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One Year Experience with Intravenous Treprostinil in Pulmonary Arterial Hypertension (PAH) Patients.

Vallerie McLaughlin


Robyn Barst


Mardi Gomberg-Maitland


Victor Tapson


Abby Poms


Allison Widlitz

Raymond Benza


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Release Date: 06.23.2006

VV McLaughlin1, RJ Barst2, M Gomberg-Maitland3, VF Tapson4, A Krichman4, AC Widlitz3, RL Benza5.

1University of Michigan Health System, Ann Arbor, MI, 2Columbia University College of Physicians & Surgeons, New York, NY, 3University of Chicago, Chicago, IL, 4Duke University Medical Center, Durham, NC, 5University of Alabama at Birmingham, Birmingham, AL

PURPOSE: Intravenous (IV) epoprostenol improves exercise tolerance, symptoms, hemodynamics, and survival in PAH.  IV treprostinil, a prostacyclin analogue, may have similar clinical benefits and a better safety profile with a longer (4 ½ hour) elimination half-life. Previous reports from this investigator initiated study have demonstrated favorable 12 week results. The purpose of this study was to assess the clinical efficacy of IV treprostinil after one year of therapy.

METHODS: In this open label, multicenter study, PAH patients were treated with IV treprostinil either as initial therapy for PAH (de novo) or transitioned to treprostinil from epoprostenol (transition). The goal of therapy was improvement in de novo patients and maintenance of functional capacity and symptoms in the transition patients. Patients were assessed with six minute walk distance (6MWD) and right heart catheterization at baseline and 1 year using a paired t-test.

RESULTS: Fourty-seven patients (16 de novo, 31 transition), mean age 43.4 years, (81% female) were enrolled. PAH was idiopathic in 62%, related to connective tissue disease 25%, and related to congenital heart disease in 13%. At baseline 49% were FC II, 47% were FC III and 4% were FC IV.  Transition patients were on epoprostenol for 4.2 ± 0.6 years at a mean dose of 40 ± 4 ng/kg/min. At one year, the mean treprostinil dose was 98

± 9 ng/kg/min in de novo patients and 111 ± 10 ng/kg/min in transition patients. One year data was available in 34 patients. Data was not available in the remaining 13 for the following reasons: death (5), adverse experiences (7) and lost to follow-up (1).  6MWD and hemodynamic results are displayed in the table. Side effects associated with treprostinil were typical of prostacyclins, eg. headache, jaw pain, leg pain, and diarrhea.

 

De Novo (n=11)

Transition (n=23)*

Parameter

Baseline

1 year

P value

Baseline

1 year

P value

6MWD

(meters)

332 ± 21

457 ± 26

<0.001

444 ± 18

443 ± 15

0.96

PAPm

(mmHg)

58 ± 5

48 ± 4

0.004

45 ± 3

48 ± 3

0.05

CI (L/min/m2)

1.6 ± 0.1

2.5 ± 0.2

<0.001

3.1 ± 0.2

3.2 ± 0.2

0.65

PVRI

(Wood units·m2)

32 ± 3

16 ± 2

<0.001

13 ± 1

13 ± 1

0.79

*n = 22 for hemodynamic results, one patient refused the cardiac cath.     ** Results = M ± SE

CONCLUSION: The clinical efficacy of IV treprostinil appears to be maintained at one year.

IMPLICATIONS: IV Treprostinil may be an effective alternative to IV epoprostenol in selected PAH patients.