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Long-term effects of inhaled treprostinil in patients with pulmonary arterial hypertension: the Treprostinil Sodium Inhalation Used in the Management of Pulmonary Arterial Hypertension (TRIUMPH) study open-label extension.
J Heart Lung Transplant. 2011 Dec; 30(12):1327-33.JH

Abstract

BACKGROUND

Inhaled treprostinil improved functional capacity as add-on therapy in the short-term management of patients with pulmonary arterial hypertension (PAH). This study investigated the long-term effects of inhaled treprostinil in patients concurrently receiving oral background therapy.

METHODS

A total of 206 patients (81% women) completing the 12-week double-blind phase of the Treprostinil Sodium Inhalation Used in the Management of Pulmonary Arterial Hypertension (TRIUMPH) study transitioned into an open-label extension. Patients were assessed every 3 months for changes in 6-minute walk distance (6MWD), Borg dyspnea score, New York Heart Association (NYHA) functional class, quality of life (QOL) scores, and signs and symptoms of PAH.

RESULTS

Patients were primarily NYHA class III (86%), with a mean baseline 6MWD of 349 ± 81 meters. A median change in 6MWD of 28, 31, 32, and 18 meters in patients continuing therapy was observed at 6, 12, 18, and 24 months, respectively. This effect was more prominent in those patients originally allocated to active therapy in the double-blind phase. Survival rates for patients remaining on therapy were 97%, 94%, and 91% at 12, 18, and 24 months, respectively. In addition, 82%, 74%, and 69% of patients maintained treatment benefit as evidenced by lack of clinical worsening at 12, 18, and 24 months. The most common adverse events were known effects of prostanoid therapy (headache [34%], nausea [21%], and vomiting [10%]) or were due to the route of administration (cough [53%], pharyngolaryngeal pain [13%], and chest pain [13%]).

CONCLUSIONS

Long-term therapy with inhaled treprostinil demonstrated persistent benefit for PAH patients who remained on therapy for up to 24 months.

Authors+Show Affiliations

Allegheny General Hospital, Pittsburgh, Pennsylvania, USA. rbenza@wpahs.orgNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

22055098

Citation

Benza, Raymond L., et al. "Long-term Effects of Inhaled Treprostinil in Patients With Pulmonary Arterial Hypertension: the Treprostinil Sodium Inhalation Used in the Management of Pulmonary Arterial Hypertension (TRIUMPH) Study Open-label Extension." The Journal of Heart and Lung Transplantation : the Official Publication of the International Society for Heart Transplantation, vol. 30, no. 12, 2011, pp. 1327-33.
Benza RL, Seeger W, McLaughlin VV, et al. Long-term effects of inhaled treprostinil in patients with pulmonary arterial hypertension: the Treprostinil Sodium Inhalation Used in the Management of Pulmonary Arterial Hypertension (TRIUMPH) study open-label extension. J Heart Lung Transplant. 2011;30(12):1327-33.
Benza, R. L., Seeger, W., McLaughlin, V. V., Channick, R. N., Voswinckel, R., Tapson, V. F., Robbins, I. M., Olschewski, H., & Rubin, L. J. (2011). Long-term effects of inhaled treprostinil in patients with pulmonary arterial hypertension: the Treprostinil Sodium Inhalation Used in the Management of Pulmonary Arterial Hypertension (TRIUMPH) study open-label extension. The Journal of Heart and Lung Transplantation : the Official Publication of the International Society for Heart Transplantation, 30(12), 1327-33. https://doi.org/10.1016/j.healun.2011.08.019
Benza RL, et al. Long-term Effects of Inhaled Treprostinil in Patients With Pulmonary Arterial Hypertension: the Treprostinil Sodium Inhalation Used in the Management of Pulmonary Arterial Hypertension (TRIUMPH) Study Open-label Extension. J Heart Lung Transplant. 2011;30(12):1327-33. PubMed PMID: 22055098.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Long-term effects of inhaled treprostinil in patients with pulmonary arterial hypertension: the Treprostinil Sodium Inhalation Used in the Management of Pulmonary Arterial Hypertension (TRIUMPH) study open-label extension. AU - Benza,Raymond L, AU - Seeger,Werner, AU - McLaughlin,Vallerie V, AU - Channick,Richard N, AU - Voswinckel,Robert, AU - Tapson,Victor F, AU - Robbins,Ivan M, AU - Olschewski,Horst, AU - Rubin,Lewis J, PY - 2011/05/25/received PY - 2011/08/09/revised PY - 2011/08/29/accepted PY - 2011/11/8/entrez PY - 2011/11/8/pubmed PY - 2012/5/5/medline SP - 1327 EP - 33 JF - The Journal of heart and lung transplantation : the official publication of the International Society for Heart Transplantation JO - J. Heart Lung Transplant. VL - 30 IS - 12 N2 - BACKGROUND: Inhaled treprostinil improved functional capacity as add-on therapy in the short-term management of patients with pulmonary arterial hypertension (PAH). This study investigated the long-term effects of inhaled treprostinil in patients concurrently receiving oral background therapy. METHODS: A total of 206 patients (81% women) completing the 12-week double-blind phase of the Treprostinil Sodium Inhalation Used in the Management of Pulmonary Arterial Hypertension (TRIUMPH) study transitioned into an open-label extension. Patients were assessed every 3 months for changes in 6-minute walk distance (6MWD), Borg dyspnea score, New York Heart Association (NYHA) functional class, quality of life (QOL) scores, and signs and symptoms of PAH. RESULTS: Patients were primarily NYHA class III (86%), with a mean baseline 6MWD of 349 ± 81 meters. A median change in 6MWD of 28, 31, 32, and 18 meters in patients continuing therapy was observed at 6, 12, 18, and 24 months, respectively. This effect was more prominent in those patients originally allocated to active therapy in the double-blind phase. Survival rates for patients remaining on therapy were 97%, 94%, and 91% at 12, 18, and 24 months, respectively. In addition, 82%, 74%, and 69% of patients maintained treatment benefit as evidenced by lack of clinical worsening at 12, 18, and 24 months. The most common adverse events were known effects of prostanoid therapy (headache [34%], nausea [21%], and vomiting [10%]) or were due to the route of administration (cough [53%], pharyngolaryngeal pain [13%], and chest pain [13%]). CONCLUSIONS: Long-term therapy with inhaled treprostinil demonstrated persistent benefit for PAH patients who remained on therapy for up to 24 months. SN - 1557-3117 UR - https://www.unboundmedicine.com/medline/citation/22055098/Long_term_effects_of_inhaled_treprostinil_in_patients_with_pulmonary_arterial_hypertension:_the_Treprostinil_Sodium_Inhalation_Used_in_the_Management_of_Pulmonary_Arterial_Hypertension__TRIUMPH__study_open_label_extension_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S1053-2498(11)01121-1 DB - PRIME DP - Unbound Medicine ER -