PMID- 22055098 OWN - NLM STAT- MEDLINE DCOM- 20120504 LR - 20220321 IS - 1557-3117 (Electronic) IS - 1053-2498 (Linking) VI - 30 IP - 12 DP - 2011 Dec TI - 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. PG - 1327-33 LID - 10.1016/j.healun.2011.08.019 [doi] AB - 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. CI - Copyright A(c) 2011 International Society for Heart and Lung Transplantation. Published by Elsevier Inc. All rights reserved. FAU - Benza, Raymond L AU - Benza RL AD - Allegheny General Hospital, Pittsburgh, Pennsylvania, USA. rbenza@wpahs.org FAU - Seeger, Werner AU - Seeger W FAU - McLaughlin, Vallerie V AU - McLaughlin VV FAU - Channick, Richard N AU - Channick RN FAU - Voswinckel, Robert AU - Voswinckel R FAU - Tapson, Victor F AU - Tapson VF FAU - Robbins, Ivan M AU - Robbins IM FAU - Olschewski, Horst AU - Olschewski H FAU - Rubin, Lewis J AU - Rubin LJ LA - eng PT - Journal Article PT - Randomized Controlled Trial PT - Research Support, Non-U.S. Gov't PL - United States TA - J Heart Lung Transplant JT - The Journal of heart and lung transplantation : the official publication of the International Society for Heart Transplantation JID - 9102703 RN - 0 (Antihypertensive Agents) RN - 0 (Piperazines) RN - 0 (Purines) RN - 0 (Sulfonamides) RN - 0 (Sulfones) RN - BW9B0ZE037 (Sildenafil Citrate) RN - DCR9Z582X0 (Epoprostenol) RN - Q326023R30 (Bosentan) RN - RUM6K67ESG (treprostinil) SB - IM MH - Administration, Inhalation MH - Adolescent MH - Adult MH - Aged MH - Antihypertensive Agents/*administration & dosage/adverse effects/*therapeutic use MH - Blood Pressure/physiology MH - Bosentan MH - Double-Blind Method MH - Drug Therapy, Combination MH - Epoprostenol/administration & dosage/adverse effects/*analogs & derivatives/therapeutic use MH - Female MH - Headache/chemically induced/epidemiology MH - Humans MH - Hypertension, Pulmonary/*drug therapy/physiopathology MH - Incidence MH - Longitudinal Studies MH - Male MH - Middle Aged MH - Nausea/chemically induced/epidemiology MH - Physical Endurance/physiology MH - Piperazines/*therapeutic use MH - Purines/therapeutic use MH - Quality of Life MH - Sildenafil Citrate MH - Sulfonamides/*therapeutic use MH - Sulfones/*therapeutic use MH - Treatment Outcome MH - Young Adult EDAT- 2011/11/08 06:00 MHDA- 2012/05/05 06:00 CRDT- 2011/11/08 06:00 PHST- 2011/05/25 00:00 [received] PHST- 2011/08/09 00:00 [revised] PHST- 2011/08/29 00:00 [accepted] PHST- 2011/11/08 06:00 [entrez] PHST- 2011/11/08 06:00 [pubmed] PHST- 2012/05/05 06:00 [medline] AID - S1053-2498(11)01121-1 [pii] AID - 10.1016/j.healun.2011.08.019 [doi] PST - ppublish SO - J Heart Lung Transplant. 2011 Dec;30(12):1327-33. doi: 10.1016/j.healun.2011.08.019.