Health Highlights: Sept. 26, 2018

Here are some of the latest health and medical news developments, compiled by the editors of HealthDay:

Fish Oil Pill Cuts Heart Dangers for High-Risk Patients

A prescription pill that contains large doses of an omega 3 fatty acid found in fish oil staved off heart attacks and strokes in folks with a history of heart disease or type 2 diabetes.

In the large clinical trial, the results were particularly potent for people with high triglycerides, a blood fat long linked to an increased risk of heart disease, the New York Times reported Monday.

The researchers focused on people whose cholesterol levels were controlled with statins, but whose triglyceride levels were still high. Because many smaller studies had not produced much evidence of any benefit in adding fish oil supplements to statin use, the hopes of heart experts were not high.

But the new trial, to be presented in November at the American Heart Association's annual meeting, showed that these patients saw a 25 percent drop in their relative risk of heart attacks, strokes and other cardiac events compared to a control group of patients who received a placebo.

"I'm very surprised by the magnitude of the results, which quite frankly are large. My expectations were very low. A lot of people are legitimately surprised by this," Dr. Michael Blaha, director of clinical research at the Ciccarone Center for the Prevention of Heart Disease at Johns Hopkins Medical School, told the Times.

"Fish oil has long been a popular supplement to protect against heart disease. It contains high levels of omega-3 fatty acids, primarily EPA and DHA, which reduce inflammation and lower triglyceride levels," explained Blaha, who was not involved in the trial. "Omega-3 fatty acids also have blood-thinning effects similar to those of aspirin."

The new trial differed from previous studies in two aspects, the newspaper reported. First, it focused on a specific group of high-risk patients: People with a history of heart disease, diabetes or heart risk factors. In addition, all of the patients were on statins, which lower cholesterol.

Secondly, Vascepa was not the typical fish oil supplement that can be bought in any drugstore or supermarket. Manufactured by Amarin, Vascepa is a prescription drug that contains highly purified EPA, according to the Times.

Fish oil supplements often contain a mixture of both EPA and DHA and, in some cases, other oils. Both EPA and DHA can lower triglycerides, but DHA also tends to raise "bad" LDL cholesterol, the newspaper said.

In the trial, more than 8,000 patients were followed for about five years, during which the drug was well tolerated and safe, the researchers noted.

Dr. Ethan Weiss, a cardiologist and associate professor at the University of California, San Francisco, told the Times that the findings carried a few caveats. All of the data remains to be seen, and the group of patients most likely to see a benefit is very specific, added Weiss, who was not involved in the study.

Vascepa is now only approved for certain patients who have very high triglyceride levels, the newspaper said.

"The worried well shouldn't run out and take fish oil," said Dr. Michael Shapiro, a site investigator for the trial and director of Oregon Health and Science University's Atherosclerosis Imaging Program.

But, "the amount of people around the world who have atherosclerotic disease or diabetes who take a statin and still have elevated triglycerides is enormous," he said. "This has huge implications."

-----

Critics Demand Stop to 'Guinea Pig' Sepsis Clinical Trial

A major nonprofit advocacy group is asking that a large government trial into the common and dangerous blood infection sepsis be shut down.

The trial, called Clovers, "places seriously ill patients at risk without the possibility of gaining information that can provide benefits either to the subjects or to future patients," according to an analysis of the trial by investigators at the U.S. National Institutes of Health Clinical Center in Bethesda, Md.

And in a letter sent to the federal Office for Human Research Protection, advocacy group Public Citizen compared the study to "an experiment that would be conducted on laboratory animals," The New York Times reported.

"The human subjects of the Clovers trial, as designed and currently conducted, are unwitting guinea pigs in a physiology experiment," Public Citizens' Dr. Michael Carome and Dr. Sidney Wolfe wrote in their letter.

The Clovers trial began in March and is funded by the NIH. It is moving forward and hopes to enroll 2,320 patients from 44 hospitals nationwide.

The scientists behind the study say it seeks to ascertain the best approach to treating sepsis, a major killer. According to the Times, at least 1 million Americans contract the condition annually, and 30 percent of them will die.

Sepsis occurs when the body's immune system mounts a massive attack against an infection, triggering inflammation throughout the body. Sepsis is typically first treated with antibiotics, but the condition can progress and cause lethal blood clots or organ failure.

The Clovers trial seeks to determine which one of two therapeutic options -- limiting fluids and using drugs that narrow blood vessels, or adding IV fluids and holding off on drug therapy -- works best to curb sepsis.

But critics claim participants enrolled in Clovers could end up being given substandard care, endangering their lives.

For example, patients might see delays in the time it takes to receive fluids, and since sepsis progresses rapidly (often within 24 hours), such delays could prove fatal, Public Citizen says.

But the scientists behind Clover say those fears are unfounded, and that because sepsis care varies widely, in essence every Clover participant will still receive "usual care."

Individual participants will also be allowed to deviate from study protocols if deemed necessary to preserve their health, added Dr. Nathan Shapiro, a professor of emergency medicine at Harvard Medical School and co-chairman of the protocol committee for the study.

"If the physician at the bedside thinks the patient needs a specific treatment, they will get it," Shapiro told the Times.

One expert not connected to the study believes more insight into proper sepsis care is needed.

"There is not a lot of data about how much fluid to give, how much is enough, how much is too much, how much is too little," said Dr. Tiffany Osborn, an emergency physician and critical care specialist who spoke to the Times on behalf of the College of Emergency Medical Physicians. "That information is hard to get a handle on."

But Public Citizen's Carome believes that Clovers' methodology is simply too dangerous for participants. Speaking to the Times, he said, "We think Clovers can't be fixed."