Upfront triple combination therapy in pulmonary arterial hypertension: a pilot study
Why the study?
Does upfront triple combination therapy improve functional capacity, hemodynamics, and survival in newly diagnosed patients with severe PAH?
Population
19 newly diagnosed patients with severe pulmonary arterial hypertension (PAH) in NYHA functional class III/IV.
Comparison
Upfront triple combination therapy consisting of… vs Expected survival calculated from the French…
Design
Cohort
Follow-up
mean 32 ± 19 months
Authors
Discussion
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Implication
Upfront triple therapy may improve survival in severe PAH; hypothesis-generating and requires randomized confirmation.
Key Points
- The aim is to evaluate the efficacy and safety of an upfront triple combination therapy in patients with severe pulmonary arterial hypertension.
- Retrospective data collection from a prospective registry of newly diagnosed patients (n=19).
- Administration of triple therapy consisting of intravenous epoprostenol, bosentan, and sildenafil.
- Follow-up assessments conducted over a mean duration of 32 months.
- Eighteen patients showed significant improvement in 6-min walk distance and haemodynamics after 4 months (p<0.01).
- Seventeen patients improved to NYHA functional class I or II by month 4.
- Overall survival estimates were 100% at 1, 2, and 3 years for the treatment cohort.
Structured PICO
Does upfront triple combination therapy improve functional capacity, hemodynamics, and survival in newly diagnosed patients with severe PAH?
P
Population
19 newly diagnosed patients with severe pulmonary arterial hypertension (PAH) in NYHA functional class III/IV.
I
Intervention
Upfront triple combination therapy consisting of intravenous epoprostenol, bosentan, and sildenafil.
C
Comparator
Expected survival calculated from the French equation (historical/calculated control).
O
Outcome
6-min walk distance, haemodynamics, and NYHA functional class at 4 months, and overall survival at 1, 2, and 3 years.hard clinical
Upfront triple combination therapy with IV epoprostenol, bosentan, and sildenafil in severe PAH provides significant clinical and hemodynamic improvements and may dramatically improve long-term survival compared to historical expectations.
Cite This Study
Sitbon et al. (2014) studied this question.