Efficacy and safety of budesonide/formeterol combination therapy in asthma patients [Učinkovitost i sigurnost kombinacije budezonida i formoterola u bolesnika sa astmom]

Jakopović, Marko and Pavičić, Fadila and Redžepi, Gzim and Pleština, Sanja and Janković, Mateja and Franić, Zrinka and Šamija, Mirko and Samaržija, Miroslav (2009) Efficacy and safety of budesonide/formeterol combination therapy in asthma patients [Učinkovitost i sigurnost kombinacije budezonida i formoterola u bolesnika sa astmom]. Collegium Antropologicum, 33 (2). pp. 587-591. ISSN 0350-6134

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Abstract

Budesonide/formoterol as single inhaler was developed for treating asthma patients who are not adequately controlled on glucocorticoides alone. The aim of this study was to evaluate efficacy, safety and patient/physician satisfaction of budesonide/formoterol therapy.Total of 268 asthma patients (120 men, mean age 38.8 +/- 37.2 years, and 148 women, mean age 42.2 +/- 32 years) were included in the study. All patients received budesonide/formoterol bid (640 mcg of budesonide and 18 mcg of formoterol daily) during run-in period for three weeks. Patients were followed during 14 weeks at 5 visits. At each visit lung function (FEV1 and PEF) was measured,presence of side affects was recorded and questionnaire was given to patients and physicians to estimate the level of satisfaction with budesonide/formoterol therapy (1 very unsatisfied to 5 very satisfied). Significant improvement was noticed in FEV1, from 76.25% of predicted value to 86.94% (p < 0.01); and in PEF from 380.84 L/min to 442.29 L/min (p < 0.01) in all patients. At the end of the study patients' satisfaction with budesonide/formeterol therapy was significantly improved comparing with satisfaction with previously taken therapy, in average grade, from 2.94 to 4.56 (p < 0.01), and similar results were noticed with physicians' satisfaction, from 2.60 to 4.41 (p < 0.01). Budesonide/formoterol in single inhaler, significantly improved lung function in patients with asthma.

Abstract in Croatian

Kombinacija budezonida i formoterola u jednom inhalatoru koristi se u bolesnika koji nemaju dobru kontrolu astme uz inhalacijske kortikosteroide. Cilj ovog rada je procijeniti učinkovitost i sigurnost fiksne kombinacije budezonida i formoterola te procijeniti zadovoljstvo bolesnika i liječnika navedenom terapijom. U studiju je uključeno ukupno 120 ispitanika. Svi bolesnici su koristili budezonid/formoterol dva puta na dan u ukupnoj dozi 640 mcg budezonida i 18 mcg formoterola kroz tri tjedna. Bolesnici su praćeni tijekom 14 tjedana u 5 posjeta. Na svakoj posjeti mjerena je plućna funkcija, bilježeno prisustvo nuspojava, te su bolesnici i liječnici ispunjavali upitnik o zadovoljstvu liječenjem. Tijekom praćenja nađeno je značajno poboljšanje u plućnoj funkciju (FEV1 i PEF). Također, na kraju studije značajno veće zadovoljstvo liječenjem pokazano je i medu ispitanicima i među liječnicima. U konačnici, budezonid i formoterol u jednom inhalatoru značajno poboljšava plućnu funkciju, te zadovoljstvo liječenjem u bolesnika s astmom.

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