Could a Vibrating Pill Ease Chronic Constipation?

Cara Murez wrote . . . . . . . . .

A new treatment for chronic constipation may bring relief without having to use drugs.

It’s a vibrating pill called Vibrant that stimulates the colon as it passes through the body.

Although the pill was approved by the U.S. Food and Drug Administration last August, doctors can start prescribing Vibrant this week.

“We are working right now with insurance companies to obtain coverage in commercial plans,” Cathy Collis, chief commercial officer for Vibrant Gastro Inc., told CNN. “But until we get that coverage, our goal and commitment is to make sure that this is accessible and affordable to patients.”

The company had to show the pills contained no toxic materials, could withstand an accidental bite and didn’t carry risk of infections, getting stuck, irritating tissues or interfering with other medical devices, CNN reported.

A person prescribed the pill would take it at bedtime daily. The pill would then travel through the stomach and small intestine before reaching the large intestine about 14 hours later and stimulating nerve cells.

In doing this, it causes muscle contractions that move food out. The pill then leaves the body with the feces.

The pills are made of medical-grade material similar to what gastroenterologists use for pill cameras, CNN reported.

Vibrant is intended for the 10% to 20% of people who live with chronic constipation, having fewer than three bowel movements each week for unknown reasons and typically experiencing hard, painful stools.

To study the pill, 200 people with chronic constipation took Vibrant for eight weeks, while another 149 took a lookalike placebo.

In the group that took the actual Vibrant pills, 40% had at least one additional bowel movement each week, softer stools and less bloating. About 23% had two or more additional bowel movements weekly.

The placebo group also reported more bowel movements, with about 23% experiencing at least one more and 12% at least two or more additional bowel movements.

Still, the vibrations might feel a little funny as it moves through your body.

“A minority could feel it,” Dr. Eamonn Quigley, chief of gastroenterology at Houston Methodist Hospital, told CNN. Quigley helped test the capsules, but he doesn’t have any financial stake in the company. “None of them felt it was being uncomfortable. And none of them stopped taking it because of that.”

While Quigley couldn’t compare the Vibrant capsules to other constipation treatments because they weren’t tested head to head in the study. But he added that the degree of relief seems similar to how prescription drugs for constipation perform.

Side effects appeared to be minimal and reported by more of those in the placebo group than in the vibrating pill group. The pill does not cause diarrhea, which isn’t true of most prescription laxatives.

The pills are authorized to treat adults who have not been helped by other constipation medication or can’t tolerate it. They are not meant for people who have trouble swallowing, have paralysis of the stomach or have a history of bowel obstructions, CNN reported.

While Vibrant isn’t covered by insurance, the company is capping out-of-pocket costs at $69 by offering a coupon, CNN reported.

Source: HealthDay






Sleeping Pills Linked to Higher Risk for Dementia

Alan Mozes wrote . . . . . . . . .

Seniors who frequently take sleeping medications may be raising their risk for developing Alzheimer’s disease, a new study warns.

Sleep medications are one of the most commonly used medications in older adults, the authors say, but their frequent use may not be without harm.

Researchers found that older white adults who said they “often” or “almost always” took sleep aids had a 79% higher chance of developing dementia compared to those who “never” or “rarely” used them.

The connection was only seen among white adults, not Black participants.

In addition, “further studies are needed to confirm whether sleep medications themselves are harmful for cognition in older adults or [if] frequent use of sleep medications is an indicator of something else that links to an increased dementia risk,” said study lead author Yue Leng.

In other words, the investigation “cannot prove causation,” stressed Leng, an assistant professor in the Department of Psychiatry and Behavioral Sciences at the University of California, San Francisco.

Percy Griffin, director of scientific engagement with the Alzheimer’s Association, seconded the thought.

“We do want to be careful,” said Griffin, who wasn’t part of the study. He noted that observational studies of this kind can only identify an association between a “modifiable risk factor” — like medication habits — and dementia risk. “They don’t prove cause and effect,” he said.

For the study, Leng and her team enlisted roughly 3,000 seniors to share their sleep medication routines starting in 1997.

Participants were between 70 and 79 years old, and none had dementia. All lived in Memphis or Pittsburgh. Nearly 6 in 10 were white and 4 in 10 were Black.

Three times over five years all were asked how often they took sleeping aids: never, rarely (once a month or less), sometimes (2 to 4 times a month), often (5 to 15 times a month), or almost always (16 to 30 times a month).

Participants also discussed the quality of their sleep, indicating how frequently they struggled with falling asleep and/or getting up too early in the morning. Routine sleep duration was also noted.

Sleep aids encompassed both over-the-counter and prescription medications. Common over-the-counter options included antihistamines, melatonin and valerian. Prescription meds included antidepressants, antipsychotics, benzodiazepines and so-called Z-drugs such as Ambien (zolpidem).

Overall, 7.7% of the white participants said they took some type of sleep medication often or almost always.

Yet 2.7% of Black participants reported a similar level of routine usage.

Among white and Black participants, frequent usage was highest among women, those struggling with depression and the more highly educated.

The team noted that benzodiazepine use for chronic insomnia — including Halcion (triazolam), Dalmane (flurazepam) and Restoril (temazepam) — was twice as high among white seniors compared with Black seniors. White participants were also seven times more likely to take a Z-drug like Ambien, and 10 times as likely to take the antidepressant trazodone (Desyrel and Oleptro).

After tracking participants for up to 15 years, the researchers found about one-fifth developed dementia.

While white seniors who used sleeping pills frequently faced a 79% higher risk for dementia, that was not the case among Black seniors — and not just because far fewer Black adults took sleeping aids frequently. Those who did use them often appeared to face no higher risk for developing dementia than those who rarely or never took a sleeping med.

Leng said the racial gap her team identified was “surprising to us,” particularly since prior research suggests that Black people generally face a higher risk for developing Alzheimer’s than their white peers.

“One possible explanation could be that Black adults who have access to sleep meds are a selected group of people with high socio-economic status,” which might afford them a mental health leg up that’s protective against dementia, Leng said.

Yet even among white seniors, Leng “wouldn’t say sleep meds ‘boost’ Alzheimer’s disease risk” based on the findings. And her team stressed that “it remains controversial whether sleep medications are good or bad for cognition in the long run.”

It could turn out that certain meds might contribute to dementia risk, while others don’t. Or that having sleep problems — the reason for using sleep meds — is a symptom of dementia onset, Leng suggested.

Both she and Griffin agreed additional research is needed.

“More work needs to be done,” said Griffin. “And we shouldn’t be sounding the alarm bells just quite yet.”

Meanwhile, he offered some cautionary advice: “In general, before anyone takes any sleep medication, or any medication for that matter, they should have a conversation with their doctor to see how it might interact with any other medication they might already be taking.” Their medical history and life story in general should also be considered, he added.

The study results appear online in the Journal of Alzheimer’s Disease.

Source: HealthDay





CDC Warns of Dangerous Infection Risk With EzriCare Eyedrops

Cara Murez wrote . . . . . . . . .

U.S. health officials are investigating whether a specific brand of over-the-counter eyedrops are behind one death and dozens of bacterial infections in several states.

The infections have not been traced to preservative-free EzriCare Artificial Tears, but a majority of people who became ill reported using the drops, the U.S. Centers for Disease Control and Prevention said in a statement.

The agency found the bacteria in bottles of the eyedrops, and it’s now testing to see if the strain found in the eyedrop bottles matches that found in patients.

CDC officials recommended that “patients immediately discontinue the use of EzriCare Artificial Tears until the epidemiological investigation and laboratory analyses are complete.”

At least 50 people in 11 states have been infected with the bacterium Pseudomonas aeruginosa, which is resistant to most antibiotics. One of those infected died after the bacterium entered the patient’s bloodstream.

“That’s what’s so concerning,” Dr. Jill Weatherhead, an assistant professor of tropical medicine and infectious diseases at the Baylor College of Medicine in Houston, told NBC News. “Our standard treatments are no longer available” to treat this infection.

In 11 cases, people developed eye infections. Three were blinded in one eye. Some of those infected had respiratory or urinary tract infections.

P. aeruginosa infections typically happen in hospital settings in people with weakened immune systems, though the bacteria can be found in water and soil. People can also carry it on their hands.

The eyedrops may have been contaminated during manufacturing or as a person with bacteria on their hands opened them. The drops being investigated do not contain preservatives to inhibit the growth of germs, NBC News reported.

Health officials have not said whether those infected had an underlying eye condition that would have made them more vulnerable to infections.

Cases were reported in California, Colorado, Connecticut, Florida, New Jersey, New Mexico, New York, Nevada, Texas, Utah and Washington.

EzriCare Artificial Tears have not been recalled at this time. They were sold on Amazon and at stores such as Walmart, NBC News reported.

Eye infection symptoms include pain and swelling. A person may experience redness, discharge, blurry vision, light sensitivity and the feeling of having a foreign object in the eye.

Source: HealthDay





FDA Approves 2nd Alzheimer’s Drug, Despite Safety Concerns

Ernie Mundell wrote . . . . . . . . .

The U.S. Food and Drug Administration on Friday approved a second Alzheimer’s drug, lecanemab, despite reports of rare brain bleeds linked to use of the drug in some patients.

However, the FDA pointed to the drug’s benefits, as well.

“Alzheimer’s disease immeasurably incapacitates the lives of those who suffer from it and has devastating effects on their loved ones,” Dr. Billy Dunn, director of the Office of Neuroscience in the FDA’s Center for Drug Evaluation and Research, said in an agency news release. “This treatment option is the latest therapy to target and affect the underlying disease process of Alzheimer’s, instead of only treating the symptoms of the disease.”

Lecanemab, made by Eisai and marketed by Biogen as Leqembi, will be only the second Alzheimer’s drug to receive the FDA’s blessing in the past 18 months; the agency’s speedy approval of the drug Aduhelm in June 2021 generated controversy in the medical community over its lack of effectiveness, brain bleed concerns and hefty price tag.

But Alzheimer’s experts said the story is somewhat different with Leqembi.

“Unlike Aduhelm, which had an incomplete data set and where clinical trial data failed to demonstrate a definitive slowing in cognitive decline, lecanemab showed statistically significant slowing in cognitive and functional decline, as well as reduction of brain amyloid levels, and downstream beneficial effects on other markers of neurodegeneration,” Dr. Sarah Kremen, who leads the Alzheimer’s Disease Clinical Trials Program at Cedars-Sinai in Los Angeles, said in a statement.

“We need — and are on the way to having — multiple drugs we can combine to personalize treatments to match each patient’s Alzheimer’s pathology, which will have a much greater impact on slowing the disease,” Dr. Howard Fillit, co-founder and chief science officer of the Alzheimer’s Drug Discovery Foundation, said in a statement.

“Today’s news is incredibly important and a source of optimism not only for patients, but also for the medical and research community,” said Fillit. “It shows us that our years of research into what is arguably the most complex disease humans face is paying off.”

Still, Leqembi has been linked to two deaths from brain bleeds among people who used it in trials.

And not every patient would stand to benefit from Leqembi, stressed the Cleveland Clinic’s Dr. Babak Tousi. He led the portion of the clinical trial that was conducted at the Cleveland Clinic, in Ohio.

“The trial was designed for patients in the earlier stage of Alzheimer’s disease, people with mild cognitive impairment or early stage of dementia,” Tousi noted. “It will probably be for people who have early stage of disease, with no to minimal assistance needed for activities of daily living.”

The results of the 18-month trial, which involved about 1,800 patients, gained wide attention when they were published Dec. 1 in theNew England Journal of Medicine, Tousi noted.

In the trial, early-stage Alzheimer’s patients who took Leqembi showed a 27% reduction in their mental decline compared to patients in the placebo arm of the trial. The drug’s users also showed less evidence of amyloid protein plaques in their brain compared to non-users.

“Lecanemab clearly did what it was designed to do — it removed amyloid plaque,” said Tousi, who heads the Clinical Trials Program at the Cleveland Clinic Center for Brain Health. “The results demonstrated all the downstream effects we hoped would happen in terms of reduction of biomarkers and less clinical decline on several functional and cognitive measures. So, this difference will likely translate to a longer period of independent living for patients.”

Two patient deaths raise questions

Still, the deaths of two patients enrolled in the trial cast a cloud on these hopeful findings. Both died from brain hemorrhages that seem linked to the use of Leqembi.

In one case, a 65-year-old woman with early-stage Alzheimer’s died from a massive brain bleed that some researchers link to Leqembi, according to a report published Nov. 27 in Science Insider.

The woman suffered a stroke, as well as a type of brain swelling and bleeding that’s been previously seen with such antibodies, the report noted.

ER doctors at Northwestern University Medical Center in Chicago treated the woman with a common but powerful clot-busting drug, tissue-plasminogen activator (t-PA). She immediately had substantial bleeding throughout her brain’s outer layer.

“As soon as they put it in her, it was like her body was on fire,” her husband told Science Insider. “She was screaming, and it took like eight people to hold her down. It was horrific.”

The woman died a few days later, the case report said.

The death follows that of an 80-year-old man who was taking part in Leqembi’s phase 3 clinical trial. His death was linked to a possible interaction between the experimental drug and a blood thinner called apixaban (Eliquis).

Rudolph Castellani, a Northwestern neuropathologist who autopsied the woman, determined that she had amyloid deposits surrounding many of her brain’s blood vessels.

The woman had been receiving biweekly infusions of Leqembi, which appears to have inflamed and weakened her blood vessels, Castellani said. These vessels then burst when exposed to the clot-buster, something that can happen even in conventional stroke cases.

“It was a one-two punch,” Castellani told Science Insider. “There’s zero doubt in my mind that this is a treatment-caused illness and death. If the patient hadn’t been on lecanemab, she would be alive today.”

While Eisai declined to comment on the woman’s case, the company did issue a statement saying that “All the available safety information indicates that lecanemab therapy is not associated with an increased risk of death overall or from any specific cause.”

The woman might have received either Leqembi or a placebo during the 18-month trial, but she was definitely given the drug during the month preceding her death. She’d opted to receive it as part of an open-label extension of the clinical trial.

Weakened blood vessels

The woman and the man both had widespread cerebral amyloid angiopathy (CAA), a condition in which amyloid deposits gradually replace the smooth muscle of blood vessel walls.

Nearly half of Alzheimer’s patients have CAA, and many also suffer from heart ailments that are normally treated with blood thinners, the report noted.

Experts explained to Science Insider that in these types of patients, stripping the amyloid away — as drugs like Leqembi are meant to do — could weaken the blood vessels and make them vulnerable to bleeds if exposed to blood thinners or clot busters.

More details on the woman’s case — including autopsy results — were released Wednesday in the New England Journal of Medicine by doctors at Northwestern Medicine in Chicago. The autopsy confirmed extensive brain bleeding and amyloid deposits within many blood vessels.

The Northwestern team believes that exposure to t-PA triggered burst blood vessels throughout the patient’s brain, causing death.

“The extensive number and variation in sizes of the cerebral hemorrhages in this patient would be unusual as a complication of t-PA solely related to cerebrovascular amyloid,” they wrote, but prior use of Leqembi may have tipped the balance, triggering the hemorrhages.

In a journal response to the article Drs. Marwan Sabbagh and Christopher H. van Dyck said they “agree that this case raises important management issues for patients with Alzheimer’s disease.”

But factors other than the patients’ use of Leqembi could have been at play, they pointed out. In the woman’s case, an extended period of very high blood pressure could have been a contributing factor. In the man’s case, a drug he was taking to counter atrial fibrillation might have played a role in the hemorrhaging.

Besides the two fatal cases, the clinical trial also showed that 2.8% of participants who took the drug had a symptomatic side effect called ARIA-E, which involves swelling in the brain. ARIA-E was not seen among any participants who got the placebo.

Risks versus benefits

However, for the millions of Americans affected by Alzheimer’s, any beneficial drug could be welcome.

After Medicare limited its coverage of Aduhelm, citing risks and unclear benefit, the expensive drug was essentially sidelined.

In a statement, Eisai said that it planned to price Leqembi at $26,500 per year. According to The New York Times, that’s somewhat higher than the price range the Institute for Clinical and Economic Review has said would be cost-effective for patients: between $8,500 and $20,600 a year.

Like Aduhelm, Leqembi — given via infusion every two weeks — is a monoclonal antibody that targets amyloid proteins, which tend to clump in the brains of people with Alzheimer’s. Years of research have uncovered precious little evidence that clearing these plaques actually helps with memory and thinking problems. Earlier this month, another anti-amyloid monoclonal antibody, gantenerumab, failed to show any benefit.

For his part, Tousi stressed that Leqembi will not produce a dramatic turnaround in the cognitive health of people with Alzheimer’s disease.

“It is not that you take this medication and your memory gets better,” he said. “It is a newer concept for many patients. It is not treating the symptoms, but it slows down the decline. … It is a small benefit but is still a benefit. The findings are promising when we don’t have any other treatments available.”

Source: HealthDay





New COVID Pill May Be Improvement Over Paxlovid, Chinese Trial Suggests

Cara Murez wrote . . . . . . . . .

COVID-19 patients could soon have a new antiviral pill they can take to guard against severe disease.

The treatment, called VV116, worked as well as Paxlovid in people who were at high risk of severe disease in a phase 3 trial in China.

The trial was a “great success,” study co-author Ren Zhao, a professor at Shanghai Jiao Tong University School of Medicine, said in a news release announcing the results.

Similar to the antiviral infusion remdesivir, but in pill form, VV116 has not yet been approved by the U.S. Food and Drug Administration.

It may first need more study in a larger, diverse group of patients to look for rare side effects and see how it fares against Omicron variants that have emerged since the trial was conducted, medical experts suggested.

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

“You have a medication that looks to be just as good as Paxlovid, but less cumbersome,” Dr. Panagis Galiatsatos, an assistant professor of medicine at Johns Hopkins Medicine in Baltimore, told NBC News.

The trial found fewer reported side effects for patients, with about 67% of people who took it reporting side effects, compared to 77% of those who took Paxlovid, as well as fewer reactions with other medications such as those that treat insomnia, seizures or high blood pressure.

“It looks like we might have another tool in the toolbox,” Galiatsatos noted.

Fewer patients in the trial had elevated levels of triglycerides (fat in blood that increases risk of heart disease or stroke) at 11% compared to 21% with Paxlovid.

Reduced side effects is “a big deal,” Galiatsatos said.

In the VV116 trial, more than 380 people took the medication for about five days. A group of similar size took Paxlovid instead.

The VV116 patients recovered (defined as no symptoms for two consecutive days) four days after starting the treatment. For Paxlovid patients, recovery happened in five days.

About 98% of patients had recovered within four weeks and none developed severe COVID-19, the findings showed.

Though Paxlovid patients sometimes have a rebound of symptoms in the days or weeks after treatment, that doesn’t happen with the infusion remdesivir, which this new pill is similar to, the researchers noted.

Gilead Sciences is testing a similar pill based on its infusion remdesivir, NBC News reported.

Source: HealthDay