Brain Bleed Risk Puts Safety of Low-Dose Aspirin in Doubt

Amy Norton wrote . . . . . . . .

Let’s say you’re one of the millions of older adults who takes a low-dose aspirin religiously, in the belief that it will guard against heart disease and heart attacks.

Now, a new review suggests your risk of a brain bleed outweighs any heart benefit that a daily aspirin might bring you.

Researchers said the findings support a recent change to guidelines on low-dose aspirin: The blood thinner should now be reserved for people at high risk of heart attack or stroke.

Others can skip it.

The change was issued in March by the American College of Cardiology (ACC) and the American Heart Association (AHA). The groups said that while the bleeding risk with aspirin has always been known, it now appears the risk is not worth it for most people.

Instead, the average person should focus on controlling their blood pressure, blood sugar and cholesterol, eating a healthy diet, getting regular exercise and not smoking.

“All of those things are more important than taking low-dose aspirin in preventing future heart attacks and strokes,” said Dr. Meng Lee, one of the authors of the new report.

“Our findings do support the latest change to the ACC/AHA guidelines,” said Lee, of Chang Gung University College of Medicine, in Taiwan.

For the study, the investigators pooled the results from 13 clinical trials testing low-dose aspirin in older adults with no history of heart problems or stroke. On average, aspirin raised the risk of bleeding in or around the brain by 37%, the findings showed.

The risk was still small: The researchers estimate that a daily aspirin would cause an additional two brain bleeds for every 1,000 people.

But for people at lower risk of heart attack or stroke, that’s a chance they probably should not take, according to the new guidelines.

And, based on two trials, people of Asian ethnicity might be at particular risk of brain bleeding. Patients in those studies saw their risk rise by 84%.

It’s not clear why, according to Lee — but other studies have found the same pattern.

The latest finding was published online in JAMA Neurology.

If it has long been known that aspirin carries a bleeding risk, why is the advice changing now?

Research in recent years has shown that the balance of risks versus benefits has changed, explained Dr. Eugene Yang, a member of the ACC’s Prevention Section and Leadership Council.

Earlier studies did suggest that the bleeding risks with aspirin were generally outweighed by its ability to curb the odds of a first-time heart attack and stroke.

But things are different today, Yang explained. People are smoking less and there have been improvements in controlling high blood pressure and cholesterol. That means for lower-risk people, the heart benefit of aspirin has diminished — making the bleeding risk more of a concern.

Yang stressed, however, that the guideline change applies only to people without “overt” cardiovascular disease. For people with a history of heart attack or stroke, or significant narrowing in the arteries supplying the heart, brain or legs, the advice stays the same.

“In those cases, you’re trying to prevent further complications,” said Yang, who is also a clinical associate professor of medicine at the University of Washington, in Seattle.

In addition, he pointed out, aspirin is not an absolute “no” for preventing first-time complications, either.

The guidelines say people over age 70 should avoid aspirin if they do not have overt cardiovascular disease. But it may still be considered for certain people ages 40 to 70 who are at heightened risk of cardiovascular complications.

“It’s not a simple, black-and-white decision,” Yang said.

If you are currently taking aspirin and wondering if you should stop, talk to your doctor first, Yang advised.

“There could be other reasons it was prescribed, such as lowering the risk of colon cancer or to prevent blood clots,” he said.

Source: HealthDay


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CBD — It’s Everywhere, But Does It Work?

Dennis Thompson wrote . . . . . . . . .

You would have to be living in a cave to have missed the CBD craze that is sweeping across America: New products are cramming store shelves as the market explodes for what many Americans believe to be a miracle cure-all.

Everything from oils to gummies to pills, creams and ointments are now for sale at supermarkets and specialty chains. You can even get massages infused with CBD, or cosmetics laced with the drug.

All of these products contain cannabidiol but not THC, the ingredient in pot that provides a “high.” But what do scientists really know about the health benefits and risks of CBD?

Precious little, experts say, and consumers should take care that they aren’t wasting their money.

“You have a flood of CBD products that are coming from hemp that are going out onto the market, and you’ve got all sorts of claims being made about those from people are trying to sell them,” said Timothy Welty, chair of the department of clinical sciences at Drake University’s College of Pharmacy and Health Sciences, in Des Moines, Iowa.

The flood of CBD products has become so overwhelming that the U.S. Food and Drug Administration recently stepped into the fray.

The agency has whipped out a flurry of warning letters to companies marketing CBD products, telling them to stop making unfounded health claims for the substance.

Companies have falsely claimed that CBD can stop cancer cells, slow the progression of Alzheimer’s disease, ease nerve pain and fibromyalgia, and curb withdrawal symptoms for people undergoing substance abuse treatment, the FDA letters state.

What started the craze?

The agency will hold a public hearing on May 31 regarding CBD products and their safety, and it has formed a working group to consider new laws and regulations to govern this Wild West market.

CBD products have swamped the market not because of any new medical evidence, but because of a change in federal law, Welty noted.

Late last year, Congress passed a farm bill that lifted a decades-old ban on growing hemp. As long as the plant contains less than 0.3% THC, hemp can be grown legally anywhere in the United States by licensed farmers.

The bill specifically said the U.S. Drug Enforcement Agency cannot regulate hemp products like CBD, Welty said. So, it’s now up to the FDA to regulate the CBD craze.

The body contains a system of receptors that respond to the compounds in marijuana, including both THC and CBD, noted Dr. David Copenhaver, director of cancer pain management and supportive care for the University of California, Davis Health Center.

Because of this, researchers have been highly interested in the potential benefits of CBD regarding a number of different health problems.

Little evidence of medical benefits

To date, there’s only one use for CBD that has significant scientific evidence behind it — curbing the symptoms of rare forms of epilepsy.

The FDA last year approved the drug Epidiolex to treat two forms of childhood epilepsy. The medical evidence has shown that the highly purified CBD in Epidiolex can ease seizures.

For the rest of CBD’s potential uses, there is simply too little evidence to make a firm conclusion.

The next potential medical use for CBD could be for the symptoms of anxiety disorder, said Welty and Yasmin Hurd, chair of translational neuroscience and director of the Addiction Institute at Mount Sinai.

Clinical trials suggest that CBD could help treat anxiety, but Welty feels there needs to be more study. Hurd is slightly more convinced, but agrees more study is needed.

“There is published evidence that CBD does decrease anxiety,” Hurd said. “That’s another indication where I can say I can believe the data; however, we still don’t know the dosing regimen that would be effective for anxiety. Those are studies that are ongoing.”

Other uses — as an anti-inflammatory, an aid for substance withdrawal, a sleep aid, a pain reliever — haven’t been conclusively proven.

In some cases, the evidence runs counter to what people might suspect.

There’s not much reason to believe CBD would be an effective means of pain relief, said Dr. Ajay Wasan, vice chair for pain medicine at the University of Pittsburgh Medical Center.

“If you think of it as a medicine, it would be a weak analgesic,” Wasan said. “It’s really the THC component of medical marijuana which is the compound that gives you pain relief.”

Possibility of harm

CBD might actually make the eye disease glaucoma worse, according to a study published last December in the journal Investigative Ophthalmology & Visual Science.

Researchers found that CBD eye drops increased ocular pressure in mice, even as THC appeared to reduce pressure — which might explain why medical marijuana has had mixed results when it comes to studies on glaucoma treatment.

“I’ve been surprised how much CBD has taken off and exploded with very little data,” Wasan said. “Most of the other herbal supplements, there are at least some studies on it before it becomes really popular. But for this, I haven’t seen anything.”

The bottom line, researchers said, is that people who want to try CBD for one reason or another should talk with their doctor first. Welty noted that Epidiolex can be put to “off-label” use for other conditions if a doctor feels it might work.

Besides that, consumers might consider buying CBD products from a state-run program. Some states like Iowa have established such programs to make CBD available medicinally, Welty said.

“Those products are more reliable, because they have a system to monitor the purity of content,” Welty said. “You’re a little more sure that you’re getting what you’re paying for.”

Many unregulated products

Welty is much less sure of the “artisanal products” containing CBD that are available in stores and dispensaries, and for good reason — studies have shown that most of these products fail tests for content and purity.

A 2017 study concluded that nearly 7 of 10 CBD products didn’t contain the amount of cannabidiol promised on the label, according to findings published in the Journal of the American Medical Association.

Nearly 43% of the products contained too little CBD, while about 26% contained too much. Worse, about 1 in 5 CBD products contained the intoxicating pot chemical THC.

“The CBD products that come through that route, there’s essentially no control, and you as a consumer have no way to know what you’re getting,” Welty said.

Copenhaver believes other legitimate uses for CBD could be found, but it will require a more extensive knowledge of the way the human body responds to marijuana’s different compounds.

People might do best to wait until the dust settles regarding the medical evidence, rather than being caught up in the CBD craze, Hurd said.

“It’s like we do this every 30 years or so,” Hurd said. “We romanticize something, that this is going to be the cure-all for every disorder. We’ve never found that.”

Source: HealthDay


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Acetaminophen Safe For Most Older Adults—But May Increase Stroke Risk For Those With Diabetes

Acetaminophen (otherwise known by brand names such as Tylenol) is one of the most widely used pain relievers. Almost 60 years of widespread use have made acetaminophen a household product. It’s distributed over the counter (OTC) in most countries and judged safe by the scientific community. However, acetaminophen is also one of the most common medications involved in overdoses (the medical term for taking more of a medicine than you should) and is the most common cause of drug-induced liver failure.

Surprisingly, we are only now coming to understand how acetaminophen works—and recent research shows that we may need to develop a better understanding of the need for caution when using acetaminophen, especially when it comes to avoiding some of the risks associated with its use. Past research suggests these can range from increased asthma to interactions with other medications or the risk for developing other health concerns (such as kidney toxicity, bone fractures, or blood cancers).

Another important reason to look more carefully at all medications is that our bodies may react to these treatments differently as we age. Older adults experience physical changes as they age including, for example, reduced muscle mass, more fat tissue, changes in body composition, and less fluid in the body systems. Older people may also have multiple chronic conditions and take several different medications. These issues affect many different body functions, and that can raise your risk of having an unwanted reaction to a medication.

For all these reasons, a team of researchers decided to study the safety of acetaminophen in a nursing home setting. Their study was published in the Journal of the American Geriatrics Society.

The researchers’ aim was to explore any connection between acetaminophen use, death, and major heart events such as strokes and heart attacks in a large group of older adults living in nursing homes in southwestern France.

The researchers used information from the IQUARE study, which relied on two different questionnaires completed online by nursing home staffers. The researchers looked at deaths, heart attacks, and strokes that took place during the 18 months of the study period.

Of the 5,429 participants in the study, 3,190 were not taking acetaminophen and 2,239 were taking acetaminophen. Participants were around 86 years old and 74 percent were women.

The researchers reported that acetaminophen did not affect the number of heart attacks the participants experienced. There also was no increase in overall deaths.

The researchers found that the number of strokes was about the same in both groups—about 5 percent of the people who took acetaminophen had strokes, while about 4 percent of those who did not take acetaminophen had strokes. However, in participants who had diabetes, there was a slightly higher risk for stroke among people who took acetaminophen.

The researchers concluded that acetaminophen is a safe first choice in pain management for most older adults but should be considered with a bit more caution for older adults with diabetes.

As the population gets older and frailer, studies need to focus on the safety of the drugs these frail older adults commonly use to better our practice, said the researchers.

“My personal message to the people in my everyday practice is that any drug they take may have some form of harmful side effect unknown to them, even those they can buy over the counter. It is always best to check with your health care provider before you take any new medication, and make sure you’re taking the dose that’s right for you,” said study author Philippe Gerard, MD.

Source: Health In Aging


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Study: Drug Reduces Risk of Kidney Failure in People with Diabetes

Amy Jeter Hansen wrote . . . . . . . . .

Canagliflozin, a drug approved to lower glucose levels in diabetic patients, can slow the progression of kidney disease, according to a study co-authored by a Stanford Medicine researcher.

A new landmark clinical trial shows that a drug lowers the risk of kidney failure by a third in people with Type 2 diabetes and kidney disease.

“For the first time in 18 years, we have a therapy for patients with Type 2 diabetes and chronic kidney disease that decreases kidney failure,” said Kenneth Mahaffey, MD, professor of medicine at the School of Medicine and co-principal investigator of the trial. “Now, patients with diabetes have a promising option to guard against one of the most severe risks of their condition.”

The trial involved 4,401 participants in 34 countries.

The drug, canagliflozin, improves on a nearly two-decades-old therapy that is currently the only treatment approved to protect kidney function in people with Type 2 diabetes. In the trial, canagliflozin also was found to reduce the risk of major cardiovascular events.

Canagliflozin increases the excretion of glucose through the kidneys. It has already been approved by the Food and Drug Administration to lower blood glucose in patients with Type 2 diabetes and to reduce the risk of major adverse cardiovascular events in patients with Type 2 diabetes and existing heart disease.

A paper describing the findings of the CREDENCE trial was published April 14 in The New England Journal of Medicine and presented at the International Society of Nephrology’s World Congress of Nephrology in Melbourne. Mahaffey, who is director of the Stanford Center for Clinical Research, is the study’s senior author. The lead author is Vlado Perkovic, MBBS, PhD, executive director of The George Institute for Global Health Australia, and a professor of medicine at the University of New South Wales in Sydney.

‘Definitive trial result’

“People with diabetes and kidney disease are at extremely high risk of kidney failure, heart attack, stroke and death,” Perkovic said. “With this definitive trial result, we now have a very effective way to reduce this risk using a once-daily pill.”

Participants in the trial received the best care available for kidney disease under current guidelines, a type of therapy called renin-angiotensin-aldosterone system, or RAAS, blockade. In addition, half were randomly selected to receive canagliflozin, while the other half were given a placebo.

The primary results of the study found that participants who took canagliflozin were 30 percent less likely than the placebo group to develop kidney failure or die from either renal failure or cardiovascular disease. Their risk of kidney failure or death from kidney failure was reduced by 34 percent, and the risk of hospitalization for heart failure or death due to cardiac causes decreased by 31 percent.

‘Eagerly sought’ treatment

People with diabetes can develop kidney disease because prolonged high blood sugar harms blood vessels in the kidney. In addition, diabetes often causes high blood pressure, which can stretch and weaken blood vessels in the organ.

For the past two decades, physicians have largely relied on RAAS blockade to prevent the deterioration of kidney function in diabetic patients. Although RAAS blockade lowers blood pressure and delays progression of kidney disease, patients undergoing this treatment remain at a high risk for renal failure and cardiovascular disease, as well as death from these conditions.

Given that the number of people with Type 2 diabetes worldwide is estimated to rise by 20 percent to 510 million in 2030, “a drug like canagliflozin that improves both cardiovascular and renal outcomes has been eagerly sought by both patients with Type 2 diabetes and clinicians caring for them,” Mahaffey said.

Source: Standford School of Medicine


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Statins Safe and Likely Effective for Preventing Cardiovascular Events in Patients with Rheumatoid Arthritis

Results from a large clinical trial indicate that patients with rheumatoid arthritis are likely to experience the same level of cardiovascular benefits from statins as other individuals, without additional risks. The findings appear in Arthritis & Rheumatology, an official journal of the American College of Rheumatology.

Patients with rheumatoid arthritis have an approximately 50 percent higher risk of experiencing cardiovascular events such as heart attack and stroke compared with the general population. By lowering LDL cholesterol, statins are known to help prevent cardiovascular events in certain high-risk individuals, but it’s unclear whether they are safe and effective for patients with inflammatory conditions such as rheumatoid arthritis.

To investigate the potential risks and benefits of statins in moderate risk patients with rheumatoid arthritis, researchers designed the Trial of Atorvastatin for the Primary Prevention of Cardiovascular Events in Patients with Rheumatoid Arthritis (TRACE RA), a multi-center, randomized, double-blind trial comparing the statin atorvastatin with placebo.

The trial included 3,002 patients with rheumatoid arthritis who were over aged 50 years or had rheumatoid arthritis for more than 10 years, without clinical atherosclerosis, diabetes, or myopathy. Patients were randomized to receive atorvastatin 40mg daily or placebo.

During a median follow-up of 2.5 years, 1.6 percent of patients who received atorvastatin and 2.4 percent of patients receiving placebo experienced cardiovascular death, heart attack, stroke, transient ischemic attack, or any arterial revascularization. After adjustments, there was a 40 percent lower risk of cardiovascular events for patients taking atorvastatin, although the difference was not statistically significant. This was because the overall rate of events was low.

At the end of the trial, patients taking atorvastatin had significantly lower LDL cholesterol as well as significantly lower levels of C-reactive protein, a marker of inflammation, compared with patients taking placebo. Adverse events in the atorvastatin and placebo groups were similar.

The paper’s lead author is Professor George Kitas of Dudley Group NHS Foundation Trust, while co-senior authors are Professor Jill Belch of the University of Dundee and Professor Deborah Symmons of the University of Manchester.

“The trial found that the statin reduced levels of cholesterol by similar amounts as has been seen in other populations studied. The results also show that it is as safe for patients with rheumatoid arthritis to take statins as for the general population,” said Prof. Symmons. “In addition, because of the low overall rate of cardiovascular events in the trial population, there is no indication for all patients with rheumatoid arthritis to be prescribed a statin. This is unlike diabetes where the great majority of patients are recommended to take a statin.”

The study authors recommend that patients with rheumatoid arthritis be prescribed statins according to national or local guidelines for managing cardiovascular risk in the general population.

Source: Wiley


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