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3 results on '"Michael S. Eggert"'

1. Delphi consensus recommendation for optimization of pulmonary hypertension therapy focusing on switching from a phosphodiesterase 5 inhibitor to riociguat

Author

Franck F. Rahaghi, Vijay P. Balasubramanian, Robert C. Bourge, Charles D. Burger, Murali M. Chakinala, Michael S. Eggert, Jean M. Elwing, Jeremy Feldman, Christopher King, James R. Klinger, Stephen C. Mathai, John Wesley McConnell, Harold I. Palevsky, Ricardo Restrepo‐Jaramillo, Zeenat Safdar, Jeffrey S. Sager, Namita Sood, Roxana Sulica, R. James White, and Nicholas S. Hill

Subjects
adherence, goal directed, tolerability, treatment escalation, treat to target, Diseases of the circulatory (Cardiovascular) system, RC666-701, Diseases of the respiratory system, RC705-779
Abstract

Abstract Dual combination therapy with a phosphodiesterase‐5 inhibitor (PDE5i) and endothelin receptor antagonist is recommended for most patients with intermediate‐risk pulmonary arterial hypertension (PAH). The RESPITE and REPLACE studies suggest that switching from a PDE5i to a soluble guanylate cyclase (sGC) activator may provide clinical improvement in this situation. The optimal approach to escalation or transition of therapy in this or other scenarios is not well defined. We developed an expert consensus statement on the transition to sGC and other treatment escalations and transitions in PAH using a modified Delphi process. The Delphi process used a panel of 20 physicians with expertise in PAH. Panelists answered three questionnaires on the management of treatment escalations and transitions in PAH. The initial questionnaire included open‐ended questions. Later questionnaires consolidated the responses into statements that panelists rated on a Likert scale from −5 (strongly disagree) to +5 (strongly agree) to determine consensus. The Delphi process produced several consensus recommendations. Escalation should be considered for patients who are at high risk or not achieving treatment goals, by adding an agent from a new class, switching from oral to parenteral prostacyclins, or increasing the dose. Switching to a new class or within a class should be considered if tolerability or other considerations unrelated to efficacy are affecting adherence. Switching from a PDE5i to an SGC activator may benefit patients with intermediate risk who are not improving on their present therapy. These consensus‐based recommendations may be helpful to clinicians and beneficial for patients when evidence‐based guidance is unavailable.

Published
2022
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2. BREEZE: Open‐label clinical study to evaluate the safety and tolerability of treprostinil inhalation powder as Tyvaso DPI™ in patients with pulmonary arterial hypertension

Author

Leslie A. Spikes, Abubakr A. Bajwa, Charles D. Burger, Sapna V. Desai, Michael S. Eggert, Karim A. El‐Kersh, Micah R. Fisher, Shilpa Johri, Joanna M. Joly, Jinesh Mehta, Harold I. Palevsky, Gautam V. Ramani, Ricardo Restrepo‐Jaramillo, Sandeep Sahay, Trushil G. Shah, Chunqin Deng, Melissa Miceli, Peter Smith, and Shelley M. Shapiro

Subjects
dry powder inhaler, PAH‐SYMPACT, pharmacokinetics, quality of life, treprostinil, Diseases of the circulatory (Cardiovascular) system, RC666-701, Diseases of the respiratory system, RC705-779
Abstract

Abstract Inhaled treprostinil is an approved therapy for pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease in the United States. Studies have confirmed the robust benefits and safety of nebulized inhaled treprostinil, but it requires a time investment for nebulizer preparation, maintenance, and treatment. A small, portable treprostinil dry powder inhaler has been developed for the treatment of PAH. The primary objective of this study was to evaluate the safety and tolerability of treprostinil inhalation powder (TreT) in patients currently treated with treprostinil inhalation solution. Fifty‐one patients on a stable dose of treprostinil inhalation solution enrolled and transitioned to TreT at a corresponding dose. Six‐minute walk distance (6MWD), device preference and satisfaction (Preference Questionnaire for Inhaled Treprostinil Devices [PQ‐ITD]), PAH Symptoms and Impact (PAH‐SYMPACT®) questionnaire, and systemic exposure and pharmacokinetics for up to 5 h were assessed at baseline for treprostinil inhalation solution and at Week 3 for TreT. Adverse events (AEs) were consistent with studies of inhaled treprostinil in patients with PAH, and there were no study drug‐related serious AEs. Statistically significant improvements occurred in 6MWD, PQ‐ITD, and PAH‐SYMPACT. Forty‐nine patients completed the 3‐week treatment phase and all elected to participate in an optional extension phase. These results demonstrate that, in patients with PAH, transition from treprostinil inhalation solution to TreT is safe, well‐tolerated, and accompanied by statistically significant improvements in key clinical assessments and patient‐reported outcomes with comparable systemic exposure between the two formulations at evaluated doses (trial registration: clinicaltrials.gov identifier: NCT03950739).

Published
2022
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3. Combination Therapy with Oral Treprostinil for Pulmonary Arterial Hypertension:A Double-Blind Placebo-controlled Clinical Trial

Author

R. James White, Carlos Jerjes-Sanchez, Gisela Martina Bohns Meyer, Tomas Pulido, Pablo Sepulveda, Kuo Yang Wang, Ekkehard Grünig, Shirish Hiremath, Zaixin Yu, Zhang Gangcheng, Wei Luen James Yip, Shuyang Zhang, Akram Khan, C. Q. Deng, Rob Grover, Victor F. Tapson, Graciela Noemi Svetliza, Adrian Jose Lescano, Guillermo Roberto Bortman, Fabian Antonio Diez, Christian Edgardo Botta, John Fitzgerald, Eelke Feenstra, Fiona Dawn Kermeen, Anne Margaret Keogh, Trevor John Williams, Peter Paul Yousseff, Benjamin Joh-Han Ng, David McNaughton Smallwood, Nathan Brent Dwyer, Martin Russell Brown, Irene M Lang, Regina Steringer-Mascherbauer, Jaquelina Sonoe Ota Arakaki, Frederico Thadeu Assis Figueiredo Campos, Ricardo de Amorim Correa, Rogerio de Souza, Gisela M. Bohns Meyer, Maria Auxiliadora Carmo Moreira, Hugo Hyung Bok Yoo, Monica Silveira Lapa, John Swiston, Naushad Hirani, Sanjay Mehta, Evangelos Michelakis, Pablo Andres Sepulveda, Monica Maria Zagolin Blancaire, Jimming Liu, Zhang Shuyang, Lei Pan, Bao Chunde, Yi Qun, Cheng Xiaoshu, Yu Zaixin, Xinli Li, Yao Hua, Xianyang Zhu, Yundai Chen, Cheng Zhaozhong, Yuanhua Yang, Zhou Daxin, Shen Jieyan, Jens Erik Nielsen-Kudsk, Jorn Carlsen, Arnaud Bourdin, Eric Hachulla, Claire Dromer, Ari Chaouat, Martine Reynaud-Gauber, Marie-France Seronde, Hans Klose, Michael Halank, Gert Hoffken, Ralf Ewert, Stephan Rosenkranz, Ekkehard Grunig, Ulrich Kruger, Juliane Kronsbein, Barbara Monika Hauptmeier, Andrea Koch, Matthias Held, Tobias Johannes Lange, Claus Neurohr, Heinrike Wilkens, Hubert Rolf Wilhelm Wirtz, Stavros Konstantinides, Paraskevi Argyropoulou-Pataka, Stylianos Orfanos, Prafulla Gopinath Kerkar, Pujar Venkateshacharya Suresh, Hemang Ashwinkumar Baxi, Abraham Oomman, Rajpal Kanaklal Abhaichand, Padma Kumar Edla Arjun, Vijay Chopra, Rahul Mehrotra, Rajeev Kumar Rajput, Jitendra Pal Singh Sawhney, Subir Bimalendu, Kamal Harishchandra Sharma, Bhagavathula Kutumba Srinivasa Sastry, Mordechai Reuben Kramer, Michael Jonathan Segel, Issahar Ben-Dov, Neville Berkman, Mordechai Yigla, Yochai Adir, Michael D’Alto, Carmine Dario Vizza, Laura Scelsi, Patrizio Vitulo, Tomas Rene Pulido, Anko Boonstra, Madelon Clementina Vonk, Bozena Sobkowicz, Tatiana Mularek-Kubzdela, Adam Torbicki, Piotr Podolec, Lim Soo Teik, Hyuk-Jae Chang, Hyung-Kwan Kim, Jun-Bean Park, Sung-A Chang, Duk-Kyung Kim, Wook-Jin Chung, Jong-Min Song, Magnus Nissell, Clara Hjalmarsson, Bengt Rundqvist, Wei-Chun Huang, Chin-Chang Cheng, Chih-Hsin Hsu, Hsao-Hsun Hsu, Kuo-Yang Wang, John Gerard Coghlan, David Gerard Kiely, Joanna Wanda Pepke-Zaba, James Lawrence Lordan, Paul Anthony Corris, Linda Cadaret, Sif Hansdottir, Ronald Jack Oudiz, David B. Badesch, Michael Mathier, Robert Schilz, Nicholas Hill, Aaron Waxman, Catherine J. Markin, Diane Lynn Zwicke, Micah Fisher, Veronica Franco, Namita Sood, Myung H. Park, Roblee Allen, Jeremy P. Feldman, Vijay Balasubramanian, Vandana Kavita Seeram, Abubakr Bajwa, Austin B. Thompson, Christina Migliore, Jean Elwing, John W. McConnell, Jinesh P. Mehta, Franck Farzad Rahaghi, J. Eduardo Rame, Bela Patel, Ron M. Oren, James R. Klinger, Hassan Alnuaimat, Samuel Allen, William Harvey, Michael S. Eggert, Antoine Hage, Chad E. Miller, Rana Lee Adawi Awdish, Hector Cajigas, Daniel Grinnan, Benjamin Howard Trichon, Clark McDonough, Franz Rischard, ACS - Pulmonary hypertension & thrombosis, Pulmonary medicine, University of Rochester Medical Center (URMC), Unidad de Investigación Clínica En Medicina, Complexo Hospitalar da Santa Casa de Misericórdia de Porto Alegre, Instituto Nacional de Cardiologia Ignacio Chavez, Pontificia Universidad Católica de Chile (UC), Taichung Veterans General Hospital, Heidelberg University Hospital [Heidelberg], Ruby Hall Clinic, The Second Xiangya Hospital of Central South University [Hunan, China], Wuhan Asia Heart Hospital, National Heart Centre Singapore & Duke-National University of Singapore, Peking Union Medical College Hospital [Beijing] (PUMCH), Oregon Health and Science University [Portland] (OHSU), United Therapeutics Corporation, and Cedars-Sinai Medical Center

Subjects
Male, Administration, Oral, Oral treprostinil, Critical Care and Intensive Care Medicine, Pulmonary arterial hypertension, [SDV.MHEP.PSR]Life Sciences [q-bio]/Human health and pathology/Pulmonology and respiratory tract, combination therapy, oral, epoprostenol, 0302 clinical medicine, pulmonary arterial hypertension, middle aged, Clinical endpoint, double-blind method, MESH: Double-Blind Method, Familial Primary Pulmonary Hypertension, 030212 general & internal medicine, humans, MESH: Aged, MESH: Middle Aged, Epoprostenol/analogs & derivatives, adult, Hazard ratio, Middle Aged, [SDV.SP]Life Sciences [q-bio]/Pharmaceutical sciences, antihypertensive agents, 3. Good health, aged, female, MESH: Young Adult, oral treprostinil, MESH: Administration, Oral, young adult, Female, Pulmonary Arterial Hypertension/drug therapy, medicine.drug, Adult, Pulmonary and Respiratory Medicine, MESH: Pulmonary Arterial Hypertension, medicine.medical_specialty, Randomization, Adolescent, clinical study, sequential therapy, administration, oral, adolescent, male, placebos, Sequential therapy, MESH: Placebos, MESH: Epoprostenol, Lower risk, Placebo, administration, Clinical study, Young Adult, 03 medical and health sciences, Double-Blind Method, [SDV.MHEP.CSC]Life Sciences [q-bio]/Human health and pathology/Cardiology and cardiovascular system, Internal medicine, medicine, Humans, Combination therapy, Adverse effect, Placebos/therapeutic use, Aged, MESH: Adolescent, Pulmonary Vascular Disease, MESH: Antihypertensive Agents, MESH: Humans, business.industry, MESH: Adult, Original Articles, MESH: Male, Clinical trial, 030228 respiratory system, Antihypertensive Agents/administration & dosage, business, MESH: Female, Treprostinil
Abstract

Rationale: Oral treprostinil improves exercise capacity in patients with pulmonary arterial hypertension (PAH), but the effect on clinical outcomes was unknown.\ud \ud Objectives: To evaluate the effect of oral treprostinil compared with placebo on time to first adjudicated clinical worsening event in participants with PAH who recently began approved oral monotherapy.\ud \ud Methods: In this event-driven, double-blind study, we randomly allocated 690 participants (1:1 ratio) with PAH to receive placebo or oral treprostinil extended-release tablets three times daily. Eligible participants were using approved oral monotherapy for over 30 days before randomization and had a 6-minute-walk distance 150 m or greater. The primary endpoint was the time to first adjudicated clinical worsening event: death; hospitalization due to worsening PAH; initiation of inhaled or parenteral prostacyclin therapy; disease progression; or unsatisfactory long-term clinical response.\ud \ud Measurements and Main Results: Clinical worsening occurred in 26% of the oral treprostinil group compared with 36% of placebo participants (hazard ratio, 0.74; 95% confidence interval, 0.56–0.97; P = 0.028). Key measures of disease status, including functional class, Borg dyspnea score, and N-terminal pro–brain natriuretic peptide, all favored oral treprostinil treatment at Week 24 and beyond. A noninvasive risk stratification analysis demonstrated that oral treprostinil–assigned participants had a substantially higher mortality risk at baseline but achieved a lower risk profile from Study Weeks 12–60. The most common adverse events in the oral treprostinil group were headache, diarrhea, flushing, nausea, and vomiting.\ud \ud Conclusions: In participants with PAH, addition of oral treprostinil to approved oral monotherapy reduced the risk of clinical worsening.\ud \ud Clinical trial registered with www.clinicaltrials.gov (NCT01560624).

Published
2020

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