Journal article

Publication year: 2019

Pages: 194-202

Journal: The Journal of Heart and Lung Transplantation

Volume number: 38

Issue number: 2

ISSN: 1053-2498

eISSN: 1557-3117

Open access status: Green

DOI Link: https://doi.org/10.1016/j.healun.2018.11.006

Publisher: Elsevier

Abstract: 

BACKGROUND: In the randomized, double-blind, event-driven AMBITION study, initial combination therapy with ambrisentan and tadalafil was associated with a 50% reduction in risk of clinical failure (first occurrence of all-cause death, hospitalization for worsening pulmonary arterial hypertension [PAH], disease progression, or unsatisfactory long-term clinical response) vs pooled monotherapy. These results were primarily driven by a reduction in PAH-related hospitalization in the combination therapy group, although a significant effect was not observed in a post-hoc analysis of all-cause hospitalization.

METHODS: The effect of initial combination therapy with ambrisentan and tadalafil in AMBITION was further explored to study PAH-related hospitalization, which was not reported in the primary publication.

RESULTS: Initial combination therapy was associated with a 63% reduction in risk of PAH-related hospitalization when compared with pooled monotherapy (hazard ratio [HR] 0.372, 95% confidence interval [CI] 0.217 to 0.639, p = 0.0002). For every 9 patients treated with combination therapy vs monotherapy, 1 PAH-related hospitalization could be prevented over a 1-year period. Serious adverse events leading to hospitalization, not necessarily PAH-related, occurred in 87 of 253 (34%) and 89 of 247 (36%) of patients on combination therapy and pooled monotherapy, respectively (post-hoc summary).

CONCLUSIONS: Initial combination therapy with ambrisentan and tadalafil was found to reduce the risk of PAH-related hospitalization by 63% compared with pooled monotherapy. (C) 2018 The Author(s). Published by Elsevier Inc. on behalf of International Society for Heart and Lung Transplantation.

Harvard Citation style: Vachiery, J., Galie, N., Barbera, J., Frost, A., Ghofrani, H., Hoeper, M., et al. (2019) Initial combination therapy with ambrisentan plus tadalafil on pulmonary arterial hypertension-related hospitalization in the AMBITION trial, The Journal of Heart and Lung Transplantation, 38(2), pp. 194-202. https://doi.org/10.1016/j.healun.2018.11.006

APA Citation style: Vachiery, J., Galie, N., Barbera, J., Frost, A., Ghofrani, H., Hoeper, M., McLaughlin, V., Peacock, A., Simonneau, G., Blair, C., Miller, K., Langley, J., & Rubin, L. (2019). Initial combination therapy with ambrisentan plus tadalafil on pulmonary arterial hypertension-related hospitalization in the AMBITION trial. The Journal of Heart and Lung Transplantation. 38(2), 194-202. https://doi.org/10.1016/j.healun.2018.11.006