Disclosures: The registry was funded by Amgen, manufacturer of the PCSK9 inhibitor evolocumab (Repatha). Cannon reports he received research grants from Amgen during the conduct of the study and Boehringer Ingelheim, Bristol Myers Squibb, Daiichi Sankyo, Janssen, Merck, Novo Nordisk and Pfizer outside the submitted work; and received consultant fees from Amgen during the conduct of the study and Aegerion, Alnylam, Amarin, Applied Therapeutics, Ascendia, Boehringer Ingelheim, Bristol Myers Squibb, Corvidia, Eli Lilly, HLS Therapeutics, Innovent, Janssen, Kowa, Merck, Pfizer, Rhoshan and Sanofi outside the submitted work. Please see the study for all other authors’ relevant financial disclosures.
July 07, 2021
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Suboptimal management of lipid levels prevalent among patients with ASCVD

Disclosures: The registry was funded by Amgen, manufacturer of the PCSK9 inhibitor evolocumab (Repatha). Cannon reports he received research grants from Amgen during the conduct of the study and Boehringer Ingelheim, Bristol Myers Squibb, Daiichi Sankyo, Janssen, Merck, Novo Nordisk and Pfizer outside the submitted work; and received consultant fees from Amgen during the conduct of the study and Aegerion, Alnylam, Amarin, Applied Therapeutics, Ascendia, Boehringer Ingelheim, Bristol Myers Squibb, Corvidia, Eli Lilly, HLS Therapeutics, Innovent, Janssen, Kowa, Merck, Pfizer, Rhoshan and Sanofi outside the submitted work. Please see the study for all other authors’ relevant financial disclosures.
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Patients with atherosclerotic CVD had low levels of lipid-lowering therapy intensification and most did not achieve LDL goals at 2 years, according to new data from the GOULD registry.

Christopher P. Cannon, MD, education director of cardiovascular innovation in the preventive cardiology section at Brigham and Women’s Hospital and professor of medicine at Harvard Medical School, and colleagues published 2-year data from the prospective, observational GOULD registry study of 5,006 patients with ASCVD (mean age, 68 years; 40% women; 86% white) in JAMA Cardiology.

Christopher P. Cannon, MD, education director of cardiovascular innovation in the preventive cardiology section at Brigham and Women’s Hospital and professor of medicine at Harvard Medical School.

Lack of urgency

“We have seen undertreatment (repeatedly) in the past, and wondered, with the clinical trials of lipid-lowering therapies and new guidelines in 2018 in the U.S., if those who are not at LDL goal would be titrated to goal with intensification of their therapies,” Cannon told Healio. “We did a prospective analysis at 120 practices across the U.S. and found, unfortunately, only 17% over a 2-year period had intensification. And in the end, only 30% were at goal. I was disappointed that there was not more change. We have so much evidence for lipid-lowering, and yet doctors and patients just don’t seem to feel the urgency to fully adopt it.”

At 2 years, lipid-lowering therapy intensification occurred in 17.1% of the cohort, including in 22.4% of those with baseline LDL 100 mg/dL or more and in 14.4% of those with baseline LDL 70 mg/dL to 99 mg/dL, according to the researchers.

Among the cohort, 6.4% of those with baseline LDL 100 mg/dL or more and 6.3% of those with baseline LDL 70 mg/dL to 99 mg/dL had their statin therapy intensified, 6.8% of those with baseline LDL 100 mg/dL or more and 4.5% of those with baseline LDL 70 mg/dL to 99 mg/dL had ezetimibe added and 6.3% of those with baseline LDL 100 mg/dL or more and 2.9% of those with baseline LDL 70 mg/dL to 99 mg/dL had a PCSK9 inhibitor added. Of those who were taking a PCSK9 inhibitor at baseline, 91.7% remained on it at 2 years.

In those with baseline LDL 100 mg/dL or more, LDL fell from a median of 120 mg/dL at baseline to a median of 95 mg/dL at 2 years (P < .001), whereas in those with baseline LDL 70 mg/dL to 95 mg/dL, LDL fell from a median of 82 mg/dL at baseline to a median of 77 mg/dL at 2 years (P < .001), and in those who were taking a PCSK9 inhibitor at baseline, LDL remained stable (baseline, 68 mg/dL; 2 years, 67 mg/dL; P = .77), Cannon and colleagues found.

At 2 years, the percentage of patients who achieved LDL less than 70 mg/dL, the threshold recommended by the American College of Cardiology and the American Heart Association for patients with ASCVD, was 21% in those with baseline LDL 100 mg/dL or more, 33.9% in those with baseline LDL 70 mg/dL to 99 mg/dL and 52.4% in those taking a PCSK9 inhibitor at baseline, according to the researchers.

Lipid-lowering therapy intensification and reaching LDL less than 70 mg/dL occurred more often in patients at teaching hospitals than in patients at nonteaching hospitals; in patients at hospitals with lipid protocols than in patients at hospitals without them; and in patients treated by cardiologists than in patients treated by noncardiologists, the researchers wrote.

Major impediments

“Generally, we MDs know what to do, and would answer the question right on a test, but in the busy world of practice, things get overlooked or other things come up (AF, chest pain, etc) and [lipid levels are] not addressed,” Cannon told Healio. “On the patient side, there is so much disinformation and then skepticism about statins that people somehow think the class of drugs is bad. Yet, they are probably the most beneficial class of drugs. And we have now four different classes of nonstatins that we can use. But with all noise on the internet, people don’t know what to believe, and so they often don’t start lipid lowering or increase the dose, even if the doctor says to. Then there are the issues with the health care system. Co-pays from insurance companies are a major impediment, even for generic statins. It is crazy, and then many times patients don’t get treated. For the newer agents like PCSK9 inhibitors, prior authorization is the barrier, and we have tried to make sure to get all the information to the insurance companies, but it takes time. Then the co-pays often are prohibitive, notably for some Medicare patients. It takes lots of doctor and pharmacist time to battle against the insurance companies’ barriers to get our patients the medications that are fully indicated for them.”

Enhanced, comprehensive surveillance of high-risk patients who are not at LDL goal could help, as could programs like the Cardiometabolic Alliance, which “develops teams to streamline care and ensure comprehensive adoption of the guidelines,” Cannon said in an interview.

For more information:

Christopher P. Cannon, MD, can be reached at cpcannon@bwh.harvard.edu.