Cardiovascular Efficacy and Safety of Bococizumab in High-Risk Patients
Open accessAbstract
BACKGROUND: Bococizumab is a humanized monoclonal antibody that inhibits proprotein convertase subtilisin-kexin type 9 (PCSK9) and reduces levels of low-density lipoprotein (LDL) cholesterol. We sought to evaluate the efficacy of bococizumab in patients at high cardiovascular risk. METHODS: In two parallel, multinational trials with different entry criteria for LDL cholesterol levels, we randomly assigned the 27,438 patients in the combined trials to receive bococizumab (at a dose of 150 mg) subcutaneously every 2 weeks or placebo. The primary end point was nonfatal myocardial infarction, nonfatal stroke, hospitalization for unstable angina requiring urgent revascularization, or cardiovascular death; 93% of the patients were receiving statin therapy at baseline. The trials were stopped early after the sponsor elected to discontinue the development of bococizumab owing in part to the development of high rates of antidrug antibodies, as seen in data from other studies in the program. The median follow-up was 10 months. RESULTS: At 14 weeks, patients in the combined trials had a mean change from baseline in LDL cholesterol levels of -56.0% in the bococizumab group and +2.9% in the placebo group, for a between-group difference of -59.0 percentage points (P<0.001) and a median reduction from baseline of 64.2% (P<0.001). In the lower-risk, shorter-duration trial (in which the patients had a baseline LDL cholesterol level of ≥70 mg per deciliter [1.8 mmol per liter] and the median follow-up was 7 months), major cardiovascular events occurred in 173 patients each in the bococizumab group and the placebo group (hazard ratio, 0.99; 95% confidence interval [CI], 0.80 to 1.22; P=0.94). In the higher-risk, longer-duration trial (in which the patients had a baseline LDL cholesterol level of ≥100 mg per deciliter [2.6 mmol per liter] and the median follow-up was 12 months), major cardiovascular events occurred in 179 and 224 patients, respectively (hazard ratio, 0.79; 95% CI, 0.65 to 0.97; P=0.02). The hazard ratio for the primary end point in the combined trials was 0.88 (95% CI, 0.76 to 1.02; P=0.08). Injection-site reactions were more common in the bococizumab group than in the placebo group (10.4% vs. 1.3%, P<0.001). CONCLUSIONS: In two randomized trials comparing the PCSK9 inhibitor bococizumab with placebo, bococizumab had no benefit with respect to major adverse cardiovascular events in the trial involving lower-risk patients but did have a significant benefit in the trial involving higher-risk patients. (Funded by Pfizer; SPIRE-1 and SPIRE-2 ClinicalTrials.gov numbers, NCT01975376 and NCT01975389 .).
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Two PCSK9 antibodies reduce the risk of ischemic cardiovascular events in patients with stable atherosclerotic disease or high cardiovascular risk and elevated atherogenic lipoproteins despite statin treatment.
“Two of these agents were reported to reduce the risk of ischemic cardiovascular events in patients who had stable atherosclerotic disease or high cardiovascular risk and an elevated level of atherogenic lipoproteins despite statin treatment, 11,13”
From Alirocumab and Cardiovascular Outcomes after Acute Coronary Syndrome (2018) · cites this paper as [13]
The Discussion reports that bococizumab significantly reduced the primary cardiovascular end point in the higher-risk SPIRE-2 trial, but found no significant benefit in SPIRE-1. Patient Enrollment describes elevated LDL cholesterol and generally required statin treatment, with an exception for statin-intolerant SPIRE-2 patients. Thus the source supports a benefit in a narrower group, not an unqualified reduction across the patients described in the claim. (LLM, conf=0.88)
Experimental — accuracy not yet measuredIn prior large trials (JUPITER, CIRT, CANTOS, SPIRE), placebo groups showed no substantive changes in LDL cholesterol, IL-1β, IL-6, or hsCRP over 3-5 years, and in STRENGTH (corn oil placebo) biomarker levels did not increase over time.
“No substantive biomarker changes were observed in the placebo groups over periods of 3 to 5 years for measures of LDL cholesterol, interleukin-1β, interleukin-6, or hsCRP in the large-scale JUPITER (Justification for the Use of Statin in Prevention: An Intervention Trial Evaluating Rosuvastatin), CIRT (Cardiovascular Inflammation Reduction Trial), CANTOS (Canakinumab Anti-Inflammatory Thrombosis”
From Effects of Randomized Treatment With Icosapent Ethyl and a Mineral Oil Comparator on Interleukin-1β, Interleukin-6, C-Reactive Protein, Oxidized Low-Density Lipoprotein Cholesterol, Homocysteine, Lipoprotein(a), and Lipoprotein-Associated Phospholipase A2: A REDUCE-IT Biomarker Substudy (2022) · cites this paper as [17]
Bococizumab versus placebo over about 1 year median exposure produced a small but significant fasting glucose increase without excess new-onset diabetes risk.
“A small but significant increase in fasting glucose without excess risk of new-onset diabetes was reported with bococizumab compared with placebo over a median exposure of about 1 year.11”
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Self-citation
- Authors
- Ridker, P. M., Revkin, J., Amarenco, P., Brunell, R., Curto, M., Civeira, F., Flather, M., Glynn, R. J., Gregoire, J., Jukema, J. W., Karpov, Y., Kastelein, J. J. P., Koenig, W., Lorenzatti, A., Manga, P., Masiukiewicz, U., Miller, M., Mosterd, A., Murin, J., Nicolau, J. C., Nissen, S., Ponikowski, P., Santos, R. D., Schwartz, P. F., Soran, H., White, H., Wright, R. S., Vrablik, M., Yunis, C., Shear, C. L., & Tardif, J.-C.
- Affiliations
- Brigham and Women's Hospital (US)
- University of East Anglia (GB)
- University of Maryland, Baltimore (US)
- ORCID
- Ridker, Paul M
- Revkin, James
- Amarenco, Pierre
- Civeira, Fernando
- Flather, Marcus
- Glynn, Robert J.
- Jukema, J. Wouter
- Kastelein, John J.P.
- Lorenzatti, Alberto
- Manga, Pravin
- Masiukiewicz, Urszula
- Miller, Michael
- Mosterd, Arend
- Nissen, Steven
- Ponikowski, Piotr
- Santos, Raul D.
- Soran, Handrean
- White, Harvey
- Yunis, Carla
- Tardif, Jean-Claude
- Venue
- New England Journal of Medicine
- Publisher
- Massachusetts Medical Society
- Published
- 2017-04-20
- Volume
- 376
- Issue
- 16
- Pages
- 1527-1539
- ISSN
- 0028-4793 (ISSN-L)
- 1533-4406
- OpenAlex
- W2596236174
- Cited by
- 624
- References
- 13
- Citations by year
- 2026: 13 · 2025: 29 · 2024: 41 · 2023: 57 · 2022: 42 · 2021: 46 · 2020: 71 · 2019: 116 · 2018: 115 · 2017: 92 · 2013: 1
- FWCI
- 110.41
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- New England Journal of Medicine (publishedVersion)
- LA Referencia (Red Federada de Repositorios Institucionales de Publicaciones Científicas) (publishedVersion, other-oa)
- PubMed (publishedVersion)
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- Amsterdam UMC (VU Amsterdam) - Institutional Repository (publishedVersion, other-oa)
- University of Southern Denmark Research Portal (University of Southern Denmark) (publishedVersion)
- ENLIGHTEN (Jurnal Bimbingan dan Konseling Islam) (acceptedVersion)
- UEA Digital Repository (University of East Anglia) (acceptedVersion)
- IRIS Research product catalog (Sapienza University of Rome) (submittedVersion, other-oa)
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- Lume (Universidade Federal do Rio Grande do Sul) (submittedVersion, other-oa)
- Lund University Publications (Lund University) (submittedVersion)
- mediaTUM (Technical University of Munich) (submittedVersion)
- Edge Hill University Research Information Repository (Edge Hill University) (submittedVersion)
- Radboud Repository (Radboud University) (submittedVersion)
- SERVAL (Université de Lausanne) (submittedVersion)
- VUBIR (Vrije Universiteit Brussel) (submittedVersion)
- LA Referencia (Red Federada de Repositorios Institucionales de Publicaciones Científicas) (submittedVersion, cc-by-nc-sa)
- Zaguan (University of Zaragoza Repository) (submittedVersion)
- Research Publications (Maastricht University) (submittedVersion, other-oa)
- Utrecht University Repository (Utrecht University) (submittedVersion, other-oa)
- 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 › Acute Myocardial Infarction Research
- Keywords
- bococizumab, PCSK9 inhibition, LDL cholesterol lowering, high cardiovascular risk, major adverse cardiovascular events, statin therapy, antidrug antibodies, cardiovascular safety, hypercholesterolemia, primary prevention of cardiovascular disease, secondary prevention of cardiovascular disease, myocardial infarction, stroke, unstable angina
- MeSH terms
- Proprotein Convertase 9, PCSK9 Inhibitors, Antibodies, Anticholesteremic Agents, Cardiovascular Diseases, Double-Blind Method, Female, Follow-Up Studies, Humans, Hypercholesterolemia, Injections, Subcutaneous, Lipids, Cholesterol, LDL, Male, Middle Aged, Risk Factors, Treatment Failure, Antibodies, Monoclonal, Humanized
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