PMID- 16778286
OWN - NLM
STAT- MEDLINE
DCOM- 20060801
LR  - 20220419
IS  - 0012-3692 (Print)
IS  - 0012-3692 (Linking)
VI  - 129
IP  - 6
DP  - 2006 Jun
TI  - Efficacy of long-term subcutaneous treprostinil sodium therapy in pulmonary 
      hypertension.
PG  - 1636-43
AB  - STUDY OBJECTIVES: The aim of this long-term multicenter analysis was to 
      investigate whether subcutaneously infused treprostinil could provide sustained 
      improvements of exercise capacity and survival benefits in patients with 
      pulmonary arterial hypertension (PAH) and inoperable chronic thromboembolic 
      pulmonary hypertension (CTEPH). Subcutaneous administration of the prostacyclin 
      analog treprostinil is an effective treatment for PAH that, unlike epoprostenol, 
      does not require the insertion of a permanent central venous catheter. DESIGN: 
      Multicenter retrospective study. SETTING: Three European university hospitals. 
      METHODS: Ninety-nine patients with PAH and 23 patients with CTEPH in New York 
      Heart Association (NYHA) classes II-IV were followed up for a mean of 26.2 +/- 
      17.2 months (+/- SE) [range, 3 to 57 months]. Long-term efficacy was assessed by 
      6-min walking distance (SMWD), Borg dyspnea score, and NYHA class. Clinical 
      events were monitored to assess survival and event-free survival. RESULTS: At 3 
      years, significant improvements from baseline were observed in mean SMWD (305 +/- 
      11 to 445 +/- 12 m, p = 0.0001), Borg dyspnea score (5.7 +/- 0.2 to 4.5 +/- 1, p 
      = 0.0006), and NYHA class (3.20 +/- 0.04 to 2.1 +/- 0.1, p = 0.0001). These 
      changes were observed under a mean dose of subcutaneously infused treprostinil at 
      40 +/- 2.6 ng/kg/min (range, 16 to 84 ng/kg/min). Subcutaneously infused 
      treprostinil was well tolerated, and local pain at the subcutaneous site 
      accounted for treatment interruption in only 5% of the cases. Survival was 88.6% 
      and 70.6% at 1 year and 3 years, respectively. At the same time points, the 
      event-free survival rates, defined as survival without hospitalization for 
      clinical worsening, transition to IV epoprostenol, and need for combination 
      therapy or atrial septostomy, were 83.2% and 69%, respectively. CONCLUSIONS: 
      Long-term subcutaneous therapy with treprostinil appears to continuously improve 
      exercise tolerance and symptoms in patients with PAH and inoperable CTEPH. 
      Moreover, treatment may provide a significant survival benefit.
FAU - Lang, Irene
AU  - Lang I
AD  - Department of Cardiology, Hopital Erasme, Route de Lennik 808, B-1070 Bruxelles, 
      Belgium.
FAU - Gomez-Sanchez, Miguel
AU  - Gomez-Sanchez M
FAU - Kneussl, Meinhard
AU  - Kneussl M
FAU - Naeije, Robert
AU  - Naeije R
FAU - Escribano, Pilar
AU  - Escribano P
FAU - Skoro-Sajer, Nika
AU  - Skoro-Sajer N
FAU - Vachiery, Jean-Luc
AU  - Vachiery JL
LA  - eng
PT  - Clinical Trial
PT  - Journal Article
PT  - Multicenter Study
PT  - Research Support, Non-U.S. Gov't
PL  - United States
TA  - Chest
JT  - Chest
JID - 0231335
RN  - 0 (Antihypertensive Agents)
RN  - DCR9Z582X0 (Epoprostenol)
RN  - RUM6K67ESG (treprostinil)
SB  - IM
MH  - Adolescent
MH  - Adult
MH  - Aged
MH  - Aged, 80 and over
MH  - Antihypertensive Agents/*administration & dosage
MH  - Child
MH  - Drug Administration Schedule
MH  - Epoprostenol/administration & dosage/*analogs & derivatives
MH  - Exercise Test
MH  - Exercise Tolerance/physiology
MH  - Female
MH  - Humans
MH  - Hypertension, Pulmonary/*drug therapy/mortality/physiopathology
MH  - Infusions, Parenteral
MH  - Male
MH  - Middle Aged
MH  - Recovery of Function/physiology
MH  - Retrospective Studies
MH  - Survival Rate
MH  - Treatment Outcome
EDAT- 2006/06/17 09:00
MHDA- 2006/08/02 09:00
CRDT- 2006/06/17 09:00
PHST- 2006/06/17 09:00 [pubmed]
PHST- 2006/08/02 09:00 [medline]
PHST- 2006/06/17 09:00 [entrez]
AID - S0012-3692(15)50771-X [pii]
AID - 10.1378/chest.129.6.1636 [doi]
PST - ppublish
SO  - Chest. 2006 Jun;129(6):1636-43. doi: 10.1378/chest.129.6.1636.