Efficacy and safety of budesonide/formeterol combination therapy in asthma patients

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. Collegium antropologicum, 33 (2). pp. 587-591. ISSN 0350-6134

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Croatian abstract

UČINKOVITOST I SIGURNOST KOMBINCIJE BUDEZONIDA I FORMOTEROLA U BOLESNIKA S ASTMOM ----- 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.

English 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.

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