scholarly journals Real-World Dosing Characteristics and Utilization of Parenteral Treprostinil in the Outpatient Setting

2021 ◽  
Author(s):  
Vijay P. Balasubramanian ◽  
Zeenat Safdar ◽  
Margaret R. Sketch ◽  
Meredith Broderick ◽  
Andrew C. Nelsen ◽  
...  
Author(s):  
Bee Ling Kelly Chng ◽  
Jin Shing Hon ◽  
Hong Chan ◽  
Yiliang Zheng ◽  
Fei Gao ◽  
...  

2022 ◽  
Vol 24 (1) ◽  
Author(s):  
M. Meehan ◽  
A. Shah ◽  
J. Lobo ◽  
J. Oates ◽  
C. Clinton ◽  
...  

Abstract Background/purpose Interstitial lung disease (ILD) is an important problem for patients with rheumatoid arthritis (RA). However, current approaches to ILD case finding in real-world data have been evaluated only in limited settings and identify only prevalent ILD and not new-onset disease. Our objective was to develop, refine, and validate a claims-based algorithm to identify both prevalent and incident ILD in RA patients compared to the gold standard of medical record review. Methods We used administrative claims data 2006–2015 from Medicare to derive a cohort of RA patients. We then identified suspected ILD using variations of ILD algorithms to classify both prevalent and incident ILD based on features of the data that included hospitalization vs. outpatient setting, physician specialty, pulmonary-related diagnosis codes, and exclusions for potentially mimicking pulmonary conditions. Positive predictive values (PPV) of several ILD algorithm variants for both prevalent and incident ILD were evaluated. Results We identified 234 linkable RA patients with sufficient data to evaluate for ILD. Overall, 108 (46.2%) of suspected cases were confirmed as ILD. Most cases (64%) were diagnosed in the outpatient setting. The best performing algorithm for prevalent ILD had a PPV of 77% (95% CI 67–84%) and for incident ILD was 96% (95% CI 85–100%). Conclusion Case finding in administrative data for both prevalent and incident interstitial lung disease in RA patients is feasible and has reasonable accuracy to support population-based research and real-world evidence generation.


2020 ◽  
Vol 7 (Supplement_1) ◽  
pp. S660-S660
Author(s):  
Taylor Morrisette ◽  
Julie V Philley ◽  
Carly Sigler ◽  
Jeremy J Frens ◽  
Andrew J Webb ◽  
...  

Abstract Background Omadacycline (OMC) is an aminomethylcycline antibiotic in the tetracycline class that has been Food and Drug Administration-approved for acute bacterial skin and skin structure infections and community-acquired bacterial pneumonia. OMC has been shown to have potent in vitro activity against a broad-spectrum of Gram-positive and Gram-negative organisms, as well as Nontuberculous Mycobacteria (NTM). Due to it’s unique activity and availability as an oral agent, off-label use of OMC has been increasing. We evaluated the real-world effectiveness and safety of OMC for a variety of infections. Methods This was a multicenter, retrospective, observational study that was conducted from January 2020 to June 2020. We included all patients ≥ 18 years of age that received OMC for ≥ 72 hours for any indication and/or pathogen. The primary outcome was clinical success, defined as a lack of 30-day (non-NTM) or 90-day (NTM) mortality or microbiologic recurrence and absence of therapy escalation or alteration. Reasons for OMC utilization and incidence of potential adverse effects attributable to OMC were also analyzed. Results A total of 18 patients were included from six geographically distinct academic health systems (median age: 56 (IQR, 49-60.5) years; 61% male; 72% Caucasian). The majority of OMC use was in NTM (61%; 100% Mycobacterium abscessus) and in Acinetobacter baumannii (22%) for bone/joint (39%) and respiratory tract (33%) infections. OMC was used primarily in the outpatient setting alone (83%) and most isolates did not have OMC susceptibility conducted (89%). Clinical success was reported in 83% of the total population (71% non-NTM and 91% NTM). The majority of patients were prescribed OMC due to antimicrobial resistance to previous antibiotic(s) (61%) and/or due to OMC’s availability as an oral agent (44%). Three patients experienced side effects while on therapy (serum creatinine elevation, AST/ALT increase, and gastrointestinal distress). Conclusion OMC appears to be effective and well-tolerated for a variety of infections caused by various pathogens, including M. abscessus and A. baumannii. Disclosures Michael J. Rybak, PharmD, MPH, PhD, Paratek (Grant/Research Support)


Author(s):  
Bassem Farah

A clinical decision report using Gu P, Lew D, Jung OS, et al. Comparing the Real-World Effectiveness of Competing Colonoscopy Preparations: Results of a Prospective Trial. Am J Gastroenterol. 2019;114(2):305-314. https://doi.org/10.14309/ajg.0000000000000057 for a patient reluctant to undergo colonoscopy screening due to concerns about GoLYTLEY's tolerability.


Blood ◽  
2010 ◽  
Vol 116 (21) ◽  
pp. 3802-3802
Author(s):  
Alpesh N Amin ◽  
Jay Lin ◽  
Stephen Thompson ◽  
Daniel Wiederkehr

Abstract Abstract 3802 Background: Deep-vein thrombosis (DVT) is a frequent complication of cancer and treatment of cancer. Among clinical guidelines, there is broad consensus regarding the importance of thromboprophylaxis in hospitalized cancer patients, including prolonged prophylaxis in high-risk patients. The objective of this analysis was to assess the real-world use of prophylaxis for DVT, as well as symptomatic rates of DVT and pulmonary embolism (PE) in cancer patients, both during hospitalization and after hospital discharge. Methods: Data were extracted from the US Premier Perspective(tm)-i3 Pharma Informatics linked database for non-surgical cancer patients who were admitted to hospital from January 2005 to November 2007. Included patients were aged ≥ 18 years and had ≥ 6 months' continuous plan enrollment. Patients were excluded if they were discharged to an acute-care facility, had length of hospital stay ≤ 0 or > 30 days, had missing/unknown gender or age data, or if they were diagnosed with atrial fibrillation during index hospitalization. Clinical rates of DVT/PE, as well as thromboprophylaxis status and duration were evaluated for during hospitalization and post-discharge. Results: Of the 3,759 cancer patients analyzed, 51.9% received inpatient pharmacological and/or mechanical prophylaxis, and 2.8% received outpatient pharmacological prophylaxis in the 14 days following discharge. During index hospitalization 40.0% of patients received mechanical prophylaxis and 21.1% pharmacological prophylaxis, with 9.3% of patients receiving a combination of mechanical and pharmacological prophylaxis. Mean (± standard deviation) duration of prophylaxis was 1.3 (± 2.3) days for inpatients and 0.7 (± 4.5) days post-discharge among all cancer patients. Symptomatic DVT/PE occurred in 2.4% of patients during hospitalization. In the 30 days following hospital discharge, 1.7% of patients was either rehospitalized for DVT/PE or treated for DVT/PE in the outpatient setting. Conclusions: This real-world analysis demonstrates considerable symptomatic rates of DVT/PE in hospitalized cancer patients, with approximately half of patients not receiving any thromboprophylaxis. The risk of DVT/PE persisted into the outpatient setting, but few patients received anticoagulants post-discharge. Further efforts are needed to ensure that patients with cancer receive appropriate thromboprophylaxis and that it is of adequate duration to reduce the large burden of DVT/PE. Acknowledgment: This study was funded by sanofi-aventis U.S., Inc. The authors received editorial/writing support in the preparation of this abstract provided by Tessa Hartog, PhD of Excerpta Medica, funded by sanofi-aventis U.S., Inc. Disclosures: Amin: sanofi-aventis US Inc.: Honoraria, Speakers Bureau. Lin:sanofi-aventis US Inc.: Employment, Research Funding. Thompson:sanofi-aventis US Inc.: Employment. Wiederkehr:sanofi-aventis US Inc.: Research Funding.


2016 ◽  
Vol 70 (4_Supplement_1) ◽  
pp. 7011500071p1
Author(s):  
Caitlin Doman ◽  
Kimberly Waddell ◽  
Ryan Bailey ◽  
Jennifer Moore ◽  
T. George Hornby ◽  
...  

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