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Clinical Trial
. 2013 Feb;31(1):38-44.
doi: 10.1111/1755-5922.12008.

Rapid transition from inhaled iloprost to inhaled treprostinil in patients with pulmonary arterial hypertension

Robert C Bourge  1 , Victor F Tapson, Zeenat Safdar, Raymond L Benza, Richard N Channick, Erika B Rosenzweig, Shelley Shapiro, R James White, Christopher Shane McSwain, Stephen Karl Gotzkowsky, Andrew C Nelsen, Lewis J Rubin
Affiliations
Free PMC article
Clinical Trial

Rapid transition from inhaled iloprost to inhaled treprostinil in patients with pulmonary arterial hypertension

Robert C Bourge et al. Cardiovasc Ther. 2013 Feb.
Free PMC article

Abstract

Background: Inhaled treprostinil is a prostacyclin analog approved for the treatment of pulmonary arterial hypertension (PAH) that may provide a more convenient treatment option for patients receiving inhaled iloprost while maintaining the clinical benefit of inhaled prostacyclin therapy.

Aims: In this open-label safety study, 73 PAH patients were enrolled with primarily World Health Organization Class II (56%) or III (42%) symptoms. At baseline, most patients (93%) were receiving 5 μg of iloprost per dose but 38% of patients reported a dosing frequency below the labeled rate of 6-9 times daily. Patients initiated inhaled treprostinil at 3 breaths four times daily (qid) at the immediate next scheduled iloprost dose. The primary objective was to assess the safety of rapid transition from iloprost to inhaled treprostinil; clinical status and quality of life were also assessed.

Results: Most patients (84%) achieved the target treprostinil dose of 9 breaths qid and remained on study until transition to commercial therapy (89%). The most frequent adverse events (AEs) were cough (74%), headache (44%), and nausea (30%), and five patients prematurely discontinued study drug due to AE (n = 3), disease progression (n = 1), or death (n = 1). At week 12, the time spent on daily treatment activities was reduced compared to baseline, with a mean total savings of 1.4 h per day. Improvements were also observed at week 12 for 6-min walk distance (+16.0; P < 0.001), N-terminal pro-B-type natriuretic peptide (-74 pg/mL; P = 0.001), and the Cambridge Pulmonary Hypertension Outcome Review (all domains P < 0.001).

Conclusions: Pulmonary arterial hypertension patients can be safely transitioned from inhaled iloprost to inhaled treprostinil while maintaining clinical status.

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Figures

Figure 1
Figure 1
Time spent on daily treatment activities. The mean (±SE) time spent on each activity (min/day) is presented for baseline (iloprost; n = 70) and week 12 (inhaled treprostinil; n = 61). aP < 0.001; bP < 0.01.
Figure 2
Figure 2
Cambridge pulmonary hypertension outcome review (CAMPHOR) and treatment satisfaction questionnaire for medicine (TSQM). (A) Mean (±SE) CAMPHOR scores presented for baseline (iloprost; n = 72), week 6 (inhaled treprostinil; n = 67), week 12 (inhaled treprostinil; n = 67), and month 12 (inhaled treprostinil; n = 24). aP < 0.001; bP < 0.05; nsnot significant. (B) The mean (±SE) TSQM score for each category is presented for baseline (iloprost; n = 72) and week 12 (inhaled treprostinil; n = 66). aP < 0.001.
Figure 3
Figure 3
Mean (±SD) plasma treprostinil concentration versus time following administration of 54 μg of inhaled treprostinil (n = 11). Values are pg/mL.
See this image and copyright information in PMC

References

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