Efficacy and Safety of Evolocumab in Reducing Lipids and Cardiovascular Events
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To convert the values for low-density lipoprotein (LDL) cholesterol to millimoles per liter, multiply by 0.02586.† Included in this category is the number of patients who underwent randomization and received at least one dose of a study drug.‡ Patients who were enrolled in phase 2 parent trials and who agreed to participate in the extension study were enrolled in OSLER-1.§ Patients who were enrolled in phase 3 parent trials and who agreed to participate in the extension study were enrolled in OSLER-2.
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One PCSK9 antibody showed benefit only among patients with a baseline LDL cholesterol level of at least 100 mg per deciliter.
“with one agent showing benefit only among patients who had a baseline LDL cholesterol level of at least 100 mg per deciliter (2.6 mmol per liter). 12”
From Alirocumab and Cardiovascular Outcomes after Acute Coronary Syndrome (2018) · cites this paper as [12]
The Cardiovascular Events section reports a lower event rate with evolocumab than with standard therapy in the overall study population. It does not report that benefit was limited to patients whose baseline LDL cholesterol was at least 100 mg/dl; the 100-mg/dl thresholds in the End Points table describe eligibility for some parent trials, not a cardiovascular-benefit subgroup. (LLM, conf=0.84)
Experimental — accuracy not yet measuredBoth the current trial and the SPIRE trial showed a more prominent absolute reduction in the risk of cardiovascular outcomes with PCSK9 inhibition among patients with a baseline LDL cholesterol level of 100 mg/dL or more.
“Both our trial and the SPIRE trial showed a more prominent absolute reduction in the risk of cardiovascular outcomes with PCSK9 inhibition among patients who had a baseline LDL cholesterol level of 100 mg or more per deciliter. 12”
From Alirocumab and Cardiovascular Outcomes after Acute Coronary Syndrome (2018) · cites this paper as [12]
The Results (page unavailable) report a lower overall cardiovascular-event rate with evolocumab than with standard therapy, but do not report a greater absolute reduction among patients with baseline LDL cholesterol of at least 100 mg/dL. The Discussion (page unavailable) describes the SPIRE outcomes trials as still in progress, so this paper does not establish the claimed SPIRE finding. (LLM, conf=0.89)
Experimental — accuracy not yet measuredIn initial trials of PCSK9 inhibitors, the incidence of neurocognitive adverse events was very low (<1%) but slightly higher albeit non-significantly in the treated groups compared with placebo (0.9% vs. 0.3% for evolocumab; 1.2% vs. 0.5% for alirocumab).
“In the initial trials of these drugs, the incidence of neurocognitive adverse events (including delirium, cognitive and attentional disturbances, dementia, thought and perceptual disturbances, and psychiatric disorders) was very low (<1%) but slightly higher albeit non-significantly in the treated groups compared with placebo (0.9% vs. 0.3% for evolocumab) (81) (1.2% vs. 0.5% for alirocumab) (82).”
From PCSK9 and the nervous system: a no-brainer? (2023) · cites this paper as [82]
Table 3 in the Discussion reports neurocognitive events in 27 evolocumab patients (0.9%) and 4 comparator patients (0.3%); the Safety and Side-Effect Profile also describes the rate as below 1% and higher with evolocumab. The comparator was standard therapy, not placebo. The cited passages do not establish that the between-group difference was statistically non-significant; the Results’ statement about non-significance concerns differences by achieved LDL-cholesterol level. (LLM, conf=0.88)
Experimental — accuracy not yet measuredThere were little more than 100 events in the phase 2 and phase 3 trials of PCSK9 inhibitors combined.
“However, there were little more than 100 events in these studies combined.”
From Evolocumab and Clinical Outcomes in Patients with Cardiovascular Disease (2017) · cites this paper as [9]
The Results passage reproduced in the Discussion reports 29 cardiovascular events in the evolocumab group and 31 in the standard-therapy group—60 in the combined OSLER trials. The paper identifies these as follow-up trials for participants from phase 2 and phase 3 studies, but it does not establish the claimed total of little more than 100 events across the studies referred to by the citing sentence. (LLM, conf=0.84)
Experimental — accuracy not yet measuredMonoclonal antibodies to PCSK9 produce substantial reductions in LDL cholesterol when administered alone or with a statin.
“These findings have led to the development of monoclonal antibodies to PCSK9 that produce substantial reductions in LDL cholesterol when administered alone or with a statin. 8-12”
From Alirocumab and Cardiovascular Outcomes after Acute Coronary Syndrome (2018) · cites this paper as [12]
Exploratory data from longer-term follow-up in phase 2 and phase 3 trials of PCSK9 inhibitors showed significant reductions in cardiovascular outcomes.
“Moreover, exploratory data from longer-term follow-up in phase 2 and phase 3 trials of PCSK9 inhibitors showed significant reductions in cardiovascular outcomes.9,10”
From Evolocumab and Clinical Outcomes in Patients with Cardiovascular Disease (2017) · cites this paper as [9]
Bile acid sequestrants have no major effect on HDL-C, but triglycerides may increase in some predisposed patients.
“No major effect on HDL-C has been reported, while TGs may increase in some predisposed patients [274].”
From 2019 ESC/EAS guidelines for the management of dyslipidaemias: lipid modification to reduce cardiovascular risk (2019) · cites this paper as [274]
At top daily doses of 24 g cholestyramine, 20 g colestipol, or 4.5 g colesevelam, LDL-C reduction of 18-25% has been observed.
“At the top daily dose of 24 g of cholestyramine, 20 g of colestipol, or 4.5 g of colesevelam, a reduction in LDL-C of 18-25% has been observed.”
From 2019 ESC/EAS guidelines for the management of dyslipidaemias: lipid modification to reduce cardiovascular risk (2019) · cites this paper as [274]
PCSK9 inhibitors and nicotinic acid reduce lipoprotein(a) by approximately 30%.
“Proprotein convertase subtilisin/ kexin type 9 (PCSK9) inhibitors and nicotinic acid reduce Lp(a) by ≏ 30%. 115-117”
From 2016 ESC/EAS Guidelines for the Management of Dyslipidaemias (2016) · cites this paper as [116]
PCSK9 inhibitors reduce LDL-C by 50-70%, independent of background therapy; preliminary phase 3 data suggest CV event reduction in line with LDL-C reduction.
“The efficacy at reducing LDL-C is in the range of 50-70%, independent of the presence of a background therapy (statins, ezetimibe, etc.); preliminary data from phase 3 trials suggest a reduction of CV events in line with the LDL-C reduction achieved.”
From 2016 ESC/EAS Guidelines for the Management of Dyslipidaemias (2016) · cites this paper as [116]
Recent data with PCSK9 inhibitors indicate similar efficacy in reducing LDL-C in women and men.
“Recent data with PCSK9 inhibitors indicate a similar efficacy in reducing LDL-C in women vs. men. 115,116”
From 2016 ESC/EAS Guidelines for the Management of Dyslipidaemias (2016) · cites this paper as [116]
Studies of PCSK9 inhibitors that included post-ACS or very high-risk patients were promising, and definitive outcome studies are awaited.
“Results in studies with PCSK9 inhibitors that included post-ACS/very high-risk patients were promising 115,116 and definitive outcome studies are awaited.”
From 2016 ESC/EAS Guidelines for the Management of Dyslipidaemias (2016) · cites this paper as [116]
The efficacy of PCSK9 inhibitors at reducing LDL cholesterol is in the range of 50-70%, independent of background therapy, and preliminary phase 3 data suggest a reduction of cardiovascular events in line with the LDL cholesterol reduction achieved.
“The efficacy at reducing LDL-C is in the range of 50e70%, independent of the presence of a background therapy (statins, ezetimibe, etc.); preliminary data from phase 3 trials suggest a reduction of CV events in line with the LDL-C reduction achieved.115,116”
From 2016 ESC/EAS Guidelines for the Management of Dyslipidaemias (2016) · cites this paper as [116]
Recent data with PCSK9 inhibitors indicate similar efficacy in reducing LDL-C in women versus men.
“Recent data with PCSK9 inhibitors indicate a similar efficacy in reducing LDL-C in women vs. men.115,116”
From 2016 ESC/EAS Guidelines for the Management of Dyslipidaemias (2016) · cites this paper as [116]
Combination therapy using a statin and ezetimibe prevents ASCVD incidence in patients with acute coronary syndrome.
“Combination therapy using statin and ezetimibe prevents ASCVD incidence in patients with ACS. (Evidence level 1+, recommendation level: B).”
From Japan Atherosclerosis Society (JAS) guidelines for prevention of atherosclerotic cardiovascular diseases 2017 (2018) · cites this paper as [636]
The IMPROVE-IT study revealed a significantly lower ASCVD incidence in ACS subjects with controlled LDL-C levels when ezetimibe was added to simvastatin treatment.
“The IMPROVE-IT study636) which enrolled ACS subjects (secondary prevention) with controlled LDL-C levels (50–100 mg/dL) under simvastatin treatment, revealed a significantly lower ASCVD incidence in the group for which ezetimibe was added on to simvastatin treatment.”
From Japan Atherosclerosis Society (JAS) guidelines for prevention of atherosclerotic cardiovascular diseases 2017 (2018) · cites this paper as [636]
The IMPROVE-IT study revealed that lowering LDL-C to 53.6 mg/dL using statin-ezetimibe combination therapy suppressed cardiovascular events by 6.4% more than controlling LDL-C at 69.5 mg/dL with statins only.
“Regarding the LDL-C management target, the IMPROVE-IT636) study revealed that lowering the LDL-C level to 53.6 mg/dL using statin–ezetimibe combination therapy suppressed cardiovascular events by 6.4% more than the group that had their LDL-C level controlled at 69.5 mg/dL with statins only.”
From Japan Atherosclerosis Society (JAS) guidelines for prevention of atherosclerotic cardiovascular diseases 2017 (2018) · cites this paper as [636]
The PCSK9 inhibitors alirocumab and evolocumab dramatically reduce LDL-C levels over and above statin therapy, with favorable short-term outcomes data up to 18 months.
“(10,11).These agents dramatically reduce LDL-C levels over and above statin therapy, with favorable short-term outcomes data up to 18 months (11,12).”
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- Authors
- Sabatine, M. S., Giugliano, R. P., Wiviott, S. D., Raal, F. J., Blom, D. J., Robinson, J., Ballantyne, C. M., Somaratne, R., Legg, J., Wasserman, S. M., Scott, R., Koren, M. J., & Stein, E. A.
- Affiliations
- University of Iowa (US)
- Harvard University (US)
- University of the Witwatersrand (ZA)
- University of Cape Town (ZA)
- Houston Methodist (US)
- Amgen (United States) (US)
- Jacksonville Center for Clinical Research (US)
- ORCID
- Venue
- New England Journal of Medicine
- Publisher
- Massachusetts Medical Society
- Published
- 2015-04-16
- Volume
- 372
- Issue
- 16
- Pages
- 1500-1509
- ISSN
- 0028-4793 (ISSN-L)
- 1533-4406
- OpenAlex
- W4238580056
- Semantic Scholar
- 3a2aa2d61647c779adc7c8fa42c75fb373940128
- Cited by
- 1,509
- References
- 26
- Citations by year
- 2026: 44 · 2025: 54 · 2024: 71 · 2023: 73 · 2022: 88 · 2021: 91 · 2020: 104 · 2019: 148 · 2018: 152 · 2017: 261 · 2016: 277 · 2015: 141 · 2013: 1
- FWCI
- 279.20
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- New England Journal of Medicine (publishedVersion)
- Topics
- Health Sciences › Medicine › Surgery › Lipoproteins and Cardiovascular Health
- Life Sciences › Immunology and Microbiology › Immunology › Atherosclerosis and Cardiovascular Diseases
- Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Antiplatelet Therapy and Cardiovascular Diseases
- Keywords
- evolocumab, PCSK9 inhibitors, LDL cholesterol lowering, cardiovascular events, lipid-lowering therapy, drug efficacy, drug safety
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