scholarly journals EXPRESS: Survival and Drug Persistence in Patients Receiving Inhaled Treprostinil at Doses Greater than 54 Mcg (9 Breaths) 4 Times Daily

2021 ◽  
pp. 204589402110522
Author(s):  
Shelley M Shapiro ◽  
Stacy Mandras ◽  
Ricardo Restrepo-Jaramillo ◽  
Eric Shen ◽  
Meredith Broderick ◽  
...  

Treprostinil is a prostacyclin analogue approved for the treatment of pulmonary arterial hypertension (PAH). Commercial data sets indicate that approximately 20-25% of patients are prescribed a higher dose than the maximum recommended dosage of 9 breaths per treatment session (bps) (54 υg), four times a day (QID) and numerous studies have demonstrated the safety of doses >9 bps QID. This phase 4, retrospective analysis of specialty pharmacy records assessed the effects of inhaled treprostinil at doses >9 bps QID. Patients receiving inhaled treprostinil between September 2009 and June 2018 were included, and a random sampling of 5,000 patients were selected for further analysis. Subjects were grouped based on the highest dose reached for ≥2 months within a rolling 6-month window and were followed for up to three years. Of the total of 5,000 patients analyzed, 28.5% received >9 bps QID. Survival rates were significantly higher in the >9 bps QID dosing group for years one, two, and three (P < 0.001). The time to transition to parenteral therapy was significantly longer for those at doses >9 bps (17.5 months) compared to doses ≤9 bps (9.5 moths; P < 0.0001). Drug persistence was also significantly higher for those taking >9 bps at years 1, 2, and 3 (P < 0.0001). Patients receiving inhaled treprostinil at doses >9 bps QID had a higher rate of survival and drug persistence over a three-year period, suggesting that higher doses may provide clinically relevant benefits while remaining tolerable.

BMC Cancer ◽  
2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Yifan Feng ◽  
Ye Wang ◽  
Yangqin Xie ◽  
Shuwei Wu ◽  
Yuyang Li ◽  
...  

Abstract Background To explore the factors that affect the prognosis of overall survival (OS) and cancer-specific survival (CSS) of patients with stage IIIC1 cervical cancer and establish nomogram models to predict this prognosis. Methods Data from patients in the Surveil-lance, Epidemiology, and End Results (SEER) programme meeting the inclusion criteria were classified into a training group, and validation data were obtained from the First Affiliated Hospital of Anhui Medical University from 2010 to 2019. The incidence, Kaplan-Meier curves, OS and CSS of patients with stage IIIC1 cervical cancer in the training group were evaluated. Nomograms were established according to the results of univariate and multivariate Cox regression models. Harrell’s C-index, calibration plots, receiver operating characteristic (ROC) curves and decision-curve analysis (DCA) were calculated to validate the prediction models. Results The incidence of pelvic lymph node metastasis, a high-risk factor for the prognosis of cervical cancer, decreased slightly over time. Eight independent prognostic variables were identified for OS, including age, race, marriage status, histology, extension range, tumour size, radiotherapy and surgery, but only seven were identified for CSS, with marriage status excluded. Nomograms of OS and CSS were established based on the results. The C-indexes for the nomograms of OS and CSS were 0.687 and 0.692, respectively, using random sampling of SEER data sets and 0.701 and 0.735, respectively, using random sampling of external data sets. The AUCs for the nomogram of OS were 0.708 and 0.705 for the SEER data sets and 0.750 and 0.750 for the external data sets, respectively. In addition, AUCs of 0.707 and 0.709 were obtained for the nomogram of CSS when validated using SEER data sets, and 0.788 and 0.785 when validated using external data sets. Calibration plots for the nomograms were almost identical to the actual observations. The DCA also indicated the value of the two models. Conclusions Eight independent prognostic variables were identified for OS. The same factors predicted CSS, with the exception of the marriage status. Both OS and CSS nomograms had good predictive and clinical application value after validation. Notably, tumour size had the largest contribution to the OS and CSS nomograms.


2015 ◽  
Vol 24 (138) ◽  
pp. 665-673 ◽  
Author(s):  
Harrison W. Farber ◽  
Simon Gibbs

Pulmonary hypertension (PH) associated with left heart disease (PH-LHD) is the most common type of PH, but its natural history is not well understood. PH-LHD is diagnosed by right heart catheterisation with a mean pulmonary arterial pressure ≥25 mmHg and a pulmonary capillary wedge pressure >15 mmHg. The primary causes of PH-LHD are left ventricular dysfunction of systolic and diastolic origin, and valvular disease. Prognosis is poor and survival rates are low. Limited progress has been made towards specific therapies for PH-LHD, and management focuses on addressing the underlying cause of the disease with supportive therapies, surgery and pharmacological treatments. Clinical trials of therapies for pulmonary arterial hypertension in patients with PH-LHD have thus far been limited and have provided disappointing or conflicting results. Robust, long-term clinical studies in appropriate target populations have the potential to improve the outlook for patients with PH-LHD. Herein, we discuss the knowledge gaps in our understanding of PH-LHD, and describe the current unmet needs and challenges that are faced by clinicians when identifying and managing patients with this disease.


2021 ◽  
pp. 2102024
Author(s):  
Marius M. Hoeper ◽  
Christine Pausch ◽  
Ekkehard Grünig ◽  
Gerd Staehler ◽  
Doerte Huscher ◽  
...  

BackgroundSince 2015, the European pulmonary hypertension guidelines recommend the use of combination therapy in most patients with pulmonary arterial hypertension (PAH). However, it is unclear to what extend this treatment strategy is adopted in clinical practice and if it is associated with improved long-term survival.MethodsWe analysed data from COMPERA, a large European pulmonary hypertension registry, to assess temporal trends in the use of combination therapy and survival of patients with newly diagnosed PAH between 2010 and 2019. For survival analyses, we look at annualized data and at cumulated data comparing the periods 2010–2014 and 2015–2019.ResultsA total of 2,531 patients were included. The use of early combination therapy (within 3 months after diagnosis) increased from 10.0% in patients diagnosed with PAH in 2010 to 25.0% in patients diagnosed with PAH in 2019. The proportion of patients receiving combination therapy 1 year after diagnosis increased from 27.7% to 46.3%. When comparing the 2010–2014 and 2015–2019 periods, 1-year survival estimates were similar (89.0% [95% CI, 87.2%, 90.9%] and 90.8% [95% CI, 89.3%, 92.4%]), respectively, whereas there was a slight but non-significant improvement in 3-year survival estimates (67.8% [95% CI, 65.0%, 70.8%] and 70.5% [95% CI, 67.8%, 73.4%]), respectively.ConclusionsThe use of combination therapy increased from 2010 to 2019, but most patients still received monotherapy. Survival rates at 1 year after diagnosis did not change over time. Future studies need to determine if the observed trend suggesting improved 3-year survival rates can be confirmed.


2017 ◽  
Vol 15 (4) ◽  
Author(s):  
David Francis Fullon Chan ◽  
Ma. Dominga B. Padilla

PURPOSE: There are currently no published studies on the outcomes of keratoplasty in the Philippines.  This study aimed to report graft survival rates at years 1, 3, and 5 after surgery, visual outcomes, and causes of graft failure among private patients of corneal surgeons in Metropolitan Manila receiving tissue from a single local eye bank in the period 2008-2012.  DESIGN: Retrospective cohort, multicenter study. METHODS: POPULATION: Private patients of Metro Manila corneal surgeons, receiving tissue from the Santa Lucia International Eye Bank of Manila in 2008-2012.  241 of 593 yielded sufficiently complete data sets. PROCEDURE: Donor and tissue characteristics, pre-op and latest follow-up characteristics/clinical findings were retrieved and processed. Data from the eye bank was merged with follow-up data from surgeons submitted March-October 2014. MAIN OUTCOME MEASURES: Survival rates at 1, 3, and 5 years; best-corrected visual acuity as of latest follow-up; causes of failure. RESULTS:  1-year survival: 90.4%, 3-year: 71.5%, 5-year: ~52.7%. Overall, 43.5% had VA of 20/50 or better, and 25% counting fingers or worse, with variations across diagnoses. CONCLUSION: Though small in sample size and response rate, survival trends parallel studies with larger populations elsewhere. Specific trends like favorable survival in keratoconus were consistent. Indications for surgery have changed little since 2005, but regraft has become the most common indication. Further data collection and completion are required for multivariate analysis on factors regarding survival.  Inflammation, infection, trauma, poor adherence are among the identified reasons for failure.  


2021 ◽  
Vol 8 ◽  
Author(s):  
Qin-Hua Zhao ◽  
Su-Gang Gong ◽  
Rong Jiang ◽  
Chao Li ◽  
Ge-Fei Chen ◽  
...  

Background: Right ventricular (RV) function is a great determination of the fate in patients with pulmonary arterial hypertension (PAH). Monitoring RV structure back to normal or improvement should be useful for evaluation of RV function. The aims of this study were to assess the prognostic relevance of changed right heart (RH) dimensions by echocardiography and attenuated RH remodeling (ARHR) in idiopathic PAH (IPAH).Methods: We retrospectively analyzed 232 consecutive adult IPAH patients at baseline assessment and included RH catheterization and echocardiography. ARHR at the mean 20 ± 12 months' follow-up was defined by a decreased right atrium area, RV mid-diameter, and left ventricular end-diastolic eccentricity index. The follow-up end point was all-cause mortality.Results: At mean 20 ± 12 months' follow-up, 33 of 232 patients (14.2%) presented with ARHR. The remaining 199 surviving patients were monitored for another 25 ± 20 months. At the end of follow-up, the survival rates at 1, 3, and 5 years were 89, 89, and 68% in patients with ARHR, respectively, and 84, 65 and 41% in patients without ARHR (log-rank p = 0.01). ARHR was an independent prognostic factor for mortality. Besides, ARHR was available to further stratify patients' risk assessment through the French PAH non-invasive-risk criteria.Conclusions: Echocardiographic ARHR is an independent determinant of prognosis in IPAH at long-term follow-up. ARHR might be a useful tool to indicate the RV morphologic and functional improvement associated with better prognostic likelihood.


2021 ◽  
Author(s):  
Yifan Feng ◽  
Ye Wang ◽  
Yangqin Xie ◽  
Shuwei Wu ◽  
Yuyang Li ◽  
...  

Abstract BackgroundThe purpose of this study is to explore the factors that affect the prognosis of overall survival (OS) and cancer special survival (CSS) in cervical cancer with stage IIIC1 and establish nomogram models to predict this prognosis.MethodsData from The Surveil-lance, Epidemiology, and End Results (SEER) Program meeting the inclusion criterions were classified into training group, and data of validation were obtained from the First Affiliated Hospital of Anhui Medical University from 2010 to 2019. The incidence, Kaplan‐Meier curves, OS and CSS of stage IIIC1 were evaluated according to the training group. Nomograms were established according to the results of univariate and multivariate Cox regression models. Harrell’s C-index and receiver operating characteristic curve (ROC) were calculated to measure the accuracy of the prediction models. Calibration plots show the relationship between the predicted probability and the actual outcome. Decision-curve analysis (DCA) was applied to evaluate the clinical applicability of the constructed nomogram.ResultsThe incidence of pelvic lymph node metastasis, a high-risk factor for prognosis in cervical cancer, decreased slightly over time. There are eight independent prognostic variables for OS, including age, race, histology, differentiation, extension range, tumor size, radiation recode and surgery, but seven for CSS with age excluded. Nomograms of OS and CSS were established based on the results. The C-index for the nomograms of OS and CSS were 0.692, 0.689 respectively when random sampling of SEER data sets, and 0.706, 0.737 respectively when random sampling of external data sets. AUCs for the nomogram of OS were 0.648, 0.644 respectively, and 0.683, 0.675 for the nomogram of CSS. Calibration plots for the nomograms were almost identical to the actual observations. The DCA also proved the value of the two models.ConclusionAge, race, histology, differentiation, extension range, tumor size, radiation recode and surgery were all independent prognosis factors for OS. Only age excepts in CSS. OS and CSS nomograms were established in our study based on the result of multivariate Cox proportional hazard regression, and both own good predictive and clinical application value after validation.


2019 ◽  
Vol 5 (3) ◽  
pp. 00075-2019 ◽  
Author(s):  
Barbro Kjellström ◽  
Magnus Nisell ◽  
David Kylhammar ◽  
Sven-Erik Bartfay ◽  
Bodil Ivarsson ◽  
...  

BackgroundWomen with idiopathic pulmonary arterial hypertension (IPAH) have been found to have a worse haemodynamic status at diagnosis, but better survival than men. Over the past decade, demographics have changed and new treatments have become available. The objective of this study was to investigate sex differences in an incident IPAH population diagnosed between 2008 and 2016.MethodsDifferences in clinical characteristics of patients included in the Swedish Pulmonary Arterial Hypertension Register (SPAHR) were analysed at the time of diagnosis. Survival by sex was investigated using Cox proportional hazard regression and Kaplan–Meier curves.ResultsThe study included 271 patients diagnosed with IPAH, median age was 68 (1st–3rd quartiles 54–74) years and 56% were women. At diagnosis, women were younger, had lower pulmonary vascular resistance and fewer comorbidities and more often received a combination of PAH-targeted therapies than men. Men had worse survival rates than women (hazard ratio 1.49; CI 1.02–2.18; p=0.038), but this difference did not remain after adjustment for age (hazard ratio 1.30; CI 0.89–1.90; p=0.178).ConclusionsMen with incident IPAH have worse crude survival than women. This is due to women being younger with a less pronounced comorbidity burden than men at the time of diagnosis.


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