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Jaclyn M Hawn, Matthew Wanek, Seth R Bauer, Mahmoud A Ammar, Steven Insler, Ahmad Adi, Heather Torbic
BACKGROUND: No previous studies exist examining inhaled Flolan compared with inhaled Veletri in a homogeneous cardiothoracic surgery patient population. OBJECTIVE: To compare the impact of inhaled Flolan and inhaled Veletri on the effectiveness, safety, or cost in cardiothoracic surgery patients. MATERIALS AND METHODS: This was a retrospective, noninferiority study comparing inhaled Flolan and inhaled Veletri in cardiothoracic surgery patients...
May 1, 2018: Annals of Pharmacotherapy
Kazuko Mihara, Aiko Ogawa, Hiromi Matsubara, Takumi Terao, Yoshitaka Ichikawa
OBJECTIVE: This study was conducted to evaluate the safety and efficacy of a new more thermostable Flolan (epoprostenol) solution prepared with the reformulated pH 12.0 diluent in Japanese patients with pulmonary arterial hypertension (PAH) receiving higher doses of Flolan than those typically administered in Western countries. METHODS: This open-label, single-arm study was conducted in 10 Japanese PAH patients. During the run-in period, patients were intravenously infused with Flolan (45 ng/kg/min or higher doses) solution prepared with the existing pH 10...
2018: PloS One
Joseph E Cruz, Ashley Ward, Shannon Anthony, Susanna Chang, Hyun Billy Bae, Evelyn R Hermes-DeSantis
OBJECTIVE: To review the evidence for using intravenous (IV) epoprostenol to treat Raynaud's phenomenon (RP). DATA SOURCES: The databases MEDLINE (1946 to March 2016), PubMed, and International Pharmaceutical Abstracts were searched using the terms epoprostenol, Flolan, Raynaud's disease, and CREST syndrome. Further literature sources were identified by reviewing article citations. STUDY SELECTION AND DATA EXTRACTION: All English-language, clinical trials and case series evaluating IV epoprostenol for the management or treatment of RP were included...
December 2016: Annals of Pharmacotherapy
Heather Torbic, Paul M Szumita, Kevin E Anger, Paul Nuccio, Susan Lagambina, Gerald Weinhouse
BACKGROUND: Flolan (iFLO) and Veletri (iVEL) are 2 inhaled epoprostenol formulations. There is no published literature comparing these formulations in critically ill patients with refractory hypoxemia. OBJECTIVE: To compare efficacy, safety, and cost outcomes in patients who received either iFLO or iVEL for hypoxic respiratory failure. METHODS: This was a retrospective, single-center analysis of adult, mechanically ventilated patients receiving iFLO or iVEL for improvement in oxygenation...
February 2016: Annals of Pharmacotherapy
Ayaka Horiuchi, Noriko Kubota, Eiko Hidaka, Atsuya Shimabukuro, Satoshi Yasukochi, Tomohiko Nakamura, Kozue Oana, Yoshiyuki Kawakami
This study was the first to describe the hitherto deficiently evaluated alkaline tolerance of Kocuria marina isolate from a pediatric patient with continuous intravenous epoprostenol dosing therapy. Our isolate from blood of a 7-year-old Japanese boy was finally identified as K. marina by the morphological, cultural, and biochemical properties together with the comparative sequence analyses of the 16S rRNA genes. The K. marina isolate, the causative agent of catheter-related blood-stream infection, was not only revealed to be salt tolerant (NaCl 15%), but also demonstrated to be stably survived with no apparent decrease of cell counts for long periods (120 h) in an alkaline environment (pH 8, 9, 10, and 11) at 35 °C...
September 2015: Journal of Infection and Chemotherapy: Official Journal of the Japan Society of Chemotherapy
Steeve Provencher, Patrap Paruchuru, Andrea Spezzi, Brian Waterhouse, Mardi Gomberg-Maitland
BACKGROUND: Flolan (epoprostenol sodium) is most commonly prescribed to patients with severe pulmonary arterial hypertension (PAH) owing to the requirement that the drug be delivered by continuous intravenous infusion and the reconstituted solution may only be administered up to 24 hours when it is maintained between a temperature of 2°C and 8°C. The aim of this single-arm, open label study was to describe the effects of the new thermostable formulation of Flolan on health-related quality of life (HRQoL) and ease of administration in subjects switching from the currently marketed Flolan to the reformulated product...
2015: PloS One
Sarah L Greig, Lesley J Scott, Greg L Plosker
A bioequivalent formulation of intravenous epoprostenol containing the excipients arginine and sucrose (epoprostenol AS) (Veletri®, Caripul®) is approved in the USA, UK, and other countries for the treatment of pulmonary arterial hypertension (PAH), and has improved thermal stability compared with epoprostenol containing glycine and mannitol (epoprostenol GM) (Flolan®). Epoprostenol, a synthetic prostacyclin, is a potent pulmonary vasodilator. Epoprostenol GM was originally approved for use as a long-term continuous infusion in patients with PAH nearly 20 years ago in the USA; however, this formulation has limited stability at room temperature, and requires the use of cooling or frequent medication changes during administration...
December 2014: American Journal of Cardiovascular Drugs: Drugs, Devices, and Other Interventions
Marie Rodling Wahlström, Magnus Olivecrona, Clas Ahlm, Anders Bengtsson, Lars-Owe D Koskinen, Silvana Naredi, Magnus Hultin
OBJECTIVE AND DESIGN: A prospective, randomised, double-blinded, clinical trial was performed at a level 1 trauma centre to determine if a prostacyclin analogue, epoprostenol (Flolan®), could attenuate systemic inflammatory response in patients with severe traumatic brain injury (TBI). SUBJECTS: 46 patients with severe TBI, randomised to epoprostenol (n = 23) or placebo (n = 23). TREATMENT: Epoprostenol, 0.5 ng · kg(-1) · min(-1), or placebo (saline) was given intravenously for 72 hours and then tapered off over the next 24 hours...
2014: SpringerPlus
Kelly M Chin, David B Badesch, Ivan M Robbins, Victor F Tapson, Harold I Palevsky, Nick H Kim, Steven M Kawut, Adaani Frost, Wade W Benton, Jean-Christophe Lemarie, Frederic Bodin, Lewis J Rubin, Vallerie McLaughlin
BACKGROUND: Epoprostenol sodium with arginine-mannitol excipients (epoprostenol AM; Veletri [Actelion Pharmaceuticals Ltd, Allschwil, Switzerland]) and epoprostenol sodium with glycine-mannitol excipients (epoprostenol GM; Flolan [GlaxoSmithKline, Triangle Park, NC]) are intravenous treatments for pulmonary arterial hypertension (PAH). Epoprostenol AM contains different inactive excipients, resulting in greater stability at room temperature compared with epoprostenol GM. METHODS: In this prospective, multicenter, open-label, randomized, phase IV exploratory study, epoprostenol-naïve patients in need of injectable prostanoid therapy were randomized 2:1 to open-label epoprostenol AM or epoprostenol GM...
February 2014: American Heart Journal
Olivier Sitbon, Marion Delcroix, Emmanuel Bergot, Anco B Boonstra, John Granton, David Langleben, Pilar Escribano Subías, Nazzareno Galiè, Thomas Pfister, Jean-Christophe Lemarié, Gérald Simonneau
BACKGROUND: Continuous infusion of epoprostenol is the treatment of choice in patients with pulmonary arterial hypertension in functional classes III to IV. However, this treatment's limitations include instability at room temperature. A new epoprostenol formulation offers improved storage conditions and patient convenience. METHODS: The EPITOME-2 trial was an open-label, prospective, multicenter, single-arm, phase IIIb study. Patients with pulmonary arterial hypertension on long-term, stable epoprostenol therapy were transitioned from epoprostenol with glycine and mannitol excipients (Flolan; GlaxoSmithKline, Durham, NC) to epoprostenol with arginine and sucrose excipients (Veletri; Actelion Pharmaceuticals Ltd, Allschwil, Switzerland)...
February 2014: American Heart Journal
Angela Arumpanayil
This article presents a case study demonstrating various rescue therapies considered in the care of a patient with severe, refractory hypoxemia secondary to acute respiratory distress syndrome. In particular, inhaled epoprostenol (Flolan) is becoming an increasingly common alternative to nitric oxide in the treatment of severe, refractory hypoxemia. Research comparing the 2 inhaled vasodilators suggests that epoprostenol is equally efficacious, easier to administer, less costly, and has fewer adverse effects...
September 2013: Dimensions of Critical Care Nursing: DCCN
Pooja Swamy, Ghulam Saydain, Kalyan Kosuri
SESSION TYPE: Cardiovascular Student/Resident Case Report Posters IIPRESENTED ON: Tuesday, October 23, 2012 at 01:30 PM - 02:30 PMINTRODUCTION: There have been cases previously reported that bring out a temporal relation between Pulmonary Arterial Hypertension (PH) and Multiple Sclerosis (MS). These case reports implied a possible causal relationship between the Interferon (IF) β therapy in MS and PH. We present two cases with MS and PHCASE PRESENTATION: The first patient is a 41 yr old female with idiopathic PH diagnosed in 2007 who presented with NYHA class 3 dyspnea...
October 1, 2012: Chest
Mirena Kovacheva, Micah Fisher, Stacey Folse
SESSION TYPE: Heart Failure PostersPRESENTED ON: Wednesday, October 24, 2012 at 01:30 PM - 02:30 PMPURPOSE: Prior studies have linked treprostinil (Remodulin®) with bloodstream infections (BSI). It is thought the acidic pH of normal saline (NS), used for mixing treprostinil, is more likely to promote bacterial growth than the basic pH of sterile diluent for Flolan® (SDF). The objective of this study was to identify and characterize the incidence of BSI in pulmonary hypertension (PH) patients receiving treprostinil mixed with NS or SDF...
October 1, 2012: Chest
Robert Frantz, Murali Chakinala, Robyn Barst, Robert Schilz, Kelly Chin, Anna Hemnes, Dave Miller, Wade Benton, Brian Hartline, Harrison Farber
SESSION TYPE: Pulmonary Hypertension IPRESENTED ON: Sunday, October 21, 2012 at 10:30 AM - 11:45 AMPURPOSE: Patients with pulmonary arterial hypertension (PAH) receiving IV therapy are at increased risk of bloodstream infections (BSIs). We determined BSI rates in the first 300 patients enrolled in the registry to PROSPECTively evaluate use of epoprostenol for injection (Veletri®, EFI) in PAH patients.METHODS: PROSPECT is an ongoing, multicenter, observational, US registry following patients with PAH for 1 year who are currently receiving, initiating, or transitioning from other PAH prostacyclin analogs to EFI...
October 1, 2012: Chest
A Y Wen, I K Weiss, R B Kelly
Treprostinil is a prostacyclin analogue approved for the treatment of pulmonary arterial hypertension (PAH). It is commonly administered through a central venous catheter (CVC). Treprostinil is associated with the incidence of Gram-negative bacterial bloodstream infections (BSI), a susceptibility that has been associated with a diluent used for treprostinil. We report the case of a 14-year-old boy with idiopathic PAH on continuous intravenous treprostinil therapy who presented with fever and fatigue. A blood culture drawn from his CVC was positive for the rare Gram-negative organism Chryseomonas luteola...
June 2013: Infection
Maryam Bita Tabrizi, Miren A Schinco, Joseph J Tepas, James Hwang, Elizabeth Spiwak, Andrew J Kerwin
BACKGROUND: Epoprostenol (Flolan), an inhalational epoprostenol vasodilator, increases pulmonary arterial flow and decreases pulmonary pressures, thereby improving gas exchange and arterial oxygenation. We evaluated the benefits of inhaled epoprostenol as a less expensive alternative to nitric oxide in ventilated surgical intensive care patients with severe hypoxemia. METHODS: After institutional review board approval was obtained, the records of mechanically ventilated surgical intensive care unit patients who received epoprostenol as a therapy for severe hypoxia (SaO₂ < 90%) in a tertiary care referral center were retrospectively reviewed...
August 2012: Journal of Trauma and Acute Care Surgery
Colin P Wozencraft, Patrick J Coyne, Daniel C Grinnan, Thomas D Morel, Katie M Muzevich, Thomas J Smith
Prostacyclin analogues such as epoprostenol (Flolan®) are commonly used in the treatment of pulmonary arterial hypertension (PAH). However, their complex administration and significant cost may limit the access that patients with PAH have to palliative and hospice care. We herein report our experience using epoprostenol in a dedicated palliative care unit and present our inpatient protocol for the drug's administration.
May 2012: Journal of Palliative Medicine
Heather Hall, Joanne Côté, Althea McBean, Margaret Purden
OBJECTIVE: Little is known about the day-to-day experiences of patients and their support persons during the course of epoprostenol treatment for pulmonary arterial hypertension (PAH). The study objective was to describe the experiences of patients and their support persons adjusting to PAH and continuous intravenous epoprostenol. METHODS: A qualitative descriptive design with semistructured interviews was conducted jointly with the patient and his/her support person...
January 2012: Heart & Lung: the Journal of Critical Care
D Zaccardelli, K Phares, R Jeffs, A Doran, M Wade
INTRODUCTION: Long-term intravenous infusion of epoprostenol and treprostinil for treatment of pulmonary arterial hypertension (PAH) via a central venous catheter is associated with the risk of bloodstream infection (BSI). While several potential explanations exist for possible differences in BSI incidence among intravenous prostanoids, one hypothesis suggests that the alkaline pH of epoprostenol in Sterile Diluent for Flolan (SDF) has greater antimicrobial activity compared with the neutral pH of other common diluents such as sterile saline or water, which have been used for treprostinil...
June 2010: International Journal of Clinical Practice
Christopher M O'Connor, Vic Hasselblad, Rajendra H Mehta, Gudaye Tasissa, Robert M Califf, Mona Fiuzat, Joseph G Rogers, Carl V Leier, Lynne W Stevenson
OBJECTIVES: Identifying high-risk heart failure (HF) patients at hospital discharge may allow more effective triage to management strategies. BACKGROUND: Heart failure severity at presentation predicts outcomes, but the prognostic importance of clinical status changes due to interventions is less well described. METHODS: Predictive models using variables obtained during hospitalization were created using data from the ESCAPE (Evaluation Study of Congestive Heart Failure and Pulmonary Artery Catheterization Effectiveness) trial and internally validated by the bootstrapping method...
March 2, 2010: Journal of the American College of Cardiology
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