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Vol. 43. Issue 5.
Pages 272-276 (January 2007)
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Vol. 43. Issue 5.
Pages 272-276 (January 2007)
Original Articles
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Clinical Efficacy of Sildenafil in Patients With Pulmonary Hypertension in Functional Class II or III
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Isabel Otero González
Corresponding author
iotero@canalejo.org

Correspondence: Dra. I. Otero González. Servicio de Neumología. Complexo Hospitalario Universitario Juan Canalejo. Xubias de Arriba, 84. 15006 A Coruña. España
, Marina Blanco Aparicio, Ana Souto Alonso, Inés Raposo Sonnenfeld, Héctor Verea Hernando
Servicio de Neumología, Complexo Hospitalario Universitario Juan Canalejo, A Coruña, Spain
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Objective

To assess the efficacy of treatment with sildenafil monotherapy in patients with pulmonary hypertension.

Patients and methods

An observational study was undertaken in 11 patients with pulmonary hypertension in functional class II or III who received treatment with sildenafil (150 mg/day). Seven of the patients had inoperable chronic thromboembolic pulmonary hypertension and 4 had pulmonary arterial hypertension. To assess treatment response, the following parameters were assessed during follow-up at 3, 6, and 12 months: exercise tolerance in the 6-minute walk test, change in functional class, and systolic pulmonary arterial pressure measured by echocardiography.

Results

We observed a significant improvement in exercise tolerance, as shown by increased 6-minute walk distance after 3, 6, and 12 months of treatment (increases of 20, 67, and 95 m, respectively). All patients showed an improvement in functional class. The results of echocardiography did not reveal statistically significant differences in systolic pulmonary arterial pressure between baseline and 6 or 12 months of treatment. No significant adverse effects were observed, although sildenafil treatment was suspended in 1 patient due to persistent headache.

Conclusions

The results of this study confirm that sildenafil is an effective drug for the management of pulmonary arterial hypertension and inoperable chronic thromboembolic pulmonary hypertension both in the short term and medium to long term, and that the drug is well tolerated and shows few side effects.

Key words:
Pulmonary hypertension
Inoperable chronic thromboembolic pulmonary hypertension
Sildenafil
Clinical efficacy
Objetivo

Valorar la eficacia del tratamiento con sildena-filo en monoterapia en pacientes con hipertensión pulmonar (HP).

Pacientes y métodos

Se ha realizado un estudio obser-vacional de 11 pacientes con HP en clases funcionales II y III, a quienes se administró tratamiento con sildenafilo (150 mg/día). Siete presentaban HP tromboembólica crónica y no quirúrgica y 4, hipertensión arterial pulmonar. Para valo-rar la respuesta analizamos a los 3, 6 y 12 meses los siguien-tes parámetros: tolerancia al esfuerzo mediante el test de la marcha de 6 min, cambio de clase funcional y ecocardiogra-ma para valorar la presión sistólica en la arteria pulmonar.

Resultados

Encontramos una mejoría significativa de la tolerancia al esfuerzo, con un incremento de la distancia ca-minada en 6 min, a los 3, 6 y 12 meses de tratamiento (+20, +67 y +95 m, respectivamente). Todos los pacientes mejora-ron de clase funcional. El seguimiento ecocardiográfico no mostró diferencias estadísticamente significativas entre los valores basal y a los 6 y 12 meses de tratamiento de la pre-sión sistólica en la arteria pulmonar. No observamos efectos adversos significativos, aun cuando se retiró el tratamiento con sildenafilo en un paciente por cefalea persistente.

Conclusiones

Los hallazgos de este estudio confirman que el sildenafilo es un fármaco eficaz para el manejo de la hipertensión arterial pulmonar y la HP tromboembólica crónica y no quirúrgica, tanto a corto como a medio-largo plazo, con buena tolerancia y escasos efectos secundarios.

Palabras clave:
Hipertensión pulmonar
Hipertensión pulmonar tromboembólica crónica y no quirúrgica
Sildenafilo
Eficacia
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REFERENCES
[1]
LJ Rubin.
Introduction. Diagnosis and management of pulmonary arterial hypertension: ACCP evidence-based clinical practice guidelines.
[2]
RL Doyle, D McCrory, RN Channick, G Simmoneau, J Conte.
Surgical treatments/interventions for pulmonary arterial hypertension. ACCP evidence-based clinical practice guidelines.
[3]
M Humbert, O Sitbon, G Simonneau.
Treatment of pulmonary arterial hypertension.
N Engl J Med, 351 (2004), pp. 1425-1436
[4]
JC Caraballo Fonseca, CD Martínez Blanco, R Sánchez de León.
Disfunción endotelial en la hipertensión pulmonar.
Arch Bronconeumol, 41 (2005), pp. 389-392
[5]
T Higenbottam, D Wheeldon, F Wells, J Wallwork.
Long-term treatment of primary pulmonary hypertension with continuous intravenous epoprostenol.
Lancet, 1 (1984), pp. 1046-1047
[6]
H Olschewski, G Simonneau, N Galie, T Higenbottan, R Naeije, LJ Rubin, et al.
Inhaled iloprost for severe pulmonary hypertension.
N Engl J Med, 347 (2002), pp. 322-329
[7]
G Simonneau, RJ Barst, N Galie, R Naeije, R Rich, RC Bourge, for the Treprostinil study group, et al.
Continuous subcutaneous infusion of treprostinil, a prostacyclin analogue, in patients with pulmonary arterial hypertension: a double-blind randomized controlled trial.
Am J Respir Crit Care Med, 165 (2002), pp. 800-804
[8]
LJ Rubin, DB Badesch, RJ Barst, N Galie, CM Black, A Keogh, et al.
Bosentan therapy for pulmonary arterial hypertension.
N Engl J Med, 346 (2002), pp. 896-903
[9]
RJ Barst, D Langleben, A Frost, EM Horn, R Oudiz, S Shapiro, STRIDE-1 study group, et al.
Sitaxsentan therapy for pulmonary arterial hypertension.
Am J Respir Crit Care Med, 169 (2004), pp. 441-447
[10]
T Reffelman, RA Kloner.
Therapeutic potential of phosphodiesterase 5 inhibition for cardiovascular disease.
Circulation, 239 (2003), pp. 239-244
[11]
MR Wilkins, GA Paul, JW Strange, N Tunariu, W Gin-Sing, W Banya, et al.
Sildenafil versus endothelin receptor antagonist for pulmonary hypertension (SERAPH) study.
Am J Respir Crit Care Med, 171 (2005), pp. 1292-1297
[12]
N Galie, HA Ghofrani, A Torbicki, RJ Barst, LJ Rubin, D Badesch, for the Sildenafil Use in Pulmonary Arterial Hypertension (SUPER) study group, et al.
Sildenafil citrate therapy for pulmonary arterial hypertension.
N Engl J Med, 353 (2005), pp. 2148-2157
[13]
J Lexchin, LA Bero, B Djulbegovic, O Clark.
Pharmaceutical industry sponsorship and research outcome and quality: systematic review.
BMJ, 326 (2003), pp. 1-10
[14]
N Galie, A Torbicki, R Barst, P Dartevelle, S Haworth, T Higenbottam, et al.
ESC guidelines. Guidelines on diagnosis and treatment of pulmonary arterial hypertension.
Eur Heart J, 25 (2004), pp. 2243-2278
[15]
D Badesch, SH Abman, GS Ahearn, RJ Barst, DC McCrory, G Simonneau, et al.
Medical therapy for pulmonary arterial hypertension. ACCP evidence-based clinical practice guidelines.
Chest, 126 (2004), pp. S35-S62
[16]
E Michelackis, W Tymchak, D Lien, L Webster, K Hashimoto, S Archer.
Oral sildenafil is an effective and specific pulmonary vasodilator in patients with pulmonary arterial hypertension: comparison with inhaled nitric oxide.
Circulation, 105 (2002), pp. 2398-2403
[17]
S Prasad, J Wilkinson, MA Gatzoulis.
Sildenafil in primary pulmonary hypertension.
N Engl J Med, 343 (2000), pp. 1342
[18]
E Michelakis, W Tymchak, D Lien, L Webster, K Hashimoto, S Archer.
Oral sildenafil is an effective and specific pulmonary vasodilator in patients with pulmonary arterial hypertension. Comparison with inhaled nitric oxide.
Circulation, 105 (2002), pp. 2398-2403
[19]
GW Mikhail, SK Prasad, W Li, P Rogers, AH Chester, S Bayne, et al.
Clinical and haemodynamic effects of sildenafil in pulmonary hypertension: acute and mid-term effects.
Eur Heart J, 25 (2004), pp. 431-436
[20]
T Humpl, T Reyes, HH Holtby, D Sthephens, I Adatia.
Beneficial effect of oral sildenafil therapy on childhood pulmonary arterial hypertension. Twelve-month clinical trial of a single-drug, open label, pilot study.
Circulation, 111 (2005), pp. 3274-3280
[21]
BKS Sastry, C Narasimhan, NK Reddy, BS Raju.
Clinical efficacy of sildenafil in primary pulmonary hypertension. A randomized, placebo-controlled, double blind, crossover study.
J Am Coll Cardiol, 43 (2004), pp. 1149-1153
[22]
N Nagaya, N Sasaki, M Ando, H Ogino, F Sakamaki, S Kyotani, et al.
Prostacyclin therapy before pulmonary thromboendarterectomy in patients with chronic thromboembolic pulmonary hypertension.
Chest, 123 (2003), pp. 338-343
[23]
HA Ghofrani, RT Schermuly, F Rose, R Wiedermann, MG Kohstall, A Kreckel, et al.
Sildenafil for long-term treatment of nonoperable chronic thromboembolic pulmonary hypertension.
Am J Respir Crit Care Med, 167 (2003), pp. 1139-1141
[24]
MM Hoeper, T Kramm, H Wilkens, C Schulze, HJ Schäfers, T Welte, et al.
Bosentan therapy for inoperable chronic thromboembolic pulmonary hypertension.
Chest, 128 (2005), pp. 2363-2367
[25]
N Galiè, L Alan, AL Hinderliter, A Torbicki, T Fourme, G Simonneau, et al.
Effects of the oral endothelin-receptor antagonist bosentan on echocardiographic and doppler measures in patients with pulmonary arterial hypertension.
J Am Coll Cardiol, 42 (2003), pp. 1380-1386
[26]
S Miyamoto, N Nagaya, T Satoh, S Kyotani, F Sakamaki, M Fujita, et al.
Clinical correlates and prognostic significance of six-minute walk test in patients with primary pulmonary hypertension. Comparison with cardiopulmonary exercise testing.
Am J Respir Crit Care Med, 161 (2000), pp. 487-492
[27]
HH Leuchte, M Holzapfel, RA Baumgartner, C Neurohr, M Vogeser, J Behr.
Characterization of brain natriuretic peptide in long term follow up of primary pulmonary arterial hypertension.
Chest, 128 (2005), pp. 2368-2374
Copyright © 2007. Sociedad Española de Neumología y Cirugía Torácica (SEPAR)
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