Metered dose inhaler delivery of treprostinil for the treatment of pulmonary hypertension

Voswinckel, Robert; Reichenberger, Frank; Gall, Henning; Schmehl, Thomas; Gessler, Tobias; Schermuly, Ralph Theo; Grimminger, Friedrich; Rubin, Lewis J.; Seeger, Werner; Ghofrani, Hossein Ardeschir; Olschewski, Horst

doi:10.1016/j.pupt.2008.11.009

Cited by 39 publications

(20 citation statements)

References 16 publications

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“…After reviewing the title, abstract or text, 44 articles were excluded because of CTEPH [8,9], heart failure [10-14], combination therapy [15-18], acute vasodilatory responses [19,20], peripheral vascular responses [21,22], limited patient numbers [23], or the management of pulmonary hypertension during or post surgery [24-31]. Three articles were extensions or a substudy of a RCT [32-35].…”

Section: Resultsmentioning

confidence: 99%

Hemodynamics in pulmonary arterial hypertension (PAH): do they explain long-term clinical outcomes with PAH-specific therapy?

Steele

Strange

Wlodarczyk³

et al. 2010

BMC Cardiovasc Disord

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BackgroundPulmonary arterial hypertension (PAH) has witnessed dramatic treatment advances over the past decade. However, with the exception of epoprostenol, data from short-term randomized controlled trials (RCTs) have not shown a benefit of these drugs on survival. There remains a need to differentiate between available therapies and current endpoint responses which in turn, could be used to guide treatment selection and provide long-term prognostic information for patients.MethodsWe performed a systematic literature search of MEDLINE and EMBASE databases for RCTs of PAH-specific therapy published between January 1980 and May 2009. Articles were selected if they contained a placebo comparator and described hemodynamic changes from baseline. We applied the weighted mean change in hemodynamic variables to the equation developed by the National Institutes of Health (NIH) Registry to estimate long-term survival with each therapy.ResultsTen RCTs involving 1,635 patients met the inclusion criteria. Suitable hemodynamic data were identified for bosentan, sitaxentan, sildenafil, epoprostenol, beraprost and treprostinil. 77.6% of patients were female and the mean (SD) age was 46.5 ± 4.9 years. 55.5% of patients had idiopathic PAH (iPAH), 23.9% PAH related to connective tissue disease, and 18.2% PAH related to congenital heart disease. Based on the effects observed in short-term trials and, relative to placebo, all analyzed therapies improved survival. The estimated 1-year survival was 78.4%, 77.8%, 76.1%, 75.8%, 75.2%, and 74.1% for epoprostenol, bosentan, treprostinil, sitaxentan, sildenafil, and beraprost, respectively. These estimates are considerably lower than the 1-year observed survival reported in several open-label and registry studies with PAH-specific therapies: 88% - 97%.ConclusionWhen applied to the NIH Registry equation, hemodynamic changes from baseline appear to underestimate the survival benefits observed with long-term PAH therapy.

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Section: Resultsmentioning

confidence: 99%

Hemodynamics in pulmonary arterial hypertension (PAH): do they explain long-term clinical outcomes with PAH-specific therapy?

Steele

Strange

Wlodarczyk³

et al. 2010

BMC Cardiovasc Disord

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“…Inhaled treprostinil has been studied in the chronic outpatient setting leading to its recent approval in 2009, but little is known about the use of inhaled treprostinil in the acute setting. In the outpatient setting, inhaled treprostinil administered four times a day lowers PAP and PVR at the same time improving 6-min walk distance (35–38). …”

Section: Treprostinilmentioning

confidence: 99%

Prostacyclin in the intensive care setting

Ivy

2010

Pediatric Critical Care Medicine

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The prostacyclins-prostanoids were one of the first medications used to treat pulmonary arterial hypertension (PAH). Three prostanoids have been developed to treat PAH: epoprostenol, treprostinil, and iloprost. In the acute setting, experience is growing, using the inhaled forms of these three medications. Inhalation may improve ventilation/perfusion matching, whereas in the intravenous form these medications may cause nonselective pulmonary vasodilation and may worsen ventilation/perfusion matching. Currently, there are no universal recommendations for dosing delivery of inhaled prostanoids to intubated patients in the intensive care unit setting.

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“…In order to release the contents of the pressurised canister, it must be triggered or actuated; which then produces a fi ne atomised spray over 100-200 ms (Voswinckel et al , 2009) of high inertia with the actuation containing large droplets (25 μ m) of high velocity, 30 ms −1 (Rubin and Fink, 2005). This results in oropharyngeal deposition, with only a small fraction of the dose actually depositing in the lungs.…”

Section: Technical Aspectsmentioning

confidence: 99%

History of inhaler devices

Preedy

Prokopovich

2013

Inhaler Devices

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Metered dose inhaler delivery of treprostinil for the treatment of pulmonary hypertension

Abstract: Background: The stable prostanoid analogue treprostinil is approved as continuous infusion

Cited by 39 publications

References 16 publications

Hemodynamics in pulmonary arterial hypertension (PAH): do they explain long-term clinical outcomes with PAH-specific therapy?

Hemodynamics in pulmonary arterial hypertension (PAH): do they explain long-term clinical outcomes with PAH-specific therapy?

Prostacyclin in the intensive care setting

History of inhaler devices

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