The Efficacy and Safety of Long-term Administration of CS-866 (Olmesartan Medoxomil), a novel Angiotensin II Receptor Antagonist, in the Treatment of Mild to Moderate Essential Hypertension-A Long-term Phase II Clinical Study-
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Accession number;03A0794393
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| Title;The Efficacy and Safety of Long-term Administration of CS-866 (Olmesartan Medoxomil), a novel Angiotensin II Receptor Antagonist, in the Treatment of Mild to Moderate Essential Hypertension-A Long-term Phase II Clinical Study- |
| Author;
ARAKAWA KIKUO
(Fukuoka Univ., Fac. of Med.)
SHIMAMOTO KAZUAKI
(Sapporo Medical Univ., School of Medicine, JPN)
ABE KEISHI
(Tohoku Univ., Sch. of Med.)
SARUTA TAKAO
(Sch. of Med., Keio Univ.)
ISHII MASAO
(Yokohama City Univ., School of Medicine, Hospital, JPN)
OGIHARA TOSHIO
(Osaka Univ., Med. Sch.)
HIWADA KUNIO
(Fac. Medicine, Ehime Univ., JPN)
FUJISHIMA MASATOSHI
(Kyushu Univ., Faculty of Medicine, JPN)
FUKIYAMA KOSHIRO
(Fac. Medicine, Univ. Ryukyus, JPN)
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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.19;NO.10;PAGE.1097-1130(2003)
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| Figure&Table&Reference;FIG.5, TBL.20, REF.12 |
| Pub. Country;Japan |
| Language;Japanese |
| Abstract;CS-866 (Olmesartan medoxomil), a novel angiotensin II receptor antagonist, at dosages from 5mg to 40mg was given once daily for 1 year (median: 52 days) in a sequential dose-escalating manner to outpatients with mild to moderate essential hypertension to determine the antihypertensive effects and safety of long-term administration of CS-866. This late Phase II study was conducted in patients who participated in a Phase II dose finding study and considered eligible for long-term treatment with CS-866. 1) Among 106 patients proceeded to the long-term treatment period, 2 patients were excluded from efficacy and safety analysis. Efficacy and safety of CS-866 were analyzed in the remaining 104 patients. 2) Antihypertensive effects, a major assessment item, including "unable to judge" were seen in 81.7 % after 6 months and 78.8 % after 1 year. Blood pressure control rating showed "good" or "nearly good" results in 89.4 % after 6 months and in 83.7% after 1 year. An assessment of blood pressure normalization rating including "unable to judge" gave 51.0 % after 6 months and 62.5 % after 1 year. 3) Blood pressure levels were maintained almost unchanged throughout the treatment period in the range from 5mg to 40mg, and significantly decreased at all the measurement time points in comparison with those in the baseline data (Dunnet type multiple comparison :p < 0.001). 4) Signs and symptoms confirmed as adverse events were seen in 72 (69.2%) of the 104 patients. Of these, adverse drug reactions were seen in 8 patients (7.7 %). 5) Abnormal changes in laboratory data were found in 56 patients (54.4 %) of 103 patients. Causality with the test drug could not be ruled out in 28 patients (27.2 %). 6) The overall safety rating including "unable to judge" was seen in 76.0 % after 6 months and 60.6 % after 1 year. 7) Usefulness including "unable to judge" was seen in 71.2 % after 6 months and 63.5 % after 1 year.... (author abst.) |
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