AACE guidance examines medication options for preventing ASCVD in adults with dyslipidemia
Key takeaways:
- AACE published its first updated guideline on the pharmacologic management of adults with dyslipidemia since 2017.
- New recommendations include medications that have been approved since the last update.
Updated guidance on preventing atherosclerotic cardiovascular disease in people with dyslipidemia includes changes reflecting newer medications that could be added to statin therapy or used on patients intolerant to statins.
The American Association of Clinical Endocrinology published in Endocrine Practice an updated guideline on the pharmacologic management of adults with dyslipidemia. This is the first time the organization has updated its dyslipidemia guideline since 2017 and the first new guideline developed using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) methodology.
Shailendra B. Patel, BM, ChB, DPhil, professor of internal medicine at the University of Cincinnati College of Medicine, attending staff physician at Cincinnati VA Medical Center and lead author of the guideline, said the GRADE methodology led to the authors putting more consideration into patient-related factors than they had in previous recommendations.
“We look into patient factors, social factors, economic factors and factors in how that outcome can relate to a patient,” Patel told Healio. “In the past, that had been the least important aspect and was usually not factored into guidelines. This time around, we’ve not only got the science base, but we’ve included the things that are important to the patients and what they perceive as important to them, putting that together and still using the science base.”
Medication recommendations
The guideline authors made 13 recommendations based on six clinical questions on preventing atherosclerotic CVD (ASCVD) events for adults with dyslipidemia. Most of the recommendations examined which medications could be added to statin therapy.
For adults with or at risk for ASCVD who are on maximally tolerated statin therapy but have not achieved LDL cholesterol less than 70 mg/dL, the authors provided a conditional recommendation to add PCSK9 monoclonal antibodies alirocumab (Praluent, Sanofi/Regeneron) or evolocumab (Repatha, Amgen) to usual care.
A conditional recommendation states that PCSK9 monoclonal antibodies or bempedoic acid (Nexletol, Esperion Therapeutics) should not be added to usual care in patients who have dyslipidemia but not ASCVD.
Adults who are statin-intolerant could receive bempedoic acid in addition to usual care, according to another conditional recommendation in the guidance. Bempedoic acid should not be used for adults who can tolerate other lipid-lowering drugs, according to the guidelines. The authors made no recommendation on inclisiran (Leqvio, Novartis), a small-interfering RNA PCSK9 inhibitor, due to insufficient evidence.
A conditional recommendation with low certainty states adults with high triglyceride levels of 150 mg/dL to 499 mg/dL could receive eicosapentaenoic acid (icosapent ethyl) alone, but not eicosapentaenoic acid plus docosahexaenoic acid. A strong recommendation states adults with hypertriglyceridemia should not receive niacin. The authors noted there is insufficient evidence to support the use of eicosapentaenoic acid or niacin for adults with severe hypertriglyceridemia with triglycerides of 500 mg/dL or higher.
“We believe the use of fish oils or niacin, and even to a large extent fibrates, are not going to be contributory to trying to lower ASCVD risk,” Patel said.
LDL cholesterol targets
The authors made a conditional recommendation to treat adults with or at risk for ASCVD to an LDL cholesterol target of less than 70 mg/dL. The 2017 guidance previously included an LDL cholesterol target of less than 70 mg/dL, with a lower target of 55 mg/dL for those at very high ASCVD risk. That lower target was removed in the new guideline.
Kathleen Wyne, MD, PhD, FACE, FNLA, director of the adult type 1 diabetes program, adult cystic fibrosis-related diabetes (CFRD) program and diabetes transition of care clinic at Ohio State University East Hospital and professor of clinical medicine in the division of endocrinology, diabetes and metabolism, department of internal medicine at The Ohio State University Wexner Medical Center, noted a lack of evidence led to the LDL cholesterol target recommendation being made with low certainty.
“One of the things we did in this guideline was we looked at what are the data to support the 55 mg/dL that we had brought out in the prior guideline,” Wyne told Healio. “Also, what are the data to support the current targets of typically less than 100 mg/dL and less than 70 mg/dL? In looking at the data, we found that even though 70 mg/dL had been the recommended target for many years, the actual number is not well supported by data.”
Research gaps
The final question the authors explored examines adding risk enhancers such as calcium artery calcification scoring and blood tests for apolipoprotein B or lipoprotein(a) to predict future ASCVD risk. The authors stated there is “limited utility in broad application” for adding risk enhancers to a risk prediction tool. The guidance states that additional testing could be done for adults at intermediate CVD risk who understand the added cost of testing and value the added information about risk.
Patel and Wyne said there are several research gaps that need to be filled in the future. Patel said one of the largest gaps is the lack of evidence on treating for people with diabetes, particularly type 1 diabetes. Wyne said more studies also need to be conducted among adults with metabolic dysfunction-associated steatotic liver disease.
“We have some data of which statins are probably better than others, but we really don’t have formal clinical trial data on, how do we evaluate and how do we treat that patient population,” Wyne said. “We know very clearly from epidemiology that they have an excess amount of death, which is all due to CVD.”
For more information:
Shailendra B. Patel, BM, ChB, DPhil, can be reached at sbpatel@ucmail.uc.edu.
Kathleen Wyne, MD, PhD, FACE, FNLA, can be reached at kathleen.wyne@osumc.edu.
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