The position of pranlukast, a cysteinyl leukotriene receptor antagonist, in the long-term treatment of asthma - 5-year follow-up study

Background: Adverse effects, tachyphylaxis, and the position of pranlukast, a cysteinyl leukotriene receptor antagonist, in asthma treatment have not been fully established. Objectives and Methods: To address these questions, adverse effects and long-term efficacy of pranlukast were evaluated in 82 patients [28 patients with moderate asthma (group I), 27 with severe persistent asthma not on oral corticosteroid (OCS; group II) and 27 with severe persistent asthma on OCS (group III)] at 4 and 16 weeks. In the following, pranlukast was either withdrawn 1 year after the start of therapy, or if that was not possible due to reappearance of symptoms, the dose of OCS or inhaled corticosteroid (ICS) was reduced. The efficacy of pranlukast was evaluated during 5 years by peak expiratory flow rate (PEFR), and symptom and treatment scores. Results: Adverse reactions appeared in 4 patients (4.9%; diarrhea, dizziness and leg edema). The mean improvement in PEFR on week 16 was 18.5 +/- 2.3, 18.8 +/- 3.2, and 15.2 +/- 3.8% in groups I-III, respectively (p < 0.01, for all groups). However, increases in PEFR in 29 of 72 patients (40.3%) were less than 15%. Pranlukast could not be withdrawn in 28 of 42 responders (66.7%), but their dose of ICS was reduced by 363 ± 97 μg/day (group II) and that of OCS by 3.4 ± 0.7 mg/day ( group III). Tachyphylaxis was not recognized during the 5-year period. Conclusion: Pranlukast is safe when taken for up to 5 years, and is effective irrespective of asthma severity. In the majority of patients with persistent asthma, pranlukast may help to control the disease in the long term. Copyright (C) 2004 S. Karger AG, Basel.