Transition from parenteral to oral treprostinil in pulmonary arterial hypertension

Chakinala, Murali M.; Feldman, Jeremy; Rischard, Franz; Mathier, Michael A.; Broderick, Meredith; Leedom, Nicole; Laliberte, Kevin; White, R. James

doi:10.1016/j.healun.2016.06.019

Cited by 54 publications

(109 citation statements)

References 22 publications

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“…Only patients who underwent parenteral to oral treprostinil transition following a previously reported transition protocol 5 were included (see transition protocol below). Patients were classified by the principal investigator (PI) at the time last assessment as:

‐ Successful transition ( S Transition): Continued FC I-II AND unchanged hemodynamics >24 weeks from transition;

‐ Unsuccessful transition ( U Transition): FC deterioration to III/IV and hemodynamic deterioration or unable to tolerate sufficient oral trerpostinil to maintain disease stability;

‐ Parenteral comparator ( C Parenteral): Individuals eligible to enroll (see inclusion/exclusion criteria) but did not transition due to early trial closure or personal choice to remain on parenteral treprostinil.

…”

Section: Methodsmentioning

confidence: 99%

Right ventricular afterload predicts long‐term transition from parenteral to oral treprostinil in pulmonary arterial hypertension

et al. 2018

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Despite the increasing trends, reports on long-term follow-up are limited on transitioning from parenteral to oral treprostinil therapy in patients with pulmonary arterial hypertension (PAH). We investigated both the effectiveness of parenteral to oral treprostinil transition and the characteristics associated with transition failure over a duration of two years. The study included 37 Group I functional class I and II patients with PAH on combination therapy. Patients were excluded if cardiac index ≤2.2 L/min/m2, right atrial pressure ≥11 mmHg, or 6-min walk distance ≤250 m. Patients were categorized as successful (STransition) or unsuccessful (UTransition) transition based on clinical stability, or a parenteral comparator (CParenteral) if they remained on parenteral therapy (no transition). All patients underwent two right heart catheterizations, one at enrollment and a second post transition. Of 24 total transition patients, 46% were classified as UTransition. UTransition occurred on average 577 days post transition. Both UTransition and STransition had similar hemodynamics at diagnosis and treprostinil dose before and after transition. Before transition, the pulmonary vascular resistance (PVR) was significantly higher in the UTransition (6.7 ± 2 WU) vs. STransition group (3.5 ± 1.5 WU). At follow-up catheterization, the UTransition group demonstrated further increases in PVR, greater than the CParenteral group, without recovery despite “rescue” therapy in the UTransition group. A pre-transition PVR of 4.16 WU discriminated the UTransition from the STransition group. While a subset of PAH patients on combination therapy may be safely transitioned from parenteral to oral treprostinil, caution should be exercised in patients with elevated baseline PVR to avoid irreversible destabilization.

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‐ Successful transition ( S Transition): Continued FC I-II AND unchanged hemodynamics >24 weeks from transition;

‐ Unsuccessful transition ( U Transition): FC deterioration to III/IV and hemodynamic deterioration or unable to tolerate sufficient oral trerpostinil to maintain disease stability;

…”

Section: Methodsmentioning

confidence: 99%

Right ventricular afterload predicts long‐term transition from parenteral to oral treprostinil in pulmonary arterial hypertension

et al. 2018

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“…Additional data are emerging from clinical practice and there is growing experience with managing this transition in the clinic. Patients receiving parenteral prostanoid therapy may request to switch to an oral drug and limited data from short-term studies on this approach are beginning to emerge [61][62][63][64][65][66][67]. Validation of this approach in RCTs will be required before it can be recommended.…”

Section: Future Perspectives: Managing Transitionsmentioning

confidence: 99%

Pulmonary arterial hypertension: tailoring treatment to risk in the current era

Gaine

McLaughlin

2017

Eur Respir Rev

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Recent advances in the treatment of pulmonary arterial hypertension (PAH) have led to improved patient outcomes. Multiple PAH therapies are now available and optimising the use of these drugs in clinical practice is vital. In this review, we discuss the management of PAH patients in the context of current treatment guidelines and supporting clinical evidence. In clinical practice, considerable emphasis is placed on the importance of making treatment decisions guided by each patient's risk status, which should be assessed using multiple prognostic parameters. As PAH is a progressive disease, regular assessments are essential to ensure that any change in risk is detected in a timely manner and treatment is adjusted accordingly. With the availability of therapies that target three different pathogenic pathways, combination therapy is now the standard of care. For most patients, this involves dual combination therapy with agents targeting the endothelin and nitric oxide pathways. Therapies targeting the prostacyclin pathway should be added for patients receiving dual combination therapy who do not achieve a low-risk status. There is also a need for a holistic approach to treatment beyond pharmacological therapies. Implementation of all these approaches will ensure that PAH patients receive maximal benefit from currently available therapies.

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“…Open-label experience with transition from parenteral to oral treprostinil in patients who were well compensated on parenteral therapy and who were on background ERA and/or PDE5 inhibitor suggests that this can be accomplished successfully in highly selected patients. 4 Transition from inhaled prostanoids to oral treprostinil has also been reported. 6 Oral treprostinil thus is in the difficult position of having a weak evidence base for its use, yet some practitioners (including the author) have been successful in utilizing it to good effect in some patients, including those on other background therapy.…”

Section: Oral Treprostinilmentioning

confidence: 99%

“…The nonrandomized studies of transition from parenteral treprostinil to oral treprostinil in highly selected, well-compensated patients included almost exclusively patients on combination therapy, and indeed this approach can be effective in some patients. 4 It must be emphasized that those patients were very highly selected and managed at expert centers; the risk of deterioration with such a transition must be kept top of mind by both the practitioner and the patient. Patients have also been successfully transitioned from inhaled prostanoids to oral treprostinil, thereby avoiding the inconvenience of qid inhalation therapy.…”

mentioning

confidence: 99%

Positioning Newer Agents: Riociguat, Selexipag, and Oral Treprostinil in the Current Landscape

Frantz

2017

Advances in Pulmonary Hypertension

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The availability of newer oral agents for therapy of pulmonary arterial hypertension entails both opportunity and uncertainty. There is the opportunity for less intrusive therapy and the potential to further lessen risk of disease progression, but there is also uncertainty regarding optimal role of these agents, concern about their expense, and risk of preventable deterioration if these agents are used in settings that clearly warrant parenteral prostanoids. Among the newer agents, the evidence is strongest for the use of the prostacyclin receptor agonist selexipag, which has been shown to reduce events in functional class II and III patients, even in the setting of background therapy with a phosphodiesterase type 5 (PDE5) inhibitor and an endothelin receptor antagonist. Riociguat is a soluble guanylate cyclase stimulator that has been shown to be beneficial, including in combination with an endothelin receptor antagonist, and may be a useful alternative to a PDE5 inhibitor in properly selected patients. It has also been shown to be beneficial in inoperable or residual thromboembolic pulmonary hypertension. Oral treprostinil has been shown to improve 6-minute walk distance as monotherapy, and has been used to transition from inhaled or parenteral treprostinil in carefully selected patients also on other agents. Herein we discuss the mechanisms of action, side effect profiles, and clinical trial data for these agents, followed by a practical approach to their use, integrating the available data with real-world experience.

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Transition from parenteral to oral treprostinil in pulmonary arterial hypertension

Abstract: Lower risk patients managed on parenteral treprostinil may be candidates for transition to a more convenient, oral form of the drug.

Cited by 54 publications

References 22 publications

Right ventricular afterload predicts long‐term transition from parenteral to oral treprostinil in pulmonary arterial hypertension

Right ventricular afterload predicts long‐term transition from parenteral to oral treprostinil in pulmonary arterial hypertension

Pulmonary arterial hypertension: tailoring treatment to risk in the current era

Positioning Newer Agents: Riociguat, Selexipag, and Oral Treprostinil in the Current Landscape

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