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        "resumen" => "<span class="elsevierStyleSectionTitle">Objective</span><p class="elsevierStyleSimplePara elsevierViewall">Bronchodilators are still the most effective drugs for controlling the symptoms of chronic obstructive pulmonary disease &#40;COPD&#41;&#46; Tiotropium bromide&#44; a long-acting anticholinergic drug&#44; has recently been added to the therapeutic arsenal for the disease&#46; To date&#44; there have been no studies combining 2 long-acting bronchodilators&#46; The aim of the present trial was to determine whether the combination of salmeterol and tiotropium improved lung function in COPD patients more than either of them alone&#46;</p> <span class="elsevierStyleSectionTitle">Patients and methods</span><p class="elsevierStyleSimplePara elsevierViewall">Twenty-two patients &#40;20 men&#41; diagnosed with COPD&#44; with a mean age of 64 years&#44; were enrolled in this cross-over trial&#46; Active smokers were excluded&#46; Mean &#40;SD&#41; forced expiratory volume in 1 second &#40;FEV<span class="elsevierStyleInf">1</span>&#41; was 43&#37; &#40;14&#37;&#41; of predicted&#46; All patients were experienced in the use of inhalers&#46; The following 3 therapeutic combinations were randomly assigned to be administered for a 1-week period&#58; <span class="elsevierStyleItalic">a</span>&#41; fluticasone &#40;500 &#956;g&#47;12 h&#41;&#44; salmeterol &#40;50 &#956;g&#47;12 h&#41; and placebo&#59; <span class="elsevierStyleItalic">b</span>&#41; fluticasone&#44; tiotropium &#40;18 &#956;g&#47;24 h&#41;&#44; and placebo&#59; and <span class="elsevierStyleItalic">c</span>&#41; fluticasone&#44; salmeterol&#44; and tiotropium&#46; At the end of each period&#44; forced spirometry was performed before inhalation of the therapeutic combination &#40;between 8&#58;30 AM and 9&#58;30 AM&#41; and 2 hours after inhalation&#46; Throughout the week&#44; morning peak flow rates measured immediately before inhalation were recorded&#44; and there was a 48-hour wash-out period between each therapeutic combination&#46;</p> <span class="elsevierStyleSectionTitle">Results</span><p class="elsevierStyleSimplePara elsevierViewall">All the patients completed the protocol&#46; There were no significant differences in preinhalation or postinhalation FEV<span class="elsevierStyleInf">1</span> with salmeterol compared to tiotropium &#40;preinhalation FEV<span class="elsevierStyleInf">1</span>&#44; 1&#46;17 &#91;0&#46;55&#93; L compared to 1&#46;19 &#91;0&#46;49&#93; L&#59; postinhalation FEV<span class="elsevierStyleInf">1</span>&#44; 1&#46;32 &#91;0&#46;65&#93; L compared to 1&#46;29 &#91;0&#46;61&#93; L&#41;&#46; In all cases postinhalation FEV<span class="elsevierStyleInf">1</span> was significantly higher than preinhalation FEV<span class="elsevierStyleInf">1</span>&#46; The combination of fluticasone&#44; salmeterol&#44; and tiotropium proved superior to the other 2 combinations with respect to both preinhalation FEV1 and postinhalation FEV<span class="elsevierStyleInf">1</span> &#40;preinhalation FEV<span class="elsevierStyleInf">1</span>&#44; 1&#46;32 &#91;0&#46;56&#93; L&#44; &#91;<span class="elsevierStyleItalic">P</span> &#60;&#46;03 in both comparisons&#93;&#59; postinhalation FEV<span class="elsevierStyleInf">1</span>&#44; 1&#46;49 &#91;0&#46;68&#93; L &#91;<span class="elsevierStyleItalic">P</span> &#60;&#46;001 in both comparisons&#93;&#41;&#46; Peak flow rate was also significantly higher with the combination of the 2 bronchodilators &#40;345 L&#47;min compared to 291 L&#47;min and 311 mL&#44; respectively &#91;<span class="elsevierStyleItalic">P</span> &#60;&#46;04 in both cases&#93;&#41;&#46; There were no notable side effects&#46;</p> <span class="elsevierStyleSectionTitle">Conclusions</span><p class="elsevierStyleSimplePara elsevierViewall">In terms of improvement in lung function&#44; the combination of salmeterol and tiotropium together with fluticasone is more effective in patients with moderate-to-severe COPD than either of the 2 bronchodilators administered alone&#46;</p>"
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        "resumen" => "<span class="elsevierStyleSectionTitle">Objetivo</span><p class="elsevierStyleSimplePara elsevierViewall">LOS broncodilatadores contin&#250;an siendo los f&#225;rmacos m&#225;s eficaces para el control de los s&#237;ntomas de la enfermedad pulmonar obstructiva cr&#243;nica &#40;EPOC&#41;&#46; Recien-temente se ha a&#241;adido un anticolin&#233;rgico de acci&#243;n larga&#44; el bromuro de tiotropio&#44; al arsenal terap&#233;utico de esta enfermedad&#46; No existen estudios que hayan asociado 2 broncodilatadores de acci&#243;n sostenida&#46; El objetivo de este estudio ha sido comprobar si la asociaci&#243;n de salmeterol y tiotropio a pacientes con EPOC mejora la funci&#243;n pulmonar respecto a cuando se administran aislados&#46;</p> <span class="elsevierStyleSectionTitle">Pacientes Y M&#233;todos</span><p class="elsevierStyleSimplePara elsevierViewall">Se incluy&#243; en el estudio a 22 pacientes diagnosticados de EPOC &#40;20 varones&#41;&#44; con una edad media de 64 a&#241;os&#46; Se excluy&#243; a los fumadores activos&#46; El volumen espira-torio forzado en el primer segundo &#40;FEV<span class="elsevierStyleInf">1</span>&#41; medio &#40;&#177; desviaci&#243;n est&#225;ndar&#41; fue un 43 &#177; 14&#37; del te&#243;rico&#46; Todos los pacientes ten&#237;an amplia experiencia en el uso de los dispositivos de inhalaci&#243;n&#46; Se realizaron 3 combinaciones terap&#233;uticas de forma aleatoria durante una semana&#58; <span class="elsevierStyleItalic">a</span>&#41; fluticasona &#40;500 &#956;g&#47;12 h&#41;&#44; salmeterol &#40;50 &#956;g&#47;12 h&#41; y placebo&#59; <span class="elsevierStyleItalic">b</span>&#41; fluticasona&#44; tiotropio &#40;18 &#956;g&#47;24 h&#41; y placebo&#44; y <span class="elsevierStyleItalic">c</span>&#41; fluticasona&#44; salmeterol y tiotropio&#46; Al final de cada per&#237;odo se realiz&#243; una espirometr&#237;a forzada entre las 8&#46;30 y las 9&#46;00 h&#44; antes de la inhalaci&#243;n de la combinaci&#243;n y 2 h despu&#233;s de &#233;sta&#46; Durante toda la semana se recogi&#243; el pico de flujo ma-tutino inmediatamente antes de la inhalaci&#243;n de los f&#225;rmacos&#44; dejando 48 h de lavado entre cada asociaci&#243;n&#46;</p> <span class="elsevierStyleSectionTitle">Resultados</span><p class="elsevierStyleSimplePara elsevierViewall">Todos los pacientes finalizaron el protocolo&#46; No hubo diferencias significativas en el FEV<span class="elsevierStyleInf">1</span> tanto valle como postinhalaci&#243;n con salmeterol y tiotropio &#40;FEV<span class="elsevierStyleInf">1</span> valle&#58; 1&#44;17 &#177; 0&#44;55 frente a 1&#44;19 &#177; 0&#44;49 l&#59; FEV<span class="elsevierStyleInf">1</span> postinhalaci&#243;n&#58; 1&#44;32 &#177; 0&#44;65 frente a 1&#44;29 &#177; 0&#44;61 l&#41;&#46; En todos los casos el FEV<span class="elsevierStyleInf">1</span> postinhalaci&#243;n fue significativamente superior al FEV<span class="elsevierStyleInf">1</span> valle&#46; La combinaci&#243;n de fluticasona&#44; salmeterol y tiotropio se mostr&#243; superior a las otras 2 tanto en el FEV<span class="elsevierStyleInf">1</span> valle como postinhalaci&#243;n &#40;FEV1 valle&#58; 1&#44;32 &#177; 0&#44;56 l&#44; p &#60; 0&#44;03 en ambos casos&#59; FEV<span class="elsevierStyleInf">1</span> postinhalaci&#243;n&#58; 1&#44;49 &#177; 0&#44;68 l&#44; p &#60; 0&#44;001 en los 2 casos&#41;&#46; El pico de flujo tambi&#233;n fue significativamente mayor con la combinaci&#243;n de los 2 broncodilatadores &#40;345 frente a 291 l&#47;m y 311 l&#47;m&#44; respectivamente&#59; p &#60; 0&#44;04 en ambos casos&#41;&#46; No hubo efectos secundarios rese&#241;ables&#46;</p> <span class="elsevierStyleSectionTitle">Conclusiones</span><p class="elsevierStyleSimplePara elsevierViewall">La asociaci&#243;n de salmeterol y tiotropio unidos a fluticasona en pacientes con EPOC de grado mode-rado-grave es m&#225;s eficaz en t&#233;rminos de mejor&#237;a funcional respiratoria que cualquiera de los 2 broncodilatadores dados de forma aislada&#46;</p>"
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Vol. 41. Issue 3.
Pages 130-134 (March 2005)
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Vol. 41. Issue 3.
Pages 130-134 (March 2005)
Original Articles
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Bronchodilator Efficacy of Combined Salmeterol and Tiotropium in Patients With Chronic Obstructive Pulmonary Disease
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A. Baloira Villar
Corresponding author
adolfobalo@eresmas.com

Correspondence: Dr. A. Baloira Villar. Sección de Neumología. Complexo Hospitalario de Pontevedra. Mourente. 36071 Pontevedra. España
, C. Vilariño Pombo
Sección de Neumología, Complexo Hospitalario de Pontevedra, Mourente, Pontevedra, Spain
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Abstract
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Objective

Bronchodilators are still the most effective drugs for controlling the symptoms of chronic obstructive pulmonary disease (COPD). Tiotropium bromide, a long-acting anticholinergic drug, has recently been added to the therapeutic arsenal for the disease. To date, there have been no studies combining 2 long-acting bronchodilators. The aim of the present trial was to determine whether the combination of salmeterol and tiotropium improved lung function in COPD patients more than either of them alone.

Patients and methods

Twenty-two patients (20 men) diagnosed with COPD, with a mean age of 64 years, were enrolled in this cross-over trial. Active smokers were excluded. Mean (SD) forced expiratory volume in 1 second (FEV1) was 43% (14%) of predicted. All patients were experienced in the use of inhalers. The following 3 therapeutic combinations were randomly assigned to be administered for a 1-week period: a) fluticasone (500 μg/12 h), salmeterol (50 μg/12 h) and placebo; b) fluticasone, tiotropium (18 μg/24 h), and placebo; and c) fluticasone, salmeterol, and tiotropium. At the end of each period, forced spirometry was performed before inhalation of the therapeutic combination (between 8:30 AM and 9:30 AM) and 2 hours after inhalation. Throughout the week, morning peak flow rates measured immediately before inhalation were recorded, and there was a 48-hour wash-out period between each therapeutic combination.

Results

All the patients completed the protocol. There were no significant differences in preinhalation or postinhalation FEV1 with salmeterol compared to tiotropium (preinhalation FEV1, 1.17 [0.55] L compared to 1.19 [0.49] L; postinhalation FEV1, 1.32 [0.65] L compared to 1.29 [0.61] L). In all cases postinhalation FEV1 was significantly higher than preinhalation FEV1. The combination of fluticasone, salmeterol, and tiotropium proved superior to the other 2 combinations with respect to both preinhalation FEV1 and postinhalation FEV1 (preinhalation FEV1, 1.32 [0.56] L, [P <.03 in both comparisons]; postinhalation FEV1, 1.49 [0.68] L [P <.001 in both comparisons]). Peak flow rate was also significantly higher with the combination of the 2 bronchodilators (345 L/min compared to 291 L/min and 311 mL, respectively [P <.04 in both cases]). There were no notable side effects.

Conclusions

In terms of improvement in lung function, the combination of salmeterol and tiotropium together with fluticasone is more effective in patients with moderate-to-severe COPD than either of the 2 bronchodilators administered alone.

Key Words:
Chronic obstructive pulmonary disease (COPD)
Salmeterol
Tiotropium
Spirometry
Objetivo

LOS broncodilatadores continúan siendo los fármacos más eficaces para el control de los síntomas de la enfermedad pulmonar obstructiva crónica (EPOC). Recien-temente se ha añadido un anticolinérgico de acción larga, el bromuro de tiotropio, al arsenal terapéutico de esta enfermedad. No existen estudios que hayan asociado 2 broncodilatadores de acción sostenida. El objetivo de este estudio ha sido comprobar si la asociación de salmeterol y tiotropio a pacientes con EPOC mejora la función pulmonar respecto a cuando se administran aislados.

Pacientes Y Métodos

Se incluyó en el estudio a 22 pacientes diagnosticados de EPOC (20 varones), con una edad media de 64 años. Se excluyó a los fumadores activos. El volumen espira-torio forzado en el primer segundo (FEV1) medio (± desviación estándar) fue un 43 ± 14% del teórico. Todos los pacientes tenían amplia experiencia en el uso de los dispositivos de inhalación. Se realizaron 3 combinaciones terapéuticas de forma aleatoria durante una semana: a) fluticasona (500 μg/12 h), salmeterol (50 μg/12 h) y placebo; b) fluticasona, tiotropio (18 μg/24 h) y placebo, y c) fluticasona, salmeterol y tiotropio. Al final de cada período se realizó una espirometría forzada entre las 8.30 y las 9.00 h, antes de la inhalación de la combinación y 2 h después de ésta. Durante toda la semana se recogió el pico de flujo ma-tutino inmediatamente antes de la inhalación de los fármacos, dejando 48 h de lavado entre cada asociación.

Resultados

Todos los pacientes finalizaron el protocolo. No hubo diferencias significativas en el FEV1 tanto valle como postinhalación con salmeterol y tiotropio (FEV1 valle: 1,17 ± 0,55 frente a 1,19 ± 0,49 l; FEV1 postinhalación: 1,32 ± 0,65 frente a 1,29 ± 0,61 l). En todos los casos el FEV1 postinhalación fue significativamente superior al FEV1 valle. La combinación de fluticasona, salmeterol y tiotropio se mostró superior a las otras 2 tanto en el FEV1 valle como postinhalación (FEV1 valle: 1,32 ± 0,56 l, p < 0,03 en ambos casos; FEV1 postinhalación: 1,49 ± 0,68 l, p < 0,001 en los 2 casos). El pico de flujo también fue significativamente mayor con la combinación de los 2 broncodilatadores (345 frente a 291 l/m y 311 l/m, respectivamente; p < 0,04 en ambos casos). No hubo efectos secundarios reseñables.

Conclusiones

La asociación de salmeterol y tiotropio unidos a fluticasona en pacientes con EPOC de grado mode-rado-grave es más eficaz en términos de mejoría funcional respiratoria que cualquiera de los 2 broncodilatadores dados de forma aislada.

Palabras clave:
Enfermedad pulmonar obstructiva crónica (EPOC)
Salmeterol
Tiotropio
Espirometría
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