Background: Evolocumab and other anti-PCSK9 antibodies reduced adverse cardiovascular outcomes in clinical trials of high-risk patients over <3 years median treatment duration.
Objectives: The OSLER-1 trial (Open Label Study of Long Term Evaluation Against LDL-C Trial) evaluated longer-term effects of evolocumab during open-label hypercholesterolemia treatment for up to 5 years.
Methods: Patients randomized to standard of care (SOC) or evolocumab 420 mg monthly (evolocumab + SOC) for year 1. After year 1, patients could enter the all-evolocumab period and receive evolocumab + SOC for an additional 4 years. The authors analyzed the persistence of lipid effects and exposure-dependent safety focusing on yearly rates of adverse events (AEs) and anti-drug antibodies over 4.951 patient-years of observation.
Results: A total of 1,255 patients (safety analysis population) randomized into the year 1 SOC-controlled period and received ≥1 evolocumab dose (mean ± SD age 57 ± 12 years; 53% female). A total of 1,151 patients (efficacy analysis population) progressed to the all-evolocumab period (year 2 and beyond). Evolocumab + SOC persistently lowered mean ± SE low-density lipoprotein cholesterol (LDL-C) by 56% ± 0.6% (n = 1,071), 57% ± 0.8% (n = 1,001), 56% ± 0.8% (n = 943), and 56% ± 0.8% (n = 803) after approximately 2, 3, 4, and 5 years, respectively, from randomization. Mean baseline LDL-C decreased from 140 to 61 mg/dl on treatment. Yearly serious AE rates during evolocumab + SOC ranged from 6.9% to 7.9%, comparable to the 6.8% rate in SOC patients during year 1. Evolocumab discontinuation due to AEs occurred in 5.7% of patients. Two SOC and 2 evolocumab + SOC patients developed new, transient, binding anti-drug antibodies; no neutralizing antibodies were observed.
Conclusions: The OSLER-1 trial demonstrated consistently excellent LDL-C-lowering efficacy, tolerance, and safety of evolocumab, with no neutralizing antibodies detected, throughout the longest-duration study of a PCSK9 inhibitor reported to date. (Open Label Study of Long Term Evaluation Against LDL-C Trial [OSLER-1]; NCT01439880).
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http://dx.doi.org/10.1016/j.jacc.2019.08.1024 | DOI Listing |
EClinicalMedicine
August 2024
Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Republic of Korea.
Background: In an interim analysis of this phase 2 trial, adding the GX-188E vaccine to pembrolizumab resulted in manageable toxicity with antitumor activities in patients with recurrent or advanced cervical cancer. Here, we report the final safety and efficacy results after a long-term follow-up at the study's completion.
Methods: This open-label, single-arm, phase II trial was conducted in nine hospitals in South Korea (ClinicalTrials.
Indian J Thorac Cardiovasc Surg
February 2025
Government Medical College, Omandurar Government Estate, Chennai 02, Tamilnadu India.
Minimally invasive mitral valve surgery (MIMVS) is revolutionizing the field of cardiothoracic surgery by offering patients less invasive alternatives to conventional sternotomy. This article reviews recent research and studies on the outcomes, challenges, and considerations surrounding MIMVS. Comparative studies reveal that while MIMVS offers advantages such as shorter hospital stays and reduced recovery times, it shows no significant differences in mortality or long-term quality-of-life outcomes compared to traditional methods.
View Article and Find Full Text PDFCurr Treatm Opt Rheumatol
December 2024
Division of Rheumatology, Inflammation, and Immunity, Brigham and Women's Hospital, Boston, MA USA.
Purpose Of Review: To summarize the current treatment landscape of rheumatoid arthritis-associated interstitial lung disease (RA-ILD) in the context of the recent 2023 American College of Rheumatology/American College of Chest Physicians guideline for ILD treatment in systemic autoimmune rheumatic diseases.
Recent Findings: The guideline conditionally recommends mycophenolate, azathioprine, and rituximab for first-line RA-ILD therapy, with cyclophosphamide and short-term glucocorticoids as additional options. For RA-ILD progression after first line, mycophenolate, rituximab, nintedanib, tocilizumab, cyclophosphamide, and pirfenidone are conditionally recommended, while long-term glucocorticoids are conditionally recommended against.
Int J Telemed Appl
January 2025
Department of Colorectal Surgery, Northern Hospital Epping, Epping, Australia.
Amidst the COVID-19 pandemic, telehealth (TH) has gained increasing relevance in colorectal patient care, prompting an audit of the TH clinic at a tertiary colorectal unit. This study evaluated telephone-based consultations' clinical efficacy and diagnostic thresholds for new lower gastrointestinal (LGI) bleeding referrals. We conducted a quality assurance audit of the per rectal (PR) bleeding TH clinic at Northern Hospital Victoria, evaluating new LGI bleeding referrals.
View Article and Find Full Text PDFSmall
January 2025
State Key Laboratory of Biocatalysis and Enzyme Engineering, Stem Cells and Tissue Engineering Manufacture Center, School of Life Science, Hubei University, Wuhan, Hubei, 430062, China.
Recent advances in drug design and compound synthesis have highlighted the increasing need for effective methods of toxicity evaluation. A specialized force sensor, known as the light wavelength-encoded "Chinese guzheng" is developed. This innovative sensor is equipped with optical fiber strings and utilizes a wavelength-encoded fiber Bragg grating (FBG) that is chemically etched to reduce its diameter.
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