Transition From Subcutaneous or Inhaled Treprostinil to Oral Treprostinil at Home in Patients With Pulmonary Arterial Hypertension: A Retrospective Case Series

Abstract

Pulmonary arterial hypertension (PAH) is a progressive condition that can lead to right ventricular failure and death. Treprostinil is a prostacyclin analogue that has proven clinical efficacy in patients with PAH. Difficulties in the administration of inhaled and parenteral prostacyclins led to the development of extended-release treprostinil diolamine for oral use. Limited data exist on the transition to oral treprostinil. The purpose of this case series is to describe the transition from subcutaneous or inhaled treprostinil to oral treprostinil in the outpatient setting. With the current availability of oral prostacyclins and prostacyclins analogues, most transitions to oral therapy are done in the hospital setting resulting in increased cost and risk of hospital-acquired infections. Four patients on background phosphodiesterase type 5 therapy with baseline World Health Organization functional class (WHO FC) II PAH were transitioned at home. Three of the 4 patients were safely transitioned as outpatients and maintained WHO FC II status at 10 and 12 months. The fourth patient had worsening right heart failure and was admitted within 2 months of the transition and started back on parenteral prostacyclin therapy. The 6-minute walk distance (6MWD) increased in patients transitioning from inhaled therapy and decreased in the patient transitioning from subcutaneous therapy. The most common adverse event was nausea.

Transitioning Between Prostanoid Therapies in Pulmonary Arterial Hypertension

“…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).…”

“…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).…”

“…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).…”

Extended-release oral treprostinil in the management of pulmonary arterial hypertension: clinical evidence and experience

“…An outpatient transition from SQ or inhaled to oral treprostinil was described in four patients. 26 Two were on inhaled therapy that transitioned due to a persistent cough, while two on SQ therapy switched due to patient preference. Three of the four patients successfully transitioned.…”

“…The oral treprostinil dose achieved in follow up from the inhaled therapy was 3 mg TID, whereas one patient reached 14 mg TID. 26 A single case report described a rapid initiation and titration of IV treprostinil with subsequent transition to oral treprostinil in a patient with severe PAH. 27 The patient had been on triple therapy with sildenafil, ambrisentan, and inhaled treprostinil.…”