac arrest, in patients with cardiac implantable devices such as implantable cardioverter defibrillators (ICDs) and pacemakers, and ablation procedures.Treatment of atrial fibrillation with catheter ablation can itself lead to silent strokes and cognitive impairment. To reduce the risk, physicians should follow recommendations for performing ablation and for the management of patients before and after the procedure.3,4
The consensus document notes that physicians may suspect cognitive impairment if a patient’s appearance or behaviour changes — for example, if appointments are missed. Family members should be asked for collateral information. If suspicions are confirmed, the consensus document recommends tools to conduct an objective assessment of cognitive function.The paper highlights gaps in knowledge and areas for further research. These include, for instance, how to identify atrial fibrillation patients at increased risk of cognitive impairment and dementia, the effect of rhythm control on cognitive function, and the impact of cardiac resynchronisation therapy (CRT) on cognitive function.

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Heart attack patients prescribed antidepressants have worse one-year survival

Posted by fidest press agency su lunedì, 5 marzo 2018

The observational study of nearly 9,000 patients found that those prescribed antidepressants at discharge from hospital after a heart attack had a 66% greater risk of mortality one year later than patients not prescribed the drugs, although they noted the cause is not necessarily related directly to the antidepressants.Lead author Ms Nadia Fehr, a medical student at the University of Zurich, Switzerland, said: “Previous studies have suggested that cardiovascular disease may increase the likelihood of being depressed. On the other hand, depression appears to increase the probability of developing cardiovascular risk factors. However, little is known about the impact of depression on outcome after a heart attack.”This study assessed the association of antidepressant prescription at hospital discharge with the one-year outcomes of patients with acute myocardial infarction (heart attack).Data from AMIS Plus, the Swiss nationwide registry for acute myocardial infarction, were used to analyse 8,911 heart attack patients admitted to hospitals in Switzerland between March 2005 and August 2016. Patients were followed up by telephone 12 months after discharge.The researchers compared patients who received antidepressant medication at discharge with those who did not with regard to baseline characteristics and one-year outcomes including mortality, a subsequent heart attack, and stroke.A total of 565 (6.3%) patients received antidepressants at discharge from hospital. Compared to those who did not receive the drugs, patients prescribed antidepressants were predominantly female, older, and more likely to have hypertension, diabetes, dyslipidaemia, obesity and comorbidities. They were less likely to undergo percutaneous coronary intervention or receive P2Y12 blockers or statins, and stayed in hospital longer.After adjusting for baseline characteristics the researchers found that the rates of stroke and subsequent heart attacks were similar between the two groups, but patients prescribed antidepressants had significantly worse survival. The rate of all-cause mortality at one-year after discharge was 7.4% in patients prescribed antidepressants compared to 3.4% for those not prescribed antidepressants (p<0.001).Antidepressant prescription was an independent predictor for mortality, and increased the odds by 66% (odds ratio: 1.66; 95% confidence interval: 1.16 to 2.39).“This was an observational study so we cannot conclude that antidepressants caused the higher death rate,” noted Ms Fehr.She concluded: “Our study showed that many patients are treated with antidepressants after a heart attack. More research is needed to pinpoint the causes and underlying pathological mechanisms for the higher mortality we observed in this patient group.”

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Rapid blood vessel scan tolerated by claustrophobic patients unable to stand longer tests

Posted by fidest press agency su domenica, 4 febbraio 2018

arterial and venous anatomyBarcelona, Spain Doctors have developed a new five-minute procedure to scan the blood vessels which offers hope for claustrophobic patients unable to tolerate the conventional longer test. The research is presented at CMR. Magnetic resonance angiography (MRA) is a magnetic resonance imaging (MRI) exam that takes pictures of the blood vessels. Physicians use the images to diagnose diseases of the blood vessels, such as aneurysms or blockages.During the test patients lie on a table inside a tunnel-like tube and must remain still. A dye, called a contrast agent, is injected into the veins so the vessels can be seen more clearly. Patients are given a headset to block out noise from the scanner. An MRA can typically take 30 minutes to one hour, from start to finish.“Lengthy scans can be problematic for patients with even modest levels of claustrophobia who may refuse the test or ask for it to be stopped early,” said Dr Puja Shahrouki, research fellow, David Geffen School of Medicine at UCLA, Los Angeles, US. “They also limit the number of patients that can be scanned each day. In addition, the usual gadolinium-based contrast agents can be an issue for patients with kidney problems.”This study aimed to shorten the scan time and still produce high quality images. The researchers used ferumoxytol as the contrast agent as it stays within the vascular system for much longer than gadolinium-based dyes. With gadolinium-based agents, there is a short time when the images can be taken, which means patients have to wait in the scanner while the clinician watches the dye move through the body in order to capture the images when the dye enters the blood vessels.
The UCLA study included seven claustrophobic patients aged 11 to 63 years with kidney failure. There were four men and three women. All patients said they were reluctant to undergo MRA due to claustrophobia, but agreed to a trial of up to ten minutes in the scanner bore.Eight MRA scans using ferumoxytol were conducted. All scans were completed and there were no adverse events. Scans took an average of 6.27 minutes (range four to ten minutes). All scans were high quality and allowed full visualisation of the arterial and venous anatomy from the neck to the thighs
“Despite being claustrophobic, all patients completed the MRA and the images could be used for diagnosis of the entire vascular system,” said Dr Shahrouki. “Some of the scans were done in less than five minutes once the procedure started, making it much shorter than the tests currently used in medical practice.” The researchers have shown that the test can be used to diagnose venous and arterial diseases, such as central venous occlusion and aneurysms, and to aid preprocedural planning, for example in transcatheter aortic valve replacement. In principle, it is possible to scan several patients in an hour as opposed to just one or two, raising promising possibilities for workflow and efficiency.
Dr Shahrouki said: “This method could enable claustrophobic patients to receive lifesaving diagnoses and procedures. For appropriate types of studies, it could also shorten waiting lists and improve the cost-benefit ratio for hospitals.” The new protocol should be technically easier than current practice because there is no time pressure for taking images. Ferumoxytol is increasingly recognised as an alternate contrast agent in patients with poor kidney function, but is not marketed outside the US. It is approved by the US Food and Drug Administration (FDA) only for the treatment of iron deficiency anaemia in adults with chronic kidney disease.Hypersensitivity reactions have occurred in patients receiving ferumoxytol as a high dose for therapy in a short period of time, and the FDA has warned against this. The new MRA protocol administers the dye by slow infusion outside the MRI machine while monitoring the patient’s vital signs, in compliance with FDA guidelines. A preliminary study showed this was safe2 and a larger registry is generating a safety profile of slow infusion under close monitoring. More safety data will be needed before any conclusions can be drawn about the true rate of hypersensitivity reactions and in the meantime close monitoring is the rule.Dr Shahrouki said: “The protocol could have huge implications for claustrophobic patients and efficient use of scanners. We envisage it being used very widely in patients with a clear clinical indication.” (photo: arterial and venous anatomy)

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Nearly 25% of chronic ischaemic heart disease patients dead or hospitalised in six months

Posted by fidest press agency su mercoledì, 17 gennaio 2018

Sophia Antipolis, Nearly a quarter of patients with chronic ischaemic cardiovascular disease are dead or hospitalised within six months, reports a European Society of Cardiology (ESC) study published today in the European Journal of Preventive Cardiology. “Coronary artery disease is the leading cause of death worldwide yet some patients appear to get lost in the system after their initial visit to a hospital or outpatient clinic,” said lead author Cardiology Professor Michel Komajda, of the University Pierre and Marie Curie and Pitié-Salpêtrière Hospital in Paris, France.
The Chronic Ischaemic Cardiovascular Disease (CICD) Pilot Registry was designed to learn what happens to these patients in the six months after being seen by a health professional. The observational study was conducted as part of the EURObservational Research Programme (EORP) of the ESC.
The study included 2,420 patients from 100 hospitals and outpatient clinics in ten European countries. Participants had stable coronary disease2 or peripheral artery disease, the most common conditions seen by a cardiologist. Risk factors and treatments were recorded at the start of the study and have been previously reported.3 Treatments and outcomes were recorded at six months.
Follow-up data were available for 2,203 patients, of whom 522 (24%) had died or been rehospitalised during the six months. Factors significantly associated with the risk of dying or being rehospitalised were older age, with a hazard ratio (HR) of 1.17 for every ten years, history of peripheral revascularisation (HR 1.45), chronic kidney disease (HR 1.31) and chronic obstructive pulmonary disease (HR 1.42) (all p<0.05). The majority of the causes of death and rehospitalisation were cardiovascular.Professor Komajda said: “These patients are at high risk of dying or being navigatore coronarierehospitalised in the short-term and should be carefully monitored by physicians. We identified clinical factors which are strongly associated with this high risk which can easily be assessed.”
The rate of prescription of angiotensin converting enzyme inhibitors, beta-blockers (both drugs reduce blood pressure) and aspirin was lower at six months compared to the start of the study (all p<0.02).Professor Komajda said: “In absolute numbers the reductions were modest but they did reach statistical significance. This shows that patients have a better chance of receiving recommended medications while in hospital or directly after an outpatient appointment. Six months later, drugs they should be taking to reduce the risk of death and rehospitalisation are prescribed less frequently.”He added: “It is likely that there is insufficient handover of these patients to a cardiologist or GP and so their prescriptions are not renewed.”While the study did not assess the reasons for the reduction in prescriptions, possible factors include: patients getting tired of taking pills or cannot afford them.Six month rates of death and rehospitalisation were significantly higher in eastern, western and northern European countries compared to those in the south. Given the relatively small number of patients, Professor Komajda said firm conclusions could not be drawn. But he said: “We anticipated that outcomes would be better in Mediterranean countries and this was correct, probably because of the diet and other lifestyle reasons.” Professor Komajda concluded: “The study shows that patients with chronic ischaemic cardiovascular disease have a high risk of poor short-term outcomes. Yet some are not receiving recommended preventive medications which could improve their outlook. More efforts are needed to ensure that these patients continue to be monitored and treated after they leave hospital or an outpatient appointment.”

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Howsden Dermatology Joins Platinum Dermatology Partners

Posted by fidest press agency su sabato, 4 novembre 2017

Kevin F. Kia, Akash A. PatelPlatinum Dermatology Partners (“Platinum”) announced today that Howsden Dermatology has joined its network, further enhancing Platinum’s presence in the Dallas-Fort Worth area. Platinum is a dermatology-focused physician services organization with a rapidly growing network of top-ranked dermatology practices in Texas. Howsden Dermatology serves the eastern Dallas communities of Garland, Rowlett and Mesquite, and is known for its superior medical and surgical dermatological care, as well as its keen focus on skin cancer detection and treatment. Founded in 1983 by Dr. F. Lester Howsden, MD, FAAD, Howsden Dermatology patients today are cared for by Dr. Akash A. Patel, MD, FAAD, and Dr. Kevin F. Kia, MD, FAAD. Drs. Patel and Kia are devoted to serving the communities in which they work, and the dermatology community at large, with their highest commitment to quality skin care. Both are long-time honorees of D Magazine’s “Best Doctors in Dallas,” and since 2005, both have remained actively involved in teaching future dermatologists at The University of Texas Southwestern—many of whom are now practicing in the Dallas-Fort Worth area.
“Times are most definitely changing, and we were looking for the right partner to help us grow and provide the best care for our patients. Platinum became an obvious choice,” said Dr. Patel. “Dr. Kia and I have worked very hard to maximize quality and efficiency. We want our patients to have the highest quality of care; so to us, it was really important to find a partner who shares our goals and priorities. Platinum stands apart from the rest because they don’t want to change how we operate—they have no interest in micromanaging us; they are enhancing our strengths and showing us ways we can grow through their vast resources. One other huge distinguishing factor for us was the quality of physicians we join in the Platinum network. We have tremendous respect for these Platinum Dermatologists—all are well-regarded by their peers and the medical community at large—and we wanted to be part of this strong team. Platinum was by far the best choice for us.” Platinum’s model is attractive to physicians because it empowers dermatologists to grow and enhance their practices while providing exceptional clinical care and retaining ownership and autonomy. Platinum’s management creates partnerships with physicians that lead to better operational and clinical outcomes, encourages collaboration among dermatology professionals, and drives practice growth opportunities that are unmatched in an independent practice. (photo: Kevin F. Kia, Akash)

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Immune-stimulatory Activity with RGX-104 in Advanced Cancer Patients

Posted by fidest press agency su lunedì, 30 ottobre 2017

PhiladelphiaPhiladelphia. Rgenix, Inc., a clinical stage biopharmaceutical company developing first-in-class small molecule and antibody cancer therapeutics, announced today preliminary data from an ongoing Phase 1a/b clinical trial with its lead oral investigational agent, RGX-104. These data demonstrate immune-stimulatory activity in solid tumor patients with highly-refractory malignancies, including patients who have failed prior checkpoint inhibitors. Also presented were pre-clinical data establishing the immune-modulatory and anti-tumor effects of RGX-104. The company presented the data at the AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics in Philadelphia. RGX-104 is a liver X receptor (LXR) agonist that upregulates the expression of the target gene, Apolipoprotein E (ApoE), triggering several downstream effects via ApoE receptors. In pre-clinical data presented today, treatment with RGX-104 in mouse models resulted in dual effects on myeloid-derived suppressor cells (MDSCs) and dendritic cells (DCs), both innate immune cells that play a central role in regulating anti-tumor immunity and response to checkpoint inhibitors. Innate immune activation with RGX-104, coupled with a reduction in tumor blood vessels, resulted in anti-tumor activity as a monotherapy as well as synergy with checkpoint inhibitors (CPI) in several drug-resistant mouse models. These data provide rationale for Rgenix’s ongoing Phase 1a/b trial of RGX-104 in advanced cancer patients and support evaluation of RGX-104 as both a monotherapy as well as in combination with CPIs.
As part of the ongoing Phase 1a/b clinical trial, 15 patients with a variety of solid tumors have been treated with escalating doses of RGX-104 monotherapy. Patients treated with RGX-104 had a median of six prior therapies with a range of 1-12, highlighting a population of patients with profoundly resistant disease.Activation of the LXR-ApoE pathway with oral administration of RGX-104 was associated with immune-stimulatory activity in 9 of 10 evaluable patients. This was demonstrated by an increase (up to 11-fold) in activated circulating PD-1+CD8+ T cells during treatment. T cell activation was observed in patients who experienced modulation of the innate immune system during treatment. The effect of RGX-104 on the innate immune system consisted of both MDSC depletion (up to 95% decrease) as well as DC activation as indicated by induction of PD-L1 expression (up to 100% increase). In most cases these effects were observed within two weeks of treatment initiation and generally preceded the onset of T cell activation.
Safety data demonstrate good tolerability with on-target safety findings in the first three dosing cohorts. One patient experienced a DLT of grade 4 reversible neutropenia – a known potential effect of LXR agonism – that reversed within one week, allowing the patient to subsequently tolerate a 50% dose reduction. No MTD has been reached to date. Stable disease has been observed in 4 of 12 evaluable patients, including three who have failed prior checkpoint inhibitor therapy, for periods of at least 8 weeks.Rgenix plans to enroll subsequent dose-escalation cohorts of the RGX-104 monotherapy trial in Q4 2017. Additionally, Rgenix is planning to initiate the Phase 1b expansion component of the study, comprised of disease directed cohorts receiving RGX-104 monotherapy as well as cohorts receiving RGX-104 combined with a CPI, projected to begin in 1H 2018.The LXR-ApoE pathway was discovered as a cancer target using a microRNA (miRNA) based target discovery approach originally developed at The Rockefeller University and now exclusively licensed to Rgenix.

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New randomized controlled study confirms the efficacy and tolerability profile of Sativex in the treatment of multiple sclerosis spasticity resistant patients

Posted by fidest press agency su domenica, 29 ottobre 2017

Paris-antenne-vue-eiffel-tourParis. Almirall, S.A. (ALM) announces that Prof. Markova (Thomayer Hospital, Prague, Czech Rep.), primary investigator, has presented at the 7th Joint ECTRIMS-ACTRIMS Meeting in Paris, the top line efficacy results of a new randomized placebo controlled clinical study, SAVANT, that further confirms the efficacy and tolerability profile of Sativex® (THC:CBD oromucosal spray cannabinoid based medicine) in the treatment of multiple sclerosis (MS) resistant spasticity (muscle rigidity) for patients who have not responded to first line therapies.SAVANT study is the first randomized clinical study with Sativex® on multiple sclerosis resistant spasticity management since 2014. Its primary objective was to evaluate the efficacy of Sativex® as an add-on therapy in patients with moderate to severe spasticity who had not gained adequate relief during treatment with two optimized standard antispasticity medications. Secondary objectives were to evaluate the effect of this treatment on spasticity and associated symptoms, and to further characterize its tolerability.The results of this study demonstrate that Sativex® is an effective and well-tolerated add-on option for treating patients with resistant multiple sclerosis spasticity, as well as burdensome associated symptoms instead of just adjusting again the first line options treatment.191 patients entered the study, of which 106 were randomized and after 12 weeks the clinically relevant responder rate was 77.4% within the Sativex® patients group, vs 32.1% within the placebo group (p<0.0001). There were also statistically significant improvements in favour of Sativex® at week 12 in the mean changes of the overall spasticity score, Ashworth spasticity score, and pain score. 22.6% of the Sativex® patient group and 13.2% of the placebo patient group reported one or more mild or moderate adverse events. No serious adverse events were reported.

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Virologic Response in Patients with Chronic Hepatitis C

Posted by fidest press agency su domenica, 22 ottobre 2017

historyMerck (NYSE:MRK), known as MSD outside of the United States and Canada, today announced the presentation of findings from a retrospective database analysis of patients with chronic hepatitis C virus (HCV) genotype (GT) 1 or 4 infection who have chronic kidney disease (CKD) and were treated with ZEPATIER® (elbasvir and grazoprevir) in the U.S. Department of Veterans Affairs (VA) healthcare system. Among patients who completed therapy, the analysis showed 95.6 percent (714/747) of patients with severe CKD (stages 4-5, defined as estimated glomerular filtration rate (eGFR) <30 mL/min/1.73 m2) and 97.1 percent (758/781) of patients with moderate CKD (stage 3, defined as eGFR 30-59 mL/min/1.73 m2) achieved sustained virologic response (SVR), defined as HCV RNA below the limit of quantification at least 10-12 weeks after the end of treatment. For patients with missing HCV RNA data after at least 10-12 weeks after treatment completion, analyses were conducted on a post-hoc basis using the last HCV RNA data available after week 4 after therapy completion. The response rates in the real-world setting of the VA further supplement findings from controlled clinical studies of ZEPATIER. These findings will be presented today at The Liver Meeting® 2017 taking place in Washington, D.C.
In the United States, ZEPATIER is indicated for the treatment of chronic HCV GT1 or GT4 infection in adults. ZEPATIER is indicated for use with ribavirin (RBV) in certain patient populations. The U.S. Prescribing Information for ZEPATIER includes a Boxed Warning about the risk of hepatitis B virus (HBV) reactivation in patients co-infected with HCV and HBV. In controlled clinical studies of ZEPATIER, SVR was the primary endpoint defined as HCV RNA less than lower limit of quantification at 12 weeks after the cessation of treatment (SVR12).The retrospective observational analysis included 5,845 patients with chronic HCV infection who received ZEPATIER (elbasvir and grazoprevir) between February 1 and December 31, 2016. Patients were identified from the VA Corporate Data Warehouse, a national repository of VA electronic medical records. Presence of chronic kidney disease was measured via eGFR, per the National Kidney Foundation’s Modification of Diet in Renal Disease equation. Of 4,693 patients evaluated in the per protocol population, 16.6 percent (781/4693) had CKD stage 3 and 15.9 percent (747/4693) had CKD stages 4 or 5. Please see additional information below about the design, methodology and limitations of this observational analysis.
Most patients with chronic kidney disease in the analysis were male (96.9%, 1481/1528); African American (67.5%, 1031/1528) and either had GT1a infection (52.2%, 798/1528) or GT1b infection (42.1%, 644/1528). The mean age for patients in the study with chronic kidney disease was 64.9 years. Comorbid conditions as defined by ICD-9/10 codes in the VA database included depression (58.5%, 894/1528), diabetes (69.2%, 1057/1528), compensated cirrhosis (18.6%, 284/1528), and HIV (5.0%, 76/1528). In the study, 19.9 percent of patients (304/1528) were coded as having decompensated cirrhosis; ZEPATIER is not for use in patients with moderate or severe hepatic impairment (Child Pugh B or C). See Selected Safety Information below for more information. (photo: MERCK)

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Boehringer Ingelheim: Advancing anticoagulation care with new data at ESC Congress 2017

Posted by fidest press agency su giovedì, 24 agosto 2017

Boehringer IngelheimBoehringer Ingelheim today announced that it will present important new data on the treatment of patients with atrial fibrillation (AF) at the ESC Congress in Barcelona, Spain, 26-30 August 2017. In total, four abstracts have been accepted, investigating different aspects of AF patient treatment. The results of the RE-DUAL PCI™ trial have been selected for one of the Late Breaking Science sessions of the congress.The RE-DUAL PCI™ trial compared dual therapy with triple therapy after percutaneous coronary intervention (PCI) with stent placement in approximately 2,500 adults with atrial fibrillation. Patients were either treated with dabigatran etexilate (Pradaxa®) and a single antiplatelet agent or with the vitamin K antagonist (VKA) warfarin and two antiplatelets. The dabigatran doses investigated in this trial are the same doses which have already demonstrated effective stroke prevention in atrial fibrillation and are therefore approved around the world in this indication. “The presentation of the results of our RE-DUAL PCI™ trial at ESC is particularly timely as the focus of the 2017 congress is ‘40 years of PCI’”, commented Professor Jörg Kreuzer, Vice President Medicine, Therapeutic Area Cardiovascular, Boehringer Ingelheim. “We are honoured that the results will be included in the congress Spotlight Session and hope that the findings from the trial will provide a valuable contribution to patient management in the PCI setting.” (photo: Boehringer Ingelheim)

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Stroke history higher in asymptomatic versus symptomatic atrial fibrillation patients

Posted by fidest press agency su giovedì, 22 giugno 2017

fibrillazione atrialeVienna, Austria Newly diagnosed asymptomatic atrial fibrillation patients have a higher rate of previous stroke than those with symptoms, according to results from the GLORIA-AF Registry presented today at EHRA EUROPACE – CARDIOSTIM 2017.1 The findings highlight the need for screening to identify atrial fibrillation patients with no symptoms so that stroke prevention treatment can be given.“Patients with non-valvular atrial fibrillation have a five-fold increased risk of stroke compared to those without atrial fibrillation,” said lead author Dr Steffen Christow, a cardiologist at Hospital Ingolstadt GmbH, Ingolstadt, Germany. “Strokes in patients with non-valvular atrial fibrillation tend to be particularly severe and disabling, with about half of patients dying within one year.”“Appropriate anticoagulant therapy substantially reduces the risk of stroke, but in many cases non-valvular atrial fibrillation is only diagnosed after a patient has had a stroke,” he continued. “When patients are unaware of their atrial fibrillation they remain untreated and unprotected from stroke.”GLORIA-AF (Global Registry on Long-Term Oral Antithrombotic Treatment in Patients with Atrial Fibrillation) is a large, multinational, prospective registry programme involving patients with newly diagnosed non-valvular atrial fibrillation. This sub-analysis compared characteristics between symptomatic and asymptomatic patients in Western Europe.The study included 6 011 consecutively enrolled patients with non-valvular atrial fibrillation in Western Europe.2 Symptom status was defined by the European Heart Rhythm Association (EHRA) score: I-II asymptomatic/minimally symptomatic; III-IV symptomatic.
A total of 4 119 patients (two-thirds) were asymptomatic/minimally symptomatic (hereafter referred to as ’asymptomatic‘) and one-third (1 892) were symptomatic at the time of diagnosis. A number of differences were observed between the two groups.In terms of medical history, asymptomatic patients were twice as likely to have permanent atrial fibrillation (15.8% versus 8.3%) and more than twice as likely to have had a previous stroke (14.7% versus 6.0%) than patients in the symptomatic group. Asymptomatic and symptomatic patients had a similar number of stroke risk factors, as indicated by a CHA2DS2-VASc score of 3.3 in each group.Dr Christow said: “The finding of a higher rate of previous stroke in the asymptomatic patients despite no differences in the number of stroke risk factors may be explained by a longer but undiagnosed history of atrial fibrillation.”“Our study found that in Western Europe, two-thirds of patients newly diagnosed with atrial fibrillation were asymptomatic,” he continued. “Without detection, patients may not receive appropriate preventive therapy and remain at increased risk of stroke.”Dr Christow concluded: “These results underline the urgent need for public programmes to detect atrial fibrillation in the general population.”

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International Forum on Cancer Patients Empowerment “Shared decisions, one policy”

Posted by fidest press agency su giovedì, 11 maggio 2017

università studi milanoMilano, 16 al 17 maggio 2017 presso l’Università degli Studi. Nella sessione di apertura dalle 9.30 alle 10.15 sono attesi gli interventi del Ministro della Salute, Beatrice Lorenzin, e del Ministro dell’Istruzione, dell’Università e della Ricerca, Valeria Fedeli. L’equilibrio tra innovazione e sostenibilità, in uno scenario caratterizzato dai nuovi trend dell’oncologia di precisione e della medicina genica e personalizzata, sarà al centro di una
successiva sessione dedicata (dalle 11.45 alle 13.30), dove interverranno tra gli altri, Mario Melazzini, Presidente dell’Agenzia Italiana del Farmaco, Massimo Scaccabarozzi, Presidente di Farmindustria, e Nathalie Moll, EFPIA General Director. Nella giornata del 17 maggio, Gianluca Vago, Rettore dell’Università degli Studi di Milano introdurrà la sessione di apertura, in cui Paolo Corradini, Direttore del Dipartimento di Oncologia ed Onco-ematologia dell’Ateneo milanese, illustrerà l’esperienza maturata negli anni da quello che oggi, con oltre 60 addetti, si propone come un centro di eccellenza, tra i più grandi a livello europeo, dedicato alla ricerca e cura oncologica. Il Forum avrà luogo presso l’Università degli Studi di Milano, sede di importanti gruppi di ricerca operanti nel contesto e partecipe di molti dei più rilevanti programmi di ricerca nazionali e internazionali sul fronte della ricerca scientifica e su quello del trasferimento tecnologico e di sviluppo applicativo dei risultati della ricerca scientifica. La partecipazione dei cittadini ai processi decisionali rappresenta uno dei valori fondamentali su cui si basa la strategia comunitaria europea, anche nella pianificazione dei nuovi programmi sanitari. “Shared decisions, one policy” è il primo Forum internazionale dedicato ai diritti dei pazienti e al loro attivo coinvolgimento nel processo decisionale clinico e nelle politiche di sanità pubblica nell’era dell’oncologia personalizzata, con particolare riferimento alle esigenze di omogeneizzazione e riequilibrio tra i diversi standard assistenziali europei.
Il Forum propone una sintesi multidisciplinare e multidimensionale, offrendo il contributo di tutte le categorie a vario titolo interessate e coinvolte su questo tema in Italia e in Europa: rappresentanti dei pazienti, operatori sanitari, politici, legislatori e regolatori, organizzazioni internazionali, organismi governativi e aziende farmaceutiche. Il Forum contribuisce al dialogo internazionale sul diritto umano ad uno stato ottimale di salute, collocandosi a pieno titolo all’interno del contesto dell’azione comune europea sul controllo del cancro.
La partecipazione al Forum non prevede costi di iscrizione ed è aperta a tutti gli interessati, previa registrazione sul sito: http://www.forumcpe.it (foto: università studi milano)

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