Clinical Evaluation of CS-866 (Olmesartan Medoxomil), a novel Angiotensin II Receptor Antagonist, in Patients with Mild-to-moderate Essential Hypertension-Pilot Phase II Study-
|
Accession number;03A0708404
|
| Title;Clinical Evaluation of CS-866 (Olmesartan Medoxomil), a novel Angiotensin II Receptor Antagonist, in Patients with Mild-to-moderate Essential Hypertension-Pilot Phase II Study- |
| Author;
ARAKAWA KIKUO
(Fukuoka Univ., Fac. of Med.)
ABE KEISHI
(Tohoku Univ., Sch. of Med.)
SARUTA TAKAO
(Sch. of Med., Keio Univ.)
OGIHARA TOSHIO
(Osaka Univ., Med. Sch.)
|
Journal Title;Journal of Clinical Therapeutics & Medicines
|
Journal Code:Y0906A
|
ISSN:0910-8211
|
|
VOL.19;NO.9;PAGE.983-1000(2003)
|
| Figure&Table&Reference;FIG.3, TBL.14, REF.15 |
| Pub. Country;Japan |
| Language;Japanese |
| Abstract;In order to evaluate the efficacy and safety of the new angiotensin II receptor antagonist CS-866 (olmesartan medoxomil) for the treatment of mild to moderate essential hypertension, a late Phase II pilot study was conducted. The study consisted of 43 outpatients who received CS-866 once daily in a stepwise dose-escalating regimen from 5 to 20mg for 8 weeks. 1) Blood pressure significantly decreased 2 weeks after initial administration, and remained stable thereafter. 2) Antihypertensive effects including "unable to judge" were seen in 32.6% at 5mg (40.0% if "unable to judge" were excluded), 58.1% up to 10mg (71.4%), and 72.1% up to 20mg (88.6%). 3) In the safety evaluation, subjective and objective adverse events were seen in 7 patients (16.3%). Of these, 6 cases were judged as adverse drug reactions, and the symptoms were "oppressive feeling/systemic malaise", "systemic weakness", "dizziness/malaise/drowsiness", "palpitation", "esophageal atresia", and "headache". 4) Abnormalities in laboratory parameters were seen in 6 patients (14.0%), and is comprised 1 case each of "increased CRP", "increased CPK", "increased BUN", "increased TC/BUN/uric acid" and 2 cases of "increased uric acid". 5) The overall safety rating gave results of "no problem" of 65.1% (70.0% if "unable to judge" were excluded). 6) Usefulness rating gave results of "useful" of 67.4% (72.5% if "unable to judge" were excluded). These results show that CS-866 is sufficiently effective for the treatment of mild to moderate essential hypertension, and suggest that the initial and maximal doses are 5-10mg and 20mg, respectively. (author abst.) |
|
|
|
Related Articles;
|
|
