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Inhaled treprostinil in pulmonary hypertension associated with COPD: PERFECT study results
Steven D Nathan1, Rahul Argula2, Maria G Trivieri3
1Inova Fairfax Hospital, Falls Church, VA, USA steven.nathan@inova.org.
The European Respiratory Journal
|May 29, 2024
Summary
Inhaled treprostinil (iTRE) showed increased risks of serious adverse events and potential mortality in patients with pulmonary hypertension (PH) and COPD (PH-COPD). The PERFECT study was terminated early due to safety concerns, not supporting iTRE for PH-COPD.
Area of Science:
- Pulmonary Medicine
- Cardiology
- Pharmacology
Background:
- Pulmonary hypertension (PH) in COPD (PH-COPD) significantly worsens patient outcomes.
- No current therapies are approved for treating PH-COPD.
- The PERFECT study investigated inhaled treprostinil (iTRE) for PH-COPD.
Purpose of the Study:
- To evaluate the safety and efficacy of inhaled treprostinil (iTRE) in patients with PH-COPD.
- To assess the change in 6-minute walk distance (6MWD) as a primary endpoint.
Main Methods:
- A 12-week, randomized, double-blind, placebo-controlled crossover study (PERFECT trial).
- Patients received iTRE (72 µg, 4 times daily) or placebo.
- A contingent parallel design was implemented based on interim analysis.
Main Results:
- The study was terminated early due to safety concerns, including increased serious adverse events and potential mortality risk with iTRE.
- The change in peak 6-minute walk distance (6MWD) was numerically worse with iTRE compared to placebo.
- 76 patients were randomized; 66 received iTRE and 58 received placebo.
Conclusions:
- The risk-benefit profile of iTRE in PH-COPD did not support study continuation.
- Inhaled treprostinil is not a viable treatment option for patients with PH-COPD based on these findings.
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