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

No products in the cart.

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

2 Minute Medicine Rewind Jan 20 – Jan 26, 2014

bys25qthea
January 28, 2014
in Cardiology, Chronic Disease, Neurology, Oncology, Public Health, Weekly Rewinds
Reading Time: 4 mins read
0
Share on FacebookShare on Twitter

Image: PD

In this section, we will highlight the key high-impact studies, updates, and analyses published in medicine during the past week. 

Phase 3 Trials of Solanezumab for Mild-to-Moderate Alzheimer’s Disease

Alzheimer’s disease is associated with the accumulation of aggregated amyloid-beta (Aβ) peptide in the cerebral cortex and hippocampus. A humanized monoclonal antibody, Solanezumab, binds soluble forms of amyloid and putatively promotes its clearance from the brain. In these two Phase 3 double-blind randomized control trial, a total of 2052 patients with mild-to-moderate Alzheimer’s were randomly assigned to receive placebo or solanezumab every 4 weeks for 18 months. Neither subgroup showed significant improvement in changes from baseline to week 80 in scores on the 11-item cognitive subscale of the Alzheimer’s Disease Assessment Scale (ADAS-cog11) [−0.8 points, 95% CI −2.1 to 0.5; P=0.24], the Alzheimer’s Disease Cooperative Study–Activities of Daily Living scale (ADCS-ADL)[ −0.4 points, 95% CI, −2.3 to 1.4; P=0.64], or on the Alzheimer’s Disease Assessment Scale (ADAS-cog14)[ −1.7 point, 95% CI, −3.5 to 0.1; P=0.06]. Thus, Solanezumab failed to improve cognition or functional ability. 

Idelalisib and Rituximab in Relapsed Chronic Lymphocytic Leukemia

Patients with relapsed chronic lymphocytic leukemia (CLL), the most prevalent leukemia among adults, who have clinically significant coexisting medical conditions are less able to undergo standard chemotherapy, creating a need for effective therapies for this patient population. The B-cell–receptor signaling pathway, which plays a key role in the pathogenesis of CLL, is mediated in part by the activation of the delta isoform of phosphatidylinositol 3-kinase (PI3Kδ). Idelalisib is a potent, oral, selective small-molecule inhibitor of PI3Kδ. In this Phase 3 randomized control trial, 220 patients with decreased renal function, previous therapy-induced myelosuppression, or major coexisting illnesses were randomly assigned to receive rituximab and either idelalisib or placebo twice daily. The median progression-free survival was 5.5 months in the placebo group and was not reached in the idelalisib group (hazard ratio for progression or death in the idelalisib group, 0.15; P<0.001). Patients receiving idelalisib had improved rates of overall response (81% vs. 13%; odds ratio, 29.92; P<0.001) and overall survival at 12 months (92% vs. 80%; hazard ratio for death, 0.28; P=0.02), compared to those receiving placebo. Thus, the combination of idelalisib and rituximab, as compared with placebo and rituximab, significantly improved progression-free survival, response rate, and overall survival among patients with relapsed CLL who were less able to undergo chemotherapy. 

RELATED REPORTS

2 Minute Medicine: Pharma Roundup – Perioperative Immunotherapy Efficacy, Expanded Prostate Cancer Indication, Rapid Subcutaneous Myeloma Administration, and Regulatory Compliance Findings [June 4 2025]

Food and Drug Administration to Fully Integrate Generative Artificial Intelligence by June

2MM: AI Roundup – FDA’s AI Push, Trial Speedups with Real-World Data, Smart Surgical Monitors, and Regulatory Overhaul Begins [May 23rd, 2025]

Scientific and Regulatory Reasons for Delay and Denial of FDA Approval of Initial Applications for New Drugs, 2000-2012

Given the fact that resubmission of failed FDA approval applications is costly and delays the availability of new drugs to patients, it is important to understand whether most new drug applications fail because of inadequate drug performance or because the information submitted to the FDA is unsatisfactory to make that determination. In this retrospective review of FDA documents, all drug applications submitted to the FDA between 2000 and 2012 for new molecular entities (NMEs), active ingredients never before marketed in the US in any form, were reviewed. Of the 302 identified NME applications, 151 (50%) were approved when first submitted and 222 (73.5%) were ultimately approved. Of the unsuccessful first-time applications, 24 (15.9%) included uncertainties related to dose selection, 20 (13.2%) choice of study end points that failed to adequately reflect a clinically meaningful effect, 20 (13.2%) inconsistent results when different end points were tested, 17 (11.3%) inconsistent results when different trials or study sites were compared, and 20 (13.2%) poor efficacy when compared with the standard of care. Thus, failure to select optimal drug doses and suitable study end points accounted for significant delays in the approval of new drugs. Both of these can be prevented with more thorough study designs, ultimately decreasing costs. 

The Accessibility of Firearms and Risk for Suicide and Homicide Victimization Among Household Members: A Systematic Review and Meta-analysis

There is ongoing controversy regarding whether access to firearms in the home increases the risk for violent death. In this meta-analysis, data were pooled from 15 observational studies that assessed the odds of suicide or homicide, yielding pooled odds ratios (ORs) of 3.24 (95% CI, 2.41 to 4.40) and 1.94 (CI, 1.44 to 2.93), respectively. When only studies that used interviews to determine firearm accessibility were considered, the pooled OR for suicide was 3.14 (CI, 2.29 to 4.43). Thus, this review concluded that access to firearms is associated with increased risk for completed suicide and being the victim of homicide. 

FDA Approval of Cardiac Implantable Electronic Devices via Original and Supplement Premarket Approval Pathways, 1979-2012

The FDA evaluates safety and effectiveness of high-risk Cardiac Implantable Electronic Devices (CIEDs) such as pacemakers, implantable cardioverter-defibrillators, and cardiac resynchronization therapy devices, via the premarket approval (PMA) process. Subsequent changes to approved high-risk devices are implemented via “supplements,” which may not require additional clinical testing. This review of FDA’s PMA database reveals that of all the CIEDs approved from 1979 through 2012, 77 were original while 5829 were supplement PMA applications. Thirty-seven percent of approved supplements involved a change to the device’s design. Among 180-day supplements approved from 2010-2012, 23% (15/64) included new clinical data to support safety and effectiveness. Thus, it is important to realize that many CIEDs are approved via the PMA supplement process, not as original PMAs. Most of these new device models are deemed safe and effective without requiring new clinical data, reinforcing the importance of rigorous postapproval surveillance of these devices. 

By Annick Aubin-Pouliot and David Ouyang

 © 2012-2014 2minutemedicine.com. All rights reserved. No works may be reproduced without written consent from 2minutemedicine.com. Disclaimer: We present factual information directly from peer reviewed medical journals. No post should be construed as medical advice and is not intended as such by the authors or by 2minutemedicine.com. PLEASE SEE A HEALTHCARE PROVIDER IN YOUR AREA IF YOU SEEK MEDICAL ADVICE OF ANY SORT. Content is produced in accordance with fair use copyrights solely and strictly for the purpose of teaching, news and criticism. No benefit, monetary or otherwise, is realized by any participants or the owner of this domain.

Tags: Alzheimer’s diseaseFDAleukemiarituximab
Previous Post

Current BMI standards may be predictive of metabolic syndrome

Next Post

New ACC/AHA cholesterol guidelines emphasize the appropriate-level statin treatment

RelatedReports

2 Minute Medicine: Pharma Roundup: Price Hikes, Breakthrough Approvals, Legal Showdowns, Biotech Expansion, and Europe’s Pricing Debate [May 12nd, 2025]
Pharma

2 Minute Medicine: Pharma Roundup – Perioperative Immunotherapy Efficacy, Expanded Prostate Cancer Indication, Rapid Subcutaneous Myeloma Administration, and Regulatory Compliance Findings [June 4 2025]

June 4, 2025
FDA-regulated clinical trials rarely report violations
AI Roundup

Food and Drug Administration to Fully Integrate Generative Artificial Intelligence by June

May 26, 2025
2MM: AI Roundup- AI Cancer Test, Smarter Hospitals, Faster Drug Discovery, and Mental Health Tech [May 2nd, 2025]
AI Roundup

2MM: AI Roundup – FDA’s AI Push, Trial Speedups with Real-World Data, Smart Surgical Monitors, and Regulatory Overhaul Begins [May 23rd, 2025]

May 23, 2025
Combined immunotherapy may improve survival in metastatic pancreatic cancer
Pharma

FDA Approves Dupilumab for Chronic Spontaneous Urticaria

May 14, 2025
Next Post
Low circulating cholesterol in neonates linked with pyloric stenosis

New ACC/AHA cholesterol guidelines emphasize the appropriate-level statin treatment

High mortality rates reported in ill patients with MERS-CoV

High mortality rates reported in ill patients with MERS-CoV

Ultrasound screening for AAAs has no effect on all-cause mortality

Ultrasound screening for AAAs has no effect on all-cause mortality

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

  • Structured Exercise after Adjuvant Chemotherapy for Colon Cancer
  • 2 Minute Medicine Rewind June 30, 2025
  • Weighted vests and resistance training confer similar outcomes for bone density in the elderly
License Content
Terms of Use | Disclaimer
Cookie Policy
Privacy Statement (EU)
Disclaimer

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

  • Specialties
    • All Specialties, All Recent Reports
    • Cardiology
    • Chronic Disease
    • Dermatology
    • Emergency
    • Endocrinology
    • Gastroenterology
    • Imaging and Intervention
    • Infectious Disease
    • Nephrology
    • Neurology
    • Obstetrics
    • Oncology
    • Ophthalmology
    • Pediatrics
    • Pharma
    • Preclinical
    • Psychiatry
    • Public Health
    • Pulmonology
    • Rheumatology
    • Surgery
  • AI Roundup
  • Pharma
  • The Scan
  • Classics™
    • 2MM+ Online Access
    • Paperback and Ebook
  • Rewinds
  • Visual
  • Podcasts
  • Partners
    • License Content
    • Submit Press Release
    • Advertise with Us
  • Account
    • Subscribe
    • Sign-in
    • My account
No Result
View All Result

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