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Practical management of oral treprostinil in patients with pulmonary arterial hypertension: Lessons from ADAPT, EXPEDITE, and expert consensus
Oral treprostinil is a prostacyclin analogue approved to treat pulmonary arterial hypertension (PAH) by delaying disease progression and improving exercise capacity. Higher doses of oral treprostinil correlate with increased treatment benefit. Titrations may be challenging due to common side effects...
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| Published in: | Respiratory medicine 2024-09, Vol.231, p.107734, Article 107734 |
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| creator | Brewer, Jacqueline Wilson, Melisa Coons, James C. Schmit, Ann Whittenhall, Mary E. Kimber, Amy Broderick, Meredith Lee, Dasom Patzlaff, Natalie Miller, Chad Ataya, Ali LaRoy, Valerie King, Christopher S. Ravichandran, Ashwin K. Kingrey, John F. Sahay, Sandeep |
| description | Oral treprostinil is a prostacyclin analogue approved to treat pulmonary arterial hypertension (PAH) by delaying disease progression and improving exercise capacity. Higher doses of oral treprostinil correlate with increased treatment benefit. Titrations may be challenging due to common side effects of prostacyclin-class therapies.
The multicenter, prospective, real-world, observational ADAPT Registry study followed adult patients with PAH for up to 78 weeks after initiating oral treprostinil (NCT03045029). Dosing, titration, and transitions of oral treprostinil were at the discretion of the prescriber. Patient-reported incidence and treatment of common side effects were collected to understand side effect management and tolerability. Insights from literature and expert recommendations were added to provide a consolidated resource for oral treprostinil use.
In total, 139 participants in ADAPT completed ≥1 weekly survey; (median age 60.0 years, 76 % female). Median treatment duration of oral treprostinil was 13.1 months. During early therapy (Months 1–5), 62 % (78/126) of patients reported headache and diarrhea, and 40 % (50/126) reported nausea. At Month 6, many patients who reported side effects during early therapy reported an improvement (61 % headache, 44 % diarrhea, 70 % nausea). Common side effect treatments, including acetaminophen, loperamide, and ondansetron, were effective. Approximately one-quarter of patients reporting the most common side effects were untreated at Month 6.
Patient selection for, and initiation and titration of, oral treprostinil should be individualized and may include parenteral treprostinil induction-transition for faster titration. Assertive side effect management may help patients reach higher and more efficacious doses of oral treprostinil.
[Display omitted]
•Oral treprostinil can be initiated de novo, by transition, or induction-transition.•Patients may benefit from side effect support during initiation and up-titration.•Common side effect treatments were reported by patients to be effective.•PAH treatment and side effects strategy need to be individualized for each patient. |
| doi_str_mv | 10.1016/j.rmed.2024.107734 |
| format | article |
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The multicenter, prospective, real-world, observational ADAPT Registry study followed adult patients with PAH for up to 78 weeks after initiating oral treprostinil (NCT03045029). Dosing, titration, and transitions of oral treprostinil were at the discretion of the prescriber. Patient-reported incidence and treatment of common side effects were collected to understand side effect management and tolerability. Insights from literature and expert recommendations were added to provide a consolidated resource for oral treprostinil use.
In total, 139 participants in ADAPT completed ≥1 weekly survey; (median age 60.0 years, 76 % female). Median treatment duration of oral treprostinil was 13.1 months. During early therapy (Months 1–5), 62 % (78/126) of patients reported headache and diarrhea, and 40 % (50/126) reported nausea. At Month 6, many patients who reported side effects during early therapy reported an improvement (61 % headache, 44 % diarrhea, 70 % nausea). Common side effect treatments, including acetaminophen, loperamide, and ondansetron, were effective. Approximately one-quarter of patients reporting the most common side effects were untreated at Month 6.
Patient selection for, and initiation and titration of, oral treprostinil should be individualized and may include parenteral treprostinil induction-transition for faster titration. Assertive side effect management may help patients reach higher and more efficacious doses of oral treprostinil.
[Display omitted]
•Oral treprostinil can be initiated de novo, by transition, or induction-transition.•Patients may benefit from side effect support during initiation and up-titration.•Common side effect treatments were reported by patients to be effective.•PAH treatment and side effects strategy need to be individualized for each patient.</description><identifier>ISSN: 0954-6111</identifier><identifier>ISSN: 1532-3064</identifier><identifier>EISSN: 1532-3064</identifier><identifier>DOI: 10.1016/j.rmed.2024.107734</identifier><language>eng</language><publisher>Elsevier Ltd</publisher><subject>Dosing ; Orenitram ; Patient selection ; Prostacyclin ; Pulmonary arterial hypertension ; Side effects ; Tolerability</subject><ispartof>Respiratory medicine, 2024-09, Vol.231, p.107734, Article 107734</ispartof><rights>2024 Elsevier Ltd</rights><rights>Copyright © 2024 Elsevier Ltd. All rights reserved.</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><cites>FETCH-LOGICAL-c214t-f7bd04547e6552fb901bbfa51989f2cc9efc50199b29e3cb4e9fbf64e7d7704f3</cites><orcidid>0000-0001-8505-1680 ; 0000-0003-3166-2069 ; 0000-0002-0672-1680 ; 0000-0001-7431-0042 ; 0000-0002-7193-3751</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>315,786,790,27957,27958</link.rule.ids></links><search><creatorcontrib>Brewer, Jacqueline</creatorcontrib><creatorcontrib>Wilson, Melisa</creatorcontrib><creatorcontrib>Coons, James C.</creatorcontrib><creatorcontrib>Schmit, Ann</creatorcontrib><creatorcontrib>Whittenhall, Mary E.</creatorcontrib><creatorcontrib>Kimber, Amy</creatorcontrib><creatorcontrib>Broderick, Meredith</creatorcontrib><creatorcontrib>Lee, Dasom</creatorcontrib><creatorcontrib>Patzlaff, Natalie</creatorcontrib><creatorcontrib>Miller, Chad</creatorcontrib><creatorcontrib>Ataya, Ali</creatorcontrib><creatorcontrib>LaRoy, Valerie</creatorcontrib><creatorcontrib>King, Christopher S.</creatorcontrib><creatorcontrib>Ravichandran, Ashwin K.</creatorcontrib><creatorcontrib>Kingrey, John F.</creatorcontrib><creatorcontrib>Sahay, Sandeep</creatorcontrib><title>Practical management of oral treprostinil in patients with pulmonary arterial hypertension: Lessons from ADAPT, EXPEDITE, and expert consensus</title><title>Respiratory medicine</title><description>Oral treprostinil is a prostacyclin analogue approved to treat pulmonary arterial hypertension (PAH) by delaying disease progression and improving exercise capacity. Higher doses of oral treprostinil correlate with increased treatment benefit. Titrations may be challenging due to common side effects of prostacyclin-class therapies.
The multicenter, prospective, real-world, observational ADAPT Registry study followed adult patients with PAH for up to 78 weeks after initiating oral treprostinil (NCT03045029). Dosing, titration, and transitions of oral treprostinil were at the discretion of the prescriber. Patient-reported incidence and treatment of common side effects were collected to understand side effect management and tolerability. Insights from literature and expert recommendations were added to provide a consolidated resource for oral treprostinil use.
In total, 139 participants in ADAPT completed ≥1 weekly survey; (median age 60.0 years, 76 % female). Median treatment duration of oral treprostinil was 13.1 months. During early therapy (Months 1–5), 62 % (78/126) of patients reported headache and diarrhea, and 40 % (50/126) reported nausea. At Month 6, many patients who reported side effects during early therapy reported an improvement (61 % headache, 44 % diarrhea, 70 % nausea). Common side effect treatments, including acetaminophen, loperamide, and ondansetron, were effective. Approximately one-quarter of patients reporting the most common side effects were untreated at Month 6.
Patient selection for, and initiation and titration of, oral treprostinil should be individualized and may include parenteral treprostinil induction-transition for faster titration. Assertive side effect management may help patients reach higher and more efficacious doses of oral treprostinil.
[Display omitted]
•Oral treprostinil can be initiated de novo, by transition, or induction-transition.•Patients may benefit from side effect support during initiation and up-titration.•Common side effect treatments were reported by patients to be effective.•PAH treatment and side effects strategy need to be individualized for each patient.</description><subject>Dosing</subject><subject>Orenitram</subject><subject>Patient selection</subject><subject>Prostacyclin</subject><subject>Pulmonary arterial hypertension</subject><subject>Side effects</subject><subject>Tolerability</subject><issn>0954-6111</issn><issn>1532-3064</issn><issn>1532-3064</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2024</creationdate><recordtype>article</recordtype><recordid>eNp9kMFuGyEURVGUSHWc_EBXLLPwuDDDDCHKxord1pKleuFI2SGGeSRYMzABnNY_kW8ulrvu6qHHPU-6B6GvlMwpoc23_TwM0M1LUrK84LxiF2hC66osKtKwSzQhomZFQyn9gq5j3BNCBGNkgj63QelkterxoJx6hQFcwt5gH_IqBRiDj8k622Pr8KiSzf8R_7bpDY-HfvBOhSNWIUGwGXg7jpDfLlrvHvAGYvQuYhP8gBfLxXY3w6uX7Wq53q1mWLkOw59THuucytAh3qAro_oIt__mFD1_X-2efhabXz_WT4tNoUvKUmF42xFWMw5NXZemFYS2rVE1FffClFoLMLomVIi2FFDploEwrWkY8I5zwkw1RXfnu7ne-wFikoONGvpeOfCHKCvC7zlljSA5Wp6jOpuIAYwcgx1ya0mJPMmXe3mSL0_y5Vl-hh7PEOQSHxaCjDqb09DZADrJztv_4X8Br4qQRA</recordid><startdate>202409</startdate><enddate>202409</enddate><creator>Brewer, Jacqueline</creator><creator>Wilson, Melisa</creator><creator>Coons, James C.</creator><creator>Schmit, Ann</creator><creator>Whittenhall, Mary E.</creator><creator>Kimber, Amy</creator><creator>Broderick, Meredith</creator><creator>Lee, Dasom</creator><creator>Patzlaff, Natalie</creator><creator>Miller, Chad</creator><creator>Ataya, Ali</creator><creator>LaRoy, Valerie</creator><creator>King, Christopher S.</creator><creator>Ravichandran, Ashwin K.</creator><creator>Kingrey, John F.</creator><creator>Sahay, Sandeep</creator><general>Elsevier Ltd</general><scope>6I.</scope><scope>AAFTH</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7X8</scope><orcidid>https://orcid.org/0000-0001-8505-1680</orcidid><orcidid>https://orcid.org/0000-0003-3166-2069</orcidid><orcidid>https://orcid.org/0000-0002-0672-1680</orcidid><orcidid>https://orcid.org/0000-0001-7431-0042</orcidid><orcidid>https://orcid.org/0000-0002-7193-3751</orcidid></search><sort><creationdate>202409</creationdate><title>Practical management of oral treprostinil in patients with pulmonary arterial hypertension: Lessons from ADAPT, EXPEDITE, and expert consensus</title><author>Brewer, Jacqueline ; 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Higher doses of oral treprostinil correlate with increased treatment benefit. Titrations may be challenging due to common side effects of prostacyclin-class therapies.
The multicenter, prospective, real-world, observational ADAPT Registry study followed adult patients with PAH for up to 78 weeks after initiating oral treprostinil (NCT03045029). Dosing, titration, and transitions of oral treprostinil were at the discretion of the prescriber. Patient-reported incidence and treatment of common side effects were collected to understand side effect management and tolerability. Insights from literature and expert recommendations were added to provide a consolidated resource for oral treprostinil use.
In total, 139 participants in ADAPT completed ≥1 weekly survey; (median age 60.0 years, 76 % female). Median treatment duration of oral treprostinil was 13.1 months. During early therapy (Months 1–5), 62 % (78/126) of patients reported headache and diarrhea, and 40 % (50/126) reported nausea. At Month 6, many patients who reported side effects during early therapy reported an improvement (61 % headache, 44 % diarrhea, 70 % nausea). Common side effect treatments, including acetaminophen, loperamide, and ondansetron, were effective. Approximately one-quarter of patients reporting the most common side effects were untreated at Month 6.
Patient selection for, and initiation and titration of, oral treprostinil should be individualized and may include parenteral treprostinil induction-transition for faster titration. Assertive side effect management may help patients reach higher and more efficacious doses of oral treprostinil.
[Display omitted]
•Oral treprostinil can be initiated de novo, by transition, or induction-transition.•Patients may benefit from side effect support during initiation and up-titration.•Common side effect treatments were reported by patients to be effective.•PAH treatment and side effects strategy need to be individualized for each patient.</abstract><pub>Elsevier Ltd</pub><doi>10.1016/j.rmed.2024.107734</doi><orcidid>https://orcid.org/0000-0001-8505-1680</orcidid><orcidid>https://orcid.org/0000-0003-3166-2069</orcidid><orcidid>https://orcid.org/0000-0002-0672-1680</orcidid><orcidid>https://orcid.org/0000-0001-7431-0042</orcidid><orcidid>https://orcid.org/0000-0002-7193-3751</orcidid><oa>free_for_read</oa></addata></record> |
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| source | ScienceDirect Freedom Collection 2022-2024 |
| subjects | Dosing Orenitram Patient selection Prostacyclin Pulmonary arterial hypertension Side effects Tolerability |
| title | Practical management of oral treprostinil in patients with pulmonary arterial hypertension: Lessons from ADAPT, EXPEDITE, and expert consensus |
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