[Single evening administration of a new antimuscarinic agent telenzepine in therapy of acute duodenal ulcer. Results of a randomized double-blind comparative study versus pirenzepine].
A multicenter, double-blind, randomized controlled study was conducted in 314 duodenal ulcer patients to compare the efficacy and safety of the antimuscarinics telenzepine and pirenzepine in the treatment of duodenal ulcer. Patients received telenzepine 3 mg (156) once-daily at bedtime or 50 mg pirenzepine (158) two times daily for 2 weeks. If ulcerous lesions persisted treatment was extended to 4 weeks. Efficacy was assessed by relief of ulcer pain and endoscopic findings of ulcer healing. Safety was determined on the basis of side effects and results of laboratory tests. The 2- and 4-week healing rates achieved with telenzepine were 21.1 and 67.3%, respectively, and with pirenzepine they were 20.0 an 69.0%, respectively; the differences in healing rates for the two drugs were not statistically significant. Similarly both drugs provided satisfactory relief of pain. The incidence of untoward effects was 24.5% with telenzepine and 29.7% with pirenzepine, dryness of mouth being most prominent (20.4 vs. 19.3%). With telenzepine blurred vision was reported in a significantly lower rate compared to pirenzepine (0.7 vs. 4.2%, p less than 0.05). Clinically relevant abnormal laboratory tests were not observed. The present study shows for the first time that the newly developed antimuscarinic drug telenzepine is in a single nocturnal dosage regimen (3 mg nocte) as effective as pirenzepine (50 mg bid) in the treatment of duodenal ulcer.
Dammann
H G
HG
Krankenhaus Bethanien, Hamburg.
Dreyer
M
M
Wolf
N
N
Müller
P
P
Merk-Härtelt
B
B
Simon
B
B
D000328:Adult; D002986:Clinical Trials as Topic; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D004381:Duodenal Ulcer / Q000188:drug therapy*; D004384:Duodenoscopy; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D010276:Parasympatholytics / Q000008:administration & dosage* / Q000009:adverse effects; D010890:Pirenzepine / Q000008:administration & dosage* / Q000009:adverse effects / Q000031:analogs & derivatives*; D011897:Random Allocation; D014945:Wound Healing / Q000187:drug effects
D010276:Parasympatholytics; C046338:telenzepine; D010890:Pirenzepine
Einmal abendliche Gabe des neuen Antimuskarinikums Telenzepin in der Therapie des akuten Ulcus duodeni. Ergebnisse einer randomisierten, doppelblinden Vergleichsstudie versus Pirenzepin.