New Data Reinforces Use of Singulair(tm) in Asthma Patients with Allergic Rhinitis

(2005-07-10)

Singulair(tm) (montelukast) significantly improved symptoms of both allergic rhinitis and asthma, compared to placebo, in asthma patients who also suffer from seasonal allergic rhinitis, according to new data analyses presented this week at the World Allergy Congress (WAC). These analyses provide additional support for the recent European Union (EU) approval of the product for the relief of seasonal allergic rhinitis symptoms in those asthma patients in which SINGULAIR(tm) is indicated.

"Until now there has been no single non-steroidal medication with an approved indication for asthma and for allergic rhinitis," said George Philip, Director, Merck Research Laboratories, co-author of both studies. "These results clearly confirm that montelukast can play an important role in helping to address this unmet treatment need. Physicians can now offer appropriate asthma patients an effective option for the management of their asthma and provide relief of seasonal allergic rhinitis symptoms."

Data from the first new analysis showed that SINGULAIR(tm) significantly improves asthma control in asthma patients with coexisting allergic rhinitis. Given the inflammatory role of cysteinyl leukotrienes in the pathophysiology of both asthma and allergic rhinitis, this post hoc analysis sought to evaluate the clinical benefit SINGULAIR(tm) may have in the large proportion of asthmatic patients who have concomitant allergic rhinitis. Data were analysed from four large asthma studies. The efficacy of SINGULAIR(tm) versus placebo was analysed in asthma patients who also had allergic rhinitis (n=1192) and patients who had asthma alone (n=286). Asthma patients with allergic rhinitis receiving SINGULAIR(tm) demonstrated significant improvements in asthma control compared to placebo, as measured by:

· 7.2 percent increase in lung function (p <0.05)

· 12.7 percent increase in number of days without asthma (p <0.05)

· 22.2 percent decrease in the need for beta-agonist therapy (p <0.05)

Asthma patients without concomitant allergic rhinitis also showed significant improvement in lung function and beta-agonist use (P <0.05).

The second analysis was a subgroup analysis of data from a previous study (Curr Med Res Opin 2004;20:1549). In the original study the primary results showed that SINGULAIR(tm) improved symptoms of seasonal allergic rhinitis in comorbid patients. There was a significant improvement in both self-reported seasonal allergic rhinitis Daily Symptoms Score (p <0.001) and global evaluation of allergic rhinitis (p <0.001) in asthma patients receiving SINGULAIR(tm) compared with those receiving placebo. A subgroup analysis was performed to examine the response of SINGULAIR(tm) in seasonal allergic rhinitis based on the baseline level of asthma (frequency of asthma symptoms and use of ICS at study start). The subanalysis included 412 asthma patients with coexisting allergic rhinitis who were randomised to receive treatment with either SINGULAIR(tm) or placebo for two weeks. Patients receiving SINGULAIR(tm), including those with more pronounced asthma, reported significant improvements in symptoms of allergic rhinitis compared to those receiving placebo in Daily Rhinitis Symptom Score (p <0.05). In addition, significantly more patients on SINGULAIR(tm) compared with placebo (42 percent versus 32 percent, p=0.02) showed simultaneous improvements in global clinical assessments of both asthma and allergic rhinitis.

Close links between asthma and allergic rhinitis

It is estimated that 30 million people in Europe have asthma and up to 80 percent of asthmatics also have allergic rhinitis. Poorly managed allergic rhinitis is associated with worsened symptoms of asthma, increasing the likelihood of an asthma attack, an urgent visit to an emergency department and being hospitalised for asthma.

Asthma and allergic rhinitis are thought to be different forms of the same inflammatory disease and share common inflammatory mediators, including cysteinyl leukotrienes, which are blocked by SINGULAIR(tm). The multinational Allergic Rhinitis and its Impact on Asthma (ARIA) panel, recommend that asthma patients be proactively evaluated for allergic rhinitis as a trigger for their asthma, and that a coordinated approach for managing both diseases, together, should be pursued when feasible.

Leading experts also call for better combined treatment of asthma and allergic rhinitis

The importance of treating both conditions together was recently supported further by experts from across the world attending a recent international meeting entitled 'The MetaForum: Improving Outcomes for Asthmatic Patients with Allergic Rhinitis'. The five major recommendations which emerged were:

· Physicians and patients need to recognise and understand the impact allergic rhinitis has on asthma symptoms, outcomes and quality of life

· Guidelines should be evaluated to ensure they reflect the latest medical knowledge

· All asthma patients should be evaluated for symptoms of allergic rhinitis and vice versa

· Asthma and allergic rhinitis should be managed together

· Key stakeholders need to be educated on the combined management of asthma and allergic rhinitis

Important information about SINGULAIR(tm)

First introduced in 1997, SINGULAIR(tm) is the world's leading asthma medication for children, and has been prescribed to more than 33 million patients in more than 90 countries. SINGULAIR(tm) is indicated in the treatment of asthma as add-on therapy in those patients with mild to moderate persistent asthma who are inadequately controlled on inhaled corticosteroids and in whom "as-needed" short acting beta-agonists provide inadequate clinical control of asthma. In those asthmatic patients in whom SINGULAIR(tm) is indicated in asthma, SINGULAIR(tm) can also provide symptomatic relief of seasonal allergic rhinitis. SINGULAIR(tm) is also indicated in the prophylaxis of asthma in which the predominant component is exercise-induced bronchoconstriction. SINGULAIR(tm) is a once-daily, non-steroidal tablet available in 10 mg tablets for patients 15 years and older, and 4 mg and 5 mg cherry chewable tablets for children 2 to 5 and 6 to 14 years, respectively.

About Merck

Merck & Co., Inc., which operates in many countries as Merck Sharp & Dohme, (MSD), is a global research-driven pharmaceutical company dedicated to putting patients first. Established in 1891, Merck discovers, develops, manufactures and markets vaccines and medicines in more than 20 therapeutic categories. The company devotes extensive efforts to increase access to medicines through far-reaching programs that not only donate Merck medicines but help deliver them to the people who need them. Merck also publishes unbiased health information as a not-for-profit service. For more information, visit http:// www.merck.com.