• About
  • Masthead
  • License Content
  • Advertise
  • Submit Press Release
  • RSS/Email List
  • Write for us
  • Contact us
2 Minute Medicine
No Result
View All Result

No products in the cart.

SUBSCRIBE
  • Specialties
    • Cardiology
    • Chronic Disease
    • Dermatology
    • Emergency
    • Endocrinology
    • Gastroenterology
    • Imaging and Intervention
    • Infectious Disease
    • Nephrology
    • Neurology
    • Obstetrics
    • Oncology
    • Ophthalmology
    • Pediatrics
    • Preclinical
    • Psychiatry
    • Public Health
    • Pulmonology
    • Rheumatology
    • Surgery
  • The Scan
  • Wellness
  • Classics™
    • 2MM+ Online Access
    • Paperback and Ebook
  • Rewinds
  • Visual
  • Partners
    • License Content
    • Submit Press Release
    • Advertise with Us
  • AccountLog-in/out
    • Subscribe
    • Sign-in
    • My account
2 Minute Medicine
  • Specialties
    • Cardiology
    • Chronic Disease
    • Dermatology
    • Emergency
    • Endocrinology
    • Gastroenterology
    • Imaging and Intervention
    • Infectious Disease
    • Nephrology
    • Neurology
    • Obstetrics
    • Oncology
    • Ophthalmology
    • Pediatrics
    • Preclinical
    • Psychiatry
    • Public Health
    • Pulmonology
    • Rheumatology
    • Surgery
  • The Scan
  • Wellness
  • Classics™
    • 2MM+ Online Access
    • Paperback and Ebook
  • Rewinds
  • Visual
  • Partners
    • License Content
    • Submit Press Release
    • Advertise with Us
  • AccountLog-in/out
    • Subscribe
    • Sign-in
    • My account
SUBSCRIBE
2 Minute Medicine
Subscribe
Home All Specialties Cardiology

Mixed cardiovascular benefit with PCSK9 inhibitior bococizumab: The SPIRE trial

byAndrew Cheung, MD MBAandJames Roebker
April 21, 2017
in Cardiology, Chronic Disease, Endocrinology
Reading Time: 3 mins read
0
Share on FacebookShare on Twitter

1. When added to statin therapy, the proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor bococizumab significantly reduced the risk of cardiovascular events in patients with low density lipoprotein cholesterol (LDL-C) levels greater than 100 mg/dL, but had no benefit in patients with LDL-C lower than 100 mg/dL.

2. Combined analyses, regardless of LDL-C levels, revealed significantly better outcomes with larger LCL-C reductions and longer duration of treatment.

Evidence Rating Level: 1 (Excellent) 

Study Rundown: While statins significantly reduce LDL-C, lipid levels and cardiovascular risk remain high in a subset of patients. Recent insight into PCSK9’s role in lipoprotein receptor degradation and increased LDL-C stimulated the development of monoclonal antibodies to inhibit PCSK9. While PCSK9 inhibitors have demonstrated powerful lipid lowering effects in synergism with statins, studies on the humanized bococizumab were discontinued in 2016 due to attenuated reductions in LDL-C and evidence of an immune response in a subset of patients. Data from the six parallel trials that focus on LDL-C have previously been published. This reports findings from the two largest trials that evaluated cardiovascular outcomes in lower-risk (SPIRE-1) and higher-risk (SPIRE-2) patients. The primary end point – a composite of adjudicated and confirmed cardiovascular events – only demonstrated significant benefit in higher-risk patients. No significant difference in serious adverse events, including new onset diabetes and cataracts, were found between bococizumab and placebo.

This was a randomized, multinational, double-blinded trial that followed a large cohort of lower-risk (SPIRE-1) and higher-risk (SPIRE-2) patients with elevated LDL-C. The primary limitation was the short-duration of the study and early termination of follow-up. While bococizumab will not be available for clinical use, the results support the role of greater LDL-C reductions for cardiovascular benefit in high-risk patients and the promise of PCSK9 inhibitors.

Click to read the study, published in NEJM

Relevant Reading: Lipid-reduction variability and antidrug-antibody formation with bococizumab

RELATED REPORTS

No known association between PCSK9 gene variants and risk of heart failure

Carotid and femoral bruits as cardiovascular risk indicators in a middle-aged Finnish population

Pemafibrate does not lower cardiovascular risk in individuals with hypertriglyceridemia

In-Depth [randomized controlled trial]: A total of 16,817 patients with LDL-C greater than 70 mg/dL (lower-risk group, mean LDL-C, 94 mg/dL) were enrolled in SPIRE-1 and 10,621 patients with LDL-C greater than 100 mg/dL (higher-risk group; mean LDL-C, 134 mg/dL) were enrolled in SPIRE-2 before trial termination (October 2013 – November 2016). A 6-week placebo run-in to ensure adherence was followed by randomization to either bococizumab or placebo. The primary end point was a composite of nonfatal myocardial infarction (MI), nonfatal stroke, hospitalization for unstable angina requiring urgent revascularization, or cardiovascular death.

In SPIRE-1, the primary end point occurred in 173 patients in both the bococizumab group and placebo (HR 0.99; 95%CI 0.80 to 1.22; p = 0.94). In SPIRE-2, the primary end point occurred in 179 patients in the bococizumab group and 224 patients in placebo (HR 0.79; 95%CI 0.65 to 0.97; p = 0.02). In the combined analysis, the primary end point occurred in 352 patients in the bococizumab group and 397 patients in placebo (HR 0.88; 95%CI 0.76 to 1.02; p = 0.08). Significant differences in the primary end point across both trials were reported among patients who had LDL-C reductions greater or equal to the median reduction values at 14 weeks, as well as patients randomized before the median date of randomization (13.8 months). Rates of serious adverse events, including newly diagnosed diabetes and cataracts, were similar between bococizumab and placebo. There was a higher rate of injection-site reactions in the bococizumab group (10.4% vs. 1.3%; p < 0.001).

Image: PD

©2017 2 Minute Medicine, Inc. All rights reserved. No works may be reproduced without expressed written consent from 2 Minute Medicine, Inc. Inquire about licensing here. No article should be construed as medical advice and is not intended as such by the authors or by 2 Minute Medicine, Inc

Tags: cardiovascular riskcholesterolpcsk9
Previous Post

Risankizumab more effective than ustekinumab for moderate-to-severe psoriasis

Next Post

Individualized screening for diabetic retinopathy with fundoscopy and HbA1c

RelatedReports

Quick Take: Association of African Ancestry with Electrocardiographic Voltage and Concentric Left Ventricular Hypertrophy: The Dallas Heart Study
Cardiology

No known association between PCSK9 gene variants and risk of heart failure

December 22, 2022
UTI associated with increased risk of preeclampsia
Cardiology

Carotid and femoral bruits as cardiovascular risk indicators in a middle-aged Finnish population

December 13, 2022
Cardiology

Pemafibrate does not lower cardiovascular risk in individuals with hypertriglyceridemia

December 2, 2022
Ivabradine ineffective in stable coronary artery disease [SIGNIFY trial]
Cardiology

Olpasiran significantly reduces lipoprotein(a) levels in patients with cardiovascular disease

November 22, 2022
Next Post
Adalimumab aids in control of noninfectious uveitis

Individualized screening for diabetic retinopathy with fundoscopy and HbA1c

Significant healthcare disparities exist between rural and non-rural children

Antidepressant use in pregnancy not linked with autism-spectrum disorder in exposed children

No significant change in bullying seen after playground alterations

No significant change in bullying seen after playground alterations

License Our Award-Winning Physician-Written Medical News and Visual Abstracts

2 Minute Medicine is the leading authoritative medical news licensing service, and the only with reports written by practicing doctors.

LICENSE CONTENT

2MM+ Premium Access

No ads & unlimited access to all current reports, over 9000 searchable archived reports, visual abstracts, Weekly Rewinds, and the online edition of The Classics Series™ textbook.

Subscription Options
2 Minute Medicine

2 Minute Medicine® is an award winning, physician-run, expert medical media company. Our content is curated, written and edited by practicing health professionals who have clinical and scientific expertise in their field of reporting. Our editorial management team is comprised of highly-trained MD physicians. Join numerous brands, companies, and hospitals who trust our licensed content.

Recent Reports

  • Dual antiplatelet therapy discontinued 9 months after percutaneous coronary intervention associated with improved morbidity and mortality
  • Concordance of diagnosis of autism spectrum disorder made by pediatricians vs multidisciplinary specialist teams
  • Cystatin C-based equation without race or sex improves accuracy of GFR estimation
License Content
Terms of Use | Disclaimer
Cookie Policy
Privacy Statement (EU)
Disclaimer

© 2021 2 Minute Medicine, Inc. - Physician-written medical news.

  • Specialties
    • Cardiology
    • Chronic Disease
    • Dermatology
    • Emergency
    • Endocrinology
    • Gastroenterology
    • Imaging and Intervention
    • Infectious Disease
    • Nephrology
    • Neurology
    • Obstetrics
    • Oncology
    • Ophthalmology
    • Pediatrics
    • Preclinical
    • Psychiatry
    • Public Health
    • Pulmonology
    • Rheumatology
    • Surgery
  • The Scan
  • Wellness
  • Classics™
    • 2MM+ Online Access
    • Paperback and Ebook
  • Rewinds
  • Visual
  • Partners
    • License Content
    • Submit Press Release
    • Advertise with Us
  • Account
    • Subscribe
    • Sign-in
    • My account

© 2021 2 Minute Medicine, Inc. - Physician-written medical news.

Want more physician-written
medical news?

Join over 10 million yearly readers and numerous companies. For healthcare professionals
and the public.

Subscribe for free today!

Subscription options