Experience of long-term use of Erespal in patients with chronic obstructive bronchitis (report II)

Abstract

The open study of efficiency and safety of long-term use of Erespal (fensplride) in patients with chronic obstructive bronchitis (COB) was conducted. The study group included COB patients with stable course of the disease during the previous 2 months; the forced expiratory volume for the 1^st sec (FEV₁) was 50-70% of the predictive values; P_a0₂ was 65 to 80 mm Hg. It corresponded to the moderate COPD (FP). The patients receiving glucocorticosteroids (oral or inhaled) and having severe underlying diseases as well as those with acute or exacerbations of chronic diseases were not included in the investigation. The therapy with Erespal was performed in outpatient conditions for 3 months in the daily dose of 160 mg. The drug was re-administered after three-month interval for another 3 months and longer if the cellular ratio in the bronchial mucosa changed in favour of neutrophiles or clinical and laboratory parameters worsened. A control examination was performed in a hospital at the end of each month for the first 3-month period (M0-M3) and every 3 months subsequently (M6, M9, M12). The drug efficiency was evaluated on the basis of visual analog scales assessing cough, dayspnea, sputum production; the blood gas content, lung function test, endoscopic features of tracheobronchial tree and cellular content of the bronchial mucosa. When finished the study (M12) the significant (p<0.05) improvement in the clinical, laboratory and functional parameters was revealed. The cytogram of tracheobronchial mucosa showed the cell ratio in all the patients tended to the normal values. Nobody of the patients had the disease exacerbation for all the treatment period. FEV₁, and ΔFEV₁ worsening, ECG abnormalities, liver or kidneys, or other organs dysfunction were not also revealed. Side effects of Erespal (epigastric discomfort, nausea, heartburn, xerostomia, sleepiness and hypotension) were observed only in 6 (12.2%) patients and did not require the drug cancellation under medication correction. So, the long-term use of the Erespal both as monotherapy and in combination with broncholytic agents is an effective anti-inflammatory therapeutic method for COPD patients. Long-term use of the drug allows to decrease the disease manifestations, to slow its progression and to improve the quality of life in COPD patients.