Author: Hill, Adam T ; Goeminne, Pieter C ; Polverino, Eva ; Stone, Glenda ; Davis, Angela ; Chalmers, James D ; Obradovic, Dusanka ; Araújo, David ; Aliberti, Stefano ; De Soyza, Anthony ; Shteinberg, Michal ; Trautmann, Marion ; Dimakou, Katerina ; McDonnell, Melissa J ; Fardon, Thomas C

Pseudomonas aeruginosais responsible for chronic infection in many bronchiectasis patients but it is not known whether it is associated with worse clinical outcomes independent of the underlying severity of disease.This study analysed data from 2596 bronchiectasis patients included from 10 different bronchiectasis clinical centres across Europe and Israel, with a 5-year follow-up period. Prevalence ofP. aeruginosachronic infection and its independent impact on exacerbations, hospitalisations, quality of life and mortality was assessed.The prevalence ofP. aeruginosachronic infection was 15.0% (n=389).P. aeruginosawas associated with a higher mortality in a univariate analysis (hazard ratio (HR) 2.02; 95% (confidence interval) CI 1.53–2.66; p<0.0001) but an independent impact on mortality was not found in a multivariate analysis (HR 0.98; 95% CI 0.70–1.36; p=0.89).P. aeruginosawas independently associated with increased mortality only in patients with frequent exacerbations (two or more per year) (HR 2.03; 95% CI 1.36–3.03; p=0.001). An independent association with worse quality of life of 7.46 points (95% CI 2.93–12.00; p=0.001) was found in a multivariable linear regression.P. aeruginosawas therefore found to be independently associated with exacerbation frequency, hospital admissions and worse quality of life. Mortality was increased in patients withP. aeruginosaparticularly in the presence of frequent exacerbations.

SSRN Electronic Journal

Two Randomised Controlled Trials of Inhaled Liposomal Ciprofloxacin (ARD-3150) in Patients with Non-Cystic Fibrosis Bronchiectasis and Chronic Lung Infection with Pseudomonas Aeruginosa

Author: Anne E. O'Donnell ; Juergen Froehlich ; Diana Bilton ; James D. Chalmers ; Igor Gonda ; Bruce Thompson ; Charles Haworth ; Angela M. Davis ; Adam Wanner

Background: In patients with non-cystic fibrosis bronchiectasis (NCFB), lung infection with Pseudomonas aeruginosa is associated with severe disease, frequent pulmonary exacerbations (PEs) and hospitalisations, reduced quality of life, and higher mortality. Although inhaled antibiotics are conditionally recommended for long-term management of NCFB with frequent exacerbations, there is no approved therapy. The safety and efficacy of inhaled, liposomal ciprofloxacin (ARD-3150) was investigated in two phase III trials. Methods: ORBIT-3 (NCT01515007) and ORBIT-4 (NCT02104245) were randomised (2:1), double-blind, placebo-controlled trials in patients with NCFB and P. aeruginosa lung infection with at least two PEs requiring antibiotics in the prior year. Inhaled ARD-3150 or placebo was self-administered once daily for six cycles of 28 days on-treatment/28 days off-treatment, for 48 weeks. Findings: In ORBIT-3, 183 patients received ARD-3150 and 95 received placebo; in ORBIT-4 206 patients received ARD-3150 and 98 received placebo. Median time to first PE (primary endpoint) was significantly delayed in ORBIT-4 only (treatment effect hazard ratio [HR with 95% confidence interval (CI)] 0·72 [0·53-0·97], p=0·032; ORBIT-3 HR 0·99 [0·71-1·38], p=0·974; pooled analysis HR 0·82 [0·65-1·02], p=0·074). Frequency of PEs was not significantly reduced in ORBIT-3; however, the frequency of all severities of PEs was significantly reduced in ORBIT-4 and the pooled analysis. Sputum density of P. aeruginosa was significantly reduced with ARD-3150 at end of on-treatment periods in both trials. The safety and tolerability of ARD-3150 was similar to placebo. Interpretation: ARD-3150 may provide benefit to patients with NCFB with chronic P. aeruginosa lung infections and frequent exacerbations. Funding: Aradigm Corporation. Declaration of Interest: CSH reports personal fees from Aradigm Corporation, personal fees from Grifols, during the conduct of the study; and reports personal fees from Chiesi, personal fees from Gilead, personal fees from GlaxoSmithKline, personal fees and grants from Insmed, personal fees and grants from Teva, personal fees and grants from Vertex, personal fees from Zambon, outside of the submitted work. DB reports personal fees from Aradigm Corporation, during the conduct of the study. JDC reports personal fees with Aradigm Corporation, grants from AstraZeneca, personal fees and grants from Bayer Healthcare, personal fees and grants from BoehringerIngelheim, personal fees and grants from GlaxoSmithKline, personal fees and grants from Grifols, Ethical Approval: The trial protocols were approved at each site by an ethics committee or institutional review board. Patients provided written informed consent at enrolment.

News (Medical) associated with Grifols, Inc.

10 Aug 2022

·www.prnewswire.com

Qardio Welcomes New Board Members and Chairman as the Company Continues to Launch Disruptive Technology

The brand is pivoting its mission in healthcare and is eager to see the continued growth it will make with these new additions. SAN FRANCISCO, Aug. 10, 2022 /PRNewswire/ -- Qardio, a leader in connected care with predictive insight for a changing world, is proud to welcome new members to its board: new Chairman Gregory Rich, and board members Dr. David Steinhaus and Leopoldo Zambeletti. Taking over as chairman is Gregory Rich, who has held various positions in the healthcare industry, including Alpha Therapeutic Corporation, and was most recently the President and CEO of Grifols Inc. "Qardio is currently paving the way in regard to patient healthcare," says Rich. "I am honored to continue my work as Chairman in order to further provide better patient care and improve patient outcomes." Joining the board of directors is Dr. David Steinhaus. Steinhaus's vast experience and previous leadership roles include Vice President and General Manager of Heart Failure and Chief Medical Officer of Cardiac Rhythm Management with Medtronic, as well as being a practicing electrophysiologist, and management of medical practices. "The progress Qardio has made in improving its presence in global healthcare has been impressive. I am pleased to be able to help oversee the company's success," says Dr. Steinhaus. Also joining the board is Leopoldo Zambeletti, who has been working in the healthcare sector for nearly 30 years, starting his career at JP Morgan, where he led the Healthcare Investment Banking business in EMEA. He is an independent advisor, executing corporate finance deals for companies worldwide. He sits on various boards and private companies. Currently, Qardio is pivoting its mission to bring improved healthcare not only to consumers but to the healthcare industry as a whole. Most recently, the brand has further expanded its global footprint with recent product developments, such as QardioDirect, and QardioCore. "I am honored to have such a world class team on the board of directors", says Mike Alvarez, CEO. "Qardio continues to launch wearable technology utilizing cloud based Artificial Intelligence to help patients and providers stay healthy. Our recent launches of QardioDirect, an innovative remote vitals monitoring platform and QardioCore, the only FDA approved ambulatory ECG holter and extended holter with dry electrode technology, is just the beginning of an exciting growth period for Qardio." About Qardio Qardio is a medical technology company that operates at the intersection of cardiology and remote monitoring. Qardio's suite of solutions provides improved outcomes for care providers and their patients across a range of care modalities via improved workflows and diagnostic yields, reduced cost, and ease of use. Founded in 2012, Qardio's primary mission is to improve outcomes for adults living with a chronic heart condition, through simplified monitoring and diagnosis. QardioDirect, the remote patient monitoring service is equally suited to primary care and to discrete applications in hypertension, cardiovascular disease, obesity, chronic kidney disease, diabetes, post-surgical care and other chronic care conditions. Our award-winning solutions are available via medical channels and select consumer channels, to deliver the greatest impact. For more information on Qardio, visit . Contact [email protected] SOURCE Qardio

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