In clinical studies involving patients aged >15 years with chronic asthma
SINGULAIR – significant efficacy across important measures of asthma control2,3
SINGULAIR provided the following benefits compared with placebo
37% reduction
in asthma attacksa
Percentage of patients experiencing asthma attacks: 11.6% for SINGULAIR (n=795) and 18.4% for placebo (n=530).
Asthma attack was defined as any of the following:
- Emergency department visit
- Hospital admission
- Unscheduled office visit
- Need for oral, intravenous, or
intramuscular corticosteroid
16% reduction
in daytime asthma symptoms2,b
Reduction in symptom score on Day 1, change from baseline: SINGULAIR –0.31, placebo 0.02.
Mean baseline daytime symptom scores (0–6 scale) were 2.51 for SINGULAIR (n=408) and 2.49 for placebo (n=273).
26% reduction
in ß-agonist usea
Reduction in ß-agonist use, mean change from baseline: SINGULAIR –1.56 puffs per day (26% reduction), placebo
–0.41 puffs per day (5% reduction).
Baseline ß-agonist use was 5.38 puffs per day for SINGULAIR (n=795) and 5.55 puffs per day for placebo (n=530).
36% reduction
in nighttime asthma symptoms1,b
Reduction in symptom score on Day 1, change from baseline: SINGULAIR –0.30, placebo –0.04.
Mean baseline nocturnal asthma score (0–3 scale) was 0.97 for both SINGULAIR (n=292) and placebo (n=193).
And SINGULAIR also provided significant improvement in FEV1 when compared with placebo (P<0.001).a
a Study II (1 of the 2 studies pooled above): A 12-week, randomized, double-blind, placebo-controlled study of 681 asthmatic patients >15 years with baseline FEV1 between 50% and 85% of predicted value and β-agonist reversibility of at least 15%. SINGULAIR was given as one 10-mg tablet daily; inhaled β-agonist was permitted as needed.3
b Study I (pooled): Combined data from two 12-week, double-blind, placebo-controlled studies of 1,576 nonsmoking asthmatic men and women >15 years with chronic, persistent daytime symptoms and FEV1 between 40% and 90% of predicted value. SINGULAIR was given as one 10-mg tablet daily; inhaled ß-agonist was permitted as needed. In one of these trials, a non-US formulation of inhaled beclomethasone dipropionate dosed at 200 mcg (2 puffs of 100 mcg ex-valve) twice daily with a spacer device was included as an active control.2
SINGULAIR is indicated for prophylaxis and chronic treatment of asthma in patients aged 12 months and older and for prevention of exercise-induced bronchoconstriction (EIB) in patients aged 15 years and older.
For prevention of EIB, a single dose of SINGULAIR should be taken at least 2 hours before exercise. An additional dose of SINGULAIR should not be taken within 24 hours of a previous dose.
Patients already taking 1 tablet daily for another indication should not take an additional dose to prevent EIB.
SELECTED SAFETY INFORMATION
- SINGULAIR should not be used as rescue medication to treat acute asthma episodes. Patients should be advised to have appropriate rescue medication available.
- Neuropsychiatric events have been reported in patients taking SINGULAIR. These events included agitation, aggressive behavior or hostility, anxiousness, depression, dream abnormalities, hallucinations, insomnia, irritability, restlessness, somnambulism, suicidal thinking and behavior (including suicide), and tremor. The clinical details of some postmarketing reports appear consistent with a drug-induced effect. Patients should be advised to report any neuropsychiatric events.
- Use of SINGULAIR may not eliminate the need for inhaled or systemic corticosteroids. Patients should not decrease the dose or stop taking any other antiasthma medications unless instructed by a physician.
- Safety and effectiveness of SINGULAIR in patients younger than 12 months with asthma have not been established.
Before prescribing SINGULAIR, please read the Prescribing Information.
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