A prospective clinical study of theophylline safety in 3810 elderly with asthma or COPD.
A large-scale prospective study was conducted in 3810 Japanese elderly (> or =65 years old) patients with asthma or chronic obstructive pulmonary disease (COPD) who had been treated with sustained-release theophylline tablets (THEODUR) 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 < or =15 microg/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 safely in elderly patients with asthma or COPD.
Ohta
Ken
K
Department of Medicine, School of Medicine, Teikyo University, 2-11-1 Kaga, Itabashi-Ku, Tokyo, Japan. kenohta@med.teikyo-u.ac.jp
Fukuchi
Yoshinosuke
Y
Grouse
Lawrence
L
Mizutani
Ryuji
R
Rabe
Klaus F
KF
Rennard
Stephen I
SI
Zhong
Nan-Shan
NS
D000368:Aged; D000369:Aged, 80 and over; D001249:Asthma / Q000188:drug therapy*; D001993:Bronchodilator Agents / Q000008:administration & dosage / Q000009:adverse effects*; D003692:Delayed-Action Preparations; D005260:Female; D006801:Humans; D008297:Male; D011446:Prospective Studies; D029424:Pulmonary Disease, Chronic Obstructive / Q000188:drug therapy*; D013806:Theophylline / Q000008:administration & dosage / Q000009:adverse effects*
D001993:Bronchodilator Agents; D003692:Delayed-Action Preparations; D013806:Theophylline