Details

Autor(en) / Beteiligte

• Ohta, Ken
• Fukuchi, Yoshinosuke
• Grouse, Lawrence
• Mizutani, Ryuji
• Rabe, Klaus F
• Rennard, Stephen I
• Zhong, Nan-Shan

Titel

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

Ist Teil von

• Respiratory medicine, 2004-10, Vol.98 (10), p.1016-1024

Ort / Verlag

Oxford: Elsevier Ltd

Erscheinungsjahr

2004

Quelle

MEDLINE

Beschreibungen/Notizen

• A large-scale prospective study was conducted in 3810 Japanese elderly (⩾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 400mg/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 ⩽15μg/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.