A prospective clinical study of theophylline safety in 3810 elderly with asthma or COPD

作者：Ohta, K^*; Fukuchi, Y; Grouse, L; Mizutani, R; Rabe, KF; Rennard, SI; Zhong, NS

来源：Respiratory Medicine, 2004, 98(10): 1016-1024.

DOI：10.1016/j.rmed.2004.02.020

• theophylline
• Japanese elderly
• adverse event
• bronchial asthma
• chronic obstructive pulmonary disease

A large-scale prospective study was conducted in 3810 Japanese elderly (greater than or equal to65 years old) patients with asthma or chronic obstructive pulmonary disease (COPD) who had been treated with sustained-release theophylline tablets (THEODUR(R)) at a dose of 400 mg/day for 1-6 months, in principle.
Among 3798 protocol-complying patients (mean age: 73.8 +/- 0.10 years, 1997 with COPD), 261 theophylline-related adverse events were observed in 179 (4.71%) patients. The 5 most frequently observed adverse events were "nausea" (40 episodes, 1.05%), "loss of appetite" (22 episodes, 0.56%), "hyperuricemia" (16 episodes, 0.42%), "palpitation" (15 episodes, 0.39%), and "increased alkaline phosphatase" (11 episodes, 0.28%). No convulsions were reported. Six patients had serious adverse events.
The incidence of theophylline-related adverse events was higher in patients with hepatic disease (odds ratio: 1:1.81) and in patients with arrhythmia (odds ratio: 1:1.88). Blood drug concentration measurements in 736 patients indicated that the drug levels were less than or equal to15 mug/ml in 641 patients (87.1%), and no correlation was noted between dose and theophylline-related adverse events.
These results suggest that sustained-release theophylline can be used safety in elderly patients with asthma or COPD.

• 出版日期2004-10
• 单位广州大学