Transitioning Parenteral or Inhaled Treprostinil to Oral Treprostinil Diolamine: Case Series and Review of the Literature

Smith, Zachary; Kelly, Bryan; Awdish, Rana; Hegab, Sara

doi:10.1177/0897190018764585

Cited by 6 publications

(9 citation statements)

References 23 publications

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“…Established guidance on transitions between various formulations within this drug class have not been standardized. A number of case reports and case series have been published describing such transitions but lack consistent processes (6)(7)(8)(9)(10)(11)(12)(13).…”

Section: Introductionmentioning

confidence: 99%

“…However, despite sharing similar dosing strategies based on these recommendations, there are still numerous variations between different institutional practices. Most notable are the durations over which the transitions are implemented (6)(7)(8)(9)(10).…”

Section: Introductionmentioning

confidence: 99%

“…There is no standardized dose conversion strategy for transitioning from oral treprostinil to inhaled treprostinil, and no recommendations are provided in the package insert (14). There is published data for patients on doses of parenteral treprostinil ranging from 22.5 to 111 ng/kg/min and inhaled treprostinil ranging from 9 to 54 mcg four times daily, who have subsequently been transitioned to oral treprostinil 1 mg twice daily to 14 mg three times daily (7,9,10). Given the linear pharmacokinetic relationship between treprostinil plasma concentrations and doses up to 125 ng/kg/min, relative dose equivalencies between different formulations can be estimated (15).…”

Section: Introductionmentioning

confidence: 99%

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Transitioning Between Prostanoid Therapies in Pulmonary Arterial Hypertension

et al. 2020

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Background: New oral prostacyclin therapies and prostacyclin agonists have become available for the treatment of pulmonary arterial hypertension (PAH). However, methods for transitioning between oral, inhaled, and parenteral formulations are not well-established, except in the form of case reports and case series. Collectively, these emphasize the lack of a standardized process and approach in transitioning patients between PAH prostanoid therapies. In this case series, we report our experience at an accredited Pulmonary Hypertension center in transitioning between various oral, inhaled, and parenteral prostanoids to offer additional guidance on safe transitions in therapy. Methods: All cases of prostanoid transitions at an accredited Pulmonary Hypertension center from March 2018 to September 2019 were included in this report. The transition approach for each case was developed through a review of the literature, extrapolation of available pharmacokinetic data, and collaboration between pharmacists and clinicians. Results: This case series describes the transition of 3 patients from selexipag to parenteral treprostinil; 1 patient transitioning from parenteral treprostinil to selexipag; 1 patient transitioning from oral treprostinil to parenteral treprostinil; and 1 patient transitioning from inhaled treprostinil to selexipag. Four of the 6 patients presented here were transitioned to an alternate prostanoid on account of clinical worsening, while the remaining 2 patients transitioned due to intolerance of parenteral therapy and poor medication adherence. This case series includes patients with various etiologies of PAH including idiopathic PAH, methamphetamine-associated PAH, and scleroderma-associated PAH. All patients successfully completed each transition without serious adverse events. Conclusions: With the increasing utilization and availability of prostanoids, there is a critical need for a standardized approach in transitioning safely between different formulations without compromising treatment efficacy. In this case series, we present our clinical experiences, guided by available pharmacokinetic data, in transitioning between various prostanoid formulations.

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Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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Transitioning Between Prostanoid Therapies in Pulmonary Arterial Hypertension

et al. 2020

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“…The mean dose achieved in the FREEDOM-M trial (and referenced in the package insert) after 12 weeks of gradual dose increase was 3.4 mg twice daily, 9,10 whereas a 2018 case series and literature review describes total daily dosage as high as 75 mg among transition patients. 14 The package insert states that ''maximum dose is determined by tolerability,'' and thus little guidance is provided in determining appropriate dosing in adults. In our multicenter experience, a wide range of doses were also employed.…”

Section: Discussionmentioning

confidence: 99%

Oral treprostinil use in children: a multicenter, observational experience

et al. 2019

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Pulmonary arterial hypertension is a progressive, incurable disease that occurs in adults and children alike. Therapeutic options for children are limited and infrequently described, including newer agents such as treprostinil, an oral prostanoid. Herein, we describe the pooled pediatric experience in 28 patients from four pediatric pulmonary hypertension programs over two years. This descriptive, observational study describes the various methods of initiation of oral treprostinil in both prostanoid-naïve patients and those transitioning from parenteral or inhaled prostanoids. The youngest patient was four years old and the smallest weighed 16 kg. We describe adverse reactions and their management. Most patients in this study (27/28) were able to successfully initiate therapy. However, gastrointestinal adverse reactions were common; half of the patients started on this therapy had discontinued it within the two-year study period.

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“…15 Remaining retrospective studies included one to two patients transitioning from inhaled to oral treprostinil, with limited findings on transition times, persistence, clinical follow up, and adverse events. [16][17][18] The current observational retrospective chart review was designed to characterize realworld transitions from inhaled to oral treprostinil by investigating the following: 1) details of the transition (reason, duration, dosing, and titration schedule), 2) oral treprostinil dosing and persistence on therapy, 3) observed efficacy assessments, and 4) concomitant medications and adverse events (AEs). The aim of the study was to investigate and analyze real-world practices for transition between these two formulations of treprostinil, assess the safety and efficacy of oral treprostinil post transition, and evaluate oral treprostinil dosing over time.…”

Section: Introductionmentioning

confidence: 99%

A multicenter retrospective study of patients with pulmonary hypertension transitioned from inhaled to oral treprostinil

et al. 2021

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Oral treprostinil has recently been shown to delay disease progression in patients with pulmonary arterial hypertension (PAH) in a long-term outcomes study. The potential advantages of an oral formulation have resulted in patients transitioning from inhaled to oral treprostinil. The current study reports a retrospective analysis of patients who transitioned from treatment with inhaled to oral treprostinil. A multicenter retrospective chart review was conducted for 30 patients with pulmonary hypertension that transitioned from inhaled to oral treprostinil. Data were collected from inhaled treprostinil initiation and patients were followed until discontinuation of oral treprostinil or the end of the observation period. Persistence was calculated using Kaplan-Meier estimates. Prior to transition to oral treprostinil, patients had received inhaled treprostinil for a median of 643 (IQR: 322, 991) days and 52% of patients were New York Heart Association (NYHA)/World Health Organization (WHO) Functional Class III. For patients that cross titrated between formulations, the median time to complete the cross titration was 24 (IQR: 1, 57) days. At 16- and 24-weeks post transition, oral treprostinil persistence was 86% and 76%, respectively. Persistence was 59% at 52 weeks post transition. Clinical stability for the majority of patients at first follow-up post transition was suggested based on available NYHA/WHO Functional Classification. Transitions from inhaled to oral treprostinil appeared safe and tolerable in the short-term. Additional prospective studies are needed to fully evaluate the safety and efficacy of transitions from inhaled to oral treprostinil.

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Transitioning Parenteral or Inhaled Treprostinil to Oral Treprostinil Diolamine: Case Series and Review of the Literature

Cited by 6 publications

References 23 publications

Transitioning Between Prostanoid Therapies in Pulmonary Arterial Hypertension

Transitioning Between Prostanoid Therapies in Pulmonary Arterial Hypertension

Oral treprostinil use in children: a multicenter, observational experience

A multicenter retrospective study of patients with pulmonary hypertension transitioned from inhaled to oral treprostinil

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