195 Safely Transitioning from Inhaled Iloprost to Inhaled Treprostinil Sodium – Results from a Multicenter Open-Label Study in Patients with Pulmonary Arterial Hypertension

Bourge, Robert C.; Tapson, Victor F.; Safdar, Zeenat; Benza, R.L.; Channick, Richard; Rosenzweig, E.B.; Shapiro, Shelley; McSwain, C. Shane; Gotzkowsky, A.; Nelsen, Andrew C.; Rubin, Leona J.

doi:10.1016/j.healun.2011.01.202

Cited by 4 publications

(7 citation statements)

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“…Changes in treatment satisfaction were accompanied by improvement in QoL scores and a decrease in total time spent on drug preparation activities. Based on these favorable results, we utilized a similar approach in designing the current study of inhaled prostacyclin among a substantially larger population of patients with PAH [17,18]. Our findings support the reliability, validity, and responsiveness of the TSQM in PAH, while providing additional insights regarding its relationship with other health status measures.…”

Section: Discussionmentioning

confidence: 71%

“…For this analysis, we utilized clinical and patient-reported outcome data obtained from a multicenter, prospective, open-label trial in patients with stable PAH rapidly transitioned from inhaled iloprost to inhaled treprostinil [17,18]. In brief, eligible patients were between the age of 18 and 75 years with a diagnosis of idiopathic/hereditary PAH, PAH associated with collagen vascular disease or human immunodeficiency virus, or PAH associated with congenital systemic-to-pulmonary shunt.…”

Section: Methodsmentioning

confidence: 99%

“…In a 12 week, multicenter, prospective, open-label trial of stable PAH patients transitioned from inhaled iloprost to inhaled treprostinil, total time spent on daily treatment activities was reduced by an average of 1.4 hours per day [17,18]. Significant improvement in 6MWD and QoL scores were also observed.…”

Section: Introductionmentioning

confidence: 99%

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Treatment satisfaction is associated with improved quality of life in patients treated with inhaled treprostinil for pulmonary arterial hypertension

Chen

Rosenzweig

Gotzkowsky

et al. 2013

Health and Quality of Life Outcomes

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BackgroundPatient treatment satisfaction is likely to be a highly relevant outcome measure in pulmonary arterial hypertension (PAH), a condition for which the benefits of treatment must be weighed against frequent, undesirable side effects, inconvenience, and complications associated with therapy. In this study, we sought to evaluate the psychometric properties of a patient-reported treatment satisfaction measure and its relationship to quality of life (QoL) among patients transitioning from inhaled iloprost (iILO) to inhaled treprostinil (iTRE).MethodsWe studied treatment satisfaction among 66 subjects with PAH in a single-arm, open-label, multi-center trial of iTRE following transition from iILO. Treatment satisfaction was assessed using the Treatment Satisfaction Questionnaire for Medication (TSQM, version 1.4) administered to subjects immediately before and 12 weeks after transition of inhaled therapy. The TSQM is comprised of 4 domains: effectiveness, side effects, convenience, and global satisfaction. Scores range from 0 to 100 with higher scores indicating greater satisfaction. Six-minute walk distance (6MWD), functional class, adverse events, drug administration time, and PAH-specific QoL (CAMPHOR) were concurrently assessed.ResultsDomains of the TSQM demonstrated evidence of strong internal consistency at baseline and at 12 weeks (Cronbach α = 0.88-0.93). Transition from iILO to iTRE was associated with an improvement in 3 of 4 TSQM domains: effectiveness (+20 ± 21, p < 0.0001), side effects (0 ± 22, p = 0.97), convenience (+39 ± 26, p < 0.0001), and global satisfaction (+20 ± 24, p = 0.0005). Change in effectiveness scores correlated with change in 6MWD (r = 0.43, p = 0.0004) and side effects scores at 12 weeks correlated inversely with number of severity-weighted treatment-emergent adverse events (r = −0.44, p = 0.0002). In multiple regression models adjusted for baseline characteristics, changes in effectiveness and convenience satisfaction scores were significantly associated with improvement in PAH-specific QoL (p = 0.002 and p = 0.01).ConclusionsThe TSQM demonstrated acceptable performance characteristics in patients with PAH. Changes in treatment satisfaction resulting from transitioning from iILO to iTRE were associated with improvements in PAH-specific QoL.

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Section: Discussionmentioning

confidence: 71%

Section: Methodsmentioning

confidence: 99%

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Treatment satisfaction is associated with improved quality of life in patients treated with inhaled treprostinil for pulmonary arterial hypertension

Chen

Rosenzweig

Gotzkowsky

et al. 2013

Health and Quality of Life Outcomes

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show abstract

“…Given the availability of a longer-acting, effective inhaled prostacyclin analog, the potential of transitioning patients from the shorter acting iloprost to inhaled treprostinil was examined 27. A 24-month, multicenter, prospective, open- label trial was designed to evaluate the long-term safety in PAH patients (n = 73) of transitioning from a stable dose of inhaled iloprost to inhaled treprostinil.…”

Section: Additional Clinical Datamentioning

confidence: 99%

Inhaled treprostinil: a therapeutic review

Channick

Voswinckel²,

Rubin

2012

DDDT

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Pulmonary arterial hypertension (PAH) is a life-threatening disease which, if untreated, leads to right ventricular failure and often death. Several effective therapies are now available for PAH, including endothelin receptor antagonists, phosphodiesterase-5 inhibitors, and prostacyclin analogs. The prostacyclin analog treprostinil has proven efficacious when delivered by subcutaneous or intravenous infusion, and most recently by inhalation. Inhaled treprostinil has been shown to be 64%–72% bioavailable in healthy volunteers. Pilot clinical studies have elucidated the acute hemodynamic effects and relative pulmonary selectivity of this agent, as well as established target dosing in PAH and nonoperable chronic thromboembolic PAH. Likewise, chronically administered inhaled treprostinil resulted in clinical and hemodynamic improvement. Both pilot studies confirmed a satisfactory safety profile in patients with PAH. The pivotal Phase III trial, TRIUMPH-I, demonstrated the efficacy and safety of inhaled treprostinil (target dose of 54 μg four times daily) in PAH patients added to background therapies of bosentan or sildenafil, as assessed by improvements in the primary endpoint, peak six-minute walk distance (median placebo-corrected treatment effect of 20 m), as well as select secondary endpoints. Inhaled treprostinil is approved by the US Food and Drug Administration for patients with World Health Organization Group I PAH to improve exercise ability. Studies establishing effectiveness included predominately patients with New York Heart Association functional class III symptoms and etiologies of idiopathic or heritable PAH (56%) or PAH associated with connective tissue diseases (33%).

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“…Significant improvements in N-terminal prohormone of brain natriuretic peptide (NT-proBNP) were also observed at 6 and 12 weeks of treprostinil therapy (519 and 419 pg/mL vs. 580 pg/mL at baseline on iloprost; P , 0.01 for both). 27 In 2005, an oral formulation of treprostinil was evaluated as a potential therapy for patients with PAH. Two Phase III multi-national, placebo-controlled clinical trials of oral treprostinil in combination with approved therapy and as monotherapy in patients with PAH to study both safety and efficacy were undertaken.…”

Section: Clinical Trialsmentioning

confidence: 99%

Clinical Utility of Treprostinil and Its Overall Place in the Treatment of Pulmonary Arterial Hypertension

Mirza

Foley

2012

Clin Med Insights Circ Respir Pulm Med

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Pulmonary arterial hypertension (PAH) is a disease that leads to characteristic vascular wall remodeling and hemodynamic alterations. Consequently, this pulmonary vascular disease contributes to substantial morbidity and mortality in afflicted patients. PAH may be idiopathic in nature or associated with connective tissue disease, chronic liver disease, human immunodeficiency virus, congenital heart disease, and a growing list of other conditions. There are currently nine Food and Drug Administration-approved therapies for specific PAH treatment. Therapeutic targets include prostacyclin replacement, endothelin-1 antagonism, and phosphodiesterase-5 inhibition. This article focuses on the prostanoid treprostinil and explores its role in the management of patients with PAH.

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195 Safely Transitioning from Inhaled Iloprost to Inhaled Treprostinil Sodium – Results from a Multicenter Open-Label Study in Patients with Pulmonary Arterial Hypertension

Cited by 4 publications

References 0 publications

Treatment satisfaction is associated with improved quality of life in patients treated with inhaled treprostinil for pulmonary arterial hypertension

Treatment satisfaction is associated with improved quality of life in patients treated with inhaled treprostinil for pulmonary arterial hypertension

Inhaled treprostinil: a therapeutic review

Clinical Utility of Treprostinil and Its Overall Place in the Treatment of Pulmonary Arterial Hypertension

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