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Experimental drug shows promise against ALS



An experimental treatment may help slow the progression of the deadly brain disease amyotrophic lateral sclerosis, or ALS, a new study finds.

Researchers called the results a promising step in the fight against a devastating and invariably fatal disease. And two advocacy groups are calling for swift action to make the drug available to patients.

ALS is also known as Lou Gehrig’s disease in memory of the baseball legend who died from the disease. It’s a progressive condition that kills nerve cells in the brain and spinal cord. Eventually, all muscles controlling voluntary movement become impaired, so that people lose their ability to move, talk, eat and breathe.

Most people with ALS die of respiratory failure within three to five years of their first symptoms, according to the U.S. National Institutes of Health.

There are currently two ALS medications approved in the United States. They can slow the disease course, but only marginally.

One drug, called riluzole, can extend patients’ lives by an average of a few months, said Dr. Sabrina Paganoni, the lead researcher on the new trial.

That’s a good thing, but clearly not enough, said Paganoni, of the Healey and AMG Center for ALS at Massachusetts General Hospital, in Boston.

So Paganoni and her colleagues tested a new medication — a combination of two existing drugs that have individually been studied for ALS. They found that when it was added to patients’ standard medication, it further delayed their progression over six months.

“The benefit they found was on top of the current standard of care,” said Kuldip Dave, vice president of research for the ALS Association. “That’s one reason I think these results are robust.”

And since the two drugs in the combination are not new, Dave said, there is already a good amount of information on their safety.

One medication — sodium phenylbutyrate — was approved in the 1990s by the U.S. Food and Drug Administration for treating a rare disorder where ammonia builds up in the body.

The other, called tauroursodeoxycholic acid, is used in some countries to treat gallstones. It’s also available as a dietary supplement.

Lab research has shown that the two drugs together can protect nerve cells from death. And drugmaker Amylyx Pharmaceuticals, of Cambridge, Mass., is now developing the combination as a treatment for both ALS and Alzheimer’s disease.

The current trial, partly funded by Amylyx, included 137 ALS patients at 25 U.S. medical centers. Eighty-nine patients were randomly assigned to take the drug — dubbed AMX0035 — every day for 24 weeks. The other 48 patients were given a placebo (inactive treatment). All stayed with their standard medications as well.

By the end, patients on AMX0035 were doing better than placebo patients on a scale that measures physical function — such basics as walking, speaking, dressing, writing and using utensils.

On average, AMX0035 patients declined at a slower rate, for a difference of about 2.5 points on a scale of 0 to 48.

“Even that small difference can be meaningful in daily life,” said Paganoni.

It could, for example, mean the difference between being able to write or not, she said.

The drug did have side effects, mostly nausea, diarrhea and abdominal pain. Those problems prompted 19% of patients to stop taking it.

The ALS Association, which also helped fund the trial, is calling for the drugmaker and the FDA to “move with urgency” to make the drug available.

The group, along with the nonprofit I AM ALS, urged Amylyx to submit an application for FDA approval — and to make AMX0035 available through the agency’s “compassionate use” program until the drug comes to market.

Progress has long been hard to come by in ALS. The underlying biology of the disease is complicated, Paganoni explained, and it appears to injure nerve cells through multiple mechanisms.

And no two people with ALS are the same. “This disease is heterogeneous,” Dave said. “Every person with ALS is different. Their progression is different.”

The two drugs in AMX0035, Paganoni said, target two separate, basic mechanisms that kill neurons. The hope is that it will better protect the cells than current medications can on their own.

A big unknown is whether the drug can help extend ALS patients’ lives. Paganoni said more answers will come soon: After this trial ended, all patients were offered AMX0035 treatment and are being followed.

Paganoni and Dave pointed to the bigger picture, as well. After years of little progress, numerous trials are testing various treatment approaches to ALS — from drugs to stem cells.

“There is hope,” Paganoni said. “I’m convinced we’re in a new era of ALS research.”

The study was published in the Sept. 3 issue of the New England Journal of Medicine.

More information

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

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People who don’t believe in God may get better sleep, study says



Atheists and agnostics are much more likely to sleep like an angel than Catholics and Baptists, a new study finds.

It included more than 1,500 participants in the Baylor University Religion Survey who were asked about their religious affiliation, behaviors and beliefs, as well as their average nightly sleep time and difficulty getting to sleep.

While 73% of atheists and agnostics said they got seven or more hours of nightly sleep, only 63% of Catholics and only 55% of Baptists said they got at least seven hours of sleep a night, preliminary data show.

Seven or more hours of sleep a night is recommended by the American Academy of Sleep Medicine, or AASM, for good health.

Catholics and Baptists were also more likely to report having difficulty falling asleep than atheists and agnostics.

Study participants who said they slept seven or more hours per night were much more likely to believe that they would get into heaven, compared to those who got less sleep.

However, beliefs about getting into heaven weren’t linked with difficulty falling asleep at night.

The researchers said that better sleep results in a more optimistic outlook and that in this study, that manifested as people believing they’d get into heaven.

“Mental health is increasingly discussed in church settings — as it should be — but sleep health is not discussed,” said study author Kyla Fergason, a student at Baylor University in Waco, Texas.

“Yet we know that sleep loss undercuts many human abilities that are considered to be core values of the church: being a positive member of a social community, expressing love and compassion rather than anger or judgment, and displaying integrity in moral reasoning and behavior,” Fergason said in AASM news release.

“Could getting better sleep help some people grow in their faith or become better Christians? We don’t know the answer to that question yet, but we do know that mental, physical and cognitive health are intertwined with sleep health in the general population,” she noted.

The findings were recently published in an online supplement of the journal Sleep, and were presented last week at the virtual annual meeting of the Associated Professional Sleep Societies.

More information

The National Sleep Foundation has more on sleep.

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Some COVID-19 survivors may have permanent nerve damage



Placing a hospitalized COVID-19 patient in a face down position to ease breathing — or “proning” — has steadily gained traction as a pandemic lifesaver. But a small new study warns that it may lead to permanent nerve damage.

The concern is based on the experience of 83 COVID-19 patients who were placed face down while attached to a ventilator. Once they improved, all began post-COVID-19 rehabilitation at a single health care facility.

By that point, roughly 14% had developed a “peripheral nerve injury” (PNI) involving one or more major joints, such as the wrist, hand, foot or shoulder.

Despite that damage, study author Dr. Colin Franz said proning “is a lifesaving intervention, and we think it is saving lives during the COVID pandemic.”

And although placing patients face down has been known to cause skin pressure injuries in non-COVID-19 patients, he said nerve compression injuries are typically uncommon with regular repositioning and careful padding.

“So we were very surprised to find 12 out of 83 patients with nerve injuries,” said Franz, neurology director of the Regenerative Neurorehabilitation Laboratory at Northwestern University Feinberg School of Medicine, in Chicago.

He characterized the nature of the nerve damage as so severe that affected patients were “unlikely to fully recover.”

The damage included loss of hand function, frozen shoulder and foot dragging that may lead to a need for a brace, cane or wheelchair.
“Full recovery for nerve damage is estimated to occur in only about 10% of patients under the best of circumstances,” Franz explained. “And the recovery that does take place will happen over 12 to 24 months.”

In other words, the nerve damage might be the longest-lasting effect of COVID-19 for most of these patients, he suggested. And if the risk seen among the study group is any indication, thousands of patients worldwide could have the same damage, Franz said.

Franz noted that some, but not all, of the patients had pre-existing conditions such as diabetes that made them more likely to have nerve injuries from compression. Many of the patients were also old or obese.

But he and his colleagues suspect something about COVID-19 infection itself makes nerves more vulnerable to damage. Among the possible triggers: the increased inflammatory state brought on by SARS-CoV-2, the virus that causes COVID-19, as well as poor blood circulation and blood clotting.

Prone-triggered PNI may also result from “the way patients are positioned and the weight it may put on certain nerves for prolonged periods of time,” said Dr. Armeen Poor, an attending physician of pulmonary critical care medicine at Metropolitan Hospital Center in New York City, who reviewed the findings.

Another possible contributor: overworked hospital staff.

During the height of the pandemic, said Poor, “many hospitals were proning more patients at a time than usual. This excess strain on staff could have compromised the frequency of careful patient repositioning while prone, and potentially increased the risk of nerve injury.”

Dr. Nicholas Caputo, an associate chief and attending emergency physician at Lincoln Medical and Mental Health Center, Bronx, N.Y., also reviewed the findings. He said it’s important to recognize that this study focused only on patients proned while on a ventilator.

But, he noted, proning has been successfully deployed among non-ventilated patients, often in hopes of staving off ventilation. Such “self-proning” patients are awake and “instructed to change positions if they become uncomfortable.”

In the intensive care unit, however, ventilated patients are generally proned for eight to 12 hours before being turned, Caputo said. “This puts much more pressure on certain areas of the body, and places the patients at risk for complications such as peripheral neuropathies,” he added.

Hoping to reduce prone-linked PNI risk among intubated patients, Franz’s team has been “mapping” regions most vulnerable to nerve damage. That information could help doctors, nurses and physical therapists deploy modified positioning, extra padding and protection of vulnerable areas. Wearable sensors could be used to “measure and monitor [the] loading of nerves,” he said.

“In medicine we focus on ‘ABCs’ — airway, breathing and circulation — when there is an emergency,” Franz said. “Intubation and proning positioning fall within these categories and save lives. This is always the first priority. We do think these added measures will help prevent these nerve injuries, however.”

The findings have not yet been peer-reviewed but were reported online recently in medRxiv in advance of publication in The British Journal of Anaesthesia.

More information

Learn more about COVID-19 and proning at the University of Pennsylvania.

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Blood pressure meds don’t increase cancer risk, study finds



Blood pressure drugs don’t increase the risk of cancer, according to the largest study to examine the issue.

A possible link between blood pressure drugs and cancer has been the subject of debate for decades, but evidence has been inconsistent and conflicting.

For this study, researchers analyzed data from 31 clinical trials of blood pressure drugs that involved 260,000 people. Investigators of all the trials provided information on which participants developed cancer. Much of this information hasn’t been published before, so the new study is the most detailed to date.

It looked at five blood pressure drugs separately: angiotensin-converting enzyme, inhibitors, angiotensin II receptor blockers, beta blockers, calcium channel blockers, and diuretics.

The researchers estimated the effect of each drug class on the risk of developing any type of cancer, of dying from cancer, and of developing breast, colon, lung, prostate and skin cancers.

The study found no evidence that any of the drug classes increased cancer risk. That was true regardless of participants’ age, gender, body size, smoking status and previous use of blood pressure medication, according to findings presented recently at an online meeting of the European Society of Cardiology.

Research presented at meetings is typically considered preliminary until published in a peer-reviewed journal.

There was no indication that cancer risk rose with longer use of blood pressure drugs.

“Our results should reassure the public about the safety of antihypertensive drugs with respect to cancer, which is of paramount importance given their proven benefit for protecting against heart attacks and strokes,” said study author Emma Copland, an epidemiologist at the University of Oxford in the U.K.

More information

The American Heart Association has more on blood pressure medications.

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