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15 / 01 / 2016

The project to cure coronary heart disease, now named One Brave Idea, opened for applications late Thursday as a collaboration among the American Heart Association, Verily (formerly Google Life Sciences), and now AstraZeneca.

The addition of the pharma company to the collaboration boosted the research grant for the winner to $75 million, bringing the total up from the initially-announced $50 million.

The team leader won't necessarily be a cardiovascular expert, Andy Conrad, CEO of Verily, noted when the project was first announced in November. "Could be a teenager from Wisconsin who has the best idea," he said.

Whoever is selected after the application period ends Feb. 14 will also get technical resources from Verily, scientific and mentoring help from AstraZeneca, and guidance from two or three leaders from each of the three funding organizations.

The interdisciplinary approach is key, AHA CEO Nancy Brown said in a press release from her group.

"We are trying to do something disruptive here," she said. "This is our moonshot -- it's an unprecedented opportunity for the world's best and brightest to address a leading health threat. It all starts with the search for a leader and a vision to end coronary heart disease."

The funding institutions stand to benefit financially from any patents that arise, but the AHA, which is responsible for administering the research program, has a policy largely aimed at getting the research into public use as soon as possible.

That, too, was the idea behind the short, 1-month formal application period, according to Amit Chitre, AHA executive vice president for corporate communications.

"One Brave Idea is fundamentally a different kind of model in many respects, including its application process and research funding, which was designed to remove the barriers and the silos that plague traditional research projects, like lengthy and time consuming application processes," he told MedPage Today via email.

12 / 01 / 2016

LONDON (Reuters) –English doctors staged their first strike in 40 years on Tuesday over government plans to reform pay and conditions for working anti-social hours, in a move health chiefs have warned could put patients' lives at risk.

Junior doctors, who represent just over half of all doctors in the state-funded National Health Service (NHS), said they would only deliver emergency care during the 24-hour walkout.

The government expects some 4,000 non-emergency operations to be canceled during the stoppage, the first industrial action by doctors since 1975, as picket lines went up outside some hospitals.

The doctors are planning a 48-hour stoppage later this month and a full withdrawal of labor, including emergency care, for nine hours on Feb. 10.

"This strike is not necessary, it will be damaging," Prime Minister David Cameron said on Monday. "We will do everything we can to mitigate its effects but you cannot have a strike on this scale in our NHS without real difficulties for patients and potentially worse."

The NHS, which delivers free care for all and accounts for a third of government spending on public services, is typically one of the most important issues for voters during elections and one which is often regarded as an Achilles' heel for Cameron's Conservatives.

Recent struggles during winter have also led to concerns as to whether the NHS has been adequately funded to maintain high standards.

Ninety-eight percent of more than 37,000 junior doctors in England voted for strikes in protest against a new employment contract Health Secretary Jeremy Hunt has proposed. Doctors in the rest of Britain are not involved.

Most people in England are supportive of the strikes, as long as emergency care is still provided, according to an Ipsos MORI poll for BBC Newsnight and the Health Service Journal.

The survey of 869 adults in England found 66% were supportive, with 41% strongly supportive. Only 16% were against the strikes.

The new contract is part of moves by the government to deliver what it says will be a consistent service seven days a week with studies showing mortality rates are higher at weekends when staffing is reduced.

The new deal would see doctors given a pay rise but some anti-social hours for which they are currently paid a premium would be considered to be standard.

The doctor’s union the British Medical Association (BMA) said the contract does not provide proper safeguards against doctors working dangerously long hours.

The dispute has led to an increasingly bitter war of words, with Hunt accusing some within the BMA of using strikes as a political opportunity to attack the Conservative government "that they hate".

08 / 01 / 2016

The newer oral anticoagulants (NOACs) are now recommended over vitamin K antagonists such as warfarin for initial and long-term treatment of venous thromboembolism (VTE) in updated CHEST guidelines.

"For VTE and no cancer, as long-term anticoagulant therapy, we suggest dabigatran [Pradaxa] (Grade 2B), rivaroxaban [Xarelto] (Grade 2B), apixaban [Eliquis] (Grade 2B) or edoxaban [Savaysa] (Grade 2B) over vitamin K antagonist therapy, and suggest vitamin K antagonist therapy over low molecular weight heparin (Grade 2C)," Elie A. Akl, MD, MPH, PhD, of the American University of Beirut, Lebanon, and colleagues recommended.

For patients with cancer, "we suggest low molecular weight heparin over vitamin K antagonists (Grade 2B), dabigatran (Grade 2C), rivaroxaban (Grade 2C), apixaban (Grade 2C) or edoxaban (Grade 2C)," they wrote online in CHEST.

The update also reversed course on compression stockings to prevent postthrombotic syndrome in acute deep vein thrombosis (DVT), now recommending these are not routinely needed.

ACCP's new recommendations aren't particularly strong, noted Deepak Bhatt, MD, of Brigham and Women's Hospital in Boston, who has been involved with the American Heart Association (AHA)'s Get With the Guidelines program. Grade 2 under the CHEST criteria is "weak," while levels of evidence B and C are moderate and low quality, respectively.

Nevertheless, NOACs have already been fairly broadly accepted in specialty practice for VTE, so it's a matter of the guidelines catching up to practice rather than driving it, Bhatt said. For primary practice, however, he predicted more of an impact in driving up NOAC use.

The last AHA/American College of Cardiology scientific statement on VTE came out in 2011, before the first NOAC approvals in this indication.

Another notable CHEST recommendation was a grade 1B recommendation against inferior vena cava (IVC) filters in acute deep vein thrombosis or pulmonary embolism patients treated with anticoagulants.

This stance "is a viewpoint the data support" but clinical use has been variable because of "a lot of uncertainty in general around who are the optimal patients for filters," Bhatt told MedPage Today.

A more controversial recommendation in the update was that thrombolytic treatment for acute pulmonary embolism should go through a peripheral vein rather than catheter-directed thrombolysis (Grade 2C).

Bhatt called this recommendation surprising. "It's important to realize these are experts assessing the data, but that doesn't make it absolutely gospel that that's the right thing to do," he said. "For example, if I had a patient who was hypotensive, I might at least consider taking them to cath lab and doing catheter-directed lysis."

The CHEST guideline acknowledged that higher bleeding-risk patients with access to the expertise and resources required to do catheter-directed thrombolysis are likely to choose that over systemic thrombolytic therapy.

"In patients with acute pulmonary embolism associated with hypotension and who have (i) a high bleeding risk, (ii) failed systemic thrombolysis, or (iii) shock that is likely to cause death before systemic thrombolysis can take effect (e.g., within hours), if appropriate expertise and resources are available, we suggest catheter assisted thrombus removal over no such intervention (Grade 2C)," the authors added.

Another change was addition of guidance suggesting no absolute need to switch anticoagulants after the first 3 months for patients who will receive extended therapy, although reasonable to change in response to changing patient circumstances or preferences. Periodic reassessment of continued use is also advised in the guideline.

Other groups endorsing the CHEST guideline included the American Association for Clinical Chemistry, the American College of Clinical Pharmacy, the International Society for Thrombosis and Haemostasis, and the American Society of Health-System Pharmacists.

The guideline was supported solely by internal funds from CHEST.

Akl disclosed having been an author on a number of systematic reviews on anticoagulation in patients with cancer.

A number of coauthors disclosed financial relationships with pharmaceutical companies that make anticoagulants.

Primary source: CHEST Source reference: Kearon C, et al " Antithrombotic therapy for VTE disease: CHEST guideline" CHEST 2015. 

06 / 01 / 2016

NEW YORK (Reuters Health) – Hormone therapy is not associated with an increased risk of recurrent venous thromboembolism (VTE) in women receiving therapeutic anticoagulation, researchers have found.

"This is the first study demonstrating that while on anticoagulant therapies women can safely use oral contraceptives, without an increased risk of recurrent venous thrombosis or uterine bleeding," Dr. Ida Martinelli of A Bianchi Bonomi Hemophilia and Thrombosis Center in Milan, Italy, told Reuters Health by email.

In a report online December 22 in Blood, Dr. Martinelli and colleagues note that women receiving vitamin K antagonists (VKAs) require contraception because of possible fetal complications. However, the World Health Organization says that VKAs along with estrogen-containing contraceptives confer an "unacceptable health risk," they add.

To investigate further, the researchers studied nearly 1,900 women under 60. With or without concomitant hormonal therapy, they were receiving anticoagulation with rivaroxaban or enoxaparin/VKAs for confirmed VTE.

In all, 475 used hormone therapy during the analysis period. There were seven recurrent blood clot events while patients were using hormone therapy and 38 when they weren't.

For women on any hormone therapy, VTE incidence-density per year was 3.7%. For those not receiving hormone therapy, the corresponding value was 4.7%, for an adjusted hazard ratio of 0.56 (P>0.05).

With estrogen-containing therapy, the figure was 3.7% per year and for progestin-only it was 3.8% per year. Also, the adjusted HR for abnormal uterine bleeding in those on hormonal therapy was 1.02.

However, abnormal uterine bleeding was seen significantly more frequently with rivaroxaban than with enoxaparin/VKAs (HR, 2.13). This finding "needs further exploration," the researchers say.

"Our findings lighten the conflict of current guidelines and make doctors confident in leaving or prescribing oral contraceptives together with anticoagulant therapies, and women free to choose the method of birth control and other hormone-containing medications they prefer," Dr. Martinelli concluded.

SOURCE: http://bit.ly/1PNfySW

Blood 2015.

06 / 01 / 2016

A handful of risk factors predicted who did worse with aggressive medical therapy alone for preventing recurrent ischemic stroke in intracranial stenosis, a post-hoc analysis of the SAMMPRIS trial showed.

Those factors include having an old infarct in the territory of the stenosis, initially presenting with stroke, and not using a statin at enrollment, reported Michael Waters, MD, PhD, of the University of Florida in Gainesville, and colleagues online in JAMA Neurology.

"Healthcare providers should understand the risk factors associated with the greatest likelihood of a repeat stroke in particularly high-risk populations," Waters told MedPage Today. "These patients should be followed very closely, and have frequent monitoring of their risk factors in an effort to prevent another stroke."

The Stenting and Aggressive Medical Management for Preventing Recurrent Stroke in Intracranial Stenosis (SAMMPRIS) trial originally found that aggressive medical therapy was more effective than stenting for preventing stroke in patients with symptomatic intracranial stenosis, who'd previously had either a stroke or a transient ischemic attack.

But 15% of patients in the medical therapy group still experienced stroke or death during 33 months of follow-up in the study.

To determine the baseline features that were associated with a higher rate of these outcomes in the medical arm of the SAMMPRIS trial, the researchers conducted a post-hoc analysis of data from the 227 patients randomized to medical management alone. A total of 82 of these patients were female, and the mean age was 59.5.

In initial bivariate analyses, seven baseline risk factors were associated with worse outcomes, albeit at a P-value less than 0.10:

  • Being female: hazard ratio 1.9 (95% CI 0.96-3.7)
  • Having diabetes mellitus: HR 1.8 (95% CI 0.9-3.5)
  • Not taking a statin at enrollment: HR 2.6 (95% CI 1.2-5.7)
  • Stroke as the qualifying event: HR 2.5 (95% CI 1.03-6.0)
  • Rankin grade of 1 or greater: HR 2.3 (95% CI 0.9-5.5)
  • Old infarct in the territory of the stenotic artery: HR 2.6 (95% CI 1.3-5.1)
  • Greater than 80% stenosis: HR 1.9 (95% CI 0.9-3.7)

In multivariate analyses, three of those risk factors remained significant, specifically old infarct in the territory (HR 2.6, 95% C, 1.3-5.3, P=0.006), stroke as the qualifying event (HR 3.0, 95% CI 1.1-7.7, P=0.03), and no statin use at enrollment (HR 2.4, 95% CI 1.1-5.2, P=0.03).

The researchers noted that the association between the absence of statin use at enrollment and high risk for recurrent stroke is "somewhat surprising given that virtually all of the patients in the SAMMPRIS trial were prescribed statins at enrollment."

A possible explanation for that finding is that the use of statins before enrollment "may have led to earlier stabilization of the symptomatic atherosclerotic plaque in these patients, which could have lowered their early and longer-term risk for stroke," they wrote.

The study had some limitations, including its post-hoc nature, multiple comparisons, and the limited sample size, which the researchers said was a result of enrollment being stopped early because of the clear superiority of medical treatment, so it's possible that both type I and type II errors were made.

Waters and colleagues said the findings imply that there is "still an urgent need to develop better treatments for this disease, especially in high-risk subgroups that fared particularly poorly with medical therapy alone. The features identified in this analysis will be useful for choosing eligibility criteria for future trials focused on novel therapies for improving the outcome of high-risk patients with intracranial stenosis."

Randall Edgell, MD, of St. Louis University, commented that it's important to look into additional therapies for these high-risk patients.

"Now that high-risk groups of patients with maximally treated ischemic stroke in the setting of intracranial atherosclerotic stenosis have been identified, new medical and/or endovascular treatments will be needed to further reduce risk," said Edgell, who was not involved in the study.

Since the SAMMPRIS trial was completed, endovascular devices have advanced significantly, he said.

"Drug-eluting balloons, more easily deliverable stents, and even bio-absorbable stents hold the promise of further bending the risk curve away from recurrent stroke and should be studied in clinical trials," Edgell told MedPage Today.

The study was funded by the National Institute of Neurological Disorders and Stroke, the NIH, Stryker Neurovascular (formerly Boston Scientific Neurovascular), AstraZeneca, INTERVENT, Walgreens pharmacies, and the San Diego Center for Health Interventions.

Waters disclosed no relevant relationships with industry. Co-authors disclosed multiple relevant relationships with AstraZeneca, Stryker Neurovascular, CardioNet, Boehringer Ingelheim, W.L. Gore and Associates, MicroVention, Penumbra, Pulse Therapeutics, Siemens, MicroVention, Sequent Medical, Covidien/Ev3, Codman and Shurtleff, Vascular Simulators, TDC Technologies, CVSL, Merck /Parexel, and Medtronic.

Reviewed by Robert Jasmer, MD; Associate Clinical Professor of Medicine, University of California, San Francisco and Dorothy Caputo, MA, BSN, RN, Nurse Planner Primary source: JAMA Neurology Source reference: Waters MF, et al "Factors associated with recurrent ischemic stroke in the medical group of the SAMMPRIS trial" JAMA Neurol; DOI: 10.1001/jamaneurol.2015.4315.

05 / 01 / 2016

NEW YORK (Reuters Health) - Three factors predicted failure of aggressive medical management for preventing recurrent stroke in the landmark SAMMPRIS trial, according to a post hoc analysis of patients in the medical group.

The trial involved patients with stroke or transient ischemic attack stemming from 70% to 99% stenosis of a major intracranial artery. Overall, aggressive medical therapy was more effective in preventing another stroke than stenting.

But 15% of patients in the medical treatment arm had an event following medical intervention.

Having an intracranial atherosclerotic stenosis, having an old infarct around the stenotic artery, and no statin use at enrollment "proved to be important factors in recurrent ischemic stroke." said Dr. Michael F. Waters, medical director of the University of Florida Health Shands Comprehensive Stroke Center, Gainesville, in a telephone interview.

"This is a very high-risk population," he said.

As reported online January 4 in JAMA Neurology, Dr. Waters and colleagues analyzed data from 227 patients in the medical treatment arm of the SAMMPRIS trial.

On bivariate analysis, the following were associated with recurrent stroke: being female (hazard ratio 1.9); a diagnosis of diabetes (HR 1.8); not on statins at enrollment (HR 2.6); stroke as a qualifying event (HR 2.5); Rankin grade of 1 or greater (HR 2.3); old infarct close to the stenotic artery (HR 2.6); and greater than 80% stenosis (HR 1.9).

On multivariate analysis, the risk for recurrent stroke was increased by an old infarct near the original stenotic artery (hazard ratio 2.6, P=0.006). Stroke as the qualifying event for enrollment into the trial (HR 3.0 P=0.03), and no statin use at the time of enrollment (HR 2.4 P=0.03).

"We've left behind a very important subgroup, we show here," Dr. Waters told Reuters Health. "For example, for people who have a qualifying stroke by reason of stenosis, about one in three will not get maximum benefit from medical management alone."

This finding, he said, "provides a platform for another clinical trial" to look for alternative therapies.

Dr. Steven C. Cramer of the University of California Irvine, praised the paper. "This is good, careful work about a group of patients that we need much more data on," he told Reuters Health by phone.

The National Institute of Neurological Disorders and Stroke and others supported this research.

SOURCE:http://bit.ly/22JdgJz

JAMA Neurol 2016.

02 / 01 / 2016

Endovascular therapy was a "game-changer" in stroke in 2015, leading specialists told MedPage Today.

Beginning in January with the MR CLEAN trial, through June with the publication of SWIFT PRIME and REVASCAT, multiple studies demonstrated that thrombectomy outperformed tPA alone in boosting 90-day functional independence by 13.5% to 31%.

An editorial in the New England Journal of Medicine called it a "sea change" and added, "It's about time."

In response to the question of what was the biggest clinical advance of 2015, six of seven leading stroke specialists agreed: endovascular therapy.

The response on stroke came from a survey of 55 neurologists, asking their opinions on the biggest clinical advance in their subspecialty. The "game-changers" selected in five major subspecialties were:

1. MS: Ocrelizumab results in ORATORIO and OPERA I and II

2. Stroke: Thrombectomy for acute Ischemic Stroke

3. Parkinson's disease: New therapies for delivering carbidopa/levodopa

4. Sleep: SERVE-HF trial showing adaptive servoventilation increased mortality

5. Alzheimer's disease: No single clinical advance stood out

Questions over optimal stroke therapy had persisted since three trials in 2013 suggested endovascular therapy was no more effective than intravenous tPA alone. But all that changed this year.

"Mechanical thrombectomy for acute ischemic strokes is a once-in-a-generation breakthrough in care," said Jeffrey L. Saver, MD, director, UCLA Comprehensive Stroke Center and first author of the SWIFT-PRIME trial.

"More patients will be going home free of disability after large ischemic stroke than ever before," said Pat Lyden, MD, chair of neurology and director of the Cedars-Sinai Stroke Center in Los Angeles.

And Joseph Broderick MD, director of the University of Cincinnati Neuroscience Institute, labeled it the "biggest change in acute stroke therapy since tPA approval for stroke in 1996."

The breakthrough of thrombectomy came about, experts say, because of several factors: improvement in technology of the stent receiver device which can achieve more complete recanalization; improved workflow efficiencies producing faster door-to-treatment times; and change in neuroimaging criteria for identifying large vessel occlusions.

The positive results of these trials is now leading to new questions about ways to improve treatment.

In imaging, said Wayne Clark, MD, director of the Oregon Health & Science University Stroke Center in Portland, "Advances in imaging technology now allow us to identify patients that can still benefit from thrombectomy even if they are past eight hours due to 'waking up' with their symptoms."

Marilyn Rymer, MD, vice president for Neuroscience, University of Kansas Medical Center, believes the field now faces a number of important questions about imaging: "Can (we) select cases likely to have a good outcome with EVT based on imaging criteria and potentially expand the number of eligible cases well beyond the usual time window? What imaging criteria should be used? Are imaging criteria the best way to select appropriate cases for EVT?"

Also, access to endovascular therapy is currently a limiting factor. It "needs to be given in advanced centers with clinical expertise and the necessary acute and post-treatment support structure," said Larry B. Goldstein, MD, Ruth L. Works professor and chair of neurology, University of Kentucky. But these patients cannot be easily transported to the centers. "It remains to be determined how best to integrate this approach into overall systems of care on a regional and state-wide basis," he said.

Lyden says possible solutions are novel approaches for triage in the field including "new paramedic tools; in-ambulance telemedicine; or even the mobile stroke units that contain a CT scanner on the ambulance."

06 / 10 / 2015

The dream of capturing the benefits of exercise in a pill is still very much that: a dream.

But there may be a pill that could mimic -- albeit poorly and on a limited scale -- the effects of exercise for patients with a spinal cord injury or other condition that could put them at risk of muscle atrophy, according to a new review published in Trends in Pharmacological Sciences.

"I don't believe that developing exercise pills is a futile effort," said Ismail Laher, PhD, at the University of British Columbia in Vancouver, in an email to MedPage Today. Laher co-authored the paper with Shunchang Li, of Beijing Sport University in China.

"There is definitely a medical aspect to this -- for example, it could be helpful in reducing muscular atrophy in patients with strokes, spinal cord injury and so on," Laher added. "Another benefit could be in augmenting the effects of physical therapy."

There are three kinds of compounds being studied as a potential exercise pill: pharmacological agonists (AICAR, GW501516, GSK4716, SR9009), hormones
(MOTS-c and irisin), and phytochemicals ([-]-epicatechin and resveratrol).

Metformin, like AICAR, can stimulate AMP-activated protein kinase, noted the authors. But although metformin lowers blood glucose and enhances insulin sensitivity, it cannot be considered a potential exercise pill because it seems to blunt the effects that a full exercise would normally have on the body.

All of the first six compounds -- the agonists and the hormones -- are in experimental stages. The two phytochemicals are theoretical only, after showing some exercise-like effects in animals. Exercise, of course, is complicated, and it may be that none of the compounds being studied result in a useful treatment. A separate paper in Cell Metabolism purported to outline all of the cellular reactions to exercise, and found that there were over 1,000 reactions in the body. A single pill would be unlikely to trigger a significant number of them.

And there are other effects to consider, too: A recent Swedish study looked at the epigenetic effects of exercise by having patients exercise four times a week for 3 months on stationary bikes. But the participants used only one leg on the modified bikes -- the other was used as a control, according to Laher and Li.

"In addition to the expected physical changes in the exercised leg, there were also almost 5,000 sites across the genome with new methylation -- with increases in sites related to structural remodeling and glucose metabolism and decreases in those associated with inflammatory/immune responses," wrote the authors of the review. "[But] it is unclear if exercise pills can enhance exercise performance in humans and how this may be related to epigenetic regulation of specific genes."

"But the exercise pill still captures the imaginations of the public and the media -- and the wallets of companies looking for a potential blockbuster pill."

The authors added that none of the candidate pills "mimic the full palette" of exercise and so may have to act in combination to have much of an effect. "Exercise pills are still at the starting line and have a long road ahead before they gain clinical application," concluded the authors. "However, we expect that as we gain an improved understanding of the molecular mechanism by which exercise induces beneficial effects, we will likely gain increased confidence in creating exercise pills that have minimal side effects with much improved efficacy."

The authors disclosed no relevant relationships with industry.

01 / 10 / 2015

Opinion Makers is a new MedPage Today video exclusive weekly series, presenting leaders from all areas of medicine offering their views on current topics in clinical care, research, and policy.

In this video, Marilyn Rymer, MD, vice president of neuroscience at the University of Kansas Hospital in Kansas City, discusses what's key to the findings of the recent positive acute stroke embolectomy trials and what is yet to come.

Below is a transcript of her comments.

"The recently published endovascular trials clearly established the efficacy of embolectomy in strokes caused by large vessel occlusions if patients could be treated within 6 hours of onset. They also set the stage for the next set of questions to be investigated. An important one of those is whether the time window for embolectomy can be extended beyond 6 hours based on imaging criteria.

"As you know, all of the positive embolectomy trials required proof of large-vessel occlusion with MRA, CTA or standard angiography. In addition, they each selected cases based on the size of the core of the stroke compared to the penumbra. This was done using either the ASPECTS score of the baseline CT scan, or using specialized software for MR or CT that provides a quantitative value for the size of the core and penumbra.

"In the trials using the ASPECTS score, favorable outcomes were seen in cases with an ASPECT score greater than 6. The first 71 patients enrolled in SWIFT-PRIME were included if the core measured less than 50 cc and the mismatch ratio was greater than 1.8. EXTEND-IA included cases with a core of less than 70 cc and a mismatch ratio greater than 1.2. It is interesting to note that of all the trials, EXTEND-IA showed the largest benefit of embolectomy compared to controls.

"An important factor in determining the size of the penumbra is the competency of collateral circulation. Some people with good collaterals may have favorable imaging well beyond 6 hours and have the potential for a good outcome.

"There are two trials addressing the question of an extended time window. The DAWN Trial has enrolled 40 of its 500 intended subjects. This is a randomized trial of embolectomy plus medical therapy versus medical therapy alone in patients with large-vessel occlusion last seen well between 6 and 24 hours before randomization with core sizes of up to 20 cc, 30 cc, or between 31 and 50 cc dependent on the NIH Stroke Scale score and age. DEFUSE-3 is a proposed trial with a similar randomization design in patients with onset between 6 and 16 hours before randomization, a core of less than 70 cc, and a mismatch ratio of greater than 1.8.

"If positive, these trials and others may help establish imaging guidelines for case selection based on physiology rather than time alone."

Rymer disclosed being on the speaker's bureau for Stryker.

From the American Heart Association.

30 / 09 / 2015

A daily soda habit might do more than cause weight gain -- it could eventually lead to diabetes, a heart attack, or even a stroke, according to a review published in the Journal of the American College of Cardiology.

The leading culprit involved is fructose, an added sugar with unique metabolic properties whose chief dietary source is sugar-sweetened beverages (SSBs), said co-authors Vasanti Malik, ScD, and Frank Hu, MD, PhD, of the Harvard T.H. Chan School of Public Health in Boston.

"Time trend data over the past 3 to 4 decades have shown a close parallel between the rise in added sugar intake and the obesity and diabetes epidemics in the United States," Malik and Hu wrote.

"Largely driving these trends has been the dramatic increase in the consumption of sugar-sweetened beverages, which are the single greatest source of calories and added sugars in the U.S. diet, accounting for nearly one-half of all added sugar intake," the review authors said.

The co-authors conducted a contemporary review of the evidence, not a systematic review or meta-analysis, Malik said in an interview with MedPage Today. The goal was to assess the impact of fructose from SSBs on cardiometabolic health.

"We pulled the most relevant and robust studies, focusing on recent evidence," she said. The investigation focused on three types of studies: prospective cohort studies, randomized clinical trials, and feeding studies. Key findings include the following:

Individuals who consumed the most SSBs (one or two servings daily) had a 26% greater risk of developing diabetes compared with those who consumed the least (none or less than one serving a month), according to a recent meta-analysis of eight prospective cohort studies.

Individuals who consumed two or more SSB servings per day had a 35% greater risk of coronary heart disease (CHD), including nonfatal myocardial infarction and fatal CHD, than infrequent consumers, according to the Nurses' Health Study, which followed 80,000 women for 24 years.

Drinking one or more SSBs per day was associated with a 16% increased risk for stroke compared with those who drank none, according to another analysis of data from the Nurse's Health Study.

Fructose is linked to cardiometabolic health risk not only because of the excess empty calories it contains, but also because of the way it is metabolized, the review authors said. Unlike glucose, which is absorbed in the gastrointestinal tract, fructose is metabolized in the liver, where it can lead to elevated triglycerides, fatty liver disease, and insulin resistance.

"Although reducing consumption of SSBs or added sugar alone is unlikely to solve the obesity epidemic entirely, limiting intake is one simple change that will have a measurable effect on weight control and prevention of cardiometabolic disease" the authors concluded.

"We know from three lines of evidence that sugar-sweetened beverages increase the risk of obesity, diabetes, and heart disease," Malik said. "I'd like to see more primary care physicians looking at this evidence and guiding their patients to reduce their intake of these beverages, particularly patients who are overweight or have pre-diabetes."

SSBs include not only carbonated sodas, but any beverage to which the manufacturer has added sugar, including fruit drinks, iced teas, and sports drinks, Malik said.

"At the individual level, physicians, health professionals, and educators can advise patients and students to consume fewer SSBs, on the basis of consistent evidence of increased risk of obesity, type 2 diabetes, and cardiovascular disease in various populations," said Maria Van Rompay, PhD, of Tufts University in Boston, in an email to MedPage Today.

Van Rompay recently published a study on the impact of SSBs on lipids in children.

"However, given the high prevalence of consumption of SSBs, population-level policies and interventions that discourage consumption of unhealthy foods, like SSBs, and encourage consumption of healthy foods, such as fruits and vegetables, while also improving the overall food environment, will be most effective at curbing SSB intake and thereby averting cardiometabolic burdens," Van Rompay said.

This research was supported by the National Institutes of Health.

Malik reported no financial relationships with industry.

Van Rompay reported no financial relationships with industry.

Reviewed by F. Perry Wilson, MD, MSCE; Assistant Professor, Section of Nephrology, Yale School of Medicine and Dorothy Caputo, MA, BSN, RN, Nurse Planner Primary source: Journal of the American College of Cardiology Source reference: Malik V. S., et al "Fructose and cardiometabolic health: what the evidence from sugar-sweetened beverages tells us" JACC 2015; 66(14): 1615-1624.

23 / 09 / 2015

NEW YORK (Reuters Health) - Atrial fibrillation (AF) is associated with an increased risk of dementia, especially in younger individuals, according to results from the Rotterdam Study.

"When we started this study, we hypothesized that the hazard of atrial fibrillation would be higher with longer exposure, but to find such a strong exposure-time association in younger participants was striking," said Dr. Frank J. Wolters from Erasmus Medical Center in Rotterdam, the Netherlands.

"It emphasizes that prevention of dementia doesn't start when people report to their physician with mild memory complaints, but years, if not decades before, by identifying those at risk and optimizing preventive strategies," he told Reuters Health by email.

An earlier report from the Rotterdam Study showed that AF is more prevalent in people with dementia, but the cross-sectional design did not allow conclusions regarding a causal relationship.

Dr. Wolters's team investigated the association between AF and dementia during a follow-up of 20 years of nearly 6,200 participants in the Rotterdam Study.

About 5% of the participants had AF at baseline, and 15.3% of these individuals developed dementia during more than 81,000 person-years of follow-up.

Another 11.7% developed AF later, and 15.0% developed dementia during more than 79,000 person-years, the researchers report in JAMA Neurology, online September 21.

People who had AF at the start of the study had a 34% increased risk of dementia (compared with those who did not have prevalent AF), and people who developed AF during follow-up had a 23% increased risk of dementia(compared with those who did not have incident AF).

The association between AF and dementia was strongest in persons younger than the median age (67 years), and in these younger participants, the risk of dementia was higher with increasing duration of AF.

"As we found atrial fibrillation to increase the risk of dementia independent of clinical stroke, either chronic hypoperfusion or more acutely silent infarcts or perhaps cortical microinfarcts could account for the increased risk of dementia," Dr. Wolters said.

"A few observational studies have suggested beneficial effect of treatment of atrial fibrillation on the risk of dementia, but more evidence on treatment efficacy is sorely needed. This includes insight into whether optimal treatment consists of anticoagulation, heart rhythm, or rate control," he noted.

"With regard to treatment of atrial fibrillation, until further evidence on efficacy becomes available, it is worth realizing that optimal adherence to current guidelines may contribute to prevention of cognitive decline in addition to prevention of stroke," Dr. Wolters added. "Although we found the strongest associations between atrial fibrillation and dementia for younger people, the need to determine treatment efficacy is just as profound in the elderly."

Dr. Sanjay Dixit, director of cardiac electrophysiology at Philadelphia VA Medical Center in Pennsylvania, told Reuters Health by email, "Although the association between AF and dementia has been shown, it's difficult to establish cause and effect. As I point out in my previous review, obstructive sleep apnea (OSA) is considered to be a major contributor to the development of neurocognitive decline and dementia. OSA is very common in the AF population and many consider this to be (a) risk factor in the development of AF. So the question remains whether AF is the cause of dementia or other co-morbidities such as OSA that frequently co-exist in the AF population."

"Look for AF in patients with dementia and also caution patients with AF of the possibility of developing this condition in the future," Dr. Dixit advised. "Since catheter ablation therapy has been shown to have better outcomes for long-term control of AF than drugs, physicians should discuss this with patients and consider referring them to cardiac electrophysiologists early in the course of the disease.

Dr. T. Jared Bunch, director of heart rhythm services for Intermountain Healthcare, Murray, Utah, told Reuters Health by email, "It is great to see another confirmatory study that found essentially the same thing we did 5 years ago. These data in aggregate make the likelihood of the association much more compelling."

"What is interesting in our subsequent work is the patients more sensitive to poor warfarin management (low times in therapeutic range) were at the highest relative risk of dementia compared to older patients," Dr. Bunch explained. "Now we all need to start to unravel the mechanisms behind it and find avenues of preventative treatment. The choice and manner of anticoagulant treatment is one and allowing faster heart rates is another."

Dr. Shih-An Chen and Dr. Tzu-Fan Chao from Taipei Veterans General Hospital, Taipei, Taiwan, who recently reported on the independent association between AF and dementia, struck a more cautious note.

"Only when a lower risk of dementia can be achieved by AF ablation in the prospective and randomized trial can we conclude that AF is the direct cause of dementia," they told Reuters Health in a joint email. "It should also be noted that the development of dementia is multifactorial, and AF only represents one of them."

SOURCE: http://bit.ly/1G2c6vo

JAMA Neurol 2015.

25 / 06 / 2015

Tokyo, Japan (June 25, 2015) – Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) today announced that the European Commission (EC) has granted Marketing Authorisation for LIXIANA® (edoxaban), an oral, once-daily selective factor Xa-inhibitor, for the prevention of stroke and systemic embolism in adult patients with nonvalvular atrial fibrillation (NVAF) with one or more risk factors, such as congestive heart failure, hypertension, age ≥ 75 years, diabetes mellitus, prior stroke or transient ischaemic attack (TIA) as well as for the treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and prevention of recurrent DVT and PE in adults.

“AF-related stroke as well as DVT and PE create a significant societal and economic health burden. We welcome the European Commission’s approval of LIXIANA, which means physicians and patients may benefit from a new treatment option to effectively manage these debilitating and life-threatening conditions,” said Jan van Ruymbeke, MD, CEO, Daiichi Sankyo Europe GmbH. “Daiichi Sankyo is committed to bringing innovative medicines to patients who need them. Once-daily LIXIANA offers the unique combination of an easy-to-use oral anticoagulant with proven efficacy across a broad range of patients and a better bleeding profile compared to well-managed warfarin.”

Atrial fibrillation (AF), a heart rhythm disorder in which the heartbeat is rapid and irregular, affects over six million Europeans.1 People with AF are at a five-fold increased risk of stroke compared to the general population,1 with an estimated financial burden of over €38 billion a year.2 VTE, a condition where a blood clot forms in a vein, also represents a major cause of morbidity and mortality, resulting in over 500,000 deaths in the EU each year.3

The EC approval is based on two phase 3 clinical trials, ENGAGE AF-TIMI 48 and Hokusai-VTE, which compared treatment with once-daily LIXIANA® to warfarin, a current standard of care for stroke prevention in patients with AF or for the treatment and prevention of VTE. These studies represent the largest single comparative trials of a novel oral anticoagulant in these patient populations, involving 21,105 and 8,292 patients, respectively.4,5

In the ENGAGE AF-TIMI 48 study, once-daily LIXIANA® showed comparable efficacy (stroke or SEs) in comparison to warfarin (1.18% vs. 1.50% per year, LIXIANA® 60 mg vs. warfarin respectively; hazard ratio [HR], 0.79; 97.5% confidence interval [CI], 0.63 to 0.99, p<0.001) and superior safety, significantly reducing major bleeding (2.75% vs. 3.43% per year, LIXIANA® 60 mg vs. warfarin respectively; HR, 0.80; 95% CI, 0.71 to 0.91, p<0.001), in a broad range of patients with NVAF.4

The Hokusai-VTE study demonstrated that LIXIANA® effectively reduces symptomatic recurrent VTE, including DVT and fatal and non-fatal PE risk across a broad range of patients (3.2% vs. 3.5% of patients, LIXIANA® 60 mg vs. warfarin respectively; HR, 0.89; 95% CI, 0.70 to 1.13, p<0.001). LIXIANA® also showed a significant 19% risk reduction of clinically relevant bleeding in patients with VTE compared to warfarin (8.5% vs. 10.3% of patients, respectively; HR, 0.81; 95% CI, 0.71 to 0.94, p=0.004).5

About LIXIANA® (edoxaban)

Once-daily LIXIANA® was developed solely by Daiichi Sankyo. It was launched in Switzerland in May 2015 for the prevention of stroke and SE in adult patients with NVAF, and for the treatment of adult patients with VTE, including DVT and PE, following previous treatment with fractionated or unfractionated heparin for five days, as well as for the prevention of recurrent VTE.6   In addition, it is currently marketed in Japan and the United States.7,8,9 In other countries, regulatory review is ongoing.

About the ENGAGE AF-TIMI 48 Study

ENGAGE AF-TIMI 48 (Effective aNticoaGulation with factor xA next GEneration in Atrial Fibrillation) was a three-arm, randomized, double-blind, double-dummy, global phase 3 clinical trial comparing once-daily edoxaban with warfarin in 21,105 patients with NVAF at moderate-to-high risk of thromboembolic events at 1,393 centers in 46 countries. ENGAGE AF-TIMI 48 compared two edoxaban treatment strategies, a higher dose arm (60 mg or 30 mg dose reduced) once-daily and a lower dose arm (30 mg or 15 mg dose reduced) once-daily, with warfarin in patients with NVAF for a median of 2.8 years. Patients were dose reduced for creatinine clearance (CrCL) 30 to 50 mL/min, body weight of 60 kg or less or certain p-glycoprotein inhibitor use. ENGAGE AF-TIMI 48 represents the largest and longest single comparative global trial with a novel anticoagulant in patients with NVAF performed to date.4 The full results were presented at the AHA Scientific Sessions 2013 in Dallas and published in the New England Journal of Medicine.

About the Hokusai-VTE Study

Hokusai-VTE was a global, event-driven, randomized, double-blind, double-dummy, parallel-group phase 3 clinical study involving 8,292 patients in 439 clinical sites across 37 countries to evaluate once-daily edoxaban with warfarin in patients with either acute symptomatic DVT, PE or both. The Hokusai-VTE study was designed to reflect clinical practice using a flexible treatment duration of 3-12 months in a broad spectrum of VTE patients, including initial use of parenteral anticoagulant (heparin) for at least 5 days, the proven global standard of care. Patients were randomized to receive initial open-label enoxaparin or unfractionated heparin therapy followed by edoxaban 60 mg once-daily (dose reduced to 30 mg for CrCL 30 to 50 mL/min, body weight of 60 kg or less, or certain p-glycoprotein inhibitor use) or the comparator, warfarin. In the comparator arm, patients received initial heparin therapy concurrently with warfarin, titrated to a target INR of 2.0 to 3.0, followed by warfarin alone. The treatment duration was from 3 months and up to a maximum of one year. The duration of study treatment was determined by the investigator based on the patient’s clinical features.5 The full results were presented at the ESC Congress 2013 in Amsterdam and published in the New England Journal of Medicine.

About Daiichi Sankyo

Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical products to address diversified, unmet medical needs of patients in both mature and emerging markets. With over 100 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 17,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. In addition to its strong portfolio of medicines for hypertension, dyslipidemia, bacterial infections, and thrombotic disorders, the Group’s research and development is focused on bringing forth novel therapies in cardiovascular-metabolic diseases, pain management, and oncology, including biologics. For more information, please visit: www.daiichisankyo.com.

Contact

Daria Munsel (Europe) Daiichi Sankyo Europe GmbH
Edoxaban Comm. & Product PR Europe
+49 (89) 7808728

Yasuki Minobe (Global)
Daiichi Sankyo Group
Corporate Communication Department
+81 (3) 62251126

Forward-looking statements

This press release contains forward-looking statements and information about future developments in the sector, and the legal and business conditions of DAIICHI SANKYO Co., Ltd. Such forward-looking statements are uncertain and are subject at all times to the risks of change, particularly to the usual risks faced by a global pharmaceutical company, including the impact of the prices for products and raw materials, medication safety, changes in exchange rates, government regulations, employee relations, taxes, political instability and terrorism as well as the results of independent demands and governmental inquiries that affect the affairs of the company. All forward-looking statements contained in this release hold true as of the date of publication. They do not represent any guarantee of future performance. Actual events and developments could differ materially from the forward-looking statements that are explicitly expressed or implied in these statements. DAIICHI SANKYO Co., Ltd. assume no responsibility for the updating of such forward-looking statements about future developments of the sector, legal and business conditions and the company.

References

1.  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):2369-429.
2.  Allender S, Scarborough P, Peto V, et al. European Cardiovascular Disease Statistics 2012 Edition.
3.  Cohen AT, et al. Venous thromboembolism (VTE) in Europe. The number of VTE events and associated morbidity and mortality. Thromb Haemost. 2007;756–764: doi:10.1160/TH07.
4.  Giugliano R, et al. Edoxaban versus warfarin in patients with atrial fibrillation. N Engl J Med. 2013;369(22):2093-104.
5.  Büller H, et al. Edoxaban versus warfarin for the treatment of symptomatic venous thromboembolism. N Engl J Med. 2013;369(15):1406-15.
6.  Daiichi Sankyo press release – Daiichi Sankyo’s Once-Daily Lixiana® (edoxaban) Approved for the Prevention of Stroke and Systemic Embolism in Non-Valvular Atrial Fibrillation and for the Treatment and Prevention of Recurrent Venous Thromboembolism in Switzerland. 15 April 2015. Available at:
http://www.daiichisankyo.com/media_investors/media_relations/press_releases/detail/006269.html [Last accessed: June 2015].
7.  Daiichi Sankyo press release – Daiichi Sankyo Receives Approval for Additional Indications of LIXIANA® (edoxaban) in Japan. 26 September 2014. Available at: http://www.daiichisankyo.com/media_investors/media_relations/press_releases/detail/006189.html. [Last accessed: June 2015].
8.  Daiichi Sankyo press release – Daiichi Sankyo launches LIXIANA® (edoxaban), a direct oral factor Xa inhibitor, in Japan for the prevention of venous thromboembolism after major orthopaedic surgery. 19 July 2011. Available at: http://www.daiichisankyo.com/media_investors/media_relations/press_releases/detail/005784.html. [Last accessed: June 2015].
9.  Daiichi Sankyo press release - U.S. FDA Approves Daiichi Sankyo’s Once-Daily SAVAYSA™ (edoxaban) Tablets for Reduction of Stroke Risk in Non-Valvular Atrial Fibrillation and for the Treatment of Venous Thromboembolism – 8 January 2015. Available at:http://www.daiichisankyo.com/media_investors/media_relations/press_releases/detail/006236.html [Last accessed: June 2015].

*Major bleeding in NVAF, clinically relevant non-major bleeding in VTE (composite of major bleeding and clinically relevant non-major bleeding)

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