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Chronic Obstructive Pulmonary Disease Two multicenter, 12-week, controlled studies have evaluated twice-daily doses of SEREVENT Inhalation Aerosol in patients with COPD. Table 4 reports the incidence of adverse events in these 2 studies. Text Continues Below
Table 4 includes all events (whether considered drug-related or nondrug-related by the investigator) that occurred at a rate of over 3% in the group treated with SEREVENT Inhalation Aerosol and were more common in the group treated with SEREVENT Inhalation Aerosol than in the placebo group. Common cold, rhinorrhea, bronchitis, cough, exacerbation of chest congestion, chest pain, and dizziness occurred at 3% or more but were equally common on placebo. Other events occurring in the group treated with SEREVENT Inhalation Aerosol at a frequency of 1% to 3% were as
follows: Ear, Nose, and Throat Cold symptoms, earache, epistaxis, nasal congestion, nasal sinus congestion, sneezing. Gastrointestinal Nausea, dyspepsia, gastric pain, gastric upset, abdominal pain, constipation, heartburn, oral candidiasis, xerostomia, vomiting, surgical removal of tooth. Musculoskeletal Leg cramps, myalgia, neck pain, pain in arm, shoulder pain, muscle injury of neck. Neurological Insomnia, sinus headache. Non-Site Specific Fatigue, fever, pain in body, discomfort in chest. Respiratory Acute bronchitis, dyspnea, influenza, lower respiratory tract infection, pneumonia, respiratory tract infection, shortness of breath, wheezing. Urogenital Urinary tract infection. Electrocardiographic Monitoring in Patients With Chronic Obstructive
Pulmonary Disease: Continuous electrocardiographic (Holter) monitoring was performed on 284 patients in 2 large COPD clinical trials during five 24-hour periods. No cases of sustained ventricular tachycardia were observed. At baseline, non-sustained, asymptomatic ventricular tachycardia was recorded for 7 (7.1%), 8 (9.4%), and 3 (3.0%) patients in the placebo, SEREVENT, and ipratropium groups, respectively. During treatment, nonsustained, asymptomatic ventricular tachycardia that represented a clinically significant change from baseline was reported for 11 (11.6%), 15 (18.3%), and 20 (20.8%) patients receiving placebo, SEREVENT, and ipratropium, respectively. Four of these cases of ventricular tachycardia were reported as adverse events (1 placebo, 3 SEREVENT) by 1 investigator based upon review of Holter data. One case of ventricular tachycardia was observed during ECG evaluation of chest pain (ipratropium) and reported as an adverse event. Page: << Prev | 1 | 2 | 3 | Next >>
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