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

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

Research output: Contribution to journalArticle

50 Scopus citations

Abstract

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 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 ≤15 μg/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.

Original languageEnglish (US)
Pages (from-to)1016-1024
Number of pages9
JournalRespiratory Medicine
Volume98
Issue number10
DOIs
StatePublished - Oct 2004

Keywords

  • Adverse event
  • Bronchial asthma
  • Chronic obstructive pulmonary disease
  • Japanese elderly
  • Theophylline

ASJC Scopus subject areas

  • Pulmonary and Respiratory Medicine

Fingerprint Dive into the research topics of 'A prospective clinical study of theophylline safety in 3810 elderly with asthma or COPD'. Together they form a unique fingerprint.

Cite this