title: [Multicenter study with a large number of patients for the validation of pharmacokinetic and clinical findings from controlled studies with small patient cohorts].
abstract: In 94 surgeries a total of 682 patients were included into a multicenter study. Serum theophylline concentrations were monitored in patients with obstructive pulmonary diseases, that were treated with theophylline dosages as recommended in the Euphylong professional information or as adjusted after a theophylline serum level control. Peak-flow rates and theophylline tolerance as stated by the patients were also monitored and documented. 72% of the patients already received theophylline in the past. The increase of the mean daily dosage of theophylline to 750 mg administered as a single dose in the evening raised the concentration of serum theophylline in average from 8.7 +/- 5.0 mg/l to 12.2 +/- 4.1 mg/l. No increase of the portion of patients with serum concentrations above 20 mg/l was observed. The patients additional bronchodilatory medication remained unchanged during the study. As a consequence of the improved theophylline medication morning and evening peak-flow rates increased in average from 272 +/- 99 l/min to 315 +/- 109 l/min and 278 +/- 101 l/min to 318 +/- 107 l/min, respectively. After a temporary increase during the first week of treatment the frequency of side effects decreased below the one stated at the starting point of the study. Out of 106 patients, that did not finish the study, 44 (= 6.5%) dropped out because of side effects. The overall assessment of effectiveness and tolerance of Euphylong by physicians and patients was good to very good. Herein the single dosage per day was well accepted by most of the patients. The results of the presented multicenter study with Euphylong therefore confirm the pharmacokinetic and clinical data gained from single center studies with small patient numbers hitherto.
authors.affiliation: Byk Gulden Pharmazeutika, Konstanz, Abt. Med. Wissenschaft Respiration.
authors.forename: J K
authors.initials: JK
authors.lastname: Götz
authors.forename: R
authors.initials: R
authors.lastname: Sauter
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D008173:Lung Diseases, Obstructive / Q000188:drug therapy* / Q000503:physiopathology; D008297:Male; D008875:Middle Aged; D010366:Peak Expiratory Flow Rate / Q000187:drug effects; D013806:Theophylline / Q000097:blood / Q000493:pharmacokinetics / Q000494:pharmacology / Q000627:therapeutic use*
chemical_list: D013806:Theophylline
vernacular_title: Multizentrische Studie mit grosser Patientenzahl zur Bestätigung pharmakokinetischer und klinischer Befunde zu Euphylong aus kontrollierten Studien mit kleinen Patientenkollektiven.