Initial tadalafil and ambrisentan combination therapy in pulmonary arterial hypertension: CLinical and haemodYnamic long-term efficacy (ITALY study)

Michele D'alto, Emanuele Romeo, Paola Argiento, Giuseppe Paciocco, Renato Prediletto, Stefano Ghio, Michele Correale, Francesco Lo Giudice, Roberto Badagliacca, Alessandra Greco, Carmine Dario Vizza

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Abstract

Aims Initial combination therapy with ambrisentan and tadalafil (upfront therapy) offers clinical benefits in pulmonary arterial hypertension (PAH) and reduces the risk of clinical failure compared with monotherapy in naïve patients. The aim of study is to assess the efficacy of a 12-month upfront therapy with ambrisentan and tadalafil in improving haemodynamics in incident PAH patients. Methods This is a multicentre retrospective analysis of real-world Italian clinical data in 56 patients with newly diagnosed PAH. Clinical evaluations, including demographics, medical history, WHO functional class, 6-min walk distance, and right heart catheterization, were collected from the patients' medical records at baseline and at 12-month follow-up. Results At baseline, there were 16, 34, and 6 patients in WHO functional class II, III, and IV, respectively. Over a median follow-up of 12 months, 54 (96%) patients were still alive, 6 (11%) of whom received parenteral prostanoids. Ambrisentan-tadalafil combination was associated with significant improvements in WHO functional class (2.2±0.8 vs. 2.8±0.6, P<0.001, improved in 29 patients), exercise capacity (395±123 vs. 353±101m, P=0.039), N-terminal probrain natriuretic peptide (528±493 vs. 829±620pg/ml; P=0.009), and haemodynamics (right atrial pressure 7±4 vs. 9±5mmHg, P=0.02; mean pulmonary artery pressure 45±15 vs. 50±13mmHg, P=0.03; cardiac index 3.0±1.0 vs. 2.5±0.9l/min/m 2, P=0.001; pulmonary vascular resistance 8±4 vs. 11±6 Wood units, P=0.001) compared with baseline. Conclusions Initial combination therapy with ambrisentan and tadalafil offers clinical benefits and significant haemodynamic improvement in newly diagnosed PAH patients.

Original languageEnglish
Pages (from-to)12-17
Number of pages6
JournalJournal of Cardiovascular Medicine
Volume19
Issue number1
DOIs
Publication statusPublished - Jan 1 2018

Fingerprint

Pulmonary Hypertension
Hemodynamics
Therapeutics
Natriuretic Peptides
Atrial Pressure
Tadalafil
ambrisentan
Cardiac Catheterization
Vascular Resistance
Pulmonary Artery
Prostaglandins
Medical Records
Demography
Exercise
Pressure

Keywords

  • outcome
  • pulmonary arterial hypertension

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine

Cite this

Initial tadalafil and ambrisentan combination therapy in pulmonary arterial hypertension : CLinical and haemodYnamic long-term efficacy (ITALY study). / D'alto, Michele; Romeo, Emanuele; Argiento, Paola; Paciocco, Giuseppe; Prediletto, Renato; Ghio, Stefano; Correale, Michele; Lo Giudice, Francesco; Badagliacca, Roberto; Greco, Alessandra; Vizza, Carmine Dario.

In: Journal of Cardiovascular Medicine, Vol. 19, No. 1, 01.01.2018, p. 12-17.

Research output: Contribution to journalArticle

D'alto, M, Romeo, E, Argiento, P, Paciocco, G, Prediletto, R, Ghio, S, Correale, M, Lo Giudice, F, Badagliacca, R, Greco, A & Vizza, CD 2018, 'Initial tadalafil and ambrisentan combination therapy in pulmonary arterial hypertension: CLinical and haemodYnamic long-term efficacy (ITALY study)', Journal of Cardiovascular Medicine, vol. 19, no. 1, pp. 12-17. https://doi.org/10.2459/JCM.0000000000000590
D'alto, Michele ; Romeo, Emanuele ; Argiento, Paola ; Paciocco, Giuseppe ; Prediletto, Renato ; Ghio, Stefano ; Correale, Michele ; Lo Giudice, Francesco ; Badagliacca, Roberto ; Greco, Alessandra ; Vizza, Carmine Dario. / Initial tadalafil and ambrisentan combination therapy in pulmonary arterial hypertension : CLinical and haemodYnamic long-term efficacy (ITALY study). In: Journal of Cardiovascular Medicine. 2018 ; Vol. 19, No. 1. pp. 12-17.
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abstract = "Aims Initial combination therapy with ambrisentan and tadalafil (upfront therapy) offers clinical benefits in pulmonary arterial hypertension (PAH) and reduces the risk of clinical failure compared with monotherapy in na{\"i}ve patients. The aim of study is to assess the efficacy of a 12-month upfront therapy with ambrisentan and tadalafil in improving haemodynamics in incident PAH patients. Methods This is a multicentre retrospective analysis of real-world Italian clinical data in 56 patients with newly diagnosed PAH. Clinical evaluations, including demographics, medical history, WHO functional class, 6-min walk distance, and right heart catheterization, were collected from the patients' medical records at baseline and at 12-month follow-up. Results At baseline, there were 16, 34, and 6 patients in WHO functional class II, III, and IV, respectively. Over a median follow-up of 12 months, 54 (96{\%}) patients were still alive, 6 (11{\%}) of whom received parenteral prostanoids. Ambrisentan-tadalafil combination was associated with significant improvements in WHO functional class (2.2±0.8 vs. 2.8±0.6, P<0.001, improved in 29 patients), exercise capacity (395±123 vs. 353±101m, P=0.039), N-terminal probrain natriuretic peptide (528±493 vs. 829±620pg/ml; P=0.009), and haemodynamics (right atrial pressure 7±4 vs. 9±5mmHg, P=0.02; mean pulmonary artery pressure 45±15 vs. 50±13mmHg, P=0.03; cardiac index 3.0±1.0 vs. 2.5±0.9l/min/m 2, P=0.001; pulmonary vascular resistance 8±4 vs. 11±6 Wood units, P=0.001) compared with baseline. Conclusions Initial combination therapy with ambrisentan and tadalafil offers clinical benefits and significant haemodynamic improvement in newly diagnosed PAH patients.",
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AU - D'alto, Michele

AU - Romeo, Emanuele

AU - Argiento, Paola

AU - Paciocco, Giuseppe

AU - Prediletto, Renato

AU - Ghio, Stefano

AU - Correale, Michele

AU - Lo Giudice, Francesco

AU - Badagliacca, Roberto

AU - Greco, Alessandra

AU - Vizza, Carmine Dario

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N2 - Aims Initial combination therapy with ambrisentan and tadalafil (upfront therapy) offers clinical benefits in pulmonary arterial hypertension (PAH) and reduces the risk of clinical failure compared with monotherapy in naïve patients. The aim of study is to assess the efficacy of a 12-month upfront therapy with ambrisentan and tadalafil in improving haemodynamics in incident PAH patients. Methods This is a multicentre retrospective analysis of real-world Italian clinical data in 56 patients with newly diagnosed PAH. Clinical evaluations, including demographics, medical history, WHO functional class, 6-min walk distance, and right heart catheterization, were collected from the patients' medical records at baseline and at 12-month follow-up. Results At baseline, there were 16, 34, and 6 patients in WHO functional class II, III, and IV, respectively. Over a median follow-up of 12 months, 54 (96%) patients were still alive, 6 (11%) of whom received parenteral prostanoids. Ambrisentan-tadalafil combination was associated with significant improvements in WHO functional class (2.2±0.8 vs. 2.8±0.6, P<0.001, improved in 29 patients), exercise capacity (395±123 vs. 353±101m, P=0.039), N-terminal probrain natriuretic peptide (528±493 vs. 829±620pg/ml; P=0.009), and haemodynamics (right atrial pressure 7±4 vs. 9±5mmHg, P=0.02; mean pulmonary artery pressure 45±15 vs. 50±13mmHg, P=0.03; cardiac index 3.0±1.0 vs. 2.5±0.9l/min/m 2, P=0.001; pulmonary vascular resistance 8±4 vs. 11±6 Wood units, P=0.001) compared with baseline. Conclusions Initial combination therapy with ambrisentan and tadalafil offers clinical benefits and significant haemodynamic improvement in newly diagnosed PAH patients.

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