“We’re all juggling a thousand things, and it can be hard to know where to focus. Paula Rizzo shows us how to create the happier, more productive lives we want, one list at a time.”
―Gretchen Rubin, New York Times bestselling author of The Happiness Project
“Listful Living is packed with practical, invaluable prompts and tools that help us accomplish the right things―the things that matter to each of us. It's honest, weaving in powerful stories from Paula's past, which inspired her to reevaluate her priorities and approach to productivity. It's also encouraging and empowering. Listful Living reminds us that we can accomplish our goals, one small, intentional step at a time―and shows us precisely how to do it.”
―Margarita Tartakovsky, MS, associate editor and writer at PsychCentral.com
“Listful Living is a compass to help you understand where you stand with your productivity efforts and how to get where you want to be. Whether that is to accomplish your life’s dreams or simply be more organized in your daily activities, this guide will show you how to get more done with less effort.”―Craig Jarrow, founder and author of Time Management Ninja
About the Author
Paula Rizzo is an Emmy Award-winning television producer, best–selling author, and a media trainer and strategist. As a former Fox senior health producer for more than a decade she produced segments with a range of top experts, including JJ Virgin, Jillian Michaels, and Deepak Chopra. A media veteran for nearly 20 years, she also worked in local New York news as a producer for WCBS, WPIX and WLNY.
Paula is the founder of ListProducer.com and best-selling author of Listful Thinking: Using Lists to be More Productive, Highly Successful and Less Stressed, which has been translated into 12 languages and featured on Health.com, Fast Company, Prevention, Business Insider, Entrepreneur, Brides and Oprah.com’s list of “Self Help Books That Actually Help.” Paula is a contributor to MindBodyGreen.com, Entrepreneur.com and Thrive Global. Listful Living: A List-Making Journey to a Less Stressed You is her second book.
DR. IAN K. SMITH JOINS JETSON AS CHIEF MEDICAL ADVISOR
World’s First Seasonal Probiotic Brand Welcomes New York Times Best-Selling Author & Gut Health Expert to Make 50M Americans Healthier
Chicago, IL – Jetson, the world’s first seasonal probiotic, welcomes Ian K. Smith, MD, a respected physician and #1 New York Times best-selling author, in the newly created role of Chief Medical Advisor. By bringing on Dr. Ian, Jetson founder, Stefan Weitz, is continuing to fulfill his mission to make healthier living attainable for the everyday American.
As Jetson’s Chief Medical Advisor, Dr. Ian will work hand in hand with Stefan, to help people understand that fat diets are not long-term solutions and miracle pills don’t exist. Together they will work with leading laboratories around the world that are pushing the envelope in gut health and its relationship to overall health. As an Ivy League-educated physician, Dr. Ian will focus on the complex, medical aspects of Jetson and contribute scientifically-validated and achievable lifestyle habits to make all Americans healthier.
“I'm excited to be working with Jetson to create novel, grounded-in-science products that could potentially help millions of people improve their gastrointestinal and overall health,” said Dr. Ian. “Preventing illnesses before they develop has been an important part of my health advocacy, and the work we have planned will only enhance this opportunity to make an impact in this critical wellness space.”
The genesis of Jetson began several years ago when Stefan was diagnosed with an incurable autoimmune disease - Multiple Sclerosis. Facing the prospect of being confined to a wheelchair, and early death he turned to a new diet, exercise and probiotics regimen to help keep his immune system in check. It worked and he is now symptom and pain-free.
Stefan wanted to share his findings with others so he enlisted some of the best scientists and health experts in the world and, after synthesizing hundreds of hours of research, Stefan created Jetson - fresh, seasonal and affordable probiotics that he would want to take himself. Stefan knew that in order for Jetson to impact the health of the greater community, he needed to educate the consumer about how to get healthier in an attainable way.
“We have been working on bringing on the right Chief Medical Advisor into Jetson for quite some time. It needed to be someone dedicated to truly changing the way Americans live with an emphasis on gut health because we now know that it is the gateway to better overall health,” said Stefan. “When I read my first book by Dr. Ian and heard him speak, I knew he was our guy. His ability, as a medical expert, to connect with everyday Americans about advancing their health is both impressive and imperative in achieving Jetson’s goal of making America healthier.”
About Jetson
Jetson is the world’s first seasonal probiotic founded by Stefan Weitz in June 2019. Jetson is made fresh, small batches using the latest bacteria strains discovered by science to constantly innovate and improve the product. Delivered fresh each month, Jetson’s seasonal probiotics provide specific formulations tailored to address your bodies’ unique needs year-round for $35 a month. Visit www.wearejetson.com and follow on Instagram @wearejetson.
About Dr. Ian K Smith
Dr. Ian's latest book, CLEAN & LEAN, instantly hit the NY Times bestsellers list and joins the wildly popular NY Times bestselling SHRED Series. A highly-sought after speaker, Dr. Smith's work has been honored by several organizations, including the National Academy of Television Arts & Sciences for his coverage on the momentous events of 911. Dr. Smith has served on the boards of the American Council on Exercise, the New York Mission Society, Prevent Cancer Foundation, The New York Council for the Humanities, Chicago Public Television and The Maya Angelou Center for Health Equity. Dr. Smith graduated from Harvard College and received a master’s in science education from Teachers College of Columbia University. He attended Dartmouth Medical School and graduated from the University of Chicago Pritzker School of Medicine. He had the prestigious honor of serving two terms on Barack Obama's President's Council for Fitness, Sports and Nutrition. Follow him on Twitter: @DrIanSmith, Instagram: @doctoriansmith. Visit his websites:www.shredlife.com andwww.doctoriansmith.com and go to Shredder Nation on Facebook atwww.facebook.com/ShredderNation
As we are back to school and getting ready for fall It is a perfect time to start decluttering.
So why not Marie Kondo your beauty routine with Alleyoop! Alleyoop is a brand-new body and beauty brand focused on simplifying and decluttering your beauty routine by encouraging women to spend more time on what matters to them and less time keeping up with beauty. If we have learned anything from the famous Marie Kondo, it is to focus on the things that bring you joy in life and creating the opportunity to live the life you’ve always dreamed of.
Each product either checks off at least two boxes on your do-do list or is compact and efficient, saving you counter space for that adorable succulent you’ve been eying or extra room in your purse for 4pm snacks!
Don’t have time to shave before your morning meeting? No problem- whip out the all-in-one razorallowing you to shave anywhere anytime with a refillable water spray bottle and moisturizing bar to soften your skin and hair pre-shave, plus two triple-blade razor cartridges. Too many makeup brushes littering your makeup bag? Check out the 4-in-1 makeup brush featuring a sponge for concealer plus blush, brow, and eyeshadow brushes all made of premium synthetic fibers. Grab this and go or use on a daily basis -- either way, it’s all you need for a flawless face (of makeup).
Back to School...and Back to Bullying
One child gently grasps the hand of a crying child as they head into school together. It is a moment of caring and comforting. You may have seen the photograph that recently went viral: https://cnn.it/30K8zU0.
Could anything be more beautiful than that? It almost makes you believe that bullying is an aberration rather than a daily reality for kids, of all ages, everywhere. However, we know that bullying, and its consequences, are in the news every day.
The beginning of a school year is always a time of remembering for me. My middle school experience was a nightmare of kids who wanted to hurt me and adults who abandoned me. I will always recall how it felt. It took me decades to recover and reclaim my peace.
More than anything, the advent of social networking helped. Using technology responsibly allowed me to connect with some of those who hurt me and ensure that I never had to worry about any of those childhood bullies again. It even created an opportunity to enjoy several very much belated friendships with people from my past.
I hope others who experienced bullying at school can heal far more quickly than I did. To help them, I wrote "Getting Past Childhood Bullying: How Adults Can Recover From Trauma That Began at School." It contains the story of my experiences and how, using a four-step program, I was finally able to get beyond the bullying.
As kids go back to school, they'll be making memories. At the same time, this time of year will trigger horrifying recollections and feelings of helplessness for the adults who never got beyond the bullying they suffered. They really could use a proven program for healing. I'd like to send you an evaluation copy of my book. Might that be of interest to you? I'd also be available for an interview. Thank you for your time and consideration.
Bio: Stacey J. Miller
Stacey J. Miller is an independent book publicist, publisher, writer, editor, and social media strategist. She has worked in, and around, the book publishing industry for nearly three decades.
She is the author of Getting Past Childhood Bullying: How Adults Can Recover From Trauma That Began at School (BPT Press). and Feline Operation Barfitty Blues: The College Emissions Scandalwhich she wrote, and published, in three days. She likes cats an awful lot.
Founder of S. J. Miller Communications, Stacey is based in a suburb of Boston, Massachusetts. Visit her online at www.bookpr.com.
Regulation of Vaping Products Should Protect Youth, Help Adult Smokers Switch
TORONTO, Sept. 4, 2019 /CNW/ - Vaping products should be regulated to protect youth from nicotine addiction and help adult smokers switch away from cigarettes, Rothmans, Benson & Hedges Inc. said in a submission today to Health Canada.
RBH's recommendations were submitted to Health Canada as it looks at incoming regulatory measures on the labelling and packaging of vape products.
RBH supports a number of the government proposals to protect public health and safety, including:
New warning labels to identify that vaping is not for youth, not risk-free and contains nicotine, which is addictive;
Nicotine levels be shown in a standardized format that allows adult smokers to make informed choices and understand the differences between products;
Prohibiting the sale of vaping products with nicotine concentrations of 66 mg/mL or more;
Vaping substances to include a list of ingredients on their packaging for standardization and safety; and
Toxicity warnings and child-resistant packaging for certain vaping products.
To that end, RBH proposed two specific changes to the regulation of vape products:
Modify proposed health warnings to state that vaping products contain nicotine and are addictive, are not risk-free but are a better alternative than continuing to smoke; and
Define tobacco vaporizers as vaping products to regulate them appropriately.
RBH's recommendations would allow Health Canada to extend its approach to reducing the health risks of nicotine consumption by continuing to let adult smokers know vaping products are a better alternative than continuing to smoke.
Health Canada recognizes that vaping products deliver nicotine in a much less harmful way than smoking cigarettes. In a statement released on May 31, 2019 the agency said "while vaping products are not intended for non-smokers or young people, smokers who switch completely from cigarettes to vaping products significantly reduce their exposure to dozens of powerful toxins and carcinogens found in cigarette smoke." Vaping product warnings and labels should reflect this reality.
In fact, RBH believes these regulations should be extended and harmonized for other vaping devices heated by a battery, including those that heat (but never burn) tobacco.
Health Canada has set a target to reduce smoking rates to five per cent by the year 2035. RBH believes that with the right technologies and policies this target can be achieved faster.
QUOTES: Peter Luongo, Managing Director, RBH
We support the government's goal of curbing youth vaping to help the next generation set Canada on a path to be smoke-free.
Vaping products are for adult smokers and the packaging and labelling should reflect that fact.
Parents are concerned about vaping. As kids head back to school, Canadians should be aware of the risks.
Health warnings need to communicate effectively the risks of vaping products for non-smokers and youth.
We want to Unsmoke Canada. For change like this to happen we need policy makers, consumers and society in general to all play a role.
The core message of Unsmoke is: if you don't smoke, don't start. If you smoke, quit. If you don't quit, change.
The best choice for any Canadian is to never start smoking or vaping, or to quit entirely.
It's time for a change. Innovation has led to better alternatives for adults who would otherwise continue to smoke cigarettes.
Government rules and regulations should encourage current adult smokers to switch away from cigarettes.
A complete copy of RBH's submission to Health Canada is available upon request.
About Rothmans, Benson & Hedges Inc. Rothmans, Benson & Hedges Inc., an affiliate of Philip Morris International Inc., is one of Canada's leading tobacco companies and employs nearly 800 people across the country with its headquarters in Toronto and a factory in Québec City. RBH is a certified Top Employer 2019 in Canada for excellence in employee conditions. For more information, visit www.rbhinc.ca and www.unsmoke.ca
SOURCE Rothmans, Benson & Hedges Inc.
New guideline clarifies role of radiation therapy in pancreatic cancer treatment
First-of-its-kind clinical guideline from leading radiation oncology society discusses radiation dosing, conventional versus stereotactic radiation and mitigating side effects
A new clinical guideline from the American Society for Radiation Oncology (ASTRO) provides recommendations on the use of radiation therapy to treat patients diagnosed with pancreatic cancer, including when radiation treatments are appropriate, as well as the optimal dosing, timing and fractionation for these treatments. The guideline, which also outlines strategies to prevent and mitigate common side effects of pancreatic radiation therapy, is published online in Practical Radiation Oncology, the clinical practice journal of ASTRO.
Despite being the 11th most common cancer diagnosed among U.S. adults, pancreatic cancer is the third leading cause of cancer death, with an estimated 45,570 deaths and 56,770 new diagnoses in 2019. The five-year relative survival rate for pancreatic cancer is 9%, which is among the lowest for any cancer type. Multiple factors underlie these high mortality rates: the disease is very aggressive compared to other cancers, symptoms can be vague, and screening is difficult. More than half of diagnoses occur after the cancer has metastasized, when the five-year relative survival rate drops to 2.9%.
The ASTRO guideline covers four main areas: (1) the use of radiation in pre-surgical, post-surgical, definitive and palliative treatment settings; (2) stereotactic versus conventional radiation therapy; (3) technical aspects of radiation therapy; and (4) mitigating common side effects. It emphasizes a patient-centered approach that integrates patients' values and preferences into treatment decisions and also stresses the importance of multidisciplinary consultations, planning and follow-up.
Standard treatment for localized pancreatic cancer, or disease that has not spread outside of the pancreas, involves surgery to remove the tumor, combined with radiation and/or chemotherapy prior to surgery and/or following surgery to target potential residual disease. More than 80% of patients are diagnosed with tumors that have spread beyond the pancreas and cannot be removed surgically, however, and even patients who undergo surgery face local and distant recurrence rates of 50-90%.
Recent breakthroughs including new systemic therapies and the emergence of stereotactic radiation have driven significant changes in pancreatic cancer treatment, which led ASTRO to develop its first guideline on this topic. "Historically, very high rates of distant metastatic disease with pancreas cancer have overshadowed its tendency to recur locally. In the past several years, newer systemic therapies are proving to be more effective at controlling this cancer when it spreads, and fewer people are dying from distant disease. This makes treatments like radiation to manage local disease more meaningful," explained Manisha Palta, MD, co-chair of the guideline task force and a radiation oncologist at Duke University.
Recommendations for Radiation Therapy for Pancreatic Cancer Patients
The guideline first presents indications for radiation therapy in the adjuvant, neoadjuvant and definitive settings. It delineates between conventionally fractionated and stereotactic radiation therapy, providing the first clinical guidance on the newer, shorter-course approach. "One thing this guideline offers that hasn't been available previously is context about the current status of ablative radiotherapy such as stereotactic body radiation therapy (SBRT) and where it might be useful for patients with pancreatic cancer," said Dr. Palta.
Recommendations on the indications of radiation therapy for pancreas cancer are as follows:
In the adjuvant/post-operative setting, conventionally fractionated radiation is recommended conditionally for patients with high-risk features such as positive lymph nodes and margins following surgical resection. SBRT is recommended only if the patient is enrolled in a clinical trial/data registry.
In the neoadjuvant/pre-operative setting, conventionally fractionated radiation therapy or SBRT is recommended conditionally following chemotherapy for patients with resectable disease. Neoadjuvant chemotherapy plus radiation (either conventional or stereotactic) is conditionally recommended following systemic therapy for select patients with borderline resectable disease.
For patients with locally advanced disease (who are not candidates for surgery), systemic chemotherapy followed by either chemoradiation or SBRT is recommended conditionally as an option for definitive treatment.
Recommendations also address:
optimal dosing and fractionation for different subgroups of patients;
sequencing of radiation with systemic chemotherapies in adjuvant, neoadjuvant and definitive settings;
simulation and setup strategies, such as image guidance and patient-specific motion management;
techniques for treatment planning and delivery, including a strong recommendation for the use of modulated radiation therapy to deliver treatment; and
treatment in the palliative setting, including a strong recommendation for palliative radiation therapy to either the primary tumor or select metastatic sites to help relieve the patient's pain and other symptoms.
Mitigating Side Effects
The guideline also addresses ways to mitigate side effects related to pancreatic radiation, whether given alone or with chemotherapy. While the side effects from radiation therapy depend on how the radiation is administered, the most common toxicities include fatigue and digestive/gastrointestinal effects such as nausea, vomiting and diarrhea.
The guideline strongly recommends that patients who undergo radiation treatments for pancreatic cancer be given prophylactic anti-nausea medicines. It also conditionally recommends the use of antacid or acid-reducing medications.
Dr. Palta explained how these medications are used preventatively with radiation: "If we know that certain side effects tend to occur with a relatively modest or high frequency – such as nausea and stomach pain – there are medications we can give to patients prior to treatment to help mitigate those side effects."
Future Directions
The guideline comments on emerging and upcoming trial reports that will add to the evidence on stereotactic radiation and other aspects of pancreatic cancer treatment, and which subsequently will shape future clinical practice and guideline updates.
"Any patient who is diagnosed with pancreatic cancer deserves to have a multidisciplinary evaluation, where she or he can have nuanced conversations about the benefits and risks of different types of treatment based on the most current information available. It's also essential that any patient who might be an appropriate candidate for radiation have access to a radiation oncologist who can provide perspective on the pros and cons of treatment, so that the patient can make an informed decision," said Dr. Palta. “This is a rapidly evolving field and some potentially practice-changing studies that are not included in this guideline may become available in the relatively near-term future.”
About the Guideline
The guideline was based on a systematic literature review of 179 articles published from May 2007 through January 2017. The 14-member task force included a multidisciplinary team of radiation oncologists from a variety of practice settings, a medical physicist, a medical oncologist, a surgical oncologist, a radiation oncology resident and a patient representative. The guideline was developed in collaboration with the American Society of Clinical Oncology (ASCO) and the Society of Surgical Oncology (SSO), who provided representatives and peer reviewers.
ASTRO's clinical guidelines are intended as a tool to promote appropriately individualized, shared decision-making between physicians and patients. None should be construed as strict or superseding the appropriately informed and considered judgments of individual physicians and patients.
“Radiation Therapy for Pancreatic Cancer: An ASTRO Clinical Practice Guideline” is available as a free access article in Practical Radiation Oncology, ASTRO’s clinical practice journal. For a copy of the guideline or to interview the task force chairs or outside experts in pancreatic cancer, contact ASTRO’s media relations team at press@astro.org or 703-286-1600.
Additional Resources on Pancreatic Cancer and Radiation Therapy
PDF: Questions for patients diagnosed with pancreatic cancer to ask when considering and receiving radiation therapy
PDF: An overview of the pancreatic radiation treatment process
Blog: New ASTRO guideline offers recommendations on RT indications and technique in pancreatic cancer
ABOUT ASTRO The American Society for Radiation Oncology (ASTRO) is the world’s largest radiation oncology society , with more than 10,000 members who are physicians, nurses, biologists, physicists, radiation therapists, dosimetrists and other health care professionals who specialize in treating patients with radiation therapies. The Society is dedicated to improving patient care through professional education and training, support for clinical practice and health policy standards, advancement of science and research, and advocacy. ASTRO publishes three medical journals, International Journal of Radiation Oncology • Biology • Physics, Practical Radiation Oncology and Advances in Radiation Oncology; developed and maintains an extensive patient website, RT Answers; and created the nonprofit foundation Radiation Oncology Institute. To learn more about ASTRO, visit our website, sign up to receive our news and follow us on our blog, Facebook, Twitterand LinkedIn.
Find time for fitness this STRESS-tember
There’s a reason it’s known as STRESS-tember. You have too much to do at work, at home, and in your social life and healthy habits take a back seat because you’re just ‘too busy.’
The reality is Canadians are fitting more activities than ever into their days. In a national survey of working Canadians, one-third of respondents feel they have more work to do than time permits. That number rises to 40 per cent when family roles are taken into account.
We’re so busy we tell ourselves we don’t have time for anything else…especially exercise. In another Canadian study, 44% of respondents said they had no time for regular physical activity and almost a third (31%) said they end up spending time commuting instead of being physically active.
According to Nsuani Baffoe, personal training manager for downtown Toronto with GoodLife Fitness, a lot of this chronic busy-ness is not always as bad as it seems, and it’s possible to find time for exercise. In fact, the busier and more stressed out you are, the more you can benefit from a workout. Exercise increases your overall sense of wellbeing and contributes to endorphin production, which makes you feel happier and more content. It also helps you sleep better and think more clearly, to better multi-task your way through it all.
The key is to take a look at the time-sucking activities (hint: it’s staring at screens) and FIND the time to exercise and prepare healthy food options. To get the right amount of exercise all we need is 1.8% of our time - just one hour three times a week.
Some ways to escape your stress and fit in a workout include:
Take stock of your time use. Track your activities for a few days. You may find you’re not quite as busy as you feel – maybe you spend 15 minutes every morning scrolling through social media, or you watch TV every night for two hours. Identify non-essential activities that are slowing you down and reassign that time to physical activity.
Schedule your workout like an appointment (and stick with it). By putting exercise into your calendar, you’re making it a priority, equal to work, paying the bills, shopping for groceries. It’s also more difficult to cancel when it’s right there in your calendar.
Tailor workouts to how you’re feeling. If you’re exhausted and stressed, you want a workout that will leave you feeling stronger and revitalized. Baffoe suggests yoga or Pilates routines for stress-release and posture improvement. Or try a simple bodyweight circuit with squats, lunges, push-ups, and crunches. Strength exercises can be done anywhere and are great for posture and toning. Bonus: both workouts help you sleep better.
Be more efficient. Try HIIT or Tabata workouts if you’re short on time. This approach means you push yourself for a short time, followed by less rest, so your work is over sooner. Just 15 minutes of HIIT (combining cardio and strength moves) once a week can have the same benefits as about 300 minutes of cardio.
Simplify your goals. If your goals are too ambitious, there’s a good chance you won’t achieve them. Try setting more bite-sized, easy goals you know you can achieve. Instead of ‘hit the gym for one hour every day’ try ‘do something active every day and hit the gym 3-4 times this week.’
Build exercise into your work and family time. At work: ditch the car and commute by bike, take regular breaks for stretching and exercise, and schedule walking meetings. Friends and family: Meet up for a group fitness class, take advantage of the fall months to jump on your bikes and tour the neighbourhood, or take the dog to the park to reconnect with your loved ones.
Nsuani Baffoe and fitness experts in your area are available to talk more about the best approach to fit in more exercise into your busy routine in STRESS-tember and beyond. They can demonstrate time-saving workout ideas (HIIT and Tabata), as well as some great exercises to reduce stress and maximize the impact of every workout.
ETNA-AF Registry Data Provide Real-world Evidence of the Efficacy and Safety Profile of LIXIANA® (edoxaban) in Elderly Non-Valvular Atrial Fibrillation Patients
MONTREAL, Sept. 4, 2019 /CNW Telbec/ - Servier Canada announces one-year outcomes results from a study of 24,962 patients with non-valvular atrial fibrillation (NVAF) treated with LIXIANA® (Edoxaban), including elderly NVAF patients and those with and without a history of intracranial haemorrhage (ICH). One-year follow up data from the ETNA-AF (Edoxaban Treatment in routiNe clinical prActice) study were presented at ESC Congress 2019 in Paris, France, reporting the effectiveness and safety of LIXIANA in patients with NVAF.
Global ETNA-AF analyses
A new analysis, which reported the outcomes of 24,962 edoxaban-treated patients with NVAF at one year follow up supports the treatment's safety and efficacy profile in elderly and very elderly AF patients. The majority of these patients were aged 65 years or over.[1] Results showed that:[1]
Rates of major bleeding (MB), as defined by the International Society on Thrombosis and Haemostasis (ISTH), including ICH and ischaemic stroke were generally low amongst all patient groups. Per year, ISTH-defined MB occurred in 0.6% of patients aged <65, 0.9% patients aged ≥65-<75, 1.2% patients aged ≥75-< 85 and 1.8% patients aged ≥85. ICH occurred in 0.2% patients aged <65, 0.3% patients aged ≥65-<75, 0.3% patients aged ≥75-< 85 and 0.3% patients aged ≥85. Ishaemic stroke occurred in 0.6% of patients aged <65, 0.7% patients aged ≥65-<75, 0.9% patients aged ≥75-< 85 and 1.3% patients aged ≥85.
Whilst all-cause and CV mortality was shown to increase with age, as would be expected, CV mortality was a minor proportion of all-cause mortality in all age groups. There was also no increase in the rate of ICH with age. Per year, all-cause mortality/CV mortality occurred in 35 (1.1%)/18 (0.5%) of patients aged <65, 136 (1.8%)/62 (0.8%) of those aged ≥65-<75, 275 (3.3%)/116 (1.4%) of those aged ≥75-<85 and 196 (8.7%)/76 (3.4%) of those aged ≥85.
"These findings are important because the prevalence of NVAF and stroke risk, and therefore the need for oral anticoagulation, all increase with age," said Professor Raffaele De Caterina, Professor of Cardiology, Institute of Cardiology at the University of Pisa, Italy. "Additionally, elderly patients are more likely to have other comorbidities and to be on various medications that may interfere with treatment. The data from this set of unselected patients support edoxaban's growing evidence of safety profile and its use as an effective treatment for elderly, and very elderly, AF patients in regular clinical care. Of particular interest is the set of data showing no apparent increase in the rate of intracranial haemorrhage in edoxaban-treated patients as a function of age, while a high rate of this occurrence and its increasing prevalence as a function of age was shown in warfarin-treated patients."
Additionally, a further 1-year follow-up analysis of the difference in outcomes between edoxaban-treated AF patients with history of ICH (i.e. those at higher risk of stroke, death and recurrent haemorrhage) and those without a history of ICH, showed that:[2]
Incidences of ISTH-defined MB (including ICH) and clinically relevant non-major bleeding (CRNMB) were generally low in both groups.
ICH occurred in 3 (1.2%) patients with history of ICH and 56 (0.3%) patients without history of ICH, per year. The rate of ischaemic stroke was higher in patients with history of ICH (6 [2.4%]) than in those without (165 [0.8%]), per year.
These new data suggest that edoxaban is an effective treatment option for patients with or without prior ICH, whilst also demonstrating the need for effective stroke prevention in NVAF patients with a history of ICH.[2]
"The global ETNA AF programme is the largest and most comprehensive repository of real-world data on the use of a DOAC, in this case Lixiana®. The sub-group analysis of the elderly/very elderly AF patients of this registry, which represents more than 21,000 patients, provides further evidences about the safety profile of Lixiana® in populations at high risk of bleeding. It also complements, the recently published ENTRUST-AF PCI results confirming the safety profile of Lixiana® in AF patients undergoing a successful PCI", mentioned Frederic Fasano, CEO of Servier Canada.
Further new European analyses at ESC 2019
Echoing the Global registry outcomes data, additional one-year follow up analyses of 12,574 unselected elderly AF patients with comorbidities, from ten European countries, showed that the incidence of clinical events for both bleeding and stroke rates were low. Per year, MB occurred in 1.05% (n=125), ICH occurred in 0.23% (n=28) and any stroke or systemic embolic events occurred in 0.82% (n=98) of cases.[2] All-cause mortality occurred in 3.55% of patients per year, which can be rated as low in a high-risk context.[3]
This snapshot real-world analysis compared the baseline and first year outcomes data from 12,574 patients (mean age of 73.6 years) with the outcome data of the European cohort from the clinical Phase III ENGAGE AF-TIMI 48 study,[3] which investigated the safety and efficacy of edoxaban compared to warfarin, for the prevention of stroke or stroke and systemic embolic events in patients with AF.[4] In ETNA-AF, edoxaban was used in a broad range of elderly NVAF patients. Additionally, dose reduction at baseline between the ETNA-AF and ENGAGE AF-TIMI 48 was similar and overall there was a good adherence (84%) to the European label.[5]
"It is interesting to note that the higher HAS-BLED score in ETNA-AF compared to ENGAGE AF-TIMI 48 suggests that in real-world clinical settings physicians are more comfortable using edoxaban in patients with higher bleeding risk," said Raffaele De Caterina, Professor of Cardiology, Institute of Cardiology at the University of Pisa, Italy. "This new analysis reinforces the safety profile and effectiveness of edoxaban in elderly NVAF patients at high CV risk, but also suggest that the ENGAGE AF-TIMI 48 study efficacy results are being largely confirmed in general practice."
About ETNA-AF
ETNA-AF (Edoxaban Treatment in routiNe clinical prActice in patients with nonvalvular Atrial Fibrillation) is a global programme that combines data from distinct non-interventional studies in Europe, East Asia, and Japan in a single database. A total of more than 28,000 patients will be included in the ETNA-AF registries and followed for two years (patients in Europe will be followed for four years). The primary objective of ETNA-AF is to collect information on the use of edoxaban in routine clinical practice, including the safety and efficacy profile in non-preselected patients with NVAF.[6],[7],[8],[9],[10]
About Atrial Fibrillation
AF is a condition where the heart beats irregularly and rapidly. When this happens, blood can pool and thicken in the chambers of the heart causing an increased risk of blood clots. These blood clots can break off and travel through the blood stream to the brain (or sometimes to another part of the body), where they have the potential to cause a stroke.[11]
AF is the most common type of heart rhythm disorder affecting approximately 350,000 Canadians and is associated with substantial morbidity and mortality.[12],[13] Compared to those without AF, people with the arrhythmia have a 3-5 times higher risk of stroke.[14] One in five of all strokes are a result of AF.[15]
About Edoxaban
Edoxaban is an oral, once-daily, direct factor Xa (pronounced "Ten A") inhibitor. Factor Xa is one of the key components responsible for blood clotting, so inhibiting this makes the blood thin and less prone to clotting. Edoxaban was discovered and developed by Daiichi Sankyo Co., Ltd. On June 27, 2016, Daiichi Sankyo and Servier Canada entered into an agreement whereby Servier Canada would market the oral, once-daily anticoagulant edoxaban in Canada, upon approval by the Canadian health authority. Edoxaban is currently marketed in more than 30 countries and regions around the world.
About Servier Canada
Servier Canada is an affiliate of the independent French Servier Group governed by a Private Foundation. We, at Servier, are committed to therapeutic progress to serve patient needs. We work assiduously to provide the Canadian medical community and its patients with innovative therapeutic solutions. As such, Servier Canada is partnering with various players in the life science ecosystem including researchers, clinicians, entrepreneurs and innovators. In addition to these research partners, the International Center for Therapeutic Research (ICTR) located in Laval, is dedicated to preclinical and clinical development with more than 50 studies conducted throughout Canada over the last 10 years. More information is available at www.servier.ca
About the Edoxaban Clinical Research Programme
More than 10 studies, more than 100,000 patients worldwide
Daiichi Sankyo, who discovered edoxaban, is committed to expanding scientific knowledge about this DOAC, as demonstrated through research programmes evaluating its use in a broad range of cardiovascular conditions, patient types and clinical settings in atrial fibrillation (AF) and venous thromboembolism (VTE) designed to further build on the results of the pivotal ENGAGE-AF and Hokusai-VTE studies. More than 100,000 patients worldwide are expected to participate in the Edoxaban Clinical Research Programme, which is comprised of more than 10 RCTs (randomised, controlled trials), registries and non-randomised clinical studies, including completed, ongoing and future research. Our goal is to generate new edoxaban clinical and real-world-data regarding its use in AF and VTE populations, providing physicians and patients worldwide with greater treatment assurance.
References:
[1]
Wang, CC. et al. One-year outcomes of elderly patients with atrial fibrillation: snapshot data from the Global Noninterventional Program on Edoxaban Treatment in Routine Clinical Practice in Atrial Fibrillation. Poster presented at ESC Congress 2019.
[2]
Kirchhof, P. et al. Clinical characteristics and 1-year outcomes in atrial fibrillation patients with or without history of intracranial haemorrhage treated with edoxaban: data from the Global ETNA-AF program. Poster presented at ESC Congress 2019.
[3]
De Caterina, R. et al. ETNA-AF Europe: First 1-year follow-up snapshot analysis of more than 7,500 AF patients treated with edoxaban in routine clinical practice. Poster presented at ESC Congress 2019.
[4]
Giugliano, RP. et al. Edoxaban versus Warfarin in Patients with Atrial Fibrillation. N Engl J Med. 2013; 369:2093-2104.
[5]
De Caterina, R. et al. Characteristics of patients initiated on edoxaban in Europe: baseline data from edoxaban treatment in routine clinical practice for patients with atrial fibrillation (AF) in Europe (ETNA-AF-Europe). BMC Cardiovasc Disord. 2019;19:165.
[6]
Edoxaban Treatment in Routine Clinical Practice for Patients With Non Valvular Atrial Fibrillation (ETNA-AF-EU). Available at: https://clinicaltrials.gov/ct2/show/NCT02944019 [2]. [Last accessed: August 2019].
[7]
Edoxaban Treatment in Routine Clinical Practice for Patients With Atrial Fibrillation in Korea and Taiwan (ETNA-AF-KOR-TWN). Available at: https://clinicaltrials.gov/ct2/show/NCT02951039 [3]. [Last accessed: August 2019].
[8]
Edoxaban Treatment in Routine Clinical Practice for Patients With Non-valvular Atrial Fibrillation (ETNA-AF-Hong Kong). Available at: https://clinicaltrials.gov/ct2/show/NCT03247582 [4]. [Last accessed: August 2019].
[9]
Edoxaban Treatment in Routine Clinical Practice for Patients With Non-Valvular Atrial Fibrillation (NVAF). Available at: https://clinicaltrials.gov/ct2/show/NCT03247569[5]. [Last accessed: August 2019].
Iqbal, MB. et al. Recent developments in atrial fibrillation. BMJ. 2005;330(7485):238-43.
[14]
Ball, J. et al. Atrial fibrillation: Profile and burden of an evolving epidemic in the 21st century. Int J Card. 2013;167:1807-1824.
[15]
Camm, A. et al. Guidelines for the management of atrial fibrillation: the Task Force for the Management of Atrial Fibrillation of the European Society of Cardiology (ESC). Eur Heart J. 2010;31(19):2369-2429.
SOURCE Servier Canada Inc.
Crohn's and Colitis Canada Announces Updated Position Statement on Biosimilar Drugs
TORONTO, Sept. 5, 2019 /CNW/ - Today, Crohn's and Colitis Canada released their updated Position on biosimilar drugs. Supporting studies, including a report on cross-Canada surveys of patients and caregivers, gastroenterologists and inflammatory bowel disease (IBD) nurses was also released.
"Crohn's and Colitis Canada is a research-based organization. We took the time to carefully review our position on biosimilars and particularly on related non-medical switching policy in order to represent our patients thoughtfully and responsibly," says Mina Mawani, President and CEO of Crohn's and Colitis Canada. "Our position that a non-medical switch policy is not in the best interest of patients is based on what we've learned these past few months. We are very pleased to share our updated Position and the studies we've developed to help inform policy across Canada."
The Crohn's and Colitis Canada Position Statement asserts that:
Biosimilars are a safe and effective treatment for people with Crohn's disease and ulcerative colitis (the two main forms of IBD).
The decision to switch a patient from a biologic drug to its biosimilar should be based on patient/doctor choice.
Non-medical switching from a biologic drug to its biosimilar is not in the best interest of patients.
The Position Statement offers details on factors that must be considered in the event of the implementation of a non-medical switch policy including critical patient exemptions, required patient supports, extraordinary monitoring requirements and significant communication and education needs. "We have serious concerns about the potential for multiple non-medical switching – this cannot be supported," says Ms. Mawani. "Further, we understand that such policies are being considered because of fiscal pressures, so should the price differential between biologics and biosimilars be eliminated, a non-medical switch should not be considered by policy-makers at all."
Canada has one of the highest rates of Crohn's and colitis in the world. Today, more than 270,000 Canadians have Crohn's and colitis, a number that is expected to increase to over 400,000 within the next decade. Alarmingly, this chronic autoimmune disease is increasingly being diagnosed in children and as our population ages, a new challenge of caring for the frail elderly with IBD will present itself. Crohn's and colitis prevalence is also increasing amongst Canada's immigrant population.
Crohn's and Colitis Canada is committed to supporting people with IBD from across the country and will continue to share information with health care decision makers in all provinces and territories to inform patient-centred policy. "Our focus is on the patient. Their health and well-being is our priority," says Ms. Mawani.
ABOUT CROHN'S AND COLITIS CANADA Crohn's and Colitis Canada is the only national, volunteer-based charity focused on finding the cures for Crohn's disease and ulcerative colitis and improving the lives of everyone impacted by these diseases. We are the world's second largest health charity funder of Crohn's and colitis research, and our patient programs and advocacy efforts support the people affected by these chronic autoimmune diseases, which cause the body to attack healthy tissue, leading to the inflammation of all or part of the gastrointestinal tract. Visit crohnsandcolitis.ca for more information.
SOURCE Crohn's and Colitis Canada
How Common are Mental Health Problems in Arthritis Patients? Research Reveals Flaw in Determining Extent of Problem
VANCOUVER, Sept. 5, 2019 /CNW/ - A recent Arthritis Research Canada study has revealed that while administrative health databases are increasingly being used to study mental health in rheumatic diseases, researchers have used different ways to identify patients who have depression and anxiety, making it challenging to draw conclusions and comparisons across publications.
Administrative health databases refer to secondary data collected for billing purposes, which may be comprised of several unique administrative data sources – such as those capturing inpatient visits, outpatient visits, and prescription claims. These databases are increasingly used to study depression and anxiety in rheumatic diseases, but they only record details of those who seek and receive treatment. And mental health problems are notoriously under-reported.
"We identified the differing methods used to evaluate depression and anxiety in 36 studies using administrative health data and recommend examining multiple administrative data sources to understand the extent of mental health problems in populations living with arthritis," said Alyssa Howren, an Arthritis Research Canada trainee and the study's lead researcher.
While there are many physical complications associated with rheumatic diseases, there is also an increased risk of depression and anxiety. A recent Canadian population-based study reported that individuals with rheumatoid arthritis have a 1.5-fold increased risk for incident depression and a 1.2-fold increased risk for incident anxiety.
"Mental illnesses can lead to increased disease activity, suboptimal treatment adherence, reduced treatment response and an overall decreased quality of life" Howren said.
While administrative health data are very accessible and reduce common biases associated with hospital- and clinic-based studies, there are many challenges associated with relying on it to identify depression and anxiety. This research is important because it is a first step for researchers at Arthritis Research Canada towards understanding mental health issues in individuals living with arthritis using administrative health data.
To read the abstract of this paper in Arthritis Care & Research, please click here.
To access a full copy of the paper, please contact:
Arthritis Research Canada is the largest clinical arthritis research centre in North America. Our mission is to transform the lives of people living with arthritis through research and engagement. Led by world-renowned rheumatologist, Dr. John Esdaile, Arthritis Research Canada's scientific team of over 100 are creating a future where people living with arthritis are empowered to triumph over pain and disability. Within British Columbia, Alberta and Quebec, Arthritis Research Canada is leading research aimed at arthritis prevention, early diagnosis and treatment, and quality of life issues.
SOURCE Arthritis Research Canada
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