Author Interviews / 11.02.2021 Interview with: Raymond L. Benza, MD, FACC, FAHA, FACP Primary Study Investigator and Professor of Medicine at The Ohio State University What is the background for this study? Would you briefly explain the significance of Pulmonary Arterial Hypertension? Response: Pulmonary arterial hypertension (PAH) is a silently progressive disease with no known cure and is often fatal. It’s a specific form of pulmonary hypertension (PH) that causes the walls of the pulmonary arteries to become thick and stiff, narrowing the space for blood to flow, and causing an increased blood pressure to develop within the lungs. PAH has a variety of etiologies and long-term impact on patients' functioning as well as their physical, psychological and social wellbeing. Assessing a patient's risk of 1-year mortality is a crucial component to the management and treatment of PAH, as the main treatment goal is for patients to achieve a low-risk status. Given the severity of the disease, physicians need to be able to risk stratify patients in order to characterize their disease better, know how to intelligently implement their medications, and when to refer them for lung transplantation. There are different approaches to assessing risk in PAH, including the use of variables, equations, and calculator tools; however, real-world evidence indicates risk assessment in the clinical setting is suboptimal. This is why we conducted an analysis to determine the validity of the Registry to Evaluate Early and Long-Term PAH Disease Management (REVEAL) Lite 2 risk calculator, an abridged version of the REVEAL 2.0 risk calculator, in patients with PAH.  (more…)
Author Interviews, Heart Disease, Pharmaceutical Companies, Pulmonary Disease / 21.10.2019 Interview with: Olivier Sitbon, MD, PhD Université Paris–Sud What is the background for this study? How does this treatment competition differ from other treatments for PAH?  Response:  Pulmonary arterial hypertension (PAH) is a complex, progressive and potentially fatal disease with no cure. Over the past decades, advances in understanding the pathophysiology of PAH have led to major prognostic improvement and developments of new treatment guidelines and therapies. Current treatment guidelines recommend initial combination therapy for these patients to target multiple PAH-associated pathways in parallel. OPTIMA was a prospective, multicenter, single-arm, open-label, Phase IV trial designed to evaluate the efficacy, safety and tolerability of initial oral combination therapy with macitentan and tadalafil in patients with newly diagnosed PAH. Treatment with macitentan 10 mg once-daily and tadalafil 20 mg once-daily was initiated on the same day. After 8±3 days, tadalafil dose was increased to 40 mg once-daily. Safety and tolerability findings were consistent with previous clinical trials that supported the approval and use of macitentan 10 mg once-daily. Efficacy outcomes were assessed at Week 16 and safety continued to be monitored until study closure. The results from the OPTIMA analysis suggest that initial treatment with macitentan in combination with tadalafil is associated with hemodynamic improvement in newly diagnosed patients with pulmonary arterial hypertension (more…)
Author Interviews, Immunotherapy, Pulmonary Disease / 17.02.2017 Interview with: Prof. Hossein-Ardeschir Ghofrani University of Giessen and Marburg Lung Center Giessen, Germany, and Member of the German Center of Lung Research and Department of Medicine Imperial College London London, UK What is the background for this study? Response: Pulmonary arterial hypertension (PAH) is characterised by increased pulmonary vascular resistance (increased resistance to blood flow in the pulmonary circulation), which can lead to right heart failure and death. Riociguat is the first of a new class of drugs – the soluble guanylate cyclase stimulators. It has been approved for the treatment of PAH based on the impressive efficacy and safety results from two pivotal Phase III studies: PATENT-1 and its long-term extension phase, PATENT-2. PATENT-1 was a 12-week, double-blind, randomized, placebo-controlled trial to evaluate the safety and efficacy of riociguat in patients with PAH. Patients who completed PATENT-1 without ongoing riociguat-related serious adverse events (AEs) could enter PATENT-2, in which they received open-label riociguat. PATENT-1 admitted patients whether they were treatment-naïve or already receiving targeted PAH therapies, such as endothelin receptor antagonists (ERAs) and prostanoids. This current analysis compared the safety and efficacy of riociguat between treatment-naïve and pretreated patients in the PATENT-2 long-term extension study. (more…)
Author Interviews, CHEST, Critical Care - Intensive Care - ICUs / 27.06.2014 Interview with: James R. Klinger, MD, FCCP Professor of Medicine, Brown University Darren Taichman, MD, PhD, FCCP Adjunct Associate Professor of Medicine, University of Pennsylvania Greg Elliott, MD, MACP, FCCP Professor of Medicine, University of Utah School of Medicine Background: The authors discuss the June 17, 2014 CHEST publication: Pharmacological Therapy for Pulmonary Arterial Hypertension in Adults: CHEST Guideline MedicalResearch: How widespread is the problem of Pulmonary Arterial Hypertension (PAH)? Greg Elliott: PAH is an uncommon, but important disorder because untreated it is usually progressive and fatal, AND there are effective treatments. This makes the guidelines important for physicians, patients and insurers. MedicalResearch: What are the most common causes of PAH? Greg Elliott: Common causes are connective tissues diseases like scleroderma, toxins like methamphetamine and cases for which the cause is not known, i.e. idiopathic. Some (about 20 %) idiopathic cases are caused by gene mutations. (more…)