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Can’t take statins? Try this new pill

Drugs known as statins are the first-choice treatment for high cholesterol, but millions of people who can’t or won’t take those pills because of side effects may have another option.

In a major study, a different kind of cholesterol-lowering drug named Nexletol reduced the risk of heart attacks and some other cardiovascular problems in people who can’t tolerate statins, researchers reported in early March.

Statins remain “the cornerstone of cholesterol-lowering therapies,” stressed Dr. Steven Nissen of the Cleveland Clinic, who led the study.

But people who can’t take those proven pills “are very needy patients; they’re extremely difficult to treat,” he said. This option “will have a huge impact on public health.”

Too much so-called LDL or “bad” cholesterol can clog arteries and lead to heart attacks and strokes.

Statin pills like Lipitor and Crestor (or their cheap generic equivalents) are the mainstay for lowering LDL cholesterol and preventing heart disease or treating those who already have it. They work by blocking some of the liver’s cholesterol production.

But some people suffer serious muscle pain from statins. While it’s not clear exactly how often that occurs, by some estimates, 10% of people who’d otherwise qualify for the pills can’t or won’t take them. They have limited options, including pricey cholesterol-lowering shots and another kind of pill sold as Zetia.

Nexletol also blocks cholesterol production in the liver but in a different way than statins and without that muscle side effect.

The new five-year study tracked nearly 14,000 people who were unable to tolerate more than a very low dose of a statin. Half got daily Nexletol and half a dummy pill.

The main finding: Nexletol-treated patients had a 13% lower risk of a group of major cardiac problems. Then researchers teased apart those different conditions and found a 23% reduced risk of a heart attack, the biggest impact.

The drug also cut by 19% procedures to unclog arteries. There wasn’t a difference in deaths, which researchers couldn’t explain but said might require longer to detect.

The data was published in the New England Journal of Medicine and presented in March at a meeting of the American College of Cardiology. The study was funded by Nexletol maker Esperion Therapeutics.

The results are “compelling,” Dr. John H. Alexander of Duke University, who wasn’t involved with the study, wrote in the journal. They “will and should” spur the use of the drug by patients unwilling or unable to take statins.

“It is premature, however, to consider bempedoic acid as an alternative to statins,” he cautioned. “Given the overwhelming evidence of the vascular benefits,” statins remain the top choice for most patients.

—Lauran Neegaard, AP

Prostate cancer treatment can wait for most men

Researchers have found long-term evidence that actively monitoring localized prostate cancer is a safe alternative to immediate surgery or radiation.

The results are encouraging for men who want to avoid treatment-related sexual and incontinence problems, said Dr. Stacy Loeb, a prostate cancer specialist who was not involved in the research.

The study directly compared the three approaches — surgery to remove tumors, radiation treatment and monitoring. Most prostate cancer grows slowly, so it takes many years to look at the disease’s outcomes.

“There was no difference in prostate cancer mortality at 15 years between the groups,” Loeb said. And prostate cancer survival for all three groups was high — 97% regardless of treatment approach. “That’s also very good news.”

The results were published in March in the New England Journal of Medicine and presented at a European Association of Urology conference in Milan, Italy. Britain’s National Institute for Health and Care Research paid for the research.

Men diagnosed with localized prostate cancer shouldn’t panic or rush treatment decisions, said lead author Dr. Freddie Hamdy of the University of Oxford. Instead, they should “consider carefully the possible benefits and harms caused by the treatment options.”

A small number of men with high-risk or more advanced disease do need urgent treatments, he added.

Researchers followed more than 1,600 U.K. men who agreed to be randomly assigned to get surgery, radiation or active monitoring. The patients’ cancer was confined to the prostate, a walnut-sized gland that’s part of the reproductive system.

Men in the monitoring group had regular blood tests, and some went on to have surgery or radiation.

Death from prostate cancer occurred in 3.1% of the active-monitoring group, 2.2% in the surgery group, and 2.9% in the radiation group, differences considered statistically insignificant.

At 15 years, cancer had spread in 9.4% of the active-monitoring group, 4.7% of the surgery group and 5% of the radiation group. The study was started in 1999, and experts said today’s monitoring practices are better, with MRI imaging and gene tests guiding decisions.

“We have more ways now to help catch that the disease is progressing before it spreads,” Loeb said. In the U.S., about 60% of low-risk patients choose monitoring, now called active surveillance.

Hamdy said the researchers had seen the difference in cancer spread at 10 years and expected it to make a difference in survival at 15 years, “but it did not.” He said spread alone doesn’t predict prostate cancer death.

“This is a new and interesting finding, useful for men when they make decisions about treatments,” he said.

—Carla K. Johnson, AP