European cholesterol guidelines push LDL targets below 55 mg/dL

PARIS – The 2019 dyslipidemia management guidelines from the European Society of Cardiology set an LDL cholesterol target for very-high-risk people of less than 55 mg/dL (as well as at least a 50% cut from baseline), a class I recommendation. This marks the first time a cardiology society has either recommended a target goal for this measure below 70 mg/dL or endorsed treating patients to still-lower cholesterol once their level was already under 70 mg/dL.*

The guidelines went further by suggesting consideration of an even lower treatment target for LDL-cholesterol in very-high-risk, secondary prevention patients who have already had at least two atherosclerotic cardiovascular disease events during the past 2 years, a setting that could justify an LDL-cholesterol goal of less than 40 mg/dL (along with a cut from baseline of at least 50%), a class IIb recommendation that denotes a “may be considered,” endorsement.

“In all the trials, lower was better. There was no lower level of LDL cholesterol that’s been studied that was not better” for patient outcomes, Colin Baigent, BMBCH, said while presenting the new guideline at the annual congress of the European Society of Cardiology (ESC). “It’s very clear” that the full treatment benefit from lowering LDL-cholesterol extends to getting very-high risk patients below these levels, said Dr. Baigent, professor of cardiology at Oxford (England) University and one of three chairs of the ESC’s dyslipidemia guideline-writing panel.

While this change was seen as a notably aggressive goal and too fixed on a specific number by at least one author of the 2018 American Heart Association/American College of Cardiology cholesterol management guideline (J Am Coll Cardiol. 2019 Jun;73[24]:e285-e350), it was embraced by another U.S. expert not involved in writing the most recent U.S. recommendations.

“A goal for LDL-cholesterol of less than 55 mg/dL is reasonable; it’s well documented” by trial evidence “and I support it,” said Robert H. Eckel, MD, an endocrinologist and professor of medicine at the University of Colorado in Aurora. Dr. Eckel added that he “also supports” an LDL-cholesterol of less than 40 mg/dL in very-high-risk patients with a history of multiple events or with multiple residual risk factors, and he said he has applied this lower LDL-cholesterol goal in his practice for selected patients. But Dr. Eckel acknowledged in an interview that the evidence for it was less clear-cut than was the evidence behind a goal of less than 55 mg/dL. He also supported the concept of including a treatment goal in U.S. lipid recommendations, which in recent versions has been missing. “I fall back on a cholesterol goal for practical purposes” of making the success of cholesterol-lowering treatment easier to track.

The new ESC goal was characterized as “arbitrary” by Neil J. Stone, MD, vice-chair of the panel that wrote the 2018 AHA/ACC guideline, which relied on treating secondary-prevention patients at high risk to an LDL-cholesterol at least 50% less than before treatment, and recommended continued intensification for patients whose LDL-cholesterol level remained at or above 70 mg/dL.

“If the patient is at 58 mg/dL I’m not sure anyone can tell me what the difference is,” compared with reaching less than 55 mg/dL, Dr. Stone said in an interview. “I worry about focusing on a number and not on the concept that people at the very highest risk deserve the most intensive treatment; the Europeans agree, but they have a different way of looking at it. Despite this difference in approach, the new ESC guidelines and the 2018 U.S. guideline “are more similar than different,” stressed Dr. Stone, professor of medicine and preventive medicine at Northwestern University, Chicago.

 

However, other experts see an important difference in the risk faced by patients who reach the ESC’s recommended treatment goals and those who fall just short.

“It’s hard to lower an LDL-cholesterol that is already relatively low. People who are close to their cholesterol target need the most intensified treatment” to reach their goal, said Rory Collins, F.Med.Sci., professor of epidemiology at Oxford University. He was not on the ESC guidelines panel.

“It’s a mind shift that clinicians need to be most aggressive in treating patients with the highest risk” even when their LDL-cholesterol is low but not yet at the target level, Dr. Collins said during a discussion session at the congress.

The new ESC guidelines is about “both getting the LDL-cholesterol down to a certain level and also about achieving a big [at least 50%] change” from baseline. “I think the ESC guidelines make that crystal clear,” said Marc S. Sabatine, MD, professor of medicine at Harvard Medical School, Boston, and the sole American to participate in the ESC guidelines-writing panel.

Mitchel L. Zoler/MDedge News

The ESC also broke new ground by advocating an aggressive path toward achieving these LDL-cholesterol goals by elevating the newest and most potent class of approved LDL-cholesterol-lowering drugs, the PCSK9 (proprotein convertase subtilisin/kexin type 9) inhibitors, to a top-tier, class I recommendation (“is recommended”) for secondary prevention in very-high-risk patients not reaching their goal LDL-cholesterol level on a maximally tolerated statin plus ezetimibe. This recommendation to unequivocally add a PCSK9 inhibitor for this patient population contrasts with the 2018 AHA/ACC guideline that deemed adding a PCSK9 inhibitor a IIa recommendation (“is reasonable”).

 

A similar uptick in treatment aggressiveness appeared in the ESC’s recommendations for managing very-high-risk patients in a primary prevention setting, including those without familial hypercholesterolemia. For these people, the ESC panel, which worked in concert with the European Atherosclerosis Society, pegged adding a PCSK9 inhibitor as a IIb (“may be considered”) recommendation when these very-high-risk people fail to reach their LDL-cholesterol target on a maximally tolerated statin and ezetimibe. Once again, this opening to use a PCSK9 inhibitor contrasted with the 2018 U.S. guideline, which never mentioned an option of adding a PCSK9 inhibitor for primary prevention except when someone also has familial hypercholesterolemia and starts treatment with an LDL level of at least 190 mg/dL (a IIb recommendation). The new European guidelines proposed using a PCSK9 inhibitor as a second-line option to consider when needed for people whose very high risk derives primarily from older age and other factors such as smoking or hypertension that give them at least a 10% 10-year risk for cardiovascular death as estimated with the European-oriented SCORE risk calculator tables.

Updated SCORE risk designations appear in the new ESC dyslipidemia guidelines, and they show, for example, that in lower-risk European countries (mostly Western European nations) virtually all men who are at least 70 years old would fall into the very-high-risk category that makes them potential candidates for treatment with a PCSK9 inhibitor regardless of any other risk they may or may not have. In higher-risk (mostly Eastern European) countries this designation kicks in for most men once they reach the age of 65.

Several Congress attendees who came to a discussion session on the guidelines voiced concerns that the new revision will lead to substantially increased use of the these drugs and hence will significantly boost medical costs, because these drugs today are priced at about $6,000 annually to treat one patient. In response, members of the guideline-writing panel defended their decision as unavoidable given what’s been reported on the clinical impact of PCSK9 inhibitors when lowering LDL cholesterol and cutting atherosclerotic cardiovascular disease events.

“I commend the [ESC] guideline for focusing on the science and on what is best for patients. The U.S. guidelines conflated the science and the cost, and the recommendations got watered down by cost considerations,” said Dr. Sabatine, who has led several studies of PCSK9 inhibitors.

Dr. Baigent added that the panel “deliberated long and hard on cost, but we felt that we had to focus on the evidence. The cost will shift” in the future, he predicted.

Other U.S. physicians highlighted the need to take drug cost into account when writing public health policy documents such as lipid-management guidelines and questioned whether this more liberal use of PCSK9 inhibitors was justified.

“I think that in the absence of familial hypercholesterolemia you need to waffle around the edges to justify a PCSK9 inhibitor,” said Dr. Eckel. “The cost of PCSK9 inhibitors has come down, but at $6,000 per year you can’t ignore their cost.”

“In the U.S. we need to be mindful of the cost of treatment,” said Dr. Stone. “The ESC guidelines are probably more aggressive” than the 2018 U.S. guideline. “They use PCSK9 inhibitors perhaps more than we do; we [in the United States] prefer generic ezetimibe. A lot has to do with the definitions of risk. The European guidelines have a lot of risk definitions that differ” from the U.S. guideline, he said.

Members of the ESC guidelines panel acknowledged that the SCORE risk-assessment charts could overestimate risk in older people who need primary prevention treatment, as well as underestimate the risk in younger adults.

This inherent age bias in the SCORE risk tables make it “extremely important to contextualize” a person’s risk “by considering other risk factors,” advised Brian A. Ference, MD, an interventional cardiologist and professor at Cambridge (England) University who was a member of the ESC guidelines writing group.

The new ESC guidelines say that risk categorization “must be interpreted in light of the clinician’s knowledge and experience, and of the patient’s pretest likelihood” of cardiovascular disease.”

Dr. Baigent has received research funding from Boehringer Ingelheim, Novartis, and Pfizer. Dr. Eckel has been an expert witness on behalf of Sanofi/Regeneron. Dr. Sabatine and Dr. Ference have received honoraria and research funding from several companies including those that market lipid-lowering drugs. Dr. Stone and Dr. Collins had no disclosures.

*Correction, 9/20/19: A previous version of this article incorrectly stated that the ESC guidelines were the first by a medical society to recommend the lower cholesterol goals. The American Association of Clinical Endocrinologists included targets below 55 mg/dL in their 2017 dyslipidemia management guidelines.

[email protected]

SOURCE: Mach F et al. Eur Heart J. 2019 Aug 31. doi: 10.1093/eurheartj/ehz455.

PARIS – The 2019 dyslipidemia management guidelines from the European Society of Cardiology set an LDL cholesterol target for very-high-risk people of less than 55 mg/dL (as well as at least a 50% cut from baseline), a class I recommendation. This marks the first time a cardiology society has either recommended a target goal for this measure below 70 mg/dL or endorsed treating patients to still-lower cholesterol once their level was already under 70 mg/dL.*

The guidelines went further by suggesting consideration of an even lower treatment target for LDL-cholesterol in very-high-risk, secondary prevention patients who have already had at least two atherosclerotic cardiovascular disease events during the past 2 years, a setting that could justify an LDL-cholesterol goal of less than 40 mg/dL (along with a cut from baseline of at least 50%), a class IIb recommendation that denotes a “may be considered,” endorsement.

“In all the trials, lower was better. There was no lower level of LDL cholesterol that’s been studied that was not better” for patient outcomes, Colin Baigent, BMBCH, said while presenting the new guideline at the annual congress of the European Society of Cardiology (ESC). “It’s very clear” that the full treatment benefit from lowering LDL-cholesterol extends to getting very-high risk patients below these levels, said Dr. Baigent, professor of cardiology at Oxford (England) University and one of three chairs of the ESC’s dyslipidemia guideline-writing panel.

While this change was seen as a notably aggressive goal and too fixed on a specific number by at least one author of the 2018 American Heart Association/American College of Cardiology cholesterol management guideline (J Am Coll Cardiol. 2019 Jun;73[24]:e285-e350), it was embraced by another U.S. expert not involved in writing the most recent U.S. recommendations.

“A goal for LDL-cholesterol of less than 55 mg/dL is reasonable; it’s well documented” by trial evidence “and I support it,” said Robert H. Eckel, MD, an endocrinologist and professor of medicine at the University of Colorado in Aurora. Dr. Eckel added that he “also supports” an LDL-cholesterol of less than 40 mg/dL in very-high-risk patients with a history of multiple events or with multiple residual risk factors, and he said he has applied this lower LDL-cholesterol goal in his practice for selected patients. But Dr. Eckel acknowledged in an interview that the evidence for it was less clear-cut than was the evidence behind a goal of less than 55 mg/dL. He also supported the concept of including a treatment goal in U.S. lipid recommendations, which in recent versions has been missing. “I fall back on a cholesterol goal for practical purposes” of making the success of cholesterol-lowering treatment easier to track.

The new ESC goal was characterized as “arbitrary” by Neil J. Stone, MD, vice-chair of the panel that wrote the 2018 AHA/ACC guideline, which relied on treating secondary-prevention patients at high risk to an LDL-cholesterol at least 50% less than before treatment, and recommended continued intensification for patients whose LDL-cholesterol level remained at or above 70 mg/dL.

“If the patient is at 58 mg/dL I’m not sure anyone can tell me what the difference is,” compared with reaching less than 55 mg/dL, Dr. Stone said in an interview. “I worry about focusing on a number and not on the concept that people at the very highest risk deserve the most intensive treatment; the Europeans agree, but they have a different way of looking at it. Despite this difference in approach, the new ESC guidelines and the 2018 U.S. guideline “are more similar than different,” stressed Dr. Stone, professor of medicine and preventive medicine at Northwestern University, Chicago.

 

However, other experts see an important difference in the risk faced by patients who reach the ESC’s recommended treatment goals and those who fall just short.

“It’s hard to lower an LDL-cholesterol that is already relatively low. People who are close to their cholesterol target need the most intensified treatment” to reach their goal, said Rory Collins, F.Med.Sci., professor of epidemiology at Oxford University. He was not on the ESC guidelines panel.

“It’s a mind shift that clinicians need to be most aggressive in treating patients with the highest risk” even when their LDL-cholesterol is low but not yet at the target level, Dr. Collins said during a discussion session at the congress.

The new ESC guidelines is about “both getting the LDL-cholesterol down to a certain level and also about achieving a big [at least 50%] change” from baseline. “I think the ESC guidelines make that crystal clear,” said Marc S. Sabatine, MD, professor of medicine at Harvard Medical School, Boston, and the sole American to participate in the ESC guidelines-writing panel.

Mitchel L. Zoler/MDedge News

The ESC also broke new ground by advocating an aggressive path toward achieving these LDL-cholesterol goals by elevating the newest and most potent class of approved LDL-cholesterol-lowering drugs, the PCSK9 (proprotein convertase subtilisin/kexin type 9) inhibitors, to a top-tier, class I recommendation (“is recommended”) for secondary prevention in very-high-risk patients not reaching their goal LDL-cholesterol level on a maximally tolerated statin plus ezetimibe. This recommendation to unequivocally add a PCSK9 inhibitor for this patient population contrasts with the 2018 AHA/ACC guideline that deemed adding a PCSK9 inhibitor a IIa recommendation (“is reasonable”).

 

A similar uptick in treatment aggressiveness appeared in the ESC’s recommendations for managing very-high-risk patients in a primary prevention setting, including those without familial hypercholesterolemia. For these people, the ESC panel, which worked in concert with the European Atherosclerosis Society, pegged adding a PCSK9 inhibitor as a IIb (“may be considered”) recommendation when these very-high-risk people fail to reach their LDL-cholesterol target on a maximally tolerated statin and ezetimibe. Once again, this opening to use a PCSK9 inhibitor contrasted with the 2018 U.S. guideline, which never mentioned an option of adding a PCSK9 inhibitor for primary prevention except when someone also has familial hypercholesterolemia and starts treatment with an LDL level of at least 190 mg/dL (a IIb recommendation). The new European guidelines proposed using a PCSK9 inhibitor as a second-line option to consider when needed for people whose very high risk derives primarily from older age and other factors such as smoking or hypertension that give them at least a 10% 10-year risk for cardiovascular death as estimated with the European-oriented SCORE risk calculator tables.

Updated SCORE risk designations appear in the new ESC dyslipidemia guidelines, and they show, for example, that in lower-risk European countries (mostly Western European nations) virtually all men who are at least 70 years old would fall into the very-high-risk category that makes them potential candidates for treatment with a PCSK9 inhibitor regardless of any other risk they may or may not have. In higher-risk (mostly Eastern European) countries this designation kicks in for most men once they reach the age of 65.

Several Congress attendees who came to a discussion session on the guidelines voiced concerns that the new revision will lead to substantially increased use of the these drugs and hence will significantly boost medical costs, because these drugs today are priced at about $6,000 annually to treat one patient. In response, members of the guideline-writing panel defended their decision as unavoidable given what’s been reported on the clinical impact of PCSK9 inhibitors when lowering LDL cholesterol and cutting atherosclerotic cardiovascular disease events.

“I commend the [ESC] guideline for focusing on the science and on what is best for patients. The U.S. guidelines conflated the science and the cost, and the recommendations got watered down by cost considerations,” said Dr. Sabatine, who has led several studies of PCSK9 inhibitors.

Dr. Baigent added that the panel “deliberated long and hard on cost, but we felt that we had to focus on the evidence. The cost will shift” in the future, he predicted.

Other U.S. physicians highlighted the need to take drug cost into account when writing public health policy documents such as lipid-management guidelines and questioned whether this more liberal use of PCSK9 inhibitors was justified.

“I think that in the absence of familial hypercholesterolemia you need to waffle around the edges to justify a PCSK9 inhibitor,” said Dr. Eckel. “The cost of PCSK9 inhibitors has come down, but at $6,000 per year you can’t ignore their cost.”

“In the U.S. we need to be mindful of the cost of treatment,” said Dr. Stone. “The ESC guidelines are probably more aggressive” than the 2018 U.S. guideline. “They use PCSK9 inhibitors perhaps more than we do; we [in the United States] prefer generic ezetimibe. A lot has to do with the definitions of risk. The European guidelines have a lot of risk definitions that differ” from the U.S. guideline, he said.

Members of the ESC guidelines panel acknowledged that the SCORE risk-assessment charts could overestimate risk in older people who need primary prevention treatment, as well as underestimate the risk in younger adults.

This inherent age bias in the SCORE risk tables make it “extremely important to contextualize” a person’s risk “by considering other risk factors,” advised Brian A. Ference, MD, an interventional cardiologist and professor at Cambridge (England) University who was a member of the ESC guidelines writing group.

The new ESC guidelines say that risk categorization “must be interpreted in light of the clinician’s knowledge and experience, and of the patient’s pretest likelihood” of cardiovascular disease.”

Dr. Baigent has received research funding from Boehringer Ingelheim, Novartis, and Pfizer. Dr. Eckel has been an expert witness on behalf of Sanofi/Regeneron. Dr. Sabatine and Dr. Ference have received honoraria and research funding from several companies including those that market lipid-lowering drugs. Dr. Stone and Dr. Collins had no disclosures.

*Correction, 9/20/19: A previous version of this article incorrectly stated that the ESC guidelines were the first by a medical society to recommend the lower cholesterol goals. The American Association of Clinical Endocrinologists included targets below 55 mg/dL in their 2017 dyslipidemia management guidelines.

[email protected]

SOURCE: Mach F et al. Eur Heart J. 2019 Aug 31. doi: 10.1093/eurheartj/ehz455.

PARIS – The 2019 dyslipidemia management guidelines from the European Society of Cardiology set an LDL cholesterol target for very-high-risk people of less than 55 mg/dL (as well as at least a 50% cut from baseline), a class I recommendation. This marks the first time a cardiology society has either recommended a target goal for this measure below 70 mg/dL or endorsed treating patients to still-lower cholesterol once their level was already under 70 mg/dL.*

The guidelines went further by suggesting consideration of an even lower treatment target for LDL-cholesterol in very-high-risk, secondary prevention patients who have already had at least two atherosclerotic cardiovascular disease events during the past 2 years, a setting that could justify an LDL-cholesterol goal of less than 40 mg/dL (along with a cut from baseline of at least 50%), a class IIb recommendation that denotes a “may be considered,” endorsement.

“In all the trials, lower was better. There was no lower level of LDL cholesterol that’s been studied that was not better” for patient outcomes, Colin Baigent, BMBCH, said while presenting the new guideline at the annual congress of the European Society of Cardiology (ESC). “It’s very clear” that the full treatment benefit from lowering LDL-cholesterol extends to getting very-high risk patients below these levels, said Dr. Baigent, professor of cardiology at Oxford (England) University and one of three chairs of the ESC’s dyslipidemia guideline-writing panel.

While this change was seen as a notably aggressive goal and too fixed on a specific number by at least one author of the 2018 American Heart Association/American College of Cardiology cholesterol management guideline (J Am Coll Cardiol. 2019 Jun;73[24]:e285-e350), it was embraced by another U.S. expert not involved in writing the most recent U.S. recommendations.

“A goal for LDL-cholesterol of less than 55 mg/dL is reasonable; it’s well documented” by trial evidence “and I support it,” said Robert H. Eckel, MD, an endocrinologist and professor of medicine at the University of Colorado in Aurora. Dr. Eckel added that he “also supports” an LDL-cholesterol of less than 40 mg/dL in very-high-risk patients with a history of multiple events or with multiple residual risk factors, and he said he has applied this lower LDL-cholesterol goal in his practice for selected patients. But Dr. Eckel acknowledged in an interview that the evidence for it was less clear-cut than was the evidence behind a goal of less than 55 mg/dL. He also supported the concept of including a treatment goal in U.S. lipid recommendations, which in recent versions has been missing. “I fall back on a cholesterol goal for practical purposes” of making the success of cholesterol-lowering treatment easier to track.

The new ESC goal was characterized as “arbitrary” by Neil J. Stone, MD, vice-chair of the panel that wrote the 2018 AHA/ACC guideline, which relied on treating secondary-prevention patients at high risk to an LDL-cholesterol at least 50% less than before treatment, and recommended continued intensification for patients whose LDL-cholesterol level remained at or above 70 mg/dL.

“If the patient is at 58 mg/dL I’m not sure anyone can tell me what the difference is,” compared with reaching less than 55 mg/dL, Dr. Stone said in an interview. “I worry about focusing on a number and not on the concept that people at the very highest risk deserve the most intensive treatment; the Europeans agree, but they have a different way of looking at it. Despite this difference in approach, the new ESC guidelines and the 2018 U.S. guideline “are more similar than different,” stressed Dr. Stone, professor of medicine and preventive medicine at Northwestern University, Chicago.

 

However, other experts see an important difference in the risk faced by patients who reach the ESC’s recommended treatment goals and those who fall just short.

“It’s hard to lower an LDL-cholesterol that is already relatively low. People who are close to their cholesterol target need the most intensified treatment” to reach their goal, said Rory Collins, F.Med.Sci., professor of epidemiology at Oxford University. He was not on the ESC guidelines panel.

“It’s a mind shift that clinicians need to be most aggressive in treating patients with the highest risk” even when their LDL-cholesterol is low but not yet at the target level, Dr. Collins said during a discussion session at the congress.

The new ESC guidelines is about “both getting the LDL-cholesterol down to a certain level and also about achieving a big [at least 50%] change” from baseline. “I think the ESC guidelines make that crystal clear,” said Marc S. Sabatine, MD, professor of medicine at Harvard Medical School, Boston, and the sole American to participate in the ESC guidelines-writing panel.

Mitchel L. Zoler/MDedge News

The ESC also broke new ground by advocating an aggressive path toward achieving these LDL-cholesterol goals by elevating the newest and most potent class of approved LDL-cholesterol-lowering drugs, the PCSK9 (proprotein convertase subtilisin/kexin type 9) inhibitors, to a top-tier, class I recommendation (“is recommended”) for secondary prevention in very-high-risk patients not reaching their goal LDL-cholesterol level on a maximally tolerated statin plus ezetimibe. This recommendation to unequivocally add a PCSK9 inhibitor for this patient population contrasts with the 2018 AHA/ACC guideline that deemed adding a PCSK9 inhibitor a IIa recommendation (“is reasonable”).

 

A similar uptick in treatment aggressiveness appeared in the ESC’s recommendations for managing very-high-risk patients in a primary prevention setting, including those without familial hypercholesterolemia. For these people, the ESC panel, which worked in concert with the European Atherosclerosis Society, pegged adding a PCSK9 inhibitor as a IIb (“may be considered”) recommendation when these very-high-risk people fail to reach their LDL-cholesterol target on a maximally tolerated statin and ezetimibe. Once again, this opening to use a PCSK9 inhibitor contrasted with the 2018 U.S. guideline, which never mentioned an option of adding a PCSK9 inhibitor for primary prevention except when someone also has familial hypercholesterolemia and starts treatment with an LDL level of at least 190 mg/dL (a IIb recommendation). The new European guidelines proposed using a PCSK9 inhibitor as a second-line option to consider when needed for people whose very high risk derives primarily from older age and other factors such as smoking or hypertension that give them at least a 10% 10-year risk for cardiovascular death as estimated with the European-oriented SCORE risk calculator tables.

Updated SCORE risk designations appear in the new ESC dyslipidemia guidelines, and they show, for example, that in lower-risk European countries (mostly Western European nations) virtually all men who are at least 70 years old would fall into the very-high-risk category that makes them potential candidates for treatment with a PCSK9 inhibitor regardless of any other risk they may or may not have. In higher-risk (mostly Eastern European) countries this designation kicks in for most men once they reach the age of 65.

Several Congress attendees who came to a discussion session on the guidelines voiced concerns that the new revision will lead to substantially increased use of the these drugs and hence will significantly boost medical costs, because these drugs today are priced at about $6,000 annually to treat one patient. In response, members of the guideline-writing panel defended their decision as unavoidable given what’s been reported on the clinical impact of PCSK9 inhibitors when lowering LDL cholesterol and cutting atherosclerotic cardiovascular disease events.

“I commend the [ESC] guideline for focusing on the science and on what is best for patients. The U.S. guidelines conflated the science and the cost, and the recommendations got watered down by cost considerations,” said Dr. Sabatine, who has led several studies of PCSK9 inhibitors.

Dr. Baigent added that the panel “deliberated long and hard on cost, but we felt that we had to focus on the evidence. The cost will shift” in the future, he predicted.

Other U.S. physicians highlighted the need to take drug cost into account when writing public health policy documents such as lipid-management guidelines and questioned whether this more liberal use of PCSK9 inhibitors was justified.

“I think that in the absence of familial hypercholesterolemia you need to waffle around the edges to justify a PCSK9 inhibitor,” said Dr. Eckel. “The cost of PCSK9 inhibitors has come down, but at $6,000 per year you can’t ignore their cost.”

“In the U.S. we need to be mindful of the cost of treatment,” said Dr. Stone. “The ESC guidelines are probably more aggressive” than the 2018 U.S. guideline. “They use PCSK9 inhibitors perhaps more than we do; we [in the United States] prefer generic ezetimibe. A lot has to do with the definitions of risk. The European guidelines have a lot of risk definitions that differ” from the U.S. guideline, he said.

Members of the ESC guidelines panel acknowledged that the SCORE risk-assessment charts could overestimate risk in older people who need primary prevention treatment, as well as underestimate the risk in younger adults.

This inherent age bias in the SCORE risk tables make it “extremely important to contextualize” a person’s risk “by considering other risk factors,” advised Brian A. Ference, MD, an interventional cardiologist and professor at Cambridge (England) University who was a member of the ESC guidelines writing group.

The new ESC guidelines say that risk categorization “must be interpreted in light of the clinician’s knowledge and experience, and of the patient’s pretest likelihood” of cardiovascular disease.”

Dr. Baigent has received research funding from Boehringer Ingelheim, Novartis, and Pfizer. Dr. Eckel has been an expert witness on behalf of Sanofi/Regeneron. Dr. Sabatine and Dr. Ference have received honoraria and research funding from several companies including those that market lipid-lowering drugs. Dr. Stone and Dr. Collins had no disclosures.

*Correction, 9/20/19: A previous version of this article incorrectly stated that the ESC guidelines were the first by a medical society to recommend the lower cholesterol goals. The American Association of Clinical Endocrinologists included targets below 55 mg/dL in their 2017 dyslipidemia management guidelines.

[email protected]

SOURCE: Mach F et al. Eur Heart J. 2019 Aug 31. doi: 10.1093/eurheartj/ehz455.