Document Detail

Comparison of the efficacy and safety of azilsartan with that of candesartan cilexetil in Japanese patients with grade I-II essential hypertension: a randomized, double-blind clinical study.
MedLine Citation:
PMID:  22278628     Owner:  NLM     Status:  MEDLINE    
Azilsartan is a novel angiotensin receptor blocker being developed for hypertension treatment. This 16-week, multicenter, randomized, double-blind study compared the efficacy and safety of azilsartan (20-40 mg once daily by forced titration) and its ability to provide 24-h blood pressure (BP) control, with that of candesartan cilexetil (candesartan; 8-12 mg once daily by forced titration) in 622 Japanese patients with grade I-II essential hypertension. Efficacy was evaluated by clinic-measured sitting BP, and by ambulatory BP monitoring (ABPM) at week 14. Participants (mean age: 57 years, 61% males) had a mean baseline sitting BP of 159.8/100.4 mm Hg. The mean change from baseline in sitting diastolic BP at week 16 (primary endpoint) was -12.4 mm Hg in the azilsartan group and -9.8 mm Hg in the candesartan group, demonstrating a statistically significant greater reduction with azilsartan vs. candesartan (difference: -2.6 mm Hg, 95% confidence interval (CI): -4.08 to -1.22 mm Hg, P=0.0003). The week 16 (secondary endpoint) mean change from baseline in sitting systolic BP was -21.8 mm Hg and -17.5 mm Hg, respectively, a significant decrease with azilsartan vs. candesartan (difference: -4.4 mm Hg, 95% CI: -6.53 to -2.20 mm Hg, P<0.0001). On ABPM, the week 14 mean changes from baseline in diastolic and systolic BP were also significantly greater with azilsartan over a 24-h period, and during the daytime, night-time and early morning. Safety and tolerability were similar among the two groups. These data demonstrate that once-daily azilsartan provides a more potent 24-h sustained antihypertensive effect than that of candesartan but with equivalent safety.
Hiromi Rakugi; Kazuaki Enya; Kenkichi Sugiura; Yoshinori Ikeda
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Publication Detail:
Type:  Comparative Study; Journal Article; Randomized Controlled Trial; Research Support, Non-U.S. Gov't     Date:  2012-01-26
Journal Detail:
Title:  Hypertension research : official journal of the Japanese Society of Hypertension     Volume:  35     ISSN:  1348-4214     ISO Abbreviation:  Hypertens. Res.     Publication Date:  2012 May 
Date Detail:
Created Date:  2012-05-07     Completed Date:  2012-09-11     Revised Date:  2013-06-26    
Medline Journal Info:
Nlm Unique ID:  9307690     Medline TA:  Hypertens Res     Country:  England    
Other Details:
Languages:  eng     Pagination:  552-8     Citation Subset:  IM    
Department of Geriatric Medicine and Nephrology, Osaka University Graduate School of Medicine, Osaka, Japan.
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MeSH Terms
Angiotensin Receptor Antagonists / adverse effects,  therapeutic use*
Antihypertensive Agents / adverse effects,  therapeutic use*
Asian Continental Ancestry Group
Benzimidazoles / adverse effects,  therapeutic use*
Biphenyl Compounds / adverse effects,  therapeutic use*
Double-Blind Method
Hypertension / drug therapy*
Middle Aged
Oxadiazoles / adverse effects,  therapeutic use*
Severity of Illness Index
Tetrazoles / adverse effects,  therapeutic use*
Reg. No./Substance:
0/Angiotensin Receptor Antagonists; 0/Antihypertensive Agents; 0/Benzimidazoles; 0/Biphenyl Compounds; 0/Oxadiazoles; 0/Tetrazoles; F9NUX55P23/azilsartan; R85M2X0D68/candesartan cilexetil

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