WAM: Singulair Added To Inhaled Steroids Increases Control Of Asthma Symptoms
BARCELONA, SPAIN -- Dec. 11, 1998 -- A new study has shown that
adding Merck & Co.'s once-a-day medicine Singulair™ (montelukast) to
inhaled steroids achieved significant improvement in the control of asthma
symptoms, while another study has demonstrated that Singulair provided greater
control of exercise-induced asthma than the long-acting beta-agonist salmeterol,
without the development of tolerance with prolonged use.
The findings of both studies, which were presented at the World Asthma
Meeting, reinforce the important role of leukotriene receptor antagonists
(LTRAs) in improving the management of asthma. LTRAs are the first new type
of asthma therapy in two decades.
The LTRAs offer a highly targeted approach to the treatment of asthma by
inhibiting the effect of the proinflammatory cysteinyl leukotrienes. The importance
of this new class of drugs has been acknowledged by their inclusion, for the first
time, in the revised Global Initiative for Asthma (GINA) Guidelines being
unveiled here this week.
An international study of 642 adult patients showed that adding Singulair (10mg)
to the inhaled steroid beclomethasone dipropionate (BDP; 400mcg daily)
achieved significant improvement in asthma symptoms and overall control. All of
the study patients were not adequately controlled on beclomethasone (200mcg
twice-daily). Patients ranged in age from 15 to 78 and were randomly allocated
to four different treatment groups. However, key results from the study focused
on two of the four treatment groups: Singulair (10mg) + BDP (400mcg) and
placebo + BDP (400mcg).
Researchers reported that Singulair achieved significant improvements in asthma
control – including FEV, morning peak flow rates, daytime and night-time asthma
symptoms, asthma exacerbations and eosinophil count, a key marker for
inflammation. Importantly, the number of patients receiving Singulair who
experienced an asthma attack decreased as well. There was no difference in
tolerability when Singulair was added to BDP over the 16-week treatment
period.
Research has now shown that many patients are concerned about the possibility
that high-dose corticosteroids may be associated with side-effects, including
osteoporosis, skin thinning and growth inhibition in children. A study published
this year in the Journal of the American Medical Association concluded that
prolonged use of high doses of inhaled corticosteroids increased the likelihood of
undergoing cataract extraction in the elderly.
A second study presented during WAM showed that Singulair achieved
additional benefits when compared against a long-acting beta-agonist. Results
showed that Singulair achieved long-lasting protection against exercise-induced
asthma (EIA), while the effects of the long-acting beta-agonist salmeterol waned
over time. EIA is believed to affect as many as 80 percent of patients with
asthma.
The study randomised 191 patients with chronic asthma (aged 15 to 45) who
suffered from EIA (defined as greater than or equal to 20 per cent maximum fall
in FEV1 post-exercise) to salmeterol (42mcg, twice-daily) or Singulair (10mg,
once-daily at night). The bronchoprotection achieved with Singulair was twice as
great (48 percent) compared with salmeterol (24 percent) after eight weeks of
treatment. Two-thirds of patients treated with Singulair had a maximum fall in
FEV post-exercise of less than 20 percent, while fewer than half achieved the
same protection with salmeterol.
The findings showed that both agents achieved similar effects after one to three
days. However, the protection provided by Singulair was maintained over the full
eight weeks of the study, while a large proportion of the effect was lost with
salmeterol due to the development of tolerance -- a decreasing sensitivity to
subsequent doses of the medicine. Researchers reported that tolerance to
salmeterol was apparent after four weeks of treatment, reflecting the results
observed in previous research. In contrast, data to date suggest that tolerance to
Singulair does not develop.
The role of Singulair in helping control exercise-induced asthma was also
demonstrated in two recently published studies. In articles that appeared earlier
this year in the New England Journal of Medicine and the Journal of
Pediatrics, Singulair was demonstrated to provide significant protection against
the disease in both adults and children six year and older.
Approximately 600,000 persons world-wide have been prescribed Singulair to
help control their asthma since this new medicine was introduced earlier this year.
Treatment with Singulair leads to an improvement in the signs and symptoms of
asthma in both adults and children six years of age and older. |
