No abstract

The article is devoted to the improvement in therapy of bronchial asthma, namely to achievement and maintenance of the control of the disease using combined drugs containing inhaled steroids and long-acting β2-agonists. We used data of multi-center, randomised, double-blind, double-masking 1-year trial CONCEPT. We demonstrated advantages of therapy with fixed-dosed Seretid (fluticasone propionate / salmeterol) compared to flexible dosed Simbicort (budesonide / formoterol). As a result of this trial, the fixed-dosed Seretid was shown to provide more symptom-free days (medians, 73.8 % and 64.9 %, respectively, p = 0.03); days without emergency drug needed (94.5 % and 90.7 %, respectively, p = 0.008); better morning peak expiratory flow rate (the corrected mean, 9.5 L / min; 95%CI, 2.7–16.3, p = 0.006), approximately two-fold decrease in moderate to severe acute exacerbation rate compared to the flexible dosing of Simbicort (the corrected exacerbation rate per year, 0.18 and 0.33, p = 0.008). The total length of therapy with systemic steroids at the Seretid group was 46 % less than that at the Simbicort group (301 and 559 days, respectively, р = 0.026).

SMART concept implies administration of Symbicort (budesonid/formoterol both as maintenance and reliever therapy of asthma (BA). The present study was designed to evaluate economic efficacy of SMART regimen (Symbicort 320 / 9 or 640 / 18 μg daily plus Symbicort 160 / 4.5 as needed) compared with current practice of asthma therapy in Russia (64 different medications administered in real practice in 34 cities of Russian federation in 2005) and combined therapy with Seretid Multidisk (fluticason / salmeterol 200 / 100 to 1000 / 100 μg daily plus salbutamol as needed). We performed economic analysis of SMART regimen based on the results of international multi center randomized COSMOS trial. We assessed direct medical costs (outpatient pharmacotherapy with the given medications, emergency care for asthma exacerbations, related hospitalisations, scheduled visits to a physician) and non medical expenses and losses (social expenses for temporary disability, loss of income tax for state budget and of non produced gross national product). As a result, cost of SMART regimen was 1.2 fold to 1.4 fold higher than that of the routine therapy but the former has been eventually decreased by 15 % due to reduction in as needed doses. The mean dose of Seretid did not changed in time but the total expenses for the drug therapy became 20 % higher when compared with SMART regimen and 1.5 fold higher when compared with the routine therapy. The BA burden, which is a sum of treatment cost and social expenses related to the disease, in routinely treated patients were 2 fold to 3 fold higher than in SMART patients. Therefore, combined drugs for management of BA (Symbicort SMART and Seretid) have great medical and economical advantaged over the routine therapy.

The aim of this study was to assess efficacy of the antiinflammatory drug fenspirid (Erespal) in patients with stable COPD. The study was opened, comparative, randomized, multicentre and involved 84 patients with 2 stage stable COPD from 7 Russian medical centres. The patients were randomly divided in 2 groups: the study group (42 patients) received Erespal during 6 months additionally to the standard therapy, the comparative group (42 patients) received the standard therapy only which included ipratropium bromide (Atrovent) 2 doses twice daily and salbutamol as needed. Significant improvement in cough severity (p = 0.004), need in salbutamol (p = 0.023). and FEV1 (p = 0.012) was noted in the Erespal group by the end of the study period. These parameters also improved in the comparative group but with no statistical significance. The exacerbation rate was lower in the Erespal group but the difference was not significant. Quality of life improved in all the parameters in the Erespal group and only in psychical health in the comparative group. Therefore, Erespal allows improving cough severity, need in salbutamol, and quality of life, slowing FEV1 decline. The rate of side effects while using Erespal is similar to the standard therapy. The results show reasonability of basic administration of Erespal in stable 2 stage COPD patients.

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