Efficacy and safety of azilsartan medoxomil, an angiotensin receptor blocker, in Korean patients with essential hypertension
Abstract Background This was a phase 3, randomized, double-blind, placebo-controlled study. Methods Adult Korean patients with essential hypertension and a baseline mean sitting clinic systolic blood pressure (scSBP) ≥150 and ≤180 mmHg were randomized to 6-week treatment with placebo (n = 65), azils...
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| Format: | Article |
| Language: | English |
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BMC
2018-02-01
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| Series: | Clinical Hypertension |
| Subjects: | |
| Online Access: | http://link.springer.com/article/10.1186/s40885-018-0086-4 |
| _version_ | 1828730211522314240 |
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| author | Attila Juhasz Jingtao Wu Michie Hisada Tomoka Tsukada Myung Ho Jeong |
| author_facet | Attila Juhasz Jingtao Wu Michie Hisada Tomoka Tsukada Myung Ho Jeong |
| author_sort | Attila Juhasz |
| collection | DOAJ |
| description | Abstract Background This was a phase 3, randomized, double-blind, placebo-controlled study. Methods Adult Korean patients with essential hypertension and a baseline mean sitting clinic systolic blood pressure (scSBP) ≥150 and ≤180 mmHg were randomized to 6-week treatment with placebo (n = 65), azilsartan medoxomil (AZL-M) 40 mg (n = 132), or AZL-M 80 mg (n = 131). The primary endpoint was the change from baseline to week 6 in trough scSBP. Results The least-squares mean (standard error) change from baseline in trough scSBP in the placebo, AZL-M 40-mg, and 80-mg groups at week 6 were − 8.8 (2.00), − 22.1 (1.41), and − 23.7 (1.40) mmHg, respectively (p < 0.001 for AZL-M 40 and 80 mg vs placebo). No clinically meaningful heterogeneity in efficacy was observed between subgroups (age, sex, diabetes status) and the overall population. Treatments were well tolerated and adverse events were similar between groups. Conclusions Results of this study confirm a positive benefit-risk profile of AZL-M for essential hypertension in Korean adults. Trial registration Clinicaltrial.gov; identifier number: NCT02203916. Registered July 28, 2014 (retrospectively registered) |
| first_indexed | 2024-04-12T17:26:46Z |
| format | Article |
| id | doaj.art-d05cae802bf44f0196fca2f5c39ae42f |
| institution | Directory Open Access Journal |
| issn | 2056-5909 |
| language | English |
| last_indexed | 2024-04-12T17:26:46Z |
| publishDate | 2018-02-01 |
| publisher | BMC |
| record_format | Article |
| series | Clinical Hypertension |
| spelling | doaj.art-d05cae802bf44f0196fca2f5c39ae42f2022-12-22T03:23:17ZengBMCClinical Hypertension2056-59092018-02-0124111110.1186/s40885-018-0086-4Efficacy and safety of azilsartan medoxomil, an angiotensin receptor blocker, in Korean patients with essential hypertensionAttila Juhasz0Jingtao Wu1Michie Hisada2Tomoka Tsukada3Myung Ho Jeong4Takeda Development Center Europe, Ltd.Takeda Development Center Americas, Inc., One Takeda ParkwayTakeda Development Center Americas, Inc., One Takeda ParkwayTakeda Development Center Asia, Pte. Ltd.Department of Cardiovascular Medicine, Chonnam National University HospitalAbstract Background This was a phase 3, randomized, double-blind, placebo-controlled study. Methods Adult Korean patients with essential hypertension and a baseline mean sitting clinic systolic blood pressure (scSBP) ≥150 and ≤180 mmHg were randomized to 6-week treatment with placebo (n = 65), azilsartan medoxomil (AZL-M) 40 mg (n = 132), or AZL-M 80 mg (n = 131). The primary endpoint was the change from baseline to week 6 in trough scSBP. Results The least-squares mean (standard error) change from baseline in trough scSBP in the placebo, AZL-M 40-mg, and 80-mg groups at week 6 were − 8.8 (2.00), − 22.1 (1.41), and − 23.7 (1.40) mmHg, respectively (p < 0.001 for AZL-M 40 and 80 mg vs placebo). No clinically meaningful heterogeneity in efficacy was observed between subgroups (age, sex, diabetes status) and the overall population. Treatments were well tolerated and adverse events were similar between groups. Conclusions Results of this study confirm a positive benefit-risk profile of AZL-M for essential hypertension in Korean adults. Trial registration Clinicaltrial.gov; identifier number: NCT02203916. Registered July 28, 2014 (retrospectively registered)http://link.springer.com/article/10.1186/s40885-018-0086-4HypertensionAzilsartan medoxomilAngiotensin II receptor antagonistBlood pressureKorea |
| spellingShingle | Attila Juhasz Jingtao Wu Michie Hisada Tomoka Tsukada Myung Ho Jeong Efficacy and safety of azilsartan medoxomil, an angiotensin receptor blocker, in Korean patients with essential hypertension Clinical Hypertension Hypertension Azilsartan medoxomil Angiotensin II receptor antagonist Blood pressure Korea |
| title | Efficacy and safety of azilsartan medoxomil, an angiotensin receptor blocker, in Korean patients with essential hypertension |
| title_full | Efficacy and safety of azilsartan medoxomil, an angiotensin receptor blocker, in Korean patients with essential hypertension |
| title_fullStr | Efficacy and safety of azilsartan medoxomil, an angiotensin receptor blocker, in Korean patients with essential hypertension |
| title_full_unstemmed | Efficacy and safety of azilsartan medoxomil, an angiotensin receptor blocker, in Korean patients with essential hypertension |
| title_short | Efficacy and safety of azilsartan medoxomil, an angiotensin receptor blocker, in Korean patients with essential hypertension |
| title_sort | efficacy and safety of azilsartan medoxomil an angiotensin receptor blocker in korean patients with essential hypertension |
| topic | Hypertension Azilsartan medoxomil Angiotensin II receptor antagonist Blood pressure Korea |
| url | http://link.springer.com/article/10.1186/s40885-018-0086-4 |
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