14 Sep

Effect of Long-term Salmeterol Therapy Compared With As-Needed Albuterol Use on Airway Hyperresponsiveness: Exacerbations of Asthma

Exacerbations of Asthma
The treatments were not significantly different with respect to the total number of subjects experiencing asthma exacerbations, defined as asthma symptoms requiring treatment other than albuterol MDI and the blinded study drug. During treatment, 25 subjects (12%) in the salmeterol group reported 31 exacerbations, and 33 subjects (16%) in the placebo group reported 42 exacerbations. Respiratory tract infection was the most common suspected cause of exacerbation and was cited for 68% and 52%, respectively, of the exacerbations in the salmeterol and placebo groups. During the posttreatment period, three patients in the salmeterol group and six patients in the placebo group experienced exacerbations. Oral steroids were used to treat 85% and 90%, respectively, of exacerbations in the salmeterol and placebo groups.
Clinical Adverse Events
A total of 149 patients (74%) in the salmeterol group and 151 patients (73%) in placebo group reported adverse events (Table 4). No significant difference in the number of subjects reporting adverse events was evident between treatments. The most common adverse event for both treatments was upper respiratory tract infection. Other adverse events occurring in > 3% of the subjects in the salmeterol group were common cold symptoms, sore throat, sinusitis, nasal sinus infection, bronchitis, cough, influenza, headache, fever, back pain, and myalgia. Click Here

In the salmeterol group, adverse events requiring hospitalization were respiratory arrest because of an alcohol overdose, tonsillitis, mononucleosis, asthma exacerbation with bronchitis, knee ligament tear, fractured leg, and anaphylaxis to an acne treatment; one subject receiving placebo was hospitalized because of status asthmaticus associated with pneumonia. None of the events was considered drug related by the reporting physician.
Table 4—Most Common Adverse E-vents (> 3%)

Adverse Events Salmeterol Group n = 202 PlaceboGroup

n = 206

Patients with any event 149 151
Patients with specific events
Upper respiratory tract infection 37 33
Cold symptoms 20 19
Bronchitis 14 4
Headache 14 (2)* 7 (2)*
Sore throat 12 (2)* 14 (1)*
Sinusitis 12 12
Nasal sinus infection 9 7
Cough 7 (3)* 7 (5)*
Myalgia(s) 7 2
Influenza 6 5
Fever 6 4
Back pain 6 3

Categories: Airway
Tags: , , ,

© 2008 HIV/AIDS News & Information