Asthma medication: How does montelukast compare?

Taken in combination with an inhaled corticosteroid, montelukast tablets are slightly less effective in relieving symptoms associated with mild to moderate chronic asthma than a combination of inhaled salmeterol and a corticosteroid. However, serious adverse effects are also slightly less common. It is still unclear whether people with exercise-induced asthma benefit from long-term treatment with montelukast.

Bronchial asthma is a chronic disease in which the airways (bronchi) are constantly inflamed and narrowed. Long-term asthma medication helps reduce the chronic inflammation, and so prevent the narrowing of the airways and shortness of breath. You can read more about asthma and asthma medication in our feature (URL: http://www.informedhealthonline.org/index.371.56.en.html) .

In people with asthma different types of immune cells collect along the inside of the walls of the airways, as though these cells were constantly on high alert. The immune cells produce various chemicals that attract other cells, affecting the mucous membranes and muscle tissue in the airways. One way to treat asthma is to selectively block the action of the chemicals released by the immune cells. These chemicals include leukotrienes. Leukotrienes only affect the airways if they come into contact with cells that have a matching “receptor” molecule for them to bind to. In turn, the receptors then trigger further reactions in the walls of the airways, which can eventually cause them to narrow.

What does montelukast do and how is it taken?

Montelukast is similar to leukotrienes, so it is able to bind to the same receptors and block them. This prevents the “real” leukotrienes from triggering the reaction. Therefore montelukast is what we call a "leukotriene receptor antagonist" or “blocker”.

So far montelukast is the only leukotriene receptor antagonist that has been licensed for use in Germany. It can be taken orally in the form of tablets or granules. Drug regulatory authorities have decided that montelukast is only allowed to be prescribed for certain types of asthma in children, teenagers and adults. For example, it can be used in mild or moderate chronic asthma if treatment with inhaled steroids is not effective enough, as well as in exercise-induced asthma. People with mild asthma do not have asthma symptoms every day. Those with moderate asthma have asthma symptoms on a daily basis, and in exercise-induced asthma people mostly have asthma attacks after physical exertion.

How well does montelukast work?

Researchers from the German Institute for Quality and Efficiency in Health Care (IQWiG) looked for trials comparing montelukast directly with either a placebo (a fake, inactive drug) or other asthma treatments for the groups of people mentioned above. The trial participants agreed to be randomly allocated to one of at least two groups. In one group the participants were then treated with montelukast, and in the other groups they received either a placebo or another drug. Neither the patients nor the doctors knew who was in which group and who was given which drug. Trials like this are called randomized controlled trials and are internationally accepted as the standard way to evaluate drugs.

IQWiG found a total of 15 trials that looked at how people with chronic asthma respond to treatment with one montelukast tablet per day in addition to a corticosteroid. Corticosteroids or glucocorticosteroids are anti-inflammatory agents, commonly referred to as “steroids”.

The analysis of the results for teenagers and adults showed that steroids taken in combination with montelukast relieved the symptoms better than steroids alone. For example, they were symptom-free on more days, had fewer asthma attacks and it was less common for them to wake up at night due to breathing difficulties. To give you a better idea of how well it worked: on average, people who only used an inhaled steroid were symptom-free on 4 out of 10 days, whereas those who used a steroid and montelukast were symptom-free on 6 to 7 out of 10 days.

People who take montelukast might need to take less steroids than those who only take steroids. But it is still not clear whether taking montelukast can reduce the amount of steroids needed by so much that it noticeably reduces the adverse effects of the steroids. So far there is no evidence to show that the combination of montelukast and steroids is associated with fewer adverse effects than treatment with steroids alone.

Many people with asthma take steroids together with the active substance salmeterol, which is also inhaled, so the IQWiG researchers looked at this combination as well. They found that the steroid/salmeterol combination relieved asthma symptoms somewhat better than the steroid/montelukast combination did. On average, people who took salmeterol and a steroid had one more symptom-free day every 2 weeks compared to those who took montelukast and a steroid.

Adverse effects

The frequency of adverse effects such as headaches or hoarseness was about the same for both of the combinations. However, the research suggests that severe adverse effects, such as those that have to be treated in a hospital, are slightly less common with the steroid/montelukast combination than with the steroid/salmeterol combination.

Bearing these results in mind, the decision about which combination to use should be considered individually for each person with chronic asthma: salmeterol works slightly better than montelukast, but montelukast has a slightly lower rate of serious adverse effects compared to salmeterol. Some trials attempted to find out whether people who took montelukast in addition to steroids had a better quality of life: that is, whether they generally felt happier about their own state of health, for instance. The results showed that people who took both steroids and montelukast did not feel any different from those who only took steroids. Similarly, there was no difference in perceived quality of life between people who took steroids in combination with salmeterol and those who took steroids in combination with montelukast.

Montelukast in exercise-induced asthma

The researchers only found a few relevant trials assessing how well montelukast works in the treatment of exercise-induced asthma in teenagers and adults, and these only involved a small number of participants. This research suggests that montelukast improves their physical fitness somewhat. However, there is not enough evidence available to reliably show whether people with exercise-induced asthma benefit more from long-term treatment with montelukast than they do from the occasional use of a “reliever” inhaler.

Montelukast in children

A low dose of montelukast has been licensed in Germany for treating children with asthma. However, the IQWiG researchers found that there is currently not enough research on how children with chronic asthma respond to a combination of steroids and montelukast as treatment. Only two trials looked at the combination treatment that has been approved in Germany – the children in the trials were between 6 and 14 years old and had mild to moderate asthma. There was only one trial that looked at the use of montelukast in the treatment of children with exercise-induced asthma, and only a small number of children in this age group took part in it. This research does not provide enough evidence to reliably evaluate the benefit of montelukast and the risk of adverse effects.

Montelukast has also been approved for treating children with mild chronic asthma without the additional use of steroids. However, this is only officially licensed for use in children who have not recently had a severe asthma attack and who have difficulties using inhalers. The benefits and adverse effects of this treatment have not yet been evaluated by IQWiG.

Author: Institute for Quality and Efficiency in Health Care (IQWiG)

Note

This health information is a summary of a scientific report published by IQWiG. It is not an assessment of the right to have health care services paid for by statutory health insurance funds in Germany. By law, decisions about paying the costs for diagnostic and therapeutic procedures can only be made by the German Federal Joint Committee (G-BA). The Federal Joint Committee takes IQWiG reports into consideration in its decision-making process. You can find information about the decisions of the German Federal Joint Committee on its English-language website, www.english.g-ba.de (URL: http://www.english.g-ba.de) .