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Accession number;02A0862851
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| Title;Clinical Evaluation of Landiolol Hydrochloride (ONO-1101) on Perioperative Supraventricular Tachyarrhythmia in patients with hypertension or cardiac ischemia. Double-blind Study in Comparison with Placebo. |
| Author;
YOSHIYA IKUTO
(Social Insurance, Hoshigaoka Koseinenkin Hospital, JPN)
OGAWA RYO
(Nippon Med. Sch.)
()
SHIMADA YASUHIRO
(Nagoyadai I Masuika)
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Journal Title;Journal of Clinical Therapeutics & Medicines
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Journal Code:Y0906A
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ISSN:0910-8211
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VOL.18;NO.9;PAGE.1049-1076(2002)
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| Figure&Table&Reference;FIG.6, TBL.22, REF.8 |
| Pub. Country;Japan |
| Language;Japanese |
| Abstract;The efficacy and safety of landiolol hydrochloride (ONO-1101); an ultra short acting .BETA.1-blocker, were compared against placebo, in a multi-center,randmized double-blind, group comparative study in high risk Patients in terms of Hypertension or Cardiac Ischemia who had perioperative supraventricular tachyarrhythmias. Patients were given either ONO-1101 at 0.125mg/kg/min * 1min loading infusion + 0.04mg/kg/min * 10min infusion(Group A) or placebo in an identical fasion(Group P) for 11min. A total of 58 (Group A: 29,Group P: 29) patients were enrolled in this study. For the full-analysis-set (FAS) analysis, 27 patients in Group A and 27 patients in Group P were valid for safety population. For the per-protocol-set(PPS) analysis, 21 patients in Group A and 20 patients in Group P were valid for efficacy population. 1)The tachycardia improvement rates were 85.7% in Group A and 10.0% in Group P. There was a significant difference between two groups (Wilcoxon test: p = 0.0001). The full-analysis-set (FAS) analysis on the tachycardia improvement rates demonstrated the same results as that of PPS analysis. 2)The safety rating "no problem in safety" was 74.1% in Group A and 85.2% in Grouop P(Wilcoxon test: p = 0.2771). Adverse effect were observed in 9 patients (33.3%) in Group A and 4 patients (14.8%) in Group P. The majority of adverse effect was hypotension in Group A which resolved after drug discontinuation or treatment with pressor agent within 30 minutes. Based on above findings, it was concluded that intravenous infusion of landiolol hydrochloride was effective useful and relatively safety for the treatment of perioperative supraventricular tachyarrhythmia in patients with hypertension or cardiac ischemia. (author abst.) |
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