Bococizumab: Difference between revisions
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===Phase III Trials=== | ===Phase III Trials=== | ||
=====SPIRE-HF===== | =====SPIRE-HF===== | ||
The SPIRE-HF trial aims to compare the effect of bococizumab in combination with a statin vs. placebo in combination with a statin on LDL-C level at 12 weeks in patients with heterozygous familial hypercholesterolemia. The trial is currently recruiting patients and is expected to be completed in January 2016. | The SPIRE-HF trial aims to compare the effect of bococizumab in combination with a statin vs. placebo in combination with a statin on LDL-C level at 12 weeks in patients with heterozygous familial hypercholesterolemia. The trial is currently recruiting patients and is expected to be completed in January 2016.<ref name="pmid24958078">{{cite journal| author=Dadu RT, Ballantyne CM| title=Lipid lowering with PCSK9 inhibitors. | journal=Nat Rev Cardiol | year= 2014 | volume= 11 | issue= 10 | pages= 563-75 | pmid=24958078 | doi=10.1038/nrcardio.2014.84 | pmc= | url=http://www.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pubmed&tool=sumsearch.org/cite&retmode=ref&cmd=prlinks&id=24958078 }} </ref> | ||
=====SPIRE-HR & SPIRE-LDL===== | =====SPIRE-HR & SPIRE-LDL===== | ||
The SPIRE-HR and SPIRE-LDL trial aims to compare the effect of bococizumab in combination with a statin vs. placebo in combination with a statin on LDL-C level at 12 weeks in patients with hypercholesterolemia and high cardiovascular risk. These trials are currently recruiting patients and are expected to be completed by January 2016. | The SPIRE-HR and SPIRE-LDL trial aims to compare the effect of bococizumab in combination with a statin vs. placebo in combination with a statin on LDL-C level at 12 weeks in patients with hypercholesterolemia and high cardiovascular risk. These trials are currently recruiting patients and are expected to be completed by January 2016.<ref name="pmid24958078">{{cite journal| author=Dadu RT, Ballantyne CM| title=Lipid lowering with PCSK9 inhibitors. | journal=Nat Rev Cardiol | year= 2014 | volume= 11 | issue= 10 | pages= 563-75 | pmid=24958078 | doi=10.1038/nrcardio.2014.84 | pmc= | url=http://www.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pubmed&tool=sumsearch.org/cite&retmode=ref&cmd=prlinks&id=24958078 }} </ref> | ||
=====SPIRE-1===== | =====SPIRE-1===== | ||
The SPIRE-1 trial aims to evaluate the effect of bococizumab vs. placebo (without specification regarding statin therapy) on the reduction of major cardiovascular events at 5 years, including cardiovascular death, myocardial infarction, stroke, and unstable angina requiring urgent revascularization. The trial will only include patients with LDL-C ≥ 70 mg/dL (1.8 mmol/L) and < 100 mg/dL (2.6 mmol/L). The trial is currently recruiting patients and is expected to be completed in August 2017. | The SPIRE-1 trial aims to evaluate the effect of bococizumab vs. placebo (without specification regarding statin therapy) on the reduction of major cardiovascular events at 5 years, including cardiovascular death, myocardial infarction, stroke, and unstable angina requiring urgent revascularization. The trial will only include patients with LDL-C ≥ 70 mg/dL (1.8 mmol/L) and < 100 mg/dL (2.6 mmol/L). The trial is currently recruiting patients and is expected to be completed in August 2017.<ref name="pmid24958078">{{cite journal| author=Dadu RT, Ballantyne CM| title=Lipid lowering with PCSK9 inhibitors. | journal=Nat Rev Cardiol | year= 2014 | volume= 11 | issue= 10 | pages= 563-75 | pmid=24958078 | doi=10.1038/nrcardio.2014.84 | pmc= | url=http://www.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pubmed&tool=sumsearch.org/cite&retmode=ref&cmd=prlinks&id=24958078 }} </ref> | ||
=====SPIRE-2===== | =====SPIRE-2===== | ||
The SPIRE-1 trial aims to investigate the effect of bococizumab vs. placebo (without specification regarding statin therapy) on the reduction of major cardiovascular events at 5 years, including cardiovascular death, myocardial infarction, stroke, and unstable angina requiring urgent revascularization. The trial will only include patients with LDL-C ≥ 100 mg/dL (2.6 mmol/L) compared to the SPIRE-1 trial. The trial is currently recruiting patients and is expected to be completed in August 2017. | The SPIRE-1 trial aims to investigate the effect of bococizumab vs. placebo (without specification regarding statin therapy) on the reduction of major cardiovascular events at 5 years, including cardiovascular death, myocardial infarction, stroke, and unstable angina requiring urgent revascularization. The trial will only include patients with LDL-C ≥ 100 mg/dL (2.6 mmol/L) compared to the SPIRE-1 trial. The trial is currently recruiting patients and is expected to be completed in August 2017.<ref name="pmid24958078">{{cite journal| author=Dadu RT, Ballantyne CM| title=Lipid lowering with PCSK9 inhibitors. | journal=Nat Rev Cardiol | year= 2014 | volume= 11 | issue= 10 | pages= 563-75 | pmid=24958078 | doi=10.1038/nrcardio.2014.84 | pmc= | url=http://www.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pubmed&tool=sumsearch.org/cite&retmode=ref&cmd=prlinks&id=24958078 }} </ref> | ||
==References== | ==References== | ||
Revision as of 19:54, 12 February 2015
For a review of all PCSK9 inhibitors please click here
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Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]
Overview
Bococizumab (PF-04950615; RN316) is a humanized monoclonal antibody that binds proprotein convertase subtilisin/kexin type 9 and is an investigational agent for the reduction of LDL-C levels in patients with hypercholesterolemia.
Properties
Major Trials
Phase II Trials
Phase III Trials
SPIRE-HF
The SPIRE-HF trial aims to compare the effect of bococizumab in combination with a statin vs. placebo in combination with a statin on LDL-C level at 12 weeks in patients with heterozygous familial hypercholesterolemia. The trial is currently recruiting patients and is expected to be completed in January 2016.[2]
SPIRE-HR & SPIRE-LDL
The SPIRE-HR and SPIRE-LDL trial aims to compare the effect of bococizumab in combination with a statin vs. placebo in combination with a statin on LDL-C level at 12 weeks in patients with hypercholesterolemia and high cardiovascular risk. These trials are currently recruiting patients and are expected to be completed by January 2016.[2]
SPIRE-1
The SPIRE-1 trial aims to evaluate the effect of bococizumab vs. placebo (without specification regarding statin therapy) on the reduction of major cardiovascular events at 5 years, including cardiovascular death, myocardial infarction, stroke, and unstable angina requiring urgent revascularization. The trial will only include patients with LDL-C ≥ 70 mg/dL (1.8 mmol/L) and < 100 mg/dL (2.6 mmol/L). The trial is currently recruiting patients and is expected to be completed in August 2017.[2]
SPIRE-2
The SPIRE-1 trial aims to investigate the effect of bococizumab vs. placebo (without specification regarding statin therapy) on the reduction of major cardiovascular events at 5 years, including cardiovascular death, myocardial infarction, stroke, and unstable angina requiring urgent revascularization. The trial will only include patients with LDL-C ≥ 100 mg/dL (2.6 mmol/L) compared to the SPIRE-1 trial. The trial is currently recruiting patients and is expected to be completed in August 2017.[2]
References
- ↑ Urban, D.; Pöss, J.; Böhm, M.; Laufs, U. (2013). "Targeting the proprotein convertase subtilisin/kexin type 9 for the treatment of dyslipidemia and atherosclerosis". J Am Coll Cardiol. 62 (16): 1401–8. doi:10.1016/j.jacc.2013.07.056. PMID 23973703. Unknown parameter
|month=ignored (help) - ↑ 2.0 2.1 2.2 2.3 Dadu RT, Ballantyne CM (2014). "Lipid lowering with PCSK9 inhibitors". Nat Rev Cardiol. 11 (10): 563–75. doi:10.1038/nrcardio.2014.84. PMID 24958078.