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Article: Non-vitamin K antagonist oral anticoagulants in older and frail patients with atrial fibrillation.

Giugliano, Robert P

European heart journal supplements : journal of the European Society of Cardiology

2022 Volume 24, Issue Suppl A, Page(s) A1–A10

Abstract: Elderly and frail patients with atrial fibrillation (AF) are at increased risk of thrombotic events, bleeding, and death compared to their counterparts, making their management challenging. With the introduction of non-vitamin K antagonist (VKA) oral ... ...

Abstract	Elderly and frail patients with atrial fibrillation (AF) are at increased risk of thrombotic events, bleeding, and death compared to their counterparts, making their management challenging. With the introduction of non-vitamin K antagonist (VKA) oral anticoagulants (NOACs) in the past decade, the risk:benefit balance in such high-risk patients with AF has tipped in favor of treating these patients with anticoagulation, and in most cases with a NOAC instead of a VKA. In patients ≥75 years of age with AF, each of the 4 approved NOACs reduced stroke or systemic embolism and vs warfarin in their landmark clinical trial and lowered mortality. However, only apixaban and edoxaban significantly reduced major bleeding vs warfarin. A similar pattern was seen in even older cohorts (≥80 and ≥85 years). Among patients age ≥80 who are not candidates for oral anticoagulants at the approved dose, edoxaban 15 mg may be a reasonable alternative. In elderly or frail individuals who are on multiple comedications (particularly if ≥1 moderate or strong cytochrome P-450 inhibitor), only edoxaban consistently reduced major bleeding compared to warfarin. Regardless of the specific OAC selected, appropriate dosing in the elderly (who frequently qualify for dose reduction per the prescribing label) is critical. In elderly and frail patients with AF, factors that may modify the efficacy-safety profile of specific oral OACs should be carefully considered to permit the optimal selection and dosing in these vulnerable patients.
Language	English
Publishing date	2022-02-14
Publishing country	England
Document type	Journal Article
ZDB-ID	1463769-8
ISSN	1554-2815 ; 1520-765X
ISSN (online)	1554-2815
ISSN	1520-765X
DOI	10.1093/eurheartj/suab150
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Zs.A 1563 -Suppl.-: Show issues

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Article ; Online: Switching to Direct Anticoagulation or Continued Vitamin-K Antagonists in Frail Patients With Atrial Fibrillation in Whom Vitamin-K Antagonists Are Tolerated?

Wallentin, Lars / Giugliano, Robert P

Circulation

2024 Volume 149, Issue 4, Page(s) 290–292

MeSH term(s)	Humans ; Aged ; Atrial Fibrillation/complications ; Atrial Fibrillation/drug therapy ; Atrial Fibrillation/epidemiology ; Frail Elderly ; Anticoagulants/adverse effects ; Blood Coagulation ; Vitamins
Chemical Substances	Anticoagulants ; Vitamins
Language	English
Publishing date	2024-01-22
Publishing country	United States
Document type	Editorial ; Comment
ZDB-ID	80099-5
ISSN	1524-4539 ; 0009-7322 ; 0069-4193 ; 0065-8499
ISSN (online)	1524-4539
ISSN	0009-7322 ; 0069-4193 ; 0065-8499
DOI	10.1161/CIRCULATIONAHA.123.067555
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Article ; Online: Benefit of Combination Ezetimibe/Simvastatin Among High-Risk Populations: Lessons from the IMPROVE-IT Trial.

Oliver, Walter / Giugliano, Robert P

Current atherosclerosis reports

2023 Volume 25, Issue 3, Page(s) 85–93

Abstract: Purpose of review: The Improved Reduction of Outcomes: Vytorin Efficacy International Trial (IMPROVE-IT) demonstrated the clinical benefit of the combination of ezetimibe-simvastatin compared to placebo-simvastatin following acute coronary syndrome (ACS) ...

Abstract	Purpose of review: The Improved Reduction of Outcomes: Vytorin Efficacy International Trial (IMPROVE-IT) demonstrated the clinical benefit of the combination of ezetimibe-simvastatin compared to placebo-simvastatin following acute coronary syndrome (ACS). This review highlights key findings from this study with particular attention to the practice-changing impact on guidelines for low-density lipoprotein cholesterol (LDL-C) reduction after ACS, especially among high-risk populations. Recent findings: Consistent reductions in LDL-C have been reported with newer lipid-lowering therapies (proprotein convertase subtilisin/kexin type 9 inhibitors, cholesterol ester transfer proteins, bempedoic acid) in combination with statin in high-risk subgroups. Since high-risk subgroups remain a focus of guidelines, exploration of high-risk subgroups can help define the optimal use of new therapies. Ezetimibe reduced the LDL-C by 16.7 mg/dL compared to placebo at 1 year, resulting in a significant reduction in the primary composite endpoint (absolute risk difference 2.0%; relative risk difference 6.4%, hazard ratio, 0.936; 95% confidence interval, 0.89 to 0.99; P = 0.016). The benefits achieved with ezetimibe in both LDL-C reduction and the primary clinical composite across 10 pre-specified high-risk subgroups, including the elderly; women; patients with diabetes, prior coronary artery bypass graft, history of stroke, polyvascular disease, low baseline LDL-C, renal dysfunction, prior heart failure, and an elevated TIMI risk score for secondary prevention, were similar or greater than in the corresponding non-high-risk subgroups. Safety events were similar between ezetimibe and placebo across the high-risk subgroups. These data support the addition of ezetimibe to statin therapy in high-risk patients who require additional therapy to lower the LDL-C post-ACS.
MeSH term(s)	Humans ; Female ; Aged ; Ezetimibe, Simvastatin Drug Combination/therapeutic use ; Hydroxymethylglutaryl-CoA Reductase Inhibitors/therapeutic use ; Anticholesteremic Agents/therapeutic use ; Cholesterol, LDL ; Treatment Outcome ; Simvastatin/therapeutic use ; Ezetimibe/therapeutic use ; Acute Coronary Syndrome/drug therapy ; Drug Therapy, Combination
Chemical Substances	Ezetimibe, Simvastatin Drug Combination ; Hydroxymethylglutaryl-CoA Reductase Inhibitors ; Anticholesteremic Agents ; Cholesterol, LDL ; Simvastatin (AGG2FN16EV) ; Ezetimibe (EOR26LQQ24)
Language	English
Publishing date	2023-02-10
Publishing country	United States
Document type	Journal Article ; Review
ZDB-ID	2057369-8
ISSN	1534-6242 ; 1523-3804
ISSN (online)	1534-6242
ISSN	1523-3804
DOI	10.1007/s11883-023-01084-4
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Zs.A 5534: Show issues

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Article ; Online: Proprotein convertase subtilisin/kexin type 9 inhibition after acute coronary syndrome or prior myocardial infarction.

Schwartz, Gregory G / Giugliano, Robert P

Current opinion in lipidology

2022 Volume 33, Issue 3, Page(s) 147–159

Abstract: Purpose of review: Lowering low-density lipoprotein cholesterol (LDL-C) with statins or ezetimibe reduces major adverse cardiovascular events (MACE) in patients with coronary heart disease. Additional treatment with proprotein convertase subtilisin/ ... ...

Abstract	Purpose of review: Lowering low-density lipoprotein cholesterol (LDL-C) with statins or ezetimibe reduces major adverse cardiovascular events (MACE) in patients with coronary heart disease. Additional treatment with proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors may lower LDL-C to levels not achievable with conventional lipid-lowering agents. This review summarizes findings from two large, placebo-controlled trials that evaluated the cardiovascular efficacy of monoclonal antibodies directed against PCSK9, added to background statin therapy, in patients with established atherosclerotic cardiovascular disease (ASCVD) or recent acute coronary syndrome (ACS) and persistent elevation of atherogenic lipoproteins despite statin treatment. Recent findings: The FOURIER trial with evolocumab and the ODYSSEY OUTCOMES trial with alirocumab demonstrated 15% overall reductions in MACE compared to placebo, associated with average achieved LDL-C levels as low as 30-40 mg/dl. Alirocumab treatment was associated with fewer deaths after ACS. Subgroups with large absolute treatment benefit included those with baseline LDL-C ≥100 mg/dl, diabetes, polyvascular or peripheral artery disease, prior coronary bypass surgery, statin intolerance, or elevated lipoprotein(a) levels. No safety concerns arose with use of PCSK9 monoclonal antibodies, even in patients who achieved LDL-C levels below 20 mg/dl. Summary: In selected patients with established ASCVD or recent ACS, PCSK9 inhibitors can play an important role in reducing the risk of MACE, and may also reduce the risk of death after ACS.
MeSH term(s)	Acute Coronary Syndrome/drug therapy ; Antibodies, Monoclonal/adverse effects ; Anticholesteremic Agents/adverse effects ; Atherosclerosis/drug therapy ; Cholesterol, LDL ; Humans ; Hydroxymethylglutaryl-CoA Reductase Inhibitors/therapeutic use ; Myocardial Infarction/drug therapy ; PCSK9 Inhibitors ; Proprotein Convertase 9/genetics ; Proprotein Convertase 9/therapeutic use ; Risk Factors ; Subtilisins/therapeutic use
Chemical Substances	Antibodies, Monoclonal ; Anticholesteremic Agents ; Cholesterol, LDL ; Hydroxymethylglutaryl-CoA Reductase Inhibitors ; PCSK9 Inhibitors ; PCSK9 protein, human (EC 3.4.21.-) ; Proprotein Convertase 9 (EC 3.4.21.-) ; Subtilisins (EC 3.4.21.-)
Language	English
Publishing date	2022-06-15
Publishing country	England
Document type	Journal Article ; Review
ZDB-ID	1045394-5
ISSN	1473-6535 ; 0957-9672
ISSN (online)	1473-6535
ISSN	0957-9672
DOI	10.1097/MOL.0000000000000830
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Zs.A 3010: Show issues

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Article ; Online: Ups and downs in PCSK9 inhibition in the cardiovascular arena: a review.

McClintick, Daniel J / Giugliano, Robert P

Current opinion in lipidology

2023 Volume 34, Issue 6, Page(s) 243–251

Abstract: Purpose of review: This article reviews PCSK9 inhibitors (PCSK9i) with a focus on clinically relevant studies published in the last 18 months.: Recent findings: Prespecified subgroup evaluations, secondary analyses, and open-label extension studies ... ...

Abstract	Purpose of review: This article reviews PCSK9 inhibitors (PCSK9i) with a focus on clinically relevant studies published in the last 18 months. Recent findings: Prespecified subgroup evaluations, secondary analyses, and open-label extension studies from the two landmark trials, FOURIER and ODYSSEY Outcomes, have provided new data on the safety and efficacy of the monoclonal PCSK9 antibodies evolocumab and alirocumab. Recent studies of PCSK9i early in ACS and post percutaneous coronary intervention have explored early effects on biomarkers and plaque morphology with various imaging modalities. Two large outcome trials with PCSK9i in lower risk patients without prior myocardial infarction or stroke are ongoing and could expand the eligible population for these potent therapies. Additionally, novel methods to inhibit PCSK9 using oral administration, vaccination, and gene therapy are in various stages of clinical development. Summary: PCSK9i represent a potent class of lipid-lowering therapies that are well tolerated and effective in a wide group of patients with high-risk atherosclerotic cardiovascular disease. Ongoing studies of PCSK9i in patients at lower risk and with acute myocardial infarction have the potential to broaden their indication. Alternative methods of PCSK9i are being evaluated and could provide easier and less expensive options for this important class of medication.
MeSH term(s)	Humans ; Anticholesteremic Agents/therapeutic use ; Proprotein Convertase 9/genetics ; PCSK9 Inhibitors ; Antibodies, Monoclonal/adverse effects ; Myocardial Infarction ; Cardiovascular Diseases/drug therapy ; Cardiovascular Diseases/chemically induced
Chemical Substances	Anticholesteremic Agents ; PCSK9 protein, human (EC 3.4.21.-) ; Proprotein Convertase 9 (EC 3.4.21.-) ; PCSK9 Inhibitors ; Antibodies, Monoclonal
Language	English
Publishing date	2023-08-22
Publishing country	England
Document type	Review ; Journal Article
ZDB-ID	1045394-5
ISSN	1473-6535 ; 0957-9672
ISSN (online)	1473-6535
ISSN	0957-9672
DOI	10.1097/MOL.0000000000000897
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Zs.A 3010: Show issues

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Article ; Online: Adenosine Triphosphate Citrate Lyase and Fatty Acid Synthesis Inhibition: A Narrative Review.

Duarte Lau, Freddy / Giugliano, Robert P

JAMA cardiology

2023 Volume 8, Issue 9, Page(s) 879–887

Abstract: Importance: Adenosine triphosphate citrate lyase (ACLY) is a key regulatory enzyme of glucose metabolism, cholesterol and fatty acid synthesis, and the inflammatory cascade. Bempedoic acid, an ACLY inhibitor, significantly reduces atherogenic lipid ... ...

Abstract	Importance: Adenosine triphosphate citrate lyase (ACLY) is a key regulatory enzyme of glucose metabolism, cholesterol and fatty acid synthesis, and the inflammatory cascade. Bempedoic acid, an ACLY inhibitor, significantly reduces atherogenic lipid markers, including low-density lipoprotein cholesterol (LDL-C), non-high-density lipoprotein cholesterol, and apolipoprotein B. Additional effects of ACLY inhibition include antitumor growth; reduction of triglycerides and proinflammatory molecules such as high-sensitivity C-reactive protein; less insulin resistance; reduction of hepatic lipogenesis; and weight loss. Observations: While numerous ACLY inhibitors have been identified, most of the clinical data have focused on bempedoic acid. The Cholesterol Lowering via Bempedoic Acid, an ACL-Inhibiting Regimen (CLEAR) program was a series of phase 3 clinical trials that evaluated its effects on lipid parameters and safety, leading to US Food and Drug Administration approval in 2020. CLEAR Outcomes was a phase 3, double-blind, randomized, placebo-controlled trial in individuals with a history of statin intolerance, serum LDL-C level of 100 mg/dL or higher, and a history of, or at high risk for, cardiovascular disease. Bempedoic acid modestly reduced the primary 4-way cardiovascular composite end point as well as the individual components of myocardial infarction and coronary revascularization but did not reduce stroke, cardiovascular death, or all-cause mortality. Rates of gout and cholelithiasis were higher with bempedoic acid, and small increases in serum creatinine, uric acid, and hepatic-enzyme levels were also observed. Conclusions and relevance: ACLY inhibition with bempedoic acid has been established as a safe and effective therapy in high-risk patients who require further LDL-C lowering, particularly for those with a history of statin intolerance. The recently published CLEAR Outcomes trial revealed modest reductions in cardiovascular events with bempedoic acid, proportional to its LDL-C lowering, in high-risk individuals with statin intolerance and LDL-C levels of 100 mg/dL or higher. The additional effects of ACLY inhibition have prompted a more thorough search for novel ACLY inhibitors for conditions such as cancer, hypertriglyceridemia, chronic inflammation, type 2 diabetes, fatty liver disease, obesity, and metabolic syndrome. Similarly, therapies that reduce fatty acid synthesis are being explored for their use in cardiometabolic conditions.
MeSH term(s)	Humans ; Cholesterol ; Cholesterol, LDL ; Clinical Trials, Phase III as Topic ; Diabetes Mellitus, Type 2/drug therapy ; Fatty Acids/antagonists & inhibitors ; Fatty Acids/metabolism ; Hydroxymethylglutaryl-CoA Reductase Inhibitors/therapeutic use ; Lipogenesis ; Randomized Controlled Trials as Topic ; ATP Citrate (pro-S)-Lyase/antagonists & inhibitors ; ATP Citrate (pro-S)-Lyase/metabolism
Chemical Substances	8-hydroxy-2,2,14,14-tetramethylpentadecanedioic acid (1EJ6Z6Q368) ; Cholesterol (97C5T2UQ7J) ; Cholesterol, LDL ; Fatty Acids ; Hydroxymethylglutaryl-CoA Reductase Inhibitors ; ATP Citrate (pro-S)-Lyase (EC 2.3.3.8)
Language	English
Publishing date	2023-08-11
Publishing country	United States
Document type	Review ; Journal Article
ISSN	2380-6591
ISSN (online)	2380-6591
DOI	10.1001/jamacardio.2023.2402
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Article ; Online: Response by O'Donoghue et al to Letter Regarding Article, "Long-Term Evolocumab in Patients With Established Atherosclerotic Cardiovascular Disease".

O'Donoghue, Michelle L / Giugliano, Robert P / Sabatine, Marc S

Circulation

2023 Volume 147, Issue 16, Page(s) 1258–1259

MeSH term(s)	Humans ; Cardiovascular Diseases/drug therapy ; Atherosclerosis/drug therapy ; Antibodies, Monoclonal, Humanized/therapeutic use ; Patients
Chemical Substances	evolocumab (LKC0U3A8NJ) ; Antibodies, Monoclonal, Humanized
Language	English
Publishing date	2023-04-17
Publishing country	United States
Document type	Journal Article ; Comment
ZDB-ID	80099-5
ISSN	1524-4539 ; 0009-7322 ; 0069-4193 ; 0065-8499
ISSN (online)	1524-4539
ISSN	0009-7322 ; 0069-4193 ; 0065-8499
DOI	10.1161/CIRCULATIONAHA.123.064048
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Article ; Online: Lipoprotein(a) and its Significance in Cardiovascular Disease: A Review.

Duarte Lau, Freddy / Giugliano, Robert P

JAMA cardiology

2022 Volume 7, Issue 7, Page(s) 760–769

Abstract: Importance: Lipoprotein(a) (Lp[a]) is a low-density lipoprotein (LDL) cholesterol-like particle bound to apolipoprotein(a). This novel marker of cardiovascular disease acts through induction of vascular inflammation, atherogenesis, calcification, and ... ...

Abstract	Importance: Lipoprotein(a) (Lp[a]) is a low-density lipoprotein (LDL) cholesterol-like particle bound to apolipoprotein(a). This novel marker of cardiovascular disease acts through induction of vascular inflammation, atherogenesis, calcification, and thrombosis. While an absolute risk threshold remains to be universally accepted, an estimated 20% to 25% of the global population have Lp(a) levels of 50 mg/dL or higher, a level noted by the European Atherosclerosis Society to confer increased cardiovascular risk. Observations: Compelling evidence from pathophysiological, observational, and genetic studies suggest a potentially causal association between high Lp(a) levels, atherosclerotic cardiovascular disease, and calcific aortic valve stenosis. Additional evidence has demonstrated that elevated Lp(a) levels are associated with a residual cardiovascular risk despite traditional risk factor optimization, including LDL cholesterol reduction. These findings have led to the formulation of the Lp(a) hypothesis, namely that Lp(a) lowering leads to cardiovascular risk reduction, intensifying the search for Lp(a)-reducing therapies. The ineffectiveness of lifestyle modification, statins, and ezetimibe to lower Lp(a); the modest Lp(a) reduction with proprotein convertase subtilisin/kexin type 9 inhibitors; the adverse effect profile and unclear cardiovascular benefit of pharmacotherapies such as niacin and mipomersen; and the impracticality of regular lipoprotein apheresis represent major challenges to currently available therapies. Nevertheless, emerging nucleic acid-based therapies, such as the antisense oligonucleotide pelacarsen and the small interfering RNA olpasiran, are generating interest because of their potent Lp(a)-lowering effects. Assessment of new-onset diabetes in patients achieving very low Lp(a) levels will be important in future trials. Conclusions and relevance: Epidemiologic and genetic studies suggest a potentially causal association between elevated Lp(a) levels, atherosclerotic cardiovascular disease, and aortic valve stenosis. Emerging nucleic acid-based therapies have potent Lp(a)-lowering effects and appear safe; phase 3 trials will establish whether they improve cardiovascular outcomes.
MeSH term(s)	Aortic Valve Stenosis/therapy ; Atherosclerosis/drug therapy ; Cardiovascular Diseases/drug therapy ; Cardiovascular Diseases/therapy ; Humans ; Hydroxymethylglutaryl-CoA Reductase Inhibitors/therapeutic use ; Lipoprotein(a)/metabolism ; Nucleic Acids/therapeutic use
Chemical Substances	Hydroxymethylglutaryl-CoA Reductase Inhibitors ; Lipoprotein(a) ; Nucleic Acids
Language	English
Publishing date	2022-05-29
Publishing country	United States
Document type	Journal Article ; Review
ISSN	2380-6591
ISSN (online)	2380-6591
DOI	10.1001/jamacardio.2022.0987
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Article ; Online: Management of LDL-cholesterol after an acute coronary syndrome: Key comparisons of the American and European clinical guidelines to the attention of the healthcare providers.

Gencer, Baris / Giugliano, Robert P

Clinical cardiology

2020 Volume 43, Issue 7, Page(s) 684–690

Abstract: Guidelines for the management of blood cholesterol were updated in the past year in the United States and Europe, reflecting a more intensive approach to lowering low-density lipoprotein cholesterol (LDL-C). The American College of Cardiology/American ... ...

Abstract	Guidelines for the management of blood cholesterol were updated in the past year in the United States and Europe, reflecting a more intensive approach to lowering low-density lipoprotein cholesterol (LDL-C). The American College of Cardiology/American Heart Association task force on practice guideline released the 2018 guideline on the management of blood cholesterol on behalf of several American societies. Approximately 9 months later, the European Society of Cardiology/European Atherosclerosis Society published their 2019 guideline for the management of dyslipidemias. Both guidelines have similarities for the management of patients with acute coronary syndromes. Both emphasize risk assessment of patients as a main approach to guide therapy; those at higher risk of cardiovascular disease have a greater clinical benefit of LDL-C reduction by at least 50%. Both guidelines reinforce the indication to lower LDL-C as an important modifiable risk factor and consider the addition of nonstatin agents, such as ezetimibe and proprotein convertase subtilisin kexin 9 (PCSK9) inhibitors, in addition to lifestyle counseling and high-intensity statin for further reduction of LDL-C levels. However, the guidelines have differences in the concepts of treatment thresholds (≥70 mg/dL in the United States) vs treatment goals (< 55 mg/dL in Europe), in the definition of very high-risk category and in the classes for recommendation for the use of PCSK9 inhibitors.
Language	English
Publishing date	2020-06-29
Publishing country	United States
Document type	Journal Article ; Review
ZDB-ID	391935-3
ISSN	1932-8737 ; 0160-9289
ISSN (online)	1932-8737
ISSN	0160-9289
DOI	10.1002/clc.23410
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Article: Low-density lipoprotein cholesterol lowering therapy for the secondary prevention of atherosclerotic cardiovascular disease.

Patel, Parth N / Giugliano, Robert P

Global cardiology science & practice

2020 Volume 2020, Issue 3, Page(s) e202039

Abstract: Atherosclerotic cardiovascular disease (ASCVD) is highly prevalent and a major contributor to morbidity and mortality worldwide. Elevated blood cholesterol is a key driver of risk for atherosclerotic events, and patients with established ASCVD comprise a ...

Abstract	Atherosclerotic cardiovascular disease (ASCVD) is highly prevalent and a major contributor to morbidity and mortality worldwide. Elevated blood cholesterol is a key driver of risk for atherosclerotic events, and patients with established ASCVD comprise a specific high-risk population in which low-density lipoprotein cholesterol (LDL-C) lowering therapy is strongly endorsed by multiple guidelines. An increasing number of medications across several pharmacologic classes are available today in clinical practice. Therefore, guidance on the appropriate use of these interventions is necessary for cost-effective solutions to managing residual atherothrombotic risk. In this review we summarize the key evidence supporting LDL-C lowering as described in the most recent 2018 multi-society Blood Cholesterol Guidelines, and provide a framework for optimizing LDL-C lowering therapy in secondary prevention populations.
Language	English
Publishing date	2020-12-31
Publishing country	Qatar
Document type	Journal Article ; Review
ZDB-ID	2738381-7
ISSN	2305-7823
ISSN	2305-7823
DOI	10.21542/gcsp.2020.39
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