AstraZeneca today announced detailed results from the positive Phase III THEMIS trial which showed Brilinta (ticagrelor) plus aspirin reduced the relative risk for the composite of cardiovascular (CV) death, heart attack, or stroke by 10% compared with aspirin alone, a statistically significant reduction.
The overall THEMIS trial population was patients with coronary artery disease (CAD) and type-2 diabetes (T2D) with no prior heart attack or stroke.
Additionally, in a clinically meaningful and prespecified sub-analysis of patients who had previously undergone a percutaneous coronary intervention (PCI), a procedure to open a blocked or narrowed coronary artery, a 15% relative risk reduction was observed for Brilinta plus aspirin for the composite of CV death, heart attack, or stroke, compared with aspirin alone.
The safety profile for Brilinta was consistent with the known profile of the medicine with an increased risk of bleeding events observed in both THEMIS and the THEMIS-PCI sub-analysis.
Results from THEMIS and THEMIS-PCI were presented on Sunday 1 September 2019 at ESC Congress 2019 (the annual meeting of the European Society of Cardiology) in Paris, France. The results for the overall THEMIS trial were published simultaneously in the New England Journal of Medicine1 and results from THEMIS-PCI were published in TheLancet.2
The Medicines Company applauds the work of the Task Force for the management of dyslipidaemias of the European Society of Cardiology (ESC) and European Atherosclerosis Society (EAS) in developing the 2019 ESC/EAS Guidelines for the Management of Dyslipidaemias: lipid modification to reduce cardiovascular risk (click here to access).1 We enthusiastically support these new treatment guidelines, which reinforce the importance of further reductions in LDL-C and maintaining reductions over the long term, especially in individuals at high-risk for atherosclerotic cardiovascular disease. Even with the known risks of high cholesterol, and available treatments to reduce it, many patients still do not reach desired LDL-C thresholds today, leaving them at continued risk.
We are also encouraged by the guidelines’ reaffirmation of the ‘compelling evidence that LDL-C is causally associated with the risk of ASCVD, and that lowering LDL-C reduces the risk of ASCVD proportionally to the absolute achieved reduction in LDL-C.’ Data provide ‘strong support for the concept that LDL particles have both a causal and cumulative effect on the risk of ASCVD. Therefore, the effect of LDL-C on the risk of ASCVD appears to be determined by both the absolute magnitude and the total duration of exposure to LDL-C.’
The European Society of Cardiology (ESC) Guidelines on acute pulmonary embolism are published online today in European Heart Journal(1), and on the ESC website.(2) They were developed in collaboration with the European Respiratory Society (ERS).
Acute pulmonary embolism is the third most common cause of cardiovascular death in Europe, after heart attack and stroke, contributing to more than 350,000 deaths each year. A blood clot (thrombus) in a deep vein, usually in the legs, is dislodged and travels to the lungs where it blocks one or more vessels. This typically occurs if the vein wall is damaged, blood flow is too slow, or the blood becomes too thick.
Major surgery such as knee or hip replacement, serious injury, prolonged bed rest and cancer are common risk factors for acute pulmonary embolism. It can also happen after long travel and in women who are pregnant or taking the oral contraceptive pill.
“Symptoms including shortness of breath and chest pain resemble other diseases so the diagnosis is often missed, or the severity of the situation is underestimated, and many patients die before getting appropriate therapy,” said Professor Stavros Konstantinides, Chairperson of the guidelines Task Force and medical director, Centre for Thrombosis and Haemostasis, Johannes Gutenberg University Mainz, Germany.
The guidelines clarify how to diagnose acute pulmonary embolism step by step. The process begins with clinical suspicion based on symptoms combined with blood tests (D-dimers). Depending on the severity and urgency of the scenario, a computed tomography (CT) scan may be used to visualise the lung vessels, or cardiac ultrasound to look at the heart chambers.
A new table shows how CT scans and lung scans compare in their ability to diagnose or exclude pulmonary embolism, and how much radiation the patient receives with each of these tests.
“The aim is to get to the diagnosis as reliably and quickly as possible, in order to start lifesaving therapy and prevent other clots from reaching the lungs,” said Professor Guy Meyer, Co-Chairperson of the guidelines Task Force and respiratory medicine physician, Hôpital Européen Georges-Pompidou, Paris, France.
Anticoagulant drugs (blood thinners) help the body dissolve clots and reopen the blocked vessels. If the patient is in shock and about to collapse, the clot must be removed immediately, and this can be achieved using thrombolytic drugs (clot busters), catheters, or surgery.
The guidelines recommend how to judge the severity of pulmonary embolism based on a combination of clinical, imaging and laboratory results. This will dictate whether blood thinners alone are sufficient or if clot busters, a catheter intervention, or surgical removal is necessary. There is new advice on how to distinguish, in the CT scan, fresh thrombi in the lungs from chronic obstructions due to a disease called chronic thromboembolic pulmonary hypertension (CTEPH), which requires a different type of therapy.
Also new is the guidance on which drugs to use in a patient with pulmonary embolism and cancer. Patients with cancer have a high risk of recurrence, and indefinite anticoagulation is often necessary.
Acute pulmonary embolism is a leading cause of maternal death in high-income countries, but diagnosis can be challenging because symptoms often overlap with those of normal pregnancy. Novel recommendations outline how to diagnose and treat pulmonary embolism in the pregnant patient.
Updated instructions state when it is safe to send patients home from the hospital. Some have a lifelong increased risk of another event. Anticoagulants are used to treat the acute episode and prevent recurrence but raise the risk of bleeding. The guidelines describe how to decide the duration of treatment. They also specify when and how (with which tools and tests) to follow patients, and which findings suggest chronic disease (CTEPH) requiring diagnosis and treatment in an expert centre.
Last but not least, the 2019 ESC Guidelines endorse a multidisciplinary approach to pulmonary embolism after the acute phase and discharge of the patient. Teams should include physicians, appropriately qualified nurses, and other allied health professionals, aiming to ensure smooth transitions between hospital specialists and practitioners, optimised long term care and prevention of recurrence.
Advice for patients
Be aware of conditions that predispose to acute pulmonary embolism.
If you are at increased risk or have previously had pulmonary embolism or deep vein thrombosis, and are admitted to hospital for another disease, ask what is being done to prevent thrombosis.
If you have one or more risk factors for pulmonary embolism and feel shortness of breath, chest discomfort or chest pain, lightheaded or faint, call a doctor or ambulance immediately. Lie down and do not move around. Do not walk or drive to the hospital or physician’s practice.
If you had an acute pulmonary embolism and are on blood thinners, when you are discharged from hospital ask when you need to see a doctor again. At the follow-up visit, report any bleeding and whether you have returned to normal or still have symptoms such as shortness of breath.
The hashtag for ESC Congress 2019 together with the World Congress of Cardiology is #ESCCongress
Funding: None.
Disclosures: The disclosure forms of all experts involved in the development of these guidelines are available on the ESC website http://www.escardio.org/guidelines.
URGENT – PORTMIAMI CLOSED FOR INBOUND TRAFFIC – CARNIVAL HORIZON 9/01/19 CRUISE DELAYED. SEE UPDATE BELOW.
Our Fleet Operations Center in Miami is actively monitoring Hurricane Dorian’s potential impact on the departures listed below. Given that storms can be so uncertain, this information reflects our plan for these sailings based on the current forecast.
As the safety of our guests and crew is our number one priority, we will continue to keep an eye on the storm and factor in guidance from the National Hurricane Center, U.S. Coast Guard and the local port authorities to provide timely updates as more information becomes available.
The following homeports and ships remain under watch:
CHARLESTON
Carnival Sunshine 09/02/19 – No change to itinerary, we plan to operate as scheduled. Please sign up for text alerts by texting CCL3 to CRUISE (278473).
FORT LAUDERDALE (PORT EVERGLADES)
Carnival Magic 08/31/19 – No change to itinerary; we plan to operate as scheduled. Please sign up for text alerts by texting CCL9 to CRUISE (278473).
JACKSONVILLE
Carnival Ecstasy 08/31/19 – No change to itinerary; we plan to operate as scheduled.
Carnival Ecstasy 09/05/19 – Still evaluating. Please sign up for text alerts by texting CCL12 to CRUISE (278473).
There is a possibility Carnival Ecstasy will not be able to return to Jacksonville on Thursday. If the port is closed, the ship will be in position to dock as soon as the authorities have reopened the port.
PORT CANAVERAL
Port Canaveral is expected to be closed on Sunday through the middle of next week. We are optimistic the port will reopen by Thursday.
Carnival Breeze 08/31/19 – No change to itinerary; we plan to operate as scheduled. Please sign up for text alerts by texting CCL10 to CRUISE (278473).
Carnival Liberty 09/02/19 – This cruise is cancelled. Guests will receive a full refund of their cruise fare and any pre-purchased items. More details to follow in our email.
Carnival Elation 09/02/19 – This cruise will now operate as a 2 day sailing, departing September 5th and returning September 7th with a visit to Nassau. Guests who sail will receive a pro-rated refund of their cruise fare and any pre-purchased beverage and Wi-Fi packages. Guests who wish to cancel will receive a future cruise credit for the full amount of their cruise fare. An email with additional details will follow.
American Beef Packers, Inc., a Chino, Calif. establishment, is recalling approximately 24,428 pounds of raw beef products that are deemed unfit for human consumption, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today.
FSIS inspection personnel retained the carcass and collected a sample for further analysis. Prior to test results being received, the carcass was erroneously released and further processed into raw intact and non-intact beef products, which were distributed in commerce.
The raw beef items were produced and packaged on Aug. 21, 2019. The following products are subject to recall: [View Labels (PDF only)]
Bulk pack combo bins containing ‘AMERICAN BEEF PACKERS 85 BONELESS BEEF CHUCKS’ with LOT NO.110 and BIN No. 85 and BIN No. 86.
Bulk pack combo bins containing ‘AMERICAN BEEF PACKERS 90 BONELESS BEEF’ with LOT NO. 110 and BIN No. 81, BIN No. 82 and BIN No. 83.
Bulk pack combo bins containing ‘AMERICAN BEEF PACKERS 85 BONELESS BEEF’ with LOT NO. 25-110 and BIN No. 84 and LOT NO 110 and BIN No. 88.
Cases containing ‘AMERICAN BEEF PACKERS RIBEYE 8/10 #1’ with codes BT190821-1178, BT190821-1185, BT190821-1188, BT190821-1190, and BT190821-1194.
66.2-lb. case containing ‘AMERICAN BEEF PACKERS RIBEYE 10 UP #1’ with code BT190821-1186.
Bulk pack combo bin containing ‘AMERICAN BEEF PACKERS 90 BONELESS BEEF SIRLOINS’ with LOT NO. 24-110 and BIN No. 80.
Cases containing ‘AMERICAN BEEF PACKERS TERDERLOIN 4 UP’ with codes BT190821-1160, BT190821-1161, BT190821-1162, BT190821-1163, BT190821-1167, BT190821-1168, BT190821-1169, and BT190821-1170.
Cases containing ‘AMERICAN BEEF PACKERS RIBEYE 10 UP’ with codes BT190821-1187 and BT190821-1192.
Cases containing ‘AMERICAN BEEF PACKERS TENDERLOIN 3/4’ with codes BT190821-1155, BT190821-1157, BT190821-1171, BT190821-1200, BT190821-1201, BT190821-1202, BT190821-1203, BT190821-1204, and BT190821-1205.
50-lb. cases containing ‘AMERICAN BEEF PACKERS DESC: BEEF FOR FURTHER PROCESSING 75/25’ with lot code 08347412719.
The products subject to recall bear establishment number ‘EST. 34741′ inside the USDA mark of inspection. These items were shipped to federal establishments in California and Oregon.
The firm notified FSIS on Aug. 30, 2019 that a carcass that was pending laboratory results had been erroneously released and further processed into raw intact and non-intact beef products.
There have been no confirmed reports of adverse reactions due to consumption of these products. Anyone concerned about a reaction should contact a healthcare provider.
FSIS is concerned that some product may be frozen and consumers’ refrigerators or freezers or both. Consumers who have purchased these products are urged not to consume them. These products should be thrown away or returned to the place of purchase.
FSIS routinely conducts recall effectiveness checks to verify recalling firms notify their customers of the recall and that steps are taken to make certain that the product is no longer available to consumers.
Consumers and members of the media with questions about the recall can contact Kari Godbey Houchens, Regulatory Manager, American Beef Packers, Inc. at (909) 628-4888 ext. 123.
Consumers with food safety questions can ‘Ask Karen,’ the FSIS virtual representative available 24 hours a day at AskKaren.gov or via smartphone at m.askkaren.gov. The toll-free USDA Meat and Poultry Hotline 1-888-MPHotline (1-888-674-6854) is available in English and Spanish and can be reached from 10 a.m. to 6 p.m. (Eastern Time) Monday through Friday. Recorded food safety messages are available 24 hours a day. The online Electronic Consumer Complaint Monitoring System can be accessed 24 hours a day at: http://www.fsis.usda.gov/reportproblem.
Mayor Bill de Blasio has aggressively pushed a bike-friendly agenda, adding about 100 miles of dedicated lanes for cyclists amid a spike in rider collisions, but he’s done little to address the danger that bikers themselves pose.
Since 2011, bicyclists have injured more than 2,250 pedestrians — including at least seven who died — according to stats from the city Department of Transportation and published reports.
Injuries are up 12 percent this year, rising to 127 through June 30 from 113 over the same period in 2018, the NYPD says.
Most of the injured last year were in Manhattan, where 134 pedestrians got hurt, nearly half the citywide total of 270.
Flatiron/Gramercy Park’s 13th Precinct topped the list with 16 injuries, followed by Chinatown/Little Italy with 13, and lower Manhattan with 12. There were 10 on the Upper West Side.
Although data show the number of hurt pedestrians dipped from 315 in 2017 to 270 last year, roughly 300 people a year have been hurt by cyclists since the city began tracking such accidents in 2011, including a high of 361 injuries in 2015 and three deaths in 2014.
Two pedestrians have been killed so far this year.
The latest was Michael Collopy, a 60-year-old Chelsea resident who was plowed into by a bicyclist while standing in a bike lane in the Flatiron District on July 31 and died a week later. The bicyclist fled.
“He was one of the good ones in the building, a nice person,” said Jay, a doorman in West 23rd Street apartment complex where Collopy lived. “He was always full of jokes.”
Also killed was Donna Strum, 67, who was smashed by a cyclist on April 24 while crossing West 57th Street near Sixth Avenue. She was in the crosswalk.
An unidentified 40-year-old cyclist ran a red light and struck her, fracturing her skull. She died on May 4. The biker told cops that his gears malfunctioned and his brakes failed. Cops issued him a summons and he was released.
“People are mad,” said Adrienne Rivetti Jensen, an Upper West Side resident whose 5-year-old daughter, Mabel, suffered a gash on her forehead when a speeding biker clipped the girl in Riverside Park on April 8.
Mabel, now with an inch-long scar, was at first afraid to return to the park after the accident, said the mother.
“She got hit while we were just walking on the pathway — and a lot of cyclists were speeding past us, yelling at us to get out of the way,” the mother recalled. “In the Uber to the hospital, I started to feel really angry. He could have killed her. He was going really fast.”
She said other parents on the Upper West Side are worried that their children aren’t safe.
“Every New Yorker I meet has a story about someone getting hit,” she said, including a mom in the neighborhood with three children who have all been injured by riders.
“It should be a public conversation. All these bicyclists have lobbying groups and are getting expanded accessibility to the city.”
Hizzoner has been putting in place a plan to install 30 new miles of bicycle lanes per year, reduce parking spaces and add hundreds of Citi Bikes.
Some of the lanes defy logic.
One that was recently installed next to the FDR Drive, between 33rd and 34th Streets, gobbled up a walkway and a vehicle lane used by ambulances trying to get to Bellevue Hospital.
Another on Eighth Avenue in Midtown stands out as an example of a poorly planned path that pits pedestrians against cyclists in a battle for limited pavement.
Tens of thousands of commuters headed to and from the Port Authority bus terminal on 42nd Street everyday overflow the narrow sidewalks onto the Eighth Avenue roadway, where the city inexplicably installed both a bike lane and parking lane in 2006.
Hordes of bikers weave through idling cabs and throngs of pedestrians, creating collisions and even sparking fistfights.
But the mayor has ignored the growing threat to walkers.
The one cyclist group he has attacked is electric-bike riders, who are primarily food-delivery workers. He has blasted them for going the wrong way on streets and riding on sidewalks and has launched a crackdown against them.
But just nine of the 270 reported pedestrian injuries from bikers last year were caused by e-bikes, according to a report on the transportation-news site Streetsblog.
A woman whose jogger husband was killed by a bike rider in Central Park in 2014 told the site that the bicyclists need to see themselves both as victims and “predators.”
“One careless move on a bike and we can take down a runner, a walker, a child skipping along,” said Hindy Schachter, whose husband, Irving, 75, was training for the New York City Marathon when he was hit on the East Loop of the park near 72nd Street by a 17-year-old cyclist.
“As we want car drivers to be alert to our rights, so too we must act to protect the rights of other people.”
It would seem that not all accidents and injuries are getting reported.
Central Park remains a hot spot for danger, as racing riders routinely blow through red lights and pedestrians risk injury merely by crossing the road.
But last year there were only four reported cyclist-caused injuries in the park’s 22nd Precinct, the data show.
The NYPD has stepped up its enforcement of rule-breaking riders.
Cops issued 19,949 moving violations to cyclists this year through June 30, up from 18,148 over the same period last year, a 10 percent increase.
The European Society of Cardiology (ESC) Guidelines on diabetes, pre-diabetes and cardiovascular diseases are published online today in European Heart Journal,(1) and on the ESC website.(2) They were developed in collaboration with the European Association for the Study of Diabetes (EASD).
Professor Francesco Cosentino, ESC Chairperson of the guidelines Task Force and professor of cardiology at the Karolinska Institute and Karolinska University Hospital in Stockholm, Sweden said: “The emphasis of these guidelines is to provide state of the art information on how to prevent and manage the effects of diabetes on the heart and vasculature, with a focus on new data that has emerged since the 2013 document.”
Professor Peter J. Grant, EASD Chairperson of the guidelines Task Force and professor of medicine at the University of Leeds, UK said: “Recent trials have shown the cardiovascular safety and efficacy of SGLT2 inhibitors and GLP-1 receptor agonists for type 2 diabetes. We provide clear recommendations here.”
The global prevalence of diabetes continues to increase. It is predicted that more than 600 million individuals will develop type 2 diabetes worldwide by 2045, with around the same number developing pre-diabetes. Estimates state that diabetes affects 10% of populations in previously underdeveloped countries such as China and India, which are now adopting western lifestyles, and 60 million Europeans, of which half are undiagnosed.
“These figures pose serious questions to developing economies, where the very individuals who support economic growth are those most likely to develop type 2 diabetes and to die of premature cardiovascular disease,” states the document.
Healthy behaviours are the mainstay of preventing cardiovascular disease. Lifestyle changes are now advised to avoid or delay the conversion of pre-diabetes states, such as impaired glucose tolerance, to diabetes. Physical activity, for example, delays conversion, improves glycaemic control and reduces cardiovascular complications.
The document states that moderate alcohol intake should not be promoted as a means to protect against cardiovascular disease. “There has been a long-standing view that moderate alcohol intake has beneficial effects on the prevalence of cardiovascular disease,” said Prof Grant. “Two high-profile analyses have reported this is not the case and that alcohol consumption does not appear to be beneficial. On the basis of these new findings we changed our recommendations.”
Self-monitoring of blood glucose and blood pressure is advocated for patients with diabetes to achieve better control. Data has emerged to implicate glucose variability in the causes of heart disease in diabetes. In addition, glucose variation at night is particularly linked with hypoglycaemia and deterioration in quality of life.
“This indicates that it is no longer appropriate to depend on occasional glucose measures to manage control, particularly in type 1 diabetes,” said Prof Cosentino. “At the same time, flash technology has been developed which uses a small sensor worn on the skin to continuously monitor glucose levels. Similar arguments pertain to home blood pressure monitoring.”
Statins are not recommended in diabetic women of childbearing potential and should be used with caution in young people. “We have no experience of the effects of 50 or 60 years of statin use in an individual and we do not advocate non-essential drugs in pregnancy when the potential adverse effects on the unborn child are unknown,” explained Prof Grant.
Clinical trials on the cardiovascular safety of medications for type 2 diabetes have led to a paradigm shift in glucose-lowering treatment. Two groups of diabetes drugs – GLP-1 receptor agonists and gliflozins – showed cardiovascular safety and benefit in patients with diabetes who either already had heart disease and/or had multiple risk factors.
“Our main recommendation in the light of these findings is that GLP-1 receptor agonists and gliflozins should be used as first line treatment in type 2 diabetes patients with established cardiovascular disease or at high risk of cardiovascular disease,” said Prof Cosentino.
Drugs that prevent blood clots – non-vitamin K antagonist oral anticoagulants, specifically rivaroxaban – have been reported to benefit peripheral vascular disease and should be considered in combination with aspirin for patients with diabetes who have poor circulation in the legs.
PCSK9 inhibitors are advised for patients with diabetes at very high risk of cardiovascular disease who do not achieve low-density lipoprotein (LDL) cholesterol goals despite treatment with statins. In these patients, a more ambitious LDL cholesterol target of below 1.4 mmol/L is recommended.
Lifestyle advice for patients with diabetes and pre-diabetes
Quit smoking.
Reduce calorie intake to lower excessive body weight.
Adopt a Mediterranean diet supplemented with olive oil and/or nuts to lower the risk of cardiovascular events.
Avoid alcohol.
Do moderate-to-vigorous physical activity (a combination of aerobic and resistance exercise) at least 150 minutes per week to prevent/control diabetes – unless contraindicated, such as in patients with severe comorbidities or limited life expectancy.
The hashtag for ESC Congress 2019 together with the World Congress of Cardiology is #ESCCongress
Funding: None.
Disclosures: The disclosure forms of all experts involved in the development of these guidelines are available on the ESC website http://www.escardio.org/guidelines.
