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The following events were reported at an incidence of 1% to 2% (3 to 4 patients) in the salmeterol group and with a higher incidence than in the albuterol and placebo groups: gastrointestinal signs and symptoms, lower respiratory signs and symptoms, photodermatitis, and arthralgia and articular rheumatism. In clinical trials evaluating concurrent therapy of salmeterol with inhaled corticosteroids, adverse events were consistent with those previously reported for salmeterol, or might otherwise be expected with the use of inhaled corticosteroids. Chronic Obstructive Pulmonary Disease: Two multicenter, 24-week, controlled studies have evaluated twice-daily doses of SEREVENT DISKUS in patients with COPD. For presentation (Table 5), the placebo data from a third trial, identical in design, patient entrance criteria, and overall conduct but comparing fluticasone propionate with placebo, were integrated with the placebo data from these 2 studies (total N = 341 for salmeterol and 576 for placebo). Text Continues Below
* Table 5 includes all events (whether considered drug-related or nondrug-related by the investigator) that occurred at a rate of 3% or greater in the group receiving SEREVENT DISKUS and were more common in the group receiving SEREVENT DISKUS than in the placebo group. Other events occurring in the group receiving SEREVENT DISKUS that occurred at a frequency of 1% to <3% and were more common than in the placebo group were as follows: Endocrine and Metabolic: Hyperglycemia. Eye: Keratitis and conjunctivitis. Gastrointestinal: Candidiasis mouth/throat, dyspeptic symptoms, hyposalivation, dental discomfort and pain, gastrointestinal infections. Lower Respiratory: Lower respiratory signs and symptoms. Musculoskeletal: Arthralgia and articular rheumatism; muscle pain; bone and skeletal pain; musculoskeletal inflammation; muscle stiffness, tightness, and rigidity. Page: << Prev | 1 | 2 | 3 | Next >>
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