Many studies have been published in the last 10 years on the efficacy and safety of montelukast in asthma since this drug entered the market. Experimental studies, in vitro and in vivo, and clinical studies on large numbers of patients with asthma of different severity have clearly demonstrated that montelukast is able to modify the pathophysiological mechanisms of the disease, and to improve to some extent the clinical and functional manifestations of asthma. Studies of montelukast as monotherapy or in combination with other drugs, mainly inhaled corticosteroids (ICS), versus different comparator drugs have contributed to the positioning of montelukast in the different levels of asthma treatment, according to the Global Initiative for Asthma Guidelines. Montelukast may be used as monotherapy as an alternative to low-dose ICS (particularly in a step-down strategy) or in addition to ICS for improving clinical manifestations by an increase in anti-inflammatory effects and a sparing of corticosteroids. The heterogeneity of asthma has received a large amount of attention in the last few years in order to better tailor treatment according to the different clinical and biological phenotypes of asthma. Montelukast has proven to be particularly effective in exercise-induced asthma and in asthma associated with allergic rhinitis. Other phenotypes where montelukast is effective include asthma in obese patients, asthma in smokers, aspirin-induced asthma and viral-induced wheezing episodes. The safety profile of montelukast is very good, and the suspicions of increased risk of Churg-Strauss syndrome or suicide have not been confirmed.
Keywords: asthma; montelukast; phenotype; remodelling.