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Abstract: Poster Presentations |

BOSENTAN THERAPY IN PATIENTS WITH PULMONARY HYPERTENSION SECONDARY TO CONGENITAL HEART DISEASE (EISENMENGER PHYSIOLOGY) FREE TO VIEW

Michele D’Alto, PhD*; Berardo Sarubbi, PhD; Carmine D. Vizza, PhD; Emanuele Romeo, MD; Giuseppe Santoro, MD; Paola Argiento, MD; Maria G. Russo, MD; Raffaele Calabrò, MD
Author and Funding Information

Chair of Cardiology, Second University, V. Monaldi Hospital, Naples, Italy


Chest


Chest. 2005;128(4_MeetingAbstracts):366S. doi:10.1378/chest.128.4_MeetingAbstracts.366S
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Abstract

PURPOSE:  To evaluate safety, tolerability, clinical and haemodynamic impact of bosentan, an orally administered endothelin-1 antagonist, in patients with pulmonary hypertension due to congenital heart disease (Eisenmenger syndrome).

METHODS:  Twelve patients with ES (5M, 7F, mean age 33.6±8.7) were treated with oral bosentan (62.5 mg x 2/die for the first month and then 125 mg x 2/die). Patient clinical status, liver enzymes, WHO functional class, resting oxygen saturations, 6 min walk test and transthoracic echocardiography were assessed at baseline and at 1, 3 and 6 month. Haemodynamic evaluation with cardiac catheterization was performed at baseline and at 6 month follow-up.

RESULTS:  At baseline 10 patients were in III and 2 in IV WHO functional class. Six had ventricular septal defect, 3 single ventricle, 2 atrio-ventricular canal, 1 truncus arteriosus. All 12 patients well tolerated bosentan, but in 2 patients we reduced the maintenance dose from 125 mg x 2/die to 62.5 mg x 2/die for a transient elevation of liver enzyme (1 patient) and transient leg oedema (1 patient). After six month therapy, oxygen saturation at rest (78.3±9.3% vs 85.8±5.6%; p<0.05) and after 6-min walk test (64.4±8.8% vs 73.5±12%; p<0.05), the distance travelled in the 6-min walk test (321±101 vs 445±45 m; p<0.05) and Borg’s index (5,9±1.4 vs 3±2.3; p<0.05) significantly improved. A significant change of total pulmonary indexed resistances (19.1±9.5 vs 9.3±5.3 WU, p<0.05), arterial pulmonary indexed resistances (15.2±7.2 vs 7.62±4.7 WU, p<0.05) and systemic-to-pulmonary blood flow ratio (0.74±0.34 vs 1.36±1.14, P<0.05) was observed suggesting an improvement of pulmonary haemodynamics. At six month follow-up 5 patients were in II, 6 in III and 1 in IV WHO functional class.

CONCLUSION:  Bosentan treatment was safe and well tolerated in adults with ES after a mid-term follow-up (6 months of oral therapy). Oxygenation, functional status and pulmonary haemodynamics of patients improved with minimal side effects.

CLINICAL IMPLICATIONS:  Bosentan is useful in the management of the Eisenmenger syndrome in adults but larger clinical investigation are necessary.

DISCLOSURE:  Michele D’Alto, None.

Wednesday, November 2, 2005

12:30 PM - 2:00 PM


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