EFFICIENCY AND SAFETY OF LEFLUNOMIDE TREATMENT IN PATIENTS WITH PULMONARY SARCOIDOSIS

Patients who have contraindications to the prescription of GCs (glucocorticosteroids), or have developed serious side effects during treatment with GCs, as well as patients with resistance to GCs therapy, are prescribed immunosuppressants. The aim of the research - to study the efficacy of leflunomide monotherapy in patients with pulmonary sarcoidosis with contraindications to prescription or serious side effects of glucocorticosteroids. Fourteen patients with sarcoidosis of the respiratory system of stage II were examined – 12 women and 2 men aged 30 to 69 years. In 10 patients there were contraindications to the appointment of GCs (diabetes mellitus – 5, hypertension – 3, obesity – 1, exacerbation of gastric ulcer – 1), which caused the appointment of immunosuppressive therapy as a starting. In 4 cases, serious side effects of SCs were noted, requiring the drug to be abolished (osteoporosis – 3, steroid diabetes – 1). Leflunomide was administered at a dose of 20 mg per day, daily for 3 months. The evaluation of efficacy was carried out using computed tomography of the thoracic cavity organs, body plethysmography, spirometry and determination of the diffusivity of the lungs. Monotherapy with leflunomide in patients with contraindications to prescription or serious side effects of GCs was successful in 7 out of 13 patients, in 2 patients there was a stabilization of the process, in 4 patients with leflunomide therapy progression of the disease was noted and in 1 case the treatment was discontinued due to serious side effects of preparation. The results obtained make it possible to recommend the use of leflunomide as monotherapy in patients with pulmonary sarcoidosis with contraindications to the prescription and/or poor tolerability of GCs and methotrexate. It is necessary to continue studying the possibilities of combined use of leflunomide with other drugs of the first line

Tiotropium versus Salmeterol for the Prevention of Exacerbations of COPD

BACKGROUND Treatment guidelines recommend the use of inhaled long-acting bronchodilators to alleviate symptoms and reduce the risk of exacerbations in patients with moderate-tovery-severe chronic obstructive pulmonary disease (COPD) but do not specify whether a long-acting anticholinergic drug or a β2-agonist is the preferred agent. We investigated whether the anticholinergic drug tiotropium is superior to the β2-agonist salmeterol in preventing exacerbations of COPD. METHODS In a 1-year, randomized, double-blind, double-dummy, parallel-group trial, we compared the effect of treatment with 18 μg of tiotropium once daily with that of 50 μg of salmeterol twice daily on the incidence of moderate or severe exacerbations in patients with moderate-to-very-severe COPD and a history of exacerbations in the preceding year. RESULTS A total of 7376 patients were randomly assigned to and treated with tiotropium (3707 patients) or salmeterol (3669 patients). Tiotropium, as compared with salmeterol, increased the time to the first exacerbation (187 days vs. 145 days), with a 17% reduction in risk (hazard ratio, 0.83; 95% confidence interval [CI], 0.77 to 0.90; P<0.001). Tiotropium also increased the time to the first severe exacerbation (hazard ratio, 0.72; 95% CI, 0.61 to 0.85; P<0.001), reduced the annual number of moderate or severe exacerbations (0.64 vs. 0.72; rate ratio, 0.89; 95% CI, 0.83 to 0.96; P=0.002), and reduced the annual number of severe exacerbations (0.09 vs. 0.13; rate ratio, 0.73; 95% CI, 0.66 to 0.82; P<0.001). Overall, the incidence of serious adverse events and of adverse events leading to the discontinuation of treatment was similar in the two study groups. There were 64 deaths (1.7%) in the tiotropium group and 78 (2.1%) in the salmeterol group. CONCLUSIONS These results show that, in patients with moderate-to-very-severe COPD, tiotropium is more effective than salmeterol in preventing exacerbations. (Funded by Boehringer Ingelheim and Pfizer; ClinicalTrials.gov number, NCT00563381.