A phase 3 double-blind randomized (CONSORT-compliant) study of azilsartan medoxomil compared to valsartan in Chinese patients with essential hypertension

Wu, Jiahui; Du, Xin; Lv, Qiang; Li, Zhanquan; Zheng, Zeqi; Xia, Yong; Tang, Chengchun; Yao, Zhuhua; Zhang, Jun; Long, Mingzhi; Hisada, Michie; Wu, Jingtao; Zhou, Wei; Ma, Changsheng

doi:10.1097/md.0000000000021465

Cited by 8 publications

(10 citation statements)

References 27 publications

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“…Ultimately, 107 articles were selected for in-depth review. Finally, 11 RCTs 11 – 21 , reporting data for 18 different regimens, were included in the final qualitative and quantitative meta-analysis. This selection process is illustrated in the PRISMA flowchart (Fig.…”

Section: Resultsmentioning

confidence: 99%

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Effect of Azilsartan on clinical blood pressure reduction compared to other angiotensin receptor blockers: a systematic review and meta-analysis

Khan,

Sharma,

Mulk

et al. 2023

Annals of Medicine &Amp; Surgery

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Background: Hypertension has significantly contributed to morbidity and mortality, necessitating effective management. Angiotensin Receptor Blockers (ARBs) have emerged as a cornerstone in hypertension treatment. Azilsartan, a relatively recent addition to the ARB family, offers unique characteristics, including prodrug activation. This systematic review and meta-analysis aimed to evaluate Azilsartan’s role in reducing clinical blood pressure compared to other ARBs and determine the most effective dosage. Methods: Following PRISMA guidelines, a comprehensive literature search was conducted in Medline, Web of Science, Cochrane Library, and clinicaltrials.gov. Eligible studies included adult hypertensive patients receiving Azilsartan compared to other ARBs, with clinical systolic and diastolic blood pressure (SBP and DBP) outcomes. Data extraction and quality assessment were performed, and statistical analysis employed Comprehensive Meta-Analysis (CMA) software. Results: Eleven randomized controlled trials encompassing eighteen studies involving 6024 patients were included. Azilsartan demonstrated significant reductions in clinical SBP (MD=-2.85 mmHg) and DBP (MD=-2.095 mmHg) compared to other ARBs. Higher doses of Azilsartan showed greater efficacy, with 80 mg exhibiting the most substantial reduction in SBP. The analysis emphasized the need for more studies investigating lower Azilsartan doses (10 and 20 mg). Conclusion: This systematic review and meta-analysis underscore Azilsartan’s effectiveness in reducing SBP and DBP. Dose-dependent effects emphasize the importance of optimal dosing when prescribing Azilsartan. These findings provide valuable insights for clinicians in managing hypertension effectively and call for further research, primarily focusing on lower Azilsartan doses and a more diverse patient population.

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Section: Resultsmentioning

confidence: 99%

“…The included studies were conducted in 4 countries. Of these studies, two had Olmesartan as a control 11 , 12 , three studies reported Valsartan 12 , 13 , 21 and Candesartan 14 , 16 , 19 as control, while four studies had Telmisartan as control 15 , 17 , 18 , 20 .…”

Section: Resultsmentioning

confidence: 99%

Effect of Azilsartan on clinical blood pressure reduction compared to other angiotensin receptor blockers: a systematic review and meta-analysis

Khan,

Sharma,

Mulk

et al. 2023

Annals of Medicine &Amp; Surgery

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“…A total of 150 cases were enrolled including 50 with ETH combined with PAF in the PAF observation group, 50 with ETH but not with PAF in the PAF control group, and 50 healthy volunteers in the healthy group. The inclusion criteria were as follows: (I) all subjects were followed up for 24 months after joining the study; (II) patients in the PAF observation group and PAF control group all met the clinical diagnosis of ETH (15,16); (III) patients in the PAF observation group were in compliance with the clinical diagnosis; (IV) after physical examination, the patients in Healthy group were completely healthy; (V) the age range was 50-65 years old. The exclusion criteria were: (I) patients with respiratory and digestive function, blood circulation and serious hematological diseases, and patients with hyperthyroidism, malignant tumors, disorders of glucose metabolism or coronary atherosclerosis, and patients with valvular diseases or other heart diseases; (II) patients who were unable to complete the study.…”

Section: Patientsmentioning

confidence: 99%

Left heart function evaluation of patients with essential hypertension and paroxysmal atrial fibrillation by two-dimensional speckle tracking imaging combined with real-time three-dimensional ultrasound imaging

et al. 2021

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Background: This study aims to assess the value of two-dimensional speckle tracking imaging (2D-STI) combined with real-time 3-dimensional echocardiography (RT-3DE) in evaluating left heart function in patients with combined ETH and PAF. Methods: A prospective study was designed, and the research period was from January 2017 to January 2020. A PAF observation group comprised of patients with ETH and PAF, a PAF control group of patients with ETH but without PAF, and a healthy volunteer group referred to as the healthy group, each comprised of 50 patients was established. All patients underwent routine ultrasound imaging examination using 2D-STI and RT-3DE. The interventricular septum thickness (IVST), left and right atrioventricular diameter (LAD), left ventricular posterior wall thickness (PWT), left ventricular ejection fraction (LVEF), the mean left atrium peak strain (mSs, mSe, mSa), strain rate (mSRs, mSRe, mSRa), the left ventricular mass (LVM), left ventricular mass index (LVMI), and left atrial total emptying volume (LATEV), the left atrial volume index (LAVI), left atrial total emptying fraction (LATEF), left atrium expansion index (LAEI), left atrium passive ejection fraction (LAPEF), and left atrial active ejection fraction (LAAEF) were calculated. Patients in the PAF observation group received telmisartan combined with rosuvastatin after diagnosis and 12-and 24-month-follow up visits were conducted. During these visits, 2D-STI combined with RT-3DE was used to evaluate cardiac function and each patient's blood pressure was monitored. Results: Patients in the PAF observation group had a significantly longer course of ETH than patients in the PAF control group (13.5±4.4 vs. 10.32±5.6, P=0.002). The comparison of routine 2D-STI and RT-3DE ultrasound indexes among the three groups also showed significant differences (P<0.01). During the 2-year follow-up period, the IVST, LAD, PWT, and LVEF of remaining patients significantly improved as treatment progressed (P<0.05). The LAVI, LATEF, and LAEI also improved significantly as the treatment progressed (P<0.05). After 12 months of treatment, the recurrence rate of atrial fibrillation was 16.33% (8/45) and after 24 months this was 34.21% (13/38).Conclusions: Cardiac function could be evaluated comprehensively by 2D-STI combined with RT-3DE in patients with ETH combined with PAF at initial diagnosis and follow-up. Ethical approvalAll procedures performed in this study involving human participants were in accordance with the Declaration of Helsinki (as revised in 2013). The study was approved by the Clinical Ethics Committee of The Central Hospital of

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“…Angiotensin type II receptor blockers (ARBs) are widely used for hypertension treatment globally, with well-established safety profiles, and are better tolerated than other classes of antihypertensive agents [ 10 , 11 ]. Especially, valsartan has been leading China's ARB market from 2011 to 2017, with high treatment adherence in patients with hypertension based on the prescription information in 2014 [ 12 , 13 ]. However, antihypertensive responses to ARBs differ from one patient to another and single nucleotide polymorphisms (SNPs) in genes involving drug-targeted receptors and drug metabolism are associated with this individual variation [ 14 ].…”

Section: Introductionmentioning

confidence: 99%

Association of AGTR1 A1166C and CYP2C9∗3 Gene Polymorphisms with the Antihypertensive Effect of Valsartan

Liu

Kong

Jiang

et al. 2022

International Journal of Hypertension

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Background. The differences in the antihypertensive treatment with angiotensin type II receptor blockers (ARBs) may be attributed to polymorphisms in genes involving drug-targeted receptor and drug metabolism. The present study aimed to investigate whether the antihypertensive effect of the ARB drug valsartan was associated with angiotensin II type 1 receptor (AGTR1) gene polymorphism (A1166 C) and cytochrome P450 enzyme 2C9 (CYP2C9) gene polymorphism (CYP2C9∗3). Methods. 281 patients with hypertension who received valsartan monotherapy in the past month were included in this retrospective study. Polymerase chain reaction-melting curve analysis was performed to genotype the AGTR1 and CYP2C9 gene polymorphisms. Based on the systolic blood pressure (SBP) and diastolic blood pressure (DBP) at the time of visit, the patients were divided into well-controlled group (n = 144, SBP/DBP <140/90 mmHg) and poorly controlled group (n = 137, SBP/DBP ≥140/90 mmHg). Results. Older age, decreased history of drinking, a higher proportion of mild-to-moderate hypertension, lower alanine aminotransferase levels, and higher high-density lipoprotein cholesterol levels were observed in the well-controlled group than the poorly controlled group. Higher frequencies of the C allele and AC + CC genotype of AGTR1 A1166C were detected in the well-controlled than the poorly controlled patients ( P = 0.005 and P = 0.006). After adjustment for demographic and environmental factors, the CC + AC genotype of AGTR1 A1166C was markedly linked to better hypertension control with valsartan treatment compared to the AA genotype (odds ratio: 2.836, 95% confidence interval: 1.199–6.705, P = 0.018). No significant difference was observed in the allele or genotype distribution of CYP2C9∗3 polymorphism between well-controlled and poorly controlled patients. Conclusions. The current data suggested that the AGTR1 A1166 C polymorphism may be associated with the antihypertensive effect of valsartan, and carriers with AC and CC genotypes may have a better antihypertensive efficacy response to valsartan treatment.

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A phase 3 double-blind randomized (CONSORT-compliant) study of azilsartan medoxomil compared to valsartan in Chinese patients with essential hypertension

Abstract: Supplemental Digital Content is available in the text

Cited by 8 publications

References 27 publications

Effect of Azilsartan on clinical blood pressure reduction compared to other angiotensin receptor blockers: a systematic review and meta-analysis

Effect of Azilsartan on clinical blood pressure reduction compared to other angiotensin receptor blockers: a systematic review and meta-analysis

Left heart function evaluation of patients with essential hypertension and paroxysmal atrial fibrillation by two-dimensional speckle tracking imaging combined with real-time three-dimensional ultrasound imaging

Association of AGTR1 A1166C and CYP2C9∗3 Gene Polymorphisms with the Antihypertensive Effect of Valsartan

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