An HIV Med Is Tied to Too-Small Heads in Newborns

FRIDAY, Nov. 22, 2019 — Children born to women who take the HIV drug efavirenz during pregnancy have a higher risk of small head size — a birth defect known as microcephaly — compared to babies exposed to other HIV drugs in the womb, new research shows.

Prenatal exposure to the drug was also linked to developmental delays in children.

But one U.S. expert said the new data shouldn’t alarm most HIV-positive women.

“Efavirenz has not been widely used in the U.S. during pregnancy for many years due to its association with neural tube defects in studies conducted in monkeys,” said Dr. Joseph McGowan, medical director of the Northwell Health HIV Service Line Program in Manhasset, N.Y.

“Antiretroviral usage patterns have shifted away from efavirenz as recommended therapy, so the impact of these findings in the U.S. and developed countries may be limited,” said McGowan, who wasn’t involved in the new study.

“The major take-home from this study for me was that use of antiretrovirals during pregnancy was found to be safe for the exposed, uninfected infant with the one exception of efavirenz,” he added. “This should be reassuring to clinicians and mothers.”

The new research was led by Dr. Rohan Hazra, chief of the maternal and pediatric infectious disease branch at the U.S. National Institute of Child Health and Human Development.

Hazra’s team tracked data from more than 3,000 children born to U.S. women who took HIV drugs during pregnancy. The children’s head circumferences were measured from age 6 months through 5 to 7 years of age.

The children’s head growth was assessed using two classification systems: one developed by the U.S. Centers for Disease Control and Prevention for children under 3 years of age, and Nellhaus charts, which are used for children older than 3 years.

The study couldn’t prove cause and effect. But based on Nellhaus charts, children whose mothers took the HIV drug efavirenz were more than twice as likely to have microcephaly than those whose mothers took other HIV drugs.

Based on the combined Nellhaus-CDC standards, children exposed to efavirenz in the womb were around 2.5 times more likely to have microcephaly than those exposed to other HIV drugs in the womb.

Children with microcephaly based on Nellhaus charts also scored lower on standardized tests of development at ages 1 and 5 years.

Of the 141 children exposed to efavirenz in the womb, 14 (9.9%) had microcephaly, compared to 142 of 2,842 who were not exposed to efavirenz (5%), according to the U.S. National Institutes of Health-funded study published online recently in The Lancet HIV.

“Our findings underlie the importance of having alternatives to combination therapy with efavirenz for pregnant women with HIV,” Hazra said in an NIH news release.

More information

The U.S. National Institute of Neurological Disorders and Stroke has more on microcephaly.

© 2019 HealthDay. All rights reserved.

Posted: November 2019

Drugs.com – Daily MedNews

Health Tip: Creating a Healthy Routine

— People are creatures of habit, so breaking old practices and forming new routines can be daunting.

To start and maintain a new routine, NorthShore University Health System recommends:

  • Figure out what needs to be in your routine.
  • Set small goals.
  • Lay out a plan.
  • Be consistent over time.
  • Be prepared.
  • Make it fun.
  • Track your progress.
  • Reward yourself.

© 2019 HealthDay. All rights reserved.

Posted: November 2019

More News Resources


Drugs.com – Daily MedNews

Obesity Rates Fall for Many Young Kids in Federal Nutrition Program

THURSDAY, Nov. 21, 2019 — Forty-one states and territories have seen drops in obesity rates among young children enrolled in a U.S. nutrition program, a new study shows.

“Improvements in national, state and caregiver guidance around nutrition and physical activity may be contributing to this decline in childhood obesity,” said Dr. Robert Redfield, director of the U.S. Centers for Disease Control and Prevention.

“We are moving in the right direction, and helping parents make healthy choices for their children is reducing the potential for complications posed by childhood obesity later in life,” he added in a CDC news release.

In the study, U.S. federal government researchers analyzed obesity trends from 2010 to 2016 among more than 12.4 million children, aged 2 to 4, in low-income families enrolled in the Special Supplemental Nutrition Program for Women, Infants, and Children (WIC). WIC helps provide supplemental foods and nutrition education.

In 2009, WIC state agencies started providing food packages more in line with the U.S. Dietary Guidelines for Americans and infant feeding practice guidelines of the American Academy of Pediatrics. This led to increased availability of healthier foods and beverages for WIC enrollees.

Between 2010 and 2016, obesity rates fell by more than 3% in seven WIC states and territories (New Jersey, New Mexico, Utah, Virginia, Guam, Northern Mariana Islands, and Puerto Rico).

However, three states had increases in obesity: Alabama (0.5%), North Carolina (0.6%), and West Virginia (2.2%).

The study appears in the Nov. 21 issue of the CDC publication Morbidity and Mortality Weekly Report.

A previous study found that 34 of 56 WIC state/territory agencies had decreases in obesity rates between 2010 and 2014.

Currently, the WIC program also helps establish successful long-term breastfeeding, provides participants with a wider variety of foods, and offers WIC state agencies flexibility in food packages for participants with cultural food preferences.

Despite these declines in obesity among children enrolled in WIC, rates remained high in most states in 2016.

“While we have seen some progress, obesity prevalence among young children remains too high,” said Dr. Ruth Petersen, director of CDC’s Division of Nutrition, Physical Activity, and Obesity.

“We must persist in our efforts to support healthy eating and physical activity for this positive trend to continue,” Petersen said in the release.

More information

Advice on preventing childhood obesity can be found at healthfinder.gov.

© 2019 HealthDay. All rights reserved.

Posted: November 2019

Drugs.com – Daily MedNews

Health Tip: Thanksgiving and Your Heart Health

— Though Thanksgiving dinner is treasured by many Americans, the meal typically isn’t heart-healthy.

Including holiday staples such as mashed potatoes and stuffing, the traditional feast is full of fatty, high-cholesterol foods, says the University of Wisconsin-Madison.

For a healthier holiday meal, the school suggests:

  • Devote most of your plate to vegetables, such as green beans, carrots and squash.
  • Don’t drench everything in gravy. Use as little as you can.
  • Limit turkey skin and dark meat.
  • Have a small slice of pie for dessert. Resist a second helping.

The school says after all is said and done, one meal won’t ruin your heart and arteries. It urges you to eat healthy during the holiday season overall.

© 2019 HealthDay. All rights reserved.

Posted: November 2019

More News Resources


Drugs.com – Daily MedNews

Doctors’ Group Calls for Ban on Most Vaping Products

WEDNESDAY, Nov. 20, 2019 — The American Medical Association (AMA) is calling for a ban on all e-cigarettes and vaping products not approved by the U.S. Food and Drug Administration to help people quit smoking tobacco cigarettes.

The move is in response to a sharp rise in youth e-cigarette use and an outbreak of more than 2,000 illnesses and 40-plus deaths caused by vaping-related lung illness.

“The recent lung illness outbreak has alarmed physicians and the broader public health community and shined a light on the fact that we have very little evidence about the short- and long-term health consequences of e-cigarettes and vaping products,” AMA president Dr. Patrice Harris said.

“It’s simple — we must keep nicotine products out of the hands of young people and that’s why we are calling for an immediate ban on all e-cigarette and vaping products from the market,” Harris said in a news release from the group.

Besides preventing kids from ever using nicotine, Harris said it’s “critical that there is research into nicotine-addiction treatments for this population.”

The ban on e-cigarettes and vaping products was one of a number of anti-nicotine policies adopted at a recent AMA meeting in San Diego.

Doctors, residents and medical students also called for funding of research to assess the safety and effectiveness of e-cigarette and vaping products in helping people quit smoking cigarettes, and a study of drug and non-drug treatments for nicotine addiction in young people.

Pharmacies should also stop selling tobacco products, the group said.

In the past, the AMA has urged media companies to reject advertising that markets e-cigarette products to young people and supported laws making 21 the minimum age to buy tobacco products, including e-cigarettes.

“Since declaring e-cigarette use and vaping an urgent public health epidemic in 2018, the AMA has pushed for more stringent policies to help protect our nation’s young people from the harmful effects of tobacco and nicotine use,” Harris said.

“For decades, we have led the public health fight to combat the harmful effects of tobacco products, and we will continue to support policies and regulations aimed at preventing another generation from becoming dependent on nicotine,” Harris concluded.

More information

The American Lung Association has more on e-cigarettes.

© 2019 HealthDay. All rights reserved.

Posted: November 2019

Drugs.com – Daily MedNews

Recalls of Blood Pressure Med Took Toll on Patients’ Health

WEDNESDAY, Nov. 20, 2019 — Emergency room visits for high blood pressure surged following last year’s recall of the popular heart drug valsartan, Canadian researchers report.

Within the first month of the recall, there was a 55% increase of people coming to Ontario-area emergency departments complaining of high blood pressure, said lead researcher Cynthia Jackevicius. She is a senior scientist with the Institute for Clinical Evaluative Sciences, in Toronto.

Some of these patients likely were valsartan users who stopped taking the blood pressure med after seeing scary recall news citing a potential carcinogen found in some lots of the drug, Jackevicius said.

“Nine out of 10 did have an alternative replacement” for valsartan within three months. “However, that means that one out of 10 did not,” Jackevicius said.

“That’s a little bit concerning, that some of these patients may have either been confused or concerned, and decided not to switch to another medication,” she added.

The recall occurred in July 2018 in both Canada and the United States, after generics maker Mylan Pharmaceuticals detected trace amounts of a probable cancer-causing chemical called N-nitrosodiethylamine (NDEA) in valsartan meds.

It was an unusually large recall that involved intense media interest, and Jackevicius and her colleagues wondered how it might have affected the drug’s users.

So they turned to Canadian prescription and medical records to track how valsartan users responded to the crisis.

Dr. Mary Norine Walsh, a past president of the American College of Cardiology and a cardiologist at St. Vincent Heart Center of Indiana, said, “It’s really interesting data, because my assumption would have been in Canada and the U.S. that substitution was made pretty much instantly.”

That’s what happened — mostly.

Within one month, 85% of patients had a new prescription for an alternative to their generic valsartan, Jackevicius said. By three months, 90% had a prescription for a different blood pressure drug.

But that left 10% of patients with recalled valsartan who hadn’t been prescribed an alternative, Jackevicius noted.

“Maybe they heard about the recall on the news and never went to their physician or clinician to get a substitution,” Walsh said.

“When there’s a recall like this, is there a patient lack of trust in the system? Do they not get back on drugs because they’re afraid? I don’t know,” Walsh asked.

In the immediate aftermath of the recall, people swarmed Ontario emergency departments for blood pressure treatment, the researchers found.

Many of these folks likely were people who were afraid to take their valsartan and went to the ER for a replacement drug when they couldn’t reach their doctor, Jackevicius suggested.

“That’s not really the best place to go” when your drug is recalled, she said. “Going to the emergency department is not a good use of the resources there, and it’s not a good use of the patient’s time.”

However, there were also probably quite a few who stopped taking the drug altogether and suffered symptoms related to high blood pressure, Jackevicius and Walsh said.

According to Walsh, “People did worse if they came off it, which is not surprising because the primary reason they were prescribed it was for hypertension.”

Jackevicius said the incident revealed holes in medicine’s response to major drug recalls.

Empowering pharmacists to reach out to patients and prescribe alternatives could be one way to improve the response to a recall, Jackevicius said.

Pharmacists have direct knowledge of the specific drugs handed out to patients that their doctors don’t, she explained.

“It would make sense that they take more responsibility and be given the authority to substitute common medications, to be a point person in the event of a recall,” Jackevicius said. “They are accessible and would know similar medications that might be OK for that condition.”

Public health officials also could help by promptly creating a consensus list of approved alternative medications, so doctors and pharmacists could quickly and efficiently move patients onto a new prescription, she added.

Jackevicius presented her study last weekend at the American Heart Association’s annual meeting, in Philadelphia. The work was also published recently in the journal Circulation.

More information

The American Heart Association has more about blood pressure drugs.

© 2019 HealthDay. All rights reserved.

Posted: November 2019

Drugs.com – Daily MedNews

As Disease Outbreaks Tied to ‘Anti-Vaxxers’ Rise, States Take Action

TUESDAY, Nov. 19, 2019 — Outbreaks of vaccine-preventable diseases are on the across rise in the United States, often fueled by “anti-vaxxer” parents reluctant to immunize their kids.

However, states are countering these trends with laws to boost childhood vaccination rates and safeguard children, a new study finds.

“Vaccines are our best public health tool for controlling many childhood diseases,” said lead author Neal Goldstein of Drexel University, in Philadelphia.

“Seeing an uptick in legislation aimed at cutting vaccine exemptions following disease outbreaks suggests that media coverage may raise public awareness and advocacy and response from legislators,” Goldstein said in a university news release.

“While it is unfortunate it took outbreaks of preventable disease to spawn legislative action, it further affirms the widespread support of this life-saving intervention,” he added. Goldstein is an assistant research professor of epidemiology and biostatistics in Drexel’s School of Public Health.

Recent outbreaks of illnesses such as measles or whooping cough in California (2015) and New York (2019) led lawmakers in those states to ban all non-medical vaccine exemptions.

To see if that trend was widespread, Goldstein’s team analyzed 2010 to 2016 state data on outbreaks of 12 childhood vaccine-preventable diseases, including hepatitis A and B, flu, measles and whooping cough.

The investigators also examined 2011 to 2017 data on state bills introduced the year after the start of an outbreak that would tighten or ease vaccination requirements for these diseases.

Each state reported an average of 25 vaccine-preventable diseases per 100,000 people per year, but there was significant year-to-year variation.

Of the 175 state vaccination-related bills proposed during 2011 to 2017, about 53% made it easier to get an exemption from vaccine requirements, while 47% made exemption more difficult.

While there were more anti-vaccine bills than pro-vaccine bills introduced overall, further analysis showed that increases in vaccine-preventable diseases were followed by increases in the number of proposed bills that restricted vaccine exemptions.

There was no association between decreases in vaccine-preventable diseases and proposed bills that made it easier to get vaccine exemptions, according to the study. The results were published Nov. 18 in JAMA Pediatrics.

Legislation to reduce vaccine exemptions is needed in the United States, the study authors said. Measles was declared eliminated in the United States in 2000, but there were 695 cases in 22 states in April 2019, according to the U.S. Centers for Disease Control and Prevention.

More information

The U.S. Centers for Disease Control and Prevention has more on vaccines.

© 2019 HealthDay. All rights reserved.

Posted: November 2019

Drugs.com – Daily MedNews

Could Short People Have an Advantage When It Comes to A-Fib?

TUESDAY, Nov. 19, 2019 — Tall folks might be able to reach that high top shelf, but there’s a price — they may be more likely to develop a potentially dangerous abnormal heart rhythm than shorter folks.

New research finds that a person’s risk of atrial fibrillation (a-fib) increases by about 3% for every inch over the average height of 5-foot-7.

Further, it appears that certain genes linked to height also are associated with a-fib, said lead researcher Dr. Michael Levin, a cardiology fellow at the University of Pennsylvania Perelman School of Medicine.

Atrial fibrillation is a quivering or irregular heartbeat that increases a person’s risk of stroke fivefold. It also raises risk of blood clots, heart failure and other heart-related diseases, the American Heart Association says.

Knowing that tall folks are at increased risk of a-fib could help prevent deaths and disease related to the heart condition, Levin said.

“While we can’t change your height, we may be able to modify other risk factors for a-fib in taller individuals and be more aggressive about controlling blood pressure or diabetes or cholesterol,” Levin said.

For this study, Levin and his colleagues analyzed genetic data from two international databases.

They looked specifically at genetic variants associated with height in one group of more than 700,000 people, and then identified mutations associated with a-fib in another group of more than 500,000 people.

Statistical analysis revealed that genetic variants linked with height were also strongly associated with a-fib, the researchers found.

Taking it a step further, they then analyzed medical data on nearly 7,000 individuals enrolled in a biobank at the University of Pennsylvania.

They found that height — and the genetic variants associated with height — are both strongly associated with an increased risk of a-fib.

However, they’re still at a loss for an explanation why, Levin said, and the study did not prove cause and effect.

One theory has held that tall people have larger hearts, and the size of the heart might increase a-fib risk, he said.

“We were able to adjust for that, and it doesn’t seem to be related to heart size,” Levin said.

Even without an easy explanation, the identification of genes associated with both height and a-fib opens up new doors for future research, said Dr. Michael Valentine, who reviewed the findings. He is immediate past president of the American College of Cardiology and a specialist in cardiac rhythm.

“I thought it was fascinating when they separated all other genetic factors, that height turned out to be a positive factor in the development of atrial fib,” said Valentine, a senior cardiologist at the Stroobants Cardiovascular Center of Centra Health in Lynchburg, Va.

“With the epidemic of a-fib we see in the world and an aging population, we’re going to need earlier and more effective genetic markers to determine where we can have impact on the disease earlier in life,” Valentine said.

The findings were presented this weekend at the American Heart Association’s annual meeting, in Philadelphia. Such research is considered preliminary until published in a peer-reviewed journal.

More information

The American Heart Association has more about atrial fibrillation.

© 2019 HealthDay. All rights reserved.

Posted: November 2019

Drugs.com – Daily MedNews

Muscle in Middle Age Might Help Men’s Hearts Later

MONDAY, Nov. 18, 2019 — Middle-aged men who maintain their muscle mass may lower their risk of heart disease as they get older, a new study suggests.

Beginning in the mid-30s, muscle begins to decline by about 3% each decade. Previous studies found that muscle mass is associated with heart attack/stroke risk, but those studies focused on people with heart disease.

In this new study, the researchers wanted to examine if muscle mass in middle age might be associated with long-term heart health in people without heart disease.

The study included more than 1,000 men and women, aged 45 and older, who were followed for 10 years. During that time, 272 participants developed heart disease, including stroke and minor stroke.

People with the most muscle were 81% less likely to develop heart disease than the least muscular. Those with the most muscle had the lowest rates of risk factors such as high blood pressure, diabetes and obesity, the investigators found.

Further analysis showed that muscle mass was significantly linked to lower heart disease risk among men, but not women.

Possible reasons for this gender disparity include age-related hormonal differences and the fact that the men had more muscle to start with, according to the study authors. Their findings were published online Nov. 11 in the Journal of Epidemiology & Community Health.

Because this was an observational study, it can’t establish cause and effect. Even so, the findings “point to the importance of [skeletal muscle mass] preservation in relation to [cardiovascular disease] risk,” the authors wrote in the report.

Regular physical activity, including resistance training, and a diet rich in protein may help preserve lean muscle mass as people get older, the researchers suggested.

Demosthenes Panagiotakos, a professor in the School of Health Science and Education at Harokopio University in Athens, Greece, led the study.

More information

The U.S. National Institute on Aging has more about exercise.

© 2019 HealthDay. All rights reserved.

Posted: November 2019

Drugs.com – Daily MedNews

Gene Test Might Someday Gauge Your Cardiac Arrest Risk

MONDAY, Nov. 18, 2019 — Sudden cardiac death is terrifying because it’s exactly that — one minute you’re fine and the next you’re facing death, with no warning and no prior symptoms.

Now, new research shows the secret to who’s at risk for cardiac arrest and who isn’t could lie in people’s genes. And a gene test might someday help predict who’s most endangered, according to a study presented this weekend at the American Heart Association’s annual meeting in Philadelphia.

Researchers said they have identified a group of 14 gene variants that appear to be linked to sudden cardiac death.

People carrying any of these variants had a more than triple the risk of dying from cardiac arrest, said lead researcher Dr. Amit Khera. He’s associate director of the Precision Medicine Unit at Massachusetts General Hospital’s Center for Genomic Medicine.

“This really lays the groundwork to say these are important mutations, and what’s exciting is if we can identify them, we have treatments for the conditions to which they are tied,” Khera explained. “My goal now is to use genetic variation as a tool to empower people to overcome whatever risk they might have been born with.”

Sudden cardiac arrest is responsible for 325,000 adult deaths in the United States each year — about half of all heart disease deaths, the Cleveland Clinic says. It strikes most often in adults in their mid-30s to mid-40s, and affects men twice as often as women.

There are four major reasons a person might fall prey to sudden cardiac death, Khera said: a weakened heart muscle, a heart attack, an abnormal heart rhythm, or a dilation or tear in the aorta (the main artery leading out from the heart).

“We know each of these diseases tends to run in families and there are genetic variants that cause each of these conditions,” Khera said.

To find out more, his team pulled together data on 600 people who’d been felled by sudden cardiac death and matched them against 600 “controls” who hadn’t.

They then performed genetic sequencing on the entire pool of 1,200 people to look for genes previously linked to heart or blood vessel disease, with no knowledge of which were victims of sudden cardiac death.

The researchers found 15 people who carried at least one of 14 different genetic mutations tied to heart health. After that, they took a step back to see which of the people had died of sudden cardiac death and which were controls.

“All 15 of these people had actually dropped dead [of cardiac arrest],” Khera said. “Zero of them were in the controls.”

As a next step, the researchers tracked a group of more than 4,500 healthy people for a median 14 years, to see whether those who carried one of these genetic variants would fall from sudden cardiac death.

The team identified 41 people — about 1% — as carrying one of these disease-causing genetic variants.

“We were able to show that from 2002 to 2017, they were at more than triple the risk for dying from sudden cardiac arrest,” Khera said.

Khera’s hope is that one day doctors will use these genes to screen for folks with hidden heart risk, and then treat them to lower the risk using therapies and drugs.

He’s already started this work, digging through Massachusetts General Hospital’s biobank of 100,000 patients to look for people carrying one of the 14 variants.

“We’ve already started calling them back, saying you have these variants, do you want to learn about it?” Khera said.

Still, Khera thinks it’s 5 to 10 years from the point where people could receive such genetic screening in their doctors office.

Dr. Kim Eagle, a cardiologist with the University of Michigan Medicine, said such a test could be even further off.

“I think you have to view this as preliminary,” he said of the new study. “Clearly, we’re still grappling with the challenge of taking the human genome and what we know about it and applying it to day-to-day practice in a cost-effective method.”

There’s still so much unknown about genetic variants that they are easy to find but hard to judge, Eagle said.

“If you talk about screening the general population for rare but potentially important genetic defects, you’re going to find a lot of people that have a variant but you don’t know how important it is,” he said.

A test could result in a lot of false-positive results that scare patients to no good purpose, Eagle believes.

He shared the story of a male patient who’d frequently asked him for a genetic screen to find his potential risk factors. When Eagle demurred, the patient took the initiative to get a genetic screening from one of the new companies that have sprung up to provide this service.

He came back to Eagle very upset, pointing out that they found a couple of genes with important variants that could really affect his health.

“I said, ‘You know what’s really interesting? Both of these genes identify diseases that only happen in women,'” Eagle said. “Here’s an example of the result of a false-positive — a guy who doesn’t understand, who’s scared to death that he’s got a rare genetic disorder, and it only happens in women.”

The study was also published Nov. 16 in the Journal of the American College of Cardiology.

For more information:

The Cleveland Clinic has more about sudden cardiac death.

© 2019 HealthDay. All rights reserved.

Posted: November 2019

Drugs.com – Daily MedNews

Cheap, Older Gout Drug, Colchicine, Could Be a Lifesaver After Heart Attack

SUNDAY, Nov. 17, 2019 — A cheap drug that’s been around for centuries as a gout treatment might also shield heart attack survivors from future heart crises, new trial results show.

The drug, colchicine, is derived from a plant called the autumn crocus, researchers explained Saturday at the annual meeting of the American Heart Association, in Philadelphia.

In the new trial, colchicine reduced by as much as 34% a heart attack survivor’s combined risk of either dying from heart disease or having cardiac arrest, a heart attack, a stroke or angioplasty.

Experts described the study as a “landmark” effort.

“These results provide confirmation that inflammation management reduces cardiovascular risk, and it was an example of a successful repurposing of a broadly available and relatively safe generic drug for a new application,” said Dr. Aruna Pradhan, a preventive medicine doctor at Brigham and Women’s Hospital in Boston.

Colchicine currently is used to treat gout and pericarditis (inflammation of the heart’s lining), two conditions caused by inflammation, said lead researcher Dr. Jean-Claude Tardif, director of research at the Montreal Heart Institute.

“You just give a few tablets of colchicine and the pain, the warmth, the redness, all the inflammatory signs go away,” Tardif said.

Tardif and his colleagues reasoned that colchicine might be able to reduce the risk of future heart problems by lowering inflammation in heart attack patients.

The trial involved more than 4,700 heart patients, with about half given daily low-dose colchicine taken by mouth and the rest provided a placebo. Nearly all patients also received the drug regimen normally prescribed to heart attack survivors — aspirin, blood thinners, statins and/or beta blockers.

Three years later, results showed that people on colchicine fared significantly better than those taking a placebo.

Besides the 34% reduction in all adverse heart events, the trial also found that patients taking colchichine had a 74% reduction in stroke risk, and a 50% reduction in their likelihood of being rushed to hospital for angioplasty/stenting after suffering chest pain.

The drug also appears to be safe. The most concerning side effect appears to be an increased risk of pneumonia, which affected about 1% of colchicine patients. Pradhan said pneumonia risk might be affected by the drug’s effect on inflammation.

Tardif said his research team is proceeding with a second trial focusing on heart risk among patients with type 2 diabetes.

Based on these findings, heart doctors will be thinking long and hard about adding colchicine to the drug cocktail prescribed to heart attack patients, said Dr. Donald Lloyd-Jones, chair of preventive medicine at Northwestern University Feinberg School of Medicine.

“When you have a safe drug that is easily available, it’s going to be hard to hold this back,” Lloyd-Jones said.

The trial was funded by the provincial government of Quebec and received no drug company funding. However, colchicine’s new promise already appears to be affecting its sticker price, even though it’s a generic drug, Lloyd-Jones added.

He said that he recently saw a patient with gout on Thursday who complained that his colchicine prescription costs had unexpectedly skyrocketed.

“He told me that just in the last month, his colchicine out-of-pocket costs went from $ 50 to $ 270 a month in Chicago,” Lloyd-Jones said. “I really wonder whether there’s some gaming going on here, and I do not want to see that.”

Tardif expressed shock, given colchicine’s low cost in Canada.

“There’s something wrong with a system where 90 minutes away you get a drug for 50 times less what others are paying,” Tardif said, referring to what his patients pay in Montreal, an hour-and-a-half flight away.

The results were also published Saturday in the New England Journal of Medicine.

More information

The Mayo Clinic has more about colchicine.

© 2019 HealthDay. All rights reserved.

Posted: November 2019

Drugs.com – Daily MedNews

Study Casts Doubt on Angioplasty, Bypass for Many Heart Patients

SUNDAY, Nov. 17, 2019 — Bypass operations, angioplasty and the placement of artery-opening stents: For decades, millions of Americans have undergone these expensive, invasive procedures to help treat clogged vessels.

However, the results of a large and long-awaited clinical trial suggests that, in most cases, these procedures may not have provided any benefit over medications and lifestyle changes.

In fact, people treated with meds and healthy changes in lifestyle wound up about as healthy as those who underwent an invasive procedure to open their hardened arteries, researchers reported Saturday at the American Heart Association (AHA) annual meeting in Philadelphia.

Only a subgroup of patients who suffered from frequent angina appeared to receive any benefit from an invasive procedure, and that benefit was in their quality of life, not in lowering their odds of death or future heart problems.

“Based on the trial results to date, I as a clinician would feel comfortable advising my patient not to undergo the invasive strategy if their angina was absent or controlled or it was tolerated,” said Dr. Alice Jacobs, director of the Cardiac Catheterization Laboratory and Interventional Cardiology at Boston Medical Center. She wasn’t involved in the new research.

Still, doctors are often uncomfortable limiting their treatment of clogged arteries to drugs, diet and exercise alone because they’re worried the patient will wind up suffering a heart attack or other heart-related illness, according to past AHA president Dr. Elliot Antman.

The new findings are expected to give physicians more confidence in saying no to invasive treatments, the experts said.

The study did not focus on people who are admitted to a hospital with a heart attack — these patients often receive bypass, angioplasty or stenting to quickly open a blocked artery.

Instead, the trial focused on patients with stable but severe heart disease.

A typical patient in this group might be a 71-year-old grandmother who has noticed during the past two months some chest heaviness walking from the parking lot to her grandkids’ soccer game, the AHA presenters said. Stress testing and imaging scans could reveal some moderately clogged arteries leading to her heart.

The new trial was very comprehensive, involving nearly 5,200 patients across 37 countries. Half were randomly assigned to undergo an invasive procedure: About three-quarters underwent angioplasty (most receiving a stent as well), while the others had a bypass operation.

The other half of patients were treated with medications and lifestyle changes alone.

Researchers mainly focused on whether the invasive procedure would reduce a patient’s risk of heart-related death, heart attack, hospitalization with unstable angina, heart failure or cardiac arrest.

Overall, an invasive strategy “did not demonstrate a reduced risk over a median 3.3 years” compared with the more conservative, drugs/lifestyle therapy, said trial co-chair Dr. Judith Hochman, a cardiologist and senior associate dean of clinical sciences at NYU Langone Health, in New York City.

However, invasive procedures did have a positive impact on one patient subgroup: People who regularly suffer the chest pain and shortness of breath associated with angina, said co-researcher Dr. John Spertus. He directs health outcomes research at Saint Luke’s Mid-America Heart Institute in Kansas City.

“For a patient who has weekly angina, there would be 15% of them who would be expected to be angina-free with the conservative approach, while 45% would be expected to be angina-free with the invasive approach,” Spertus said. “This is such a large difference that you would only have to treat about three patients with weekly angina for one to be angina-free at three months.”

On the other hand, patients who did not regularly have angina received only minimal quality-of-life or symptom benefits after undergoing an invasive procedure, Spertus added.

A smaller set of trials — this time focused on patients with chronic kidney disease — revealed even less promising results, researchers said. Patients didn’t gain any health benefits and didn’t have any improvement in their quality of life after getting an invasive treatment. Angioplasty might even help put them on dialysis earlier or increase their risk of stroke, the study found.

Dr. Glenn Levine, a professor of cardiology with Baylor College of Medicine in Houston, said that when it comes to kidney patients with clogged arteries, he “will treat them with medical [drug] therapy alone” unless they have marked or uncontrolled angina.

Experts said the main message from these studies is that doctors shouldn’t feel pressured to immediately send patients with clogged arteries into a catheterization lab, especially if they aren’t suffering any symptoms.

That could free up physicians to focus on getting patients to take their medications, Jacobs said. If drug therapy helps relieve their occasional angina or other symptoms, then angioplasty might be avoided in two out of every three patients, she estimated.

The trials were funded by the U.S. National Heart, Lung, and Blood Institute.

For more information:

There’s more on common heart procedures at the American Heart Association.

© 2019 HealthDay. All rights reserved.

Posted: November 2019

Drugs.com – Daily MedNews

High Blood Pressure During Pregnancy Tied to Future Heart Risks

FRIDAY, Nov. 15, 2019 — Pregnancy-related high blood pressure puts women at higher risk of heart disease later on, new research suggests.

In the study, researchers analyzed an average of seven years of follow-up data on more than 220,000 women in the United Kingdom. Those who had gestational high blood pressure or preeclampsia in at least one pregnancy had stiffer arteries, and two to five times the rate of chronic high blood pressure later on, the findings showed.

These women were more likely to develop heart problems, including coronary artery disease, heart failure and valve disease, according to the report published online Nov. 11 in the Journal of the American College of Cardiology.

Up to half the risk was driven by chronic high blood pressure, the investigators found. That “implies that treating high blood pressure may be especially important in this population,” said study lead author Dr. Michael Honigberg. He’s a cardiologist at Massachusetts General Hospital in Boston.

Future research could assess new ways of treating high blood pressure (“hypertension”) or simply treating it more aggressively in women who have had it at least once during pregnancy, Honigberg suggested.

“Research over the past decade has shown there are sex-specific risk factors for cardiovascular disease among women,” Honigberg said in a hospital news release. “But there were still some significant gaps in our understanding of those risks, and one gap is whether the elevated risk persists long-term after a hypertensive pregnancy, or whether other women ‘catch up’ as cardiovascular risk increases with age in the population overall.”

Doctors are still figuring out how to predict and prevent high blood pressure problems during pregnancy, he noted. “But what we can do is look ahead and try to mitigate the risk of these women developing cardiovascular disease later in life,” Honigberg said.

That includes heart-healthy lifestyle changes such as exercise, eating a healthy diet, not smoking and controlling weight. Some women may also benefit from medication, he explained.

“You’d be shocked at how few physicians who aren’t obstetrician/gynecologists — including cardiologists — ask their female patients if they’ve had a hypertensive disorder of pregnancy,” Honigberg said. “This research really underscores the importance of clinicians asking about this history, and of women sharing it.”

More information

The U.S. Office on Women’s Health has more about heart disease.

© 2019 HealthDay. All rights reserved.

Posted: November 2019

Drugs.com – Daily MedNews

Fetroja Approved to Treat Complicated Urinary Tract Infections

FRIDAY, Nov. 15, 2019 — Antibacterial drug Fetroja (cefiderocol) has been approved to treat patients aged 18 years and older with complicated urinary tract infections (cUTIs), the U.S. Food and Drug Administration announced yesterday.

The drug is indicated for patients with limited or no alternative treatment options for cUTI, including kidney infections caused by susceptible Gram-negative microorganisms. Dosage is 2 g of Fetroja every eight hours administered by intravenous infusion over three hours. Dose adjustments are required based on creatinine clearance. Prescription labeling on Fetroja includes a warning for a higher all-cause mortality rate in Fetroja-treated critically ill patients with multidrug-resistant Gram-negative bacterial infections.

Approval of Fetroja was based on safety and efficacy data from 448 patients with cUTI in the APEKS-cUTI study. Symptoms resolved and bacteria were eradicated in 72.6 percent of patients who received Fetroja seven days after treatment completion versus 54.6 percent of patients who received imipenem/cilastatin. Clinical response rates were similar between the two groups of patients.

The cause of the higher mortality rate with Fetroja in critically ill patients with multidrug-resistant Gram-negative bacterial infections is unknown. According to the FDA, some of the deaths were due to worsening or complications of infection or underlying comorbidities. This higher mortality rate was also seen among patients treated for hospital-acquired/ventilator-associated pneumonia, bloodstream infections, or sepsis. The agency noted that the safety and efficacy of Fetroja for treating these types of infections has not been determined.

The most commonly reported adverse reactions with Fetroja included diarrhea, constipation, nausea, vomiting, elevations in liver tests, rash, infusion site reactions, candidiasis, cough, headache, and hypokalemia. Patients who have had severe hypersensitivity to beta-lactam antibacterial drugs should not take Fetroja.

Approval was granted to Shionogi & Co.

More Information

© 2019 HealthDay. All rights reserved.

Posted: November 2019

Drugs.com – Daily MedNews

AHA News: Quitting Smoking Could Lead to Major Changes in Gut Bacteria

FRIDAY, Nov. 15, 2019 (American Heart Association News) — Quitting smoking leads to major changes in intestinal bacteria, according to new research. But just what the changes mean will need further investigation.

The small pilot study, to be presented Monday during the American Heart Association’s Scientific Sessions in Philadelphia, comes in the wake of past research showing a link between bacteria in the gut and cardiovascular health. That past work has shown smoking is associated with a decrease in diversity in the types of beneficial bacteria living in the gut.

For the new study, researchers looked at 26 people who were trying to quit smoking and analyzed their stool samples at the start of the study and again two weeks and 12 weeks later.

“We concluded that smoking cessation changes the gut microbiota, and I think that’s a significant piece of science,” said the study’s lead author, Dr. Marcus Sublette.

“It’s already been established that smoking changes the gut microbiome. What we’re adding here is that smoking cessation itself will continue to change the gut microbiome. Then the question of course is, ‘Is this good? Or is it bad?’ We don’t know yet.”

The study showed improvements in bacterial diversity were associated with reductions in heart rate, systolic blood pressure and C-reactive protein levels, which rise in response to inflammation. It also showed an increase in hemoglobin, the red blood cells that carry oxygen.

“All of those changes are indirect markers of potentially better health,” said Sublette, a cardiology fellow at the University of Wisconsin, Madison. “It adds greater fuel to the hypothesis that the gut microbiome is really doing something for cardiovascular disease.”

Sublette said researchers also found that people who quit smoking had decreases in some bacteria called firmicutes and increases in others called bacteroides that past studies have shown could be measures for lower risk for diabetes and obesity.

“It’s hard to know exactly yet what that ratio means, because we are very early on in the study of the gut microbiome and cardiovascular disease. But it adds to the overall picture and helps us start to understand this,” he said.

The study was limited by its small patient size and its relatively narrow focus, Sublette said.”We are not digging down to the exact species of bacteria. Rather, we’re looking at larger proportions or ratios of large groups of bacteria.”

Sublette said he plans to do future research in which mice are fed living bacteria from humans.

“If we give the microbiota of both an ongoing smoker and a successful quitter to a sterile mouse, how does that change their atherosclerotic disease progression?”

Dr. Stanley Hazen, director of the Center for Microbiome & Human Health at the Cleveland Clinic, said the study results “hint at the need to take a global view of one’s metabolism, including the gut microbial community within.”

Hazen, who was not involved in the research, said “a change in our environmental exposure impacts the host in many different ways, including shifts in the gut microbial community. What changes occur as a result of smoking cessation is an interesting question that remains to be determined.”

© 2019 HealthDay. All rights reserved.

Posted: November 2019

Drugs.com – Daily MedNews