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Home Science & Environment Medical Research

When statins aren’t enough, this drug may help lower ‘bad’ cholesterol

May 8, 2025
in Medical Research
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by I. Edwards

When statins aren't enough, this drug may help lower 'bad' cholesterol

A new drug combo lowers “bad” LDL cholesterol for people whose levels remain high even after taking statins. The new pill pairs a new drug called obicetrapib with an existing one, ezetimibe. In a Phase 3 clinical trial, this combo reduced LDL levels by nearly 49% over about three months, according to Cleveland Clinic researchers.

The results were presented on Wednesday at the European Atherosclerosis Society meeting in Glasgow, Scotland, and simultaneously published in The Lancet.

“High LDL is one of the leading risk factors for heart disease, and we have such a poor handle on controlling that risk,” Dr. Corey Bradley, a cardiologist at Columbia University, told NBC News. “Many people have such a high LDL they will require multiple agents to control it.”

The trial included 407 people with an average age of 68. Even though they were taking cholesterol-lowering medications, everyone had LDL levels above 70 mg/dL. Researchers divided participants into four groups: One took the combo pill; two groups took each drug separately; and another group took a placebo. All participants continued their usual cholesterol medications.

Dr. Ashish Sarraju, a preventive cardiologist at the Cleveland Clinic, led the study.

“We need to give patients and their doctors all the options we can to try to get LDL under control if they are at risk for—or already have—cardiovascular disease,” Sarraju said. “In higher-risk patients, you want to get LDL down as quickly as possible and keep it there as long as possible.”

High-risk patients are those who have had a stroke or heart attack, or are likely to have one. Even high-intensity statins are sometimes not enough to bring LDL to safe levels.

The American Heart Association (AHA) recommends keeping LDL below 100 mg/dL, and under 70 mg/dL for high-risk patients.

NewAmsterdam Pharma, the Dutch company that makes obicetrapib, plans to speak with the U.S. Food and Drug Administration (FDA) “over the course of the year,” about possible approval of the combo drug, a spokesperson told NBC News.

In the past, some similar drugs have not worked. Dr. Robert Rosenson of Mount Sinai Health System noted that some drugs in this class have failed to prevent strokes or heart attacks. “But I am cautiously hopeful,” he said.

NewAmsterdam Pharma is now running another trial to see if the combo drug not only lowers cholesterol but also protects against major heart events.

While lifestyle changes like eating healthily, exercising and avoiding smoking can help lower LDL, many people still struggle to reach safe levels. Only about 20% of patients are able to manage their LDL, said Bradley, of Columbia.

More information:
Ashish Sarraju et al, Fixed-dose combination of obicetrapib and ezetimibe for LDL cholesterol reduction (TANDEM): a phase 3, randomised, double-blind, placebo-controlled trial, The Lancet (2025). DOI: 10.1016/S0140-6736(25)00721-4

The Mayo Clinic has more on lifestyle changes to improve your cholesterol.

2025 HealthDay. All rights reserved.

Citation:
When statins aren’t enough, this drug may help lower ‘bad’ cholesterol (2025, May 8)
retrieved 8 May 2025
from https://medicalxpress.com/news/2025-05-statins-drug-bad-cholesterol.html

This document is subject to copyright. Apart from any fair dealing for the purpose of private study or research, no
part may be reproduced without the written permission. The content is provided for information purposes only.



by I. Edwards

When statins aren't enough, this drug may help lower 'bad' cholesterol

A new drug combo lowers “bad” LDL cholesterol for people whose levels remain high even after taking statins. The new pill pairs a new drug called obicetrapib with an existing one, ezetimibe. In a Phase 3 clinical trial, this combo reduced LDL levels by nearly 49% over about three months, according to Cleveland Clinic researchers.

The results were presented on Wednesday at the European Atherosclerosis Society meeting in Glasgow, Scotland, and simultaneously published in The Lancet.

“High LDL is one of the leading risk factors for heart disease, and we have such a poor handle on controlling that risk,” Dr. Corey Bradley, a cardiologist at Columbia University, told NBC News. “Many people have such a high LDL they will require multiple agents to control it.”

The trial included 407 people with an average age of 68. Even though they were taking cholesterol-lowering medications, everyone had LDL levels above 70 mg/dL. Researchers divided participants into four groups: One took the combo pill; two groups took each drug separately; and another group took a placebo. All participants continued their usual cholesterol medications.

Dr. Ashish Sarraju, a preventive cardiologist at the Cleveland Clinic, led the study.

“We need to give patients and their doctors all the options we can to try to get LDL under control if they are at risk for—or already have—cardiovascular disease,” Sarraju said. “In higher-risk patients, you want to get LDL down as quickly as possible and keep it there as long as possible.”

High-risk patients are those who have had a stroke or heart attack, or are likely to have one. Even high-intensity statins are sometimes not enough to bring LDL to safe levels.

The American Heart Association (AHA) recommends keeping LDL below 100 mg/dL, and under 70 mg/dL for high-risk patients.

NewAmsterdam Pharma, the Dutch company that makes obicetrapib, plans to speak with the U.S. Food and Drug Administration (FDA) “over the course of the year,” about possible approval of the combo drug, a spokesperson told NBC News.

In the past, some similar drugs have not worked. Dr. Robert Rosenson of Mount Sinai Health System noted that some drugs in this class have failed to prevent strokes or heart attacks. “But I am cautiously hopeful,” he said.

NewAmsterdam Pharma is now running another trial to see if the combo drug not only lowers cholesterol but also protects against major heart events.

While lifestyle changes like eating healthily, exercising and avoiding smoking can help lower LDL, many people still struggle to reach safe levels. Only about 20% of patients are able to manage their LDL, said Bradley, of Columbia.

More information:
Ashish Sarraju et al, Fixed-dose combination of obicetrapib and ezetimibe for LDL cholesterol reduction (TANDEM): a phase 3, randomised, double-blind, placebo-controlled trial, The Lancet (2025). DOI: 10.1016/S0140-6736(25)00721-4

The Mayo Clinic has more on lifestyle changes to improve your cholesterol.

2025 HealthDay. All rights reserved.

Citation:
When statins aren’t enough, this drug may help lower ‘bad’ cholesterol (2025, May 8)
retrieved 8 May 2025
from https://medicalxpress.com/news/2025-05-statins-drug-bad-cholesterol.html

This document is subject to copyright. Apart from any fair dealing for the purpose of private study or research, no
part may be reproduced without the written permission. The content is provided for information purposes only.


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