New study demonstrates adding 'Singulair'® (montelukast) to children's usual asthma treatment halves the number of days they experience worsened asthma symptoms

4 October 2007: The short term addition of 'Singulair'® (montelukast) to usual asthma therapy for six weeks after school return could substantially reduce asthma morbidity and unscheduled physician visits during this predictably high-risk period1.

The new study published in the journal Pediatrics found that asthmatic children in Canada aged 2 to 14, randomly assigned montelukast in addition to their regular therapy*, experienced half the number of days with worsened asthma symptoms than those taking placebo (3.9% vs 8.3%; p<.02)1. The montelukast group were also four times less likely than those receiving placebo to require unscheduled medical intervention for asthma symptoms (78% decrease; p=.011).1

In the Canadian study 194 asthmatic children aged 2 to 14, stratified according to age group
and gender (98 randomly assigned to montelukast and 96 placebo), took part in the doubleblind, randomized, placebo-controlled 45 day trial. A magnet-backed fridge calendar was
used to record daily symptom rate, with dated, coloured stickers to indicate asthma symptom
rating.1

UK studies have demonstrated that the number of admissions of children with asthma is seasonal with a large peak in autumn and a smaller peak in spring.2,3 The sharp rise in
September is probably a combination of viral infection and increased exposure to airborne
allergens.4,5 When children with asthma are re-exposed to risk factors on return to school,
lack of adequate controller medication may increase their risk of worsening asthma1. In this
study, the addition of an oral therapy, montelukast, to a child’s usual asthma therapy was
effective in reducing morbidity, with high compliance (92% for montelukast, 93% for
placebo)1.

Commenting on the results Dr Mark Everard, Consultant Respiratory Paediatrician from
Sheffield Children’s Hospital said: “The increase in asthma exacerbations in September,
coinciding with the return to school, is well known. This interesting study suggests that
starting montelukast before asthmatic children return to school in September may
significantly reduce the morbidity they experience in the early autumn.”

*Over 90% of children were prescribed an ICS, and 30% in each group were prescribed a combination product (ICS with LABA).

No children were prescribed a LABA without ICS.

ISSUED BY PUBLIC AFFAIRS

SINGULAIR® is a registered trademark of Merck & Co., Inc. of Whitehouse Station, NJ, USA.
On average there are three children with asthma in every classroom in the UK, and half a
million children with asthma miss school at least once a month because of their symptoms6.

---Ends---

For further information or material please contact:

Tola Awogbamiye

Merck Sharp & Dohme

Tel: 01992 452 730

Email: tola_awogbamiye@merck.com

Lizz Fort

Galliard Healthcare Communications

Tel: 020 7663 2280

Email: lfort@galliardhealth.com

Notes to editors

The study was funded by an unrestricted medical school grant from Merck Frosst Canada Ltd.

About Singulair

‘SINGULAIR’ is indicated as an alternative treatment option to low-dose inhaled corticosteroids for 2 to 14 year old patients with mild persistent asthma who do not have a recent history of serious asthma attacks that required oral corticosteroid use and who have demonstrated that they are not capable of using inhaled corticosteroids7. Mild persistent asthma is defined as asthma symptoms more than once a week but less than once a day, nocturnal symptoms more than twice a month but less than once a week, normal lung function between episodes7.

If satisfactory control of asthma is not achieved at follow-up (generally by one month), the need for an additional or different antiinflammatory therapy based on the step system for asthma therapy should be evaluated. Patients should be periodically

evaluated for their asthma control7. Most common side effects of Singulair in clinical trials of children include abdominal pain,

headache, and thirst7.

Forward-looking statement

This press release contains "forward-looking statements" about product development, product potential or about financial performance based on current expectations of the management of Merck & Co., Inc. No forward-looking statement can be guaranteed, and actual results may differ materially from those projected. Merck & Co., Inc. undertakes no obligation to publicly
update any forward-looking statement, whether as a result of new information, future events, or otherwise.

About Merck Sharp & Dohme Limited (MSD)

Merck Sharp Dohme Limited (MSD) is the UK subsidiary of Merck & Co., Inc. of Whitehouse Station, New Jersey, USA, a leading research-based pharmaceutical company that discovers, develops, manufactures and markets a wide range of innovative pharmaceutical products to improve human health.

References

1 Johnston NW, Mandhane PJ, Dai J, Duncan JM, Greene JM, Lambert K, and Sears MR. Attenuation of the September

Epidemic of Asthma Exacerbations in Children: A Randomized, Controlled Trial of Montelukast Added to Usual Therapy.

Pediatrics 2007;120: 3: e702-e712

2 Khot A, Evans N, Lenney W. Seasonal trends in childhood asthma in South East England. Br Med J 1983; 287:1257-8

3 Ashley JS. Seasonal trends in childhood asthma. Br Med J 1983; 287:1721

4 Storr J, Lenney W. School holidays and admissions with asthma. Arch Dis Child 1989;64:103-107

5 Carlsen KH, Orstavik I, Leegaard J, Hoeg H. Respiratory virus infections and aeroallergens in acute bronchial asthma. Arch

Dis Child 1984; 59:310-5

6 Asthma UK (2005) Making School and Stress Free Zone (online). Last accessed 25 September 2007. Available at:

http://www.asthma.org.uk/news_media/news/making_school_a.html

7 Singulair SPC

Healthcare Republic does not have an editorial influence or input in to these press releases. The views expressed within these documents are not endorsed by Healthcare Republic or Haymarket Medical Publications Limited.

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