Bococizumab: Difference between revisions
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==Major Trials== | ==Major Trials== | ||
===Phase II Trials=== | ===Phase II Trials=== | ||
A 24 week, randomized, placebo-controlled, dose-ranging phase IIB trial was conducted in 354 patients to examine two different doses of bococizumab: a twice monthly dose of either 50, 100 or 150 mg; and a once monthly dose of either 200 or 300 mg. A dose reduction was made at week 6 for the twice monthly and at week 8 for the once monthly regimen in patients with LDL-C ≤25 mg/dL. The primary efficacy endpoint was the placebo-adjusted change from baseline in LDL-C at week 12. The study met its primary endpoint across all doses with a safety and tolerability profile equivalent to placebo. | |||
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| align="center" style="background:#f0f0f0;"|'''Dosing regimens''' | |||
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| Primary Analysis: | |||
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| Mean change from | |||
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| baseline in LDL-C at | |||
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| Week 12 (placebo-adjusted) | |||
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| Maximum mean change | |||
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| from baseline in | |||
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| LDL-C (placebo-adjusted) | |||
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| 150mg twice monthly|| || ||-53.4 mg/dL|| || ||-66.9 mg/dL (week 8) | |||
|- | |||
| 300mg once monthly|| || ||-44.9 mg/dL|| || ||-54.9 mg/dL (week 4) | |||
|} | |||
===Phase III Trials=== | ===Phase III Trials=== | ||
Revision as of 20:14, 12 February 2015
For a review of all PCSK9 inhibitors please click here
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WikiDoc Resources for Bococizumab |
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Articles |
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Most recent articles on Bococizumab Most cited articles on Bococizumab |
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Media |
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Powerpoint slides on Bococizumab |
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Evidence Based Medicine |
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Clinical Trials |
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Ongoing Trials on Bococizumab at Clinical Trials.gov Clinical Trials on Bococizumab at Google
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Guidelines / Policies / Govt |
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US National Guidelines Clearinghouse on Bococizumab
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Definitions |
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Patient resources on Bococizumab Discussion groups on Bococizumab Patient Handouts on Bococizumab Directions to Hospitals Treating Bococizumab Risk calculators and risk factors for Bococizumab
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Causes & Risk Factors for Bococizumab |
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Experimental / Informatics |
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
A 24 week, randomized, placebo-controlled, dose-ranging phase IIB trial was conducted in 354 patients to examine two different doses of bococizumab: a twice monthly dose of either 50, 100 or 150 mg; and a once monthly dose of either 200 or 300 mg. A dose reduction was made at week 6 for the twice monthly and at week 8 for the once monthly regimen in patients with LDL-C ≤25 mg/dL. The primary efficacy endpoint was the placebo-adjusted change from baseline in LDL-C at week 12. The study met its primary endpoint across all doses with a safety and tolerability profile equivalent to placebo.
| Dosing regimens | ' | ' | ' | |||
| Primary Analysis: | ||||||
| Mean change from | ||||||
| baseline in LDL-C at | ||||||
| Week 12 (placebo-adjusted) | ||||||
| Maximum mean change | ||||||
| from baseline in | ||||||
| LDL-C (placebo-adjusted) | ||||||
| 150mg twice monthly | -53.4 mg/dL | -66.9 mg/dL (week 8) | ||||
| 300mg once monthly | -44.9 mg/dL | -54.9 mg/dL (week 4) |
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.