Evaluation of effectiveness and safety of the first Russian-manufactured generic bosentan use in patients with pulmonary arterial hypertension

Objective. To study effectiveness and safety of generic bosentan use for 24 weeks in patients with pulmonary arterial hypertension (PAH). Materials and methods. The study included 42 patients. In 22 patients Bosentan therapy (Bosenex®, Sotex, Russia) was used for the first time. In 20 patients switching therapy from original bosentan (Tracleer, Аctelion Pharmaceuticals Ltd., Switzerland) was performed. The patients were followed up for 24±2 weeks. Results. After 24 weeks of treatment percent of patients with functional class (FC) III decreased from 55 to 30%, percent of patients with FC II increased from 45 to 55%, some patients (15%) achieved FC I, and the 6-minute walk distance increased on 52.1 meters. In the group of therapy change heart failure FC stabilization was observed, 6-minute walk distance increased on +14.8 meters (р>0.05). Echocardiography in the first group showed significant decrease of pulmonary artery systolic pressure (PASP) at -4 mm Hg and of right atrium area on 0.9 cm2. In the switched therapy group the difference was not significant. According to chest X-ray examination change of cardio-thoracic ratio, Murray and Lupi indexes was not significant in both groups. According to results of right heart catheterization improvement of mean pulmonary arterial pressure (-6.7 mm Hg), mean right atrial pressure (-1.6 mm Hg with reference value reached), and pulmonary vascular resistance (-293.2 dynes×sec/cm-5) was achieved; р<0.05. Bosenex therapy was tolerated well and development of clinically significant adverse effects was not observed. Conclusion. Use of first generic bosentan for 24 weeks resulted in improvement of clinical and haemodynamic parameters as well as in improvement of functional ability of patients with PAH of II-III FC (World Health Organization). Switching from original medication to Bosenex® was not followed by patients’ clinical status impairment or with adverse effects development. Patients who used Bosenex® developed only adverse effects that typically occur in this medications class use, the frequency of adverse effects development did not exceed the claimed one

pulmonary arterial hypertension , pulmonary hypertension treatment, receptor antagonists, Bosenex

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