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Cardiovascular Efficacy and Safety of Bococizumab in High-Risk Patients
Journal Contribution - Journal Article
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.
Journal: N. Engl. J. Med.
ISSN: 0028-4793
Issue: 16
Volume: 376
Pages: 1527-1539
Publication year:2017
Keywords:Statin therapy, GENETIC-VARIANTS, REDUCING LIPIDS
- VABB Id: c:vabb:487776
- ORCID: /0000-0003-3211-7134/work/105290015
- ORCID: /0000-0001-5273-5453/work/79832606
- ORCID: /0000-0001-9946-6158/work/71701077
- ORCID: /0000-0001-6991-5493/work/71466549
- Scopus Id: 85018314556
- ORCID: /0000-0002-6581-7009/work/65860492
- DOI: https://doi.org/10.1056/nejmoa1701488
Authors:International
Accessibility:Closed
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- P. G. Suryanarayana (Author)
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- Michael Lee (Author)
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- M. Kelberman (Author)
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- R. H. Chochinov (Author)
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- Sophie Singh (Author)
- D. Baldari (Author)
- Sr Kaster (Author)
- J. P. Lovell (Author)
- B. S. Horowitz (Author)
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- Anh Dao Nguyen Pham (Author)
- J. S. Landzberg (Author)
- K. I. Mootoo (Author)
- Eun-Yi Moon (Author)
- J. Krawczyk (Author)
- A. D. Alfieri (Author)
- M. J. Janik (Author)
- D. M. Herrington (Author)
- R. N. Koilpillai (Author)
- A. R. Waxler (Author)
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- Z. H. Sahul (Author)
- Barry Gumbiner (Author)
- Anne Cropp (Author)
- Kayo Fujita (Author)
- Pamela Garzone (Author)
- Keiji Imai (Author)
- Matteo Levisetti (Author)
- David Plowchalk (Author)
- Stephen Sasson (Author)
- Judy Skaggs (Author)
- Kevin Sweeney (Author)
- John Vincent (Author)
- Massachussetts Medical Society (Publisher)
Research units
- Faculty of Sciences and Bioengineering Sciences(Faculty)
- Mechanics of Materials and Constructions(Department)
- Geography(Department)
- Internal Medicine Specializations(Department)
- Diabetes Clinic(Department)
- Clinical sciences(Department)
- Cardiology(Department)
- Biomechanics and Human Biometry(Department)
- Faculty of Engineering(Faculty)
- Electronics and Informatics(Department)
- Faculty of Psychology and Educational Sciences(Faculty)
- Faculty of Arts and Philosophy(Faculty)
- Vriendenkring VUB(Office)
- Faculty of Law and Criminology(Faculty)
- Faculty of Economic and Social Sciences and Solvay Business School(Faculty)
- Political Science(Department)
- Dental Clinic(Administrative office)
- Faculty of Medicine and Pharmacy(Faculty)
- Administrative Information Processing(Administrative office)
- Artistic Research(Research group)
- Private and Economic Law(Department)
- Analytical, Environmental & Geo-Chemistry(Research group)
- Informatics and Applied Informatics(Department)
- Pediatrics(Department)
- Hydrology and Hydraulic Engineering(Department)
- Metajuridica(Department)
- Faculty of Physical Education and Physical Therapy(Faculty)
- Structural Biology Brussels(Department)
- Infopunt Studenten(Office)
- Chemical Engineering and Separation Science(Research group)
- Conservative Dentistry and Prosthodontics(Department)
- Physiotherapy, Human Physiology and Anatomy(Department)
- Human Physiology and Sports Physiotherapy Research Group(Research group)