Klinická farmakologie a farmacie – 3/2018

KLINICKÁ FARMAKOLOGIE A FARMACIE / Klin Farmakol Farm 2019; 33(3): 11–16 /  www.klinickafarmakologie.cz 14 ORIGINÁLNÍ PRÁCE Targeting asthma control in real‑life clinical practice by using ICS/LABA combination Limitation in daily activities A similar trend was observed for limitation in the patients’ daily activities. The proportion of patients with a limitation in daily activities gra­ dually decreased from 67% at the baseline visit to 5% at the end of the study period (p < 0.001). Use of reliever medication Eighty‑seven percent of the patients reported rescue medication use during the week prece­ ding the baseline visit. During the study period, the proportion of patients requiring rescue me­ dication at least once a week decreased to 19% at the final visit (p < 0.001). Similarly, the proportion of patients requiring reliever medication ≥ twice a week decreased from 62% at the baseline visit to 8% at the final visit 4 (p < 0.001) (Fig. 2). Exacerbations Within a period of 3months before the baseli­ ne visit, 61%of the patients suffered froman acute flare‑up of asthma. Between the baseline visit and visit 1 (twoweeks), an asthma flare‑up occurred in 20%of the patients. However, between visit 1 and visit 2 (two weeks) an exacerbation occurred only in 6% of the patients. At the end of the study, less than 3% of the patients had an asthma flare‑up. Pulmonary function testing Spirometry testing at the baseline visit indicated that 79% of the patients had a ven­ tilatory disorder. From this group, 41% of the patients suffered frommoderate‑to‑very severe obstruction or combined ventilatory disorder. As shown in Fig. 3, the proportion of patients who achieved normal lung functions according to spirometry increased to 85% by the end of the study. Evolution of Asthma Control Test score The mean ACT score at the baseline visit was 16.7 (SD 3.8). During follow‑up, the score increased continually to 23.8 (SD 1.7) at the final visit 4 (p < 0.001). At the end of the treatment period, 55% of patients achieved the highest ACT score (25) (Fig. 4). Pharmacological asthma treatment According to the study protocol, FSC therapy was prescribed in dosages based on the physi­ cian’s clinical judgment. The mean daily dose of FCS prescribed at the baseline visit was 721 (SD 289) μg. However, as asthma control improved in the course of the treatment, the dose of FSC dropped to 672 (SD 317) μg at the final visit (p = 0.041). Modificationof FSCdosage during the study periodwas not required for nearly two thirds of the patients. This implies that themajority of subjects remained guideline concordant on initial FSC daily dose with respect to the 12-week duration of the study. Other medications frequently used inclu­ ded oral antihistamines (44% at the baseline and 39%at the final visit 4), topical corticosteroids (10% and 12%, respectively), montelukast (6%and 10%, respectively), oral theophylline with slow release (7%and 8%, respectively), systemic corticosteroids (1.8%and 1%, respectively), and inhaled tiotropium bromide (1% and 1%, respectively). Impact of comorbidities on treatment success rate At the baseline visit, there was no correlation between the ACT score and the number of co­ morbidities (p = 0.299). Total asthma control at the final visit 4 was achieved by 57% and 60% of pa­ tients with no or one comorbidity, compared to 41%of patients with ≥ 2 comorbidities (p = 0.019). Multivariate analysis A multivariable logistic regression was used for evaluation of the significance of the impact of various initial parameters for asthma control (accor­ ding to the ACT score). Given the high number of these variables, we also carried out a subsequent logistic regression analysis. The probability of achieving a higher level of asthma control signi­ ficantly decreased due to the patient’s age ≥ 40 years (OR = 0.552, p = 0.002) and smoking (OR = 0.527, p= 0.021). On the contrary, achieving asthma control was more likely in patients with a docu­ mented presence of hypersensitivity to inhalation allergens (OR = 1.736, p = 0.019). Discussion Our results demonstrated that for the ma­ jority of patients with uncontrolled asthma a guideline‑defined asthma control can be achieved. Due to a common failure to reach goals in the management of asthma in routine clinical practice, we included all of the available possibilities for improving the treatment results. Guidelines based interventions rely on a choice of an appropriate antiasthmatic drug with a hi­ gh therapeutic potential, in combination with education and emphasis on adherence for im­ provement. We showed that such interventions could lead to clinical success as early as in three months. The results of treatment became evi­ dent in all established efficacy indicators inclu­ ding the occurrence of day‑time and night‑time symptoms, limitation in activities, use of reliever medication, exacerbations, spirometry resul­ ts, and ACT score. At the end of the treatment p < 0.001 Day-time symptoms Fig. 1.  Occurrence of day-time and night-time symptoms (n = 494) Baseline visit Visit 1 Visit 2 Visit 3 Visit 4 Night-time symptoms/awakings 93 % 81 % 66 % 48 % 42 % 22 % 31 % 13 % 23 % 10 % 100 % 100 % p < 0.001 Once a week Fig. 2.  Use of reliever medication (n = 494) Baseline visit Visit 1 Visit 2 Visit 3 Visit 4 Two or more thimes a week Patients (%) Patients (%) 90 % 90 % 80 % 80 % 70 % 70 % 60 % 60 % 62 % 38 % 27 % 22 % 20 % 13 % 14 % 11 % 8 % 25 % 50 % 50 % 40 % 40 % 30 % 30 % 20 % 20 % 10 % 10 % 0 % 0 %