The following information is obtained from various newswires,
published medical journal articles, and medical conference presentations.
Company: Merck
Approval Status: Approved February 1998
Treatment for: asthma
General Information
Of the new class of asthma medicines called leukotriene blockers,
Singulair is the first intended for both adults and children as young as six,
and the first developed for once-daily use. Singulair works by blocking
leukotrienes, powerful substances that are involved in the inflammatory
process associated with asthma.
Singulair has been studied for the long-term control of asthma, but is not
intended for the relief of acute asthma episodes or symptoms. It should not
be used to relieve an asthma episode or be abruptly substituted for oral or
inhaled corticosteroids. Patients should have quick-relief medicines
available to treat worsening asthma.
Clinical Results
The marketing clearance of Singulair is based on clinical studies that
measured efficacy and safety in more than 3,000 adults and children, aged six
to 14 years.
In clinical studies, Singulair improved asthma control in many patients
by significantly decreasing asthma attacks, preventing daytime and night-time
asthma symptoms, and reducing reliance on other asthma medicines, such as
quick-relieving bronchodilators. It also allowed many patients to reduce
gradually their use of inhaled steroids. Inhaled steroids are the most
commonly used drugs for long-term asthma control, but they can be difficult to
use and have been associated with potential side effects, particularly at high
doses and with long-term use. However, Singulair may not completely eliminate
the need for inhaled or systemic corticosteroids. Patients should not
decrease or stop taking other asthma medicines unless instructed by their
doctor.
Side Effects
Side effects with Singulair were usually mild and generally did not
require patients to stop taking Singulair. Side effects seen in adults and
children during the clinical trials were similar for the groups treated with
Singulair and for those treated with placebo. The most commonly reported side
effects in adults for both placebo and Singulair were headache, influenza and
abdominal pain. There was no increase in side effects with extended
treatment, and no clinically meaningful drug interactions.
