AI Article Synopsis
- The Phase IIIb CTEPH early access study evaluated the safety and tolerability of riociguat, a drug for treating inoperable or recurrent chronic thromboembolic pulmonary hypertension (CTEPH), allowing early patient access before its official launch.
- 300 adult patients received riociguat, with many switching from less effective therapies, and 87% completed the study over a median of 47 weeks, reporting a variety of adverse events.
- The results showed that riociguat was generally well tolerated, with some improvements in patients' walking distance, regardless of whether they were new to treatment or had switched from other therapies.
Article Abstract
Background: Following positive results from the Phase III CHEST-1 study in patients with inoperable or persistent/recurrent chronic thromboembolic pulmonary hypertension (CTEPH), the Phase IIIb CTEPH early access study (EAS) was designed to assess the safety and tolerability of riociguat in real-world clinical practice, as well as to provide patients with early access to riociguat before launch. Riociguat is approved for the treatment of inoperable and persistent/recurrent CTEPH.
Methods: We performed an open-label, uncontrolled, single-arm, early access study in which 300 adult patients with inoperable or persistent/recurrent CTEPH received riociguat adjusted from 1 mg three times daily (tid) to a maximum of 2.5 mg tid. Patients switching from unsatisfactory prior pulmonary arterial hypertension (PAH)-targeted therapy (n = 84) underwent a washout period of at least 3 days before initiating riociguat. The primary aim was to assess the safety and tolerability of riociguat, with World Health Organization functional class and 6-min walking distance (6MWD) as exploratory efficacy endpoints.
Results: In total, 262 patients (87%) completed study treatment and entered the safety follow-up (median treatment duration 47 weeks). Adverse events were reported in 273 patients (91%). The most frequently reported serious adverse events were syncope (6%), right ventricular failure (3%), and pneumonia (2%). There were five deaths, none of which was considered related to study medication. The safety and tolerability of riociguat was similar in patients switched from other PAH-targeted therapies and those who were treatment naïve. In patients with data available, mean ± standard deviation 6MWD had increased by 33 ± 42 m at Week 12 with no clinically relevant differences between the switched and treatment-naïve subgroups.
Conclusions: Riociguat was well tolerated in patients with CTEPH who were treatment naïve, and in those who were switched from other PAH-targeted therapies. No new safety signals were observed.
Trial Registration: ClinicalTrials.org NCT01784562 . Registered February 4, 2013.
Download full-text PDF |
Source |
|---|---|
| http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5745920 | PMC |
| http://dx.doi.org/10.1186/s12890-017-0563-7 | DOI Listing |
Publication Analysis
Top Keywords
Similar Publications
Pain Management Services Can Be a Cost-Effective Option over Surgery for the Treatment of Chronic Pain.
Curr Pain Headache Rep
January 2025
Department of Anesthesiology, University of Wisconsin, Madison, WI, 53711, USA.
Purpose Of Commentary: The number of facilities and physicians that offer pain management services has grown significantly since the 1970s. Despite the rise in prevalence of individuals with chronic pain during that time, interventional pain physicians remain underutilized. One reason why this may be the case is a large number of patients are referred directly to surgical specialists prior to being seen by an interventional pain physician.
View Article and Find Full Text PDFChromatin landscape alteration uncovers multiple transcriptional circuits during memory CD8+ T cell differentiation.
Protein Cell
January 2025
Zhongshan School of Medicine, Sun Yat-Sen University, Guangzhou 510080, China.
Extensive epigenetic reprogramming involves in memory CD8+ T-cell differentiation. The elaborate epigenetic rewiring underlying the heterogeneous functional states of CD8+ T cells remains hidden. Here, we profile single-cell chromatin accessibility and map enhancer-promoter interactomes to characterize the differentiation trajectory of memory CD8+ T cells.
View Article and Find Full Text PDFRadiolabeling of Siamenoside I with Carbon-14.
Org Lett
January 2025
The Coca-Cola Company, One Coca-Cola Plaza, Atlanta, Georgia 30313, United States.
The synthesis of radiolabeled [25-C]-siamenoside I following a synthetic route developed using unlabeled materials is disclosed. The synthesis features an early stage labeling of the mogrol's C25 an oxidative cleavage-reconstruction strategy and regioselective glycosylations directed by protecting group manipulations. This route provided access to adequate amounts of [25-C]-siamenoside I for ADME and PK studies.
View Article and Find Full Text PDFDisparities in Triple Negative Breast Cancer Among Hispanic Population Living in Latin America Versus the United States.
J Surg Oncol
January 2025
Division of Surgical Oncology, Tufts Medical Center, Boston, Massachusetts, USA.
Introduction: Triple-negative breast cancer (TNBC) has a prevalence of 12%-24% in the Hispanic population. Previous research has demonstrated that disparities in healthcare access significantly influence patient outcomes. We aimed to compare the clinicopathological characteristics and outcomes of Hispanic females with TNBC living in Latin America (HPLA) to the Hispanic population in the United States (HPUS).
View Article and Find Full Text PDFNeurotropic viruses are a major public health concern as they can cause encephalitis and other severe brain diseases. Many of these viruses, including flaviviruses, herpesviruses, rhabdoviruses and alphaviruses enter the brain through the olfactory neuroepithelium (ONE) in the olfactory bulbs (OB). Due to the low percentage of encephalitis that occurs following these infections, it's thought that the OBs have specialized innate immune responses to eliminate viruses.
View Article and Find Full Text PDFWant AI Summaries of new PubMed Abstracts delivered to your In-box?
Enter search terms and have AI summaries delivered each week - change queries or unsubscribe any time!