Methods Conversion FROM Candesartan Use clinical judgement; … Compared to Other Sartans Jung Ho Heo MD, PhD Division of Cardiology ... Azilsartan and azilsartan combined with chlorthalidone were donated by Takeda Pharmaceuticals International ... Telmisartan 80% 60% 120% 100% 0% –20% 40% 20% –40% 80% 60% 120% 100% 0% … The difference in SBP and DBP between Group I (AZL) and II (Telmisartan) was statistically significant at 4 weeks (p<0.05) and was highly significant at 8 … Only one drug-related TEAE (mild decrease in blood pressure) was reported in one patient in the azilsartan group. Data Availability: This minimal data set for this study is owned by Takeda Pharmaceutical Company. Investigation, This multicenter, randomized, open-label, parallel-group exploratory study was conducted in Japan. Azilsartan medoxomil is an angiotensin receptor blocker (ARB) being developed for hypertension treatment. Yes 10.1161/01.HYP.0000123072.34629.57 The specific roles of the authors are articulated in the ‘author contribution’ section. Writing – original draft, For more information about PLOS Subject Areas, click Hypertens Res. For more information about PLOS Subject Areas, click We chose the change in HOMA-R from baseline at the end of the treatment period as the primary efficacy endpoint. Department of Endocrinology and Metabolism, Hiroshima Red Cross Hospital & Atomic-bomb Survivors Hospital, Hiroshima, Japan, Affiliation Conceptualization, MA is an employee of A2 Healthcare Corporation. We compared the efficacy, safety, and metabolic effects of AZL-M to both valsartan (VAL) and olmesartan (OLM), separately in patients with impaired … We found no clinically remarkable changes between the groups in diabetes-related variables such as fasting blood glucose, fasting insulin, HbA1c (NGSP), HOMA-β, or 1,5-anhydroglucitol. Discover a faster, simpler path to publishing in a high-quality journal. Effects of azilsartan compared with telmisartan on insulin resistance in patients with essential hypertension and type 2 diabetes mellitus: An open-label, randomized clinical trial. Azilsartan is a relatively new ARB that has considerable clinical hypotensive action compared with other ARBs [12, 13]. No, Is the Subject Area "Antihypertensive drug therapy" applicable to this article? These findings indicate that the beneficial effect of ARBs on insulin resistance in patients with hypertension and type 2 diabetes mellitus is likely affected by unknown factors. Citation: Naruse M, Koike Y, Kamei N, Sakamoto R, Yambe Y, Arimitsu M (2019) Effects of azilsartan compared with telmisartan on insulin resistance in patients with essential hypertension and type 2 diabetes mellitus: An open-label, randomized clinical trial. Mean clinic blood pressure values…. The mean (SD) treatment durations were 80.5 days (±19.37) in the azilsartan group and 87.6 days ((4.65) in the telmisartan group. Expert Opin Pharmacother 2011;12: 2719–2735. Supervision, Conclusion: The present study is aimed to explore the effect of azilsartan compared to telmisartan on insulin sensitivity in hypertensive patients in the clinical setting.METHODS: This multicenter, randomized, open-label, parallel-group exploratory study was conducted in Japan. The present study is aimed to explore the effect of azilsartan compared to telmisartan on insulin sensitivity in hypertensive patients in the clinical setting. Division of Endocrinology, Metabolism, and Hypertension, Clinical Research Institute for Endocrine and Metabolic Diseases, National Hospital Organization, Kyoto Medical Center, Kyoto, Japan, Roles Edarbi (azilsartan) lowers blood pressure, but is more expensive than other medicines that work similarly. Background: Handy reference while reading echos, especially useful for guideline-based prosthetic valve evaluation. Background Based on non-clinical data, it is expected that azilsartan, an angiotensin II receptor blocker, will help improve insulin resistance in addition to its hypotensive action. CONCLUSION:Neither azilsartan nor telmisartan had any clinically remarkable effects on insulin resistance parameters when administered for 12 weeks to patients with grade I or II essential hypertension and coexisting type 2 diabetes mellitus. Azilsartan significantly increased after patients changed from their past ARBs. Yes PLoS ONE 14(4): Results: Patients receiving AZL 40mg and telmisartan 40mg showed a significant fall (p<0.05) in systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at 4 weeks and 8 weeks, when compared to baseline. -. Clin Ther. https://doi.org/10.1371/journal.pone.0214727.t005. Effects of azilsartan compared with telmisartan on insulin resistance in patients with essential hypertension and type 2 diabetes mellitus: An open-label, randomized clinical trial. 2021 Feb;69(2):35-39. We also found no clinically remarkable effects of azilsartan or telmisartan on the other diabetes-related variables (Table 4). Fig 1. Thus, we randomly assigned 33 patients to either one of the two treatment groups (17, azilsartan group; 16, telmisartan group) and included them in the FAS and SAS populations (Fig 1). Since the incidence of cerebrovascular disease and/or ischemic heart disease increases in the concurrent presence of hypertension and type 2 diabetes mellitus, strict management of blood pressure and blood glucose levels is recommended in hypertensive patients with type 2 diabetes mellitus [1, 2]. USA.gov. The mean changes in HOMA-R at the end of treatment were 0.22 (95% CI, −1.09–1.52) in the azilsartan group and −0.23 (95% CI, −0.72–0.27) in the telmisartan group. The small sample size in this exploratory trial may also have led to false negative results. The percentages of patients with normal clinic blood pressure levels at the end of treatment (systolic blood pressure <130 mmHg and diastolic blood pressure <80 mmHg) were 31.3% (5/16) in the azilsartan group and 18.8% (3/16) in the telmisartan group (S2 Table). Clipboard, Search History, and several other advanced features are temporarily unavailable. Therefore, although we failed to obtain data indicating the clinical insulin resistance-improving effects of azilsartan and telmisartan, it is considered that the variety of the disease status, rather than the potential activity of ARBs, would affect the effect of ARBs on such patients in the clinical settings. Azilsartan medoxomil: a review of its use in hypertension. MA is an employee of A2 Healthcare Corporation. Amlodipine and telmisartan side effects. Naruse M, Koike Y, Kamei N, Sakamoto R, Yambe Y, … Japan Medical Affairs, Takeda Pharmaceutical Company Limited, Tokyo, Japan, Roles Jiang F, Chen Y, Wu L, Zhang Y, Liu J, Sun X, Li J, Mao M, Yang S. J Thorac Dis. Sitting systolic and diastolic blood pressure levels were measured at the clinic before initiating dosing at scheduled clinic visits in weeks 4, 8, and 12. The secondary efficacy endpoints were changes in the following variables: fasting blood glucose, fasting insulin, HbA1c (NGSP), HOMA-β, and 1, 5-anhydroglucitol (AG). Data Science Division, Biostatistics Department I, A2 Healthcare Corporation, Tokyo, Japan. Azilsartan Compared to ACE‐I. When efficacy was compared, it was found that azilsartan was as effective as telmisartan in reducing systolic and diastolic BP The mean (95% CI) changes from the baseline values in HOMA-R at the end of the treatment period were 0.22 (−1.09–1.52) in the azilsartan group and −0.23 (−0.72–0.27) in the telmisartan group, thus indicating that azilsartan and telmisartan did not clinically remarkably improve insulin resistance, although telmisartan showed a trend of slightly decreasing insulin sensitivity. Azilsartan (20 mg/day) and telmisartan (40 mg/day) exerted comparable antihypertensive effects. No, Is the Subject Area "Type 2 diabetes" applicable to this article? Therefore, when selecting antihypertensive agents for hypertensive patients with type 2 diabetes mellitus, not only the antihypertensive effect but also effects on insulin sensitivity, glucose metabolism, and lipid metabolism should be considered. Azilsartan and telmisartan both demonstrated favorable safety and tolerability profiles in our patient population, and we did not identify any new safety signals. We also prohibited the concomitant use of oral hypoglycemic agents other than those that had been taken at the time of obtaining informed consent. Reductions in clinic systolic and diastolic blood pressure were observed at week 4 and the reduced levels were maintained throughout the treatment period in both groups. Azilsartan medoxomil (AZL-M) is the most recently approved ARB , and has demonstrated the capacity to reduce BP to a greater extent than olmesartan, which is considered to be the most potent of the sartans used clinically [11, 12]. The registration center performed the randomization, and the related information was not disclosed to the sponsors/investigators until the end of the study. HHS We randomized adult patients (≥20 years old) with grade I or II essential hypertension and coexisting type 2 diabetes (1:1) to receive either oral azilsartan (20 mg/day;17 patients) or telmisartan (40 mg/day;16 patients) for 12 weeks. http://www.jds.or.jp/modules/en/index.php?content_id=44, Shimamoto K, Ando K, Fujita T, Hasebe N, Higaki J, Horiuchi M, et al. YK is an employee of the funder, Takeda Pharmaceutical Company Limited. No serious treatment-emergent adverse events (TEAEs) were observed. PPARγ activation is believed to promote adiponectin production by adipose cells, which in turn enhances insulin sensitivity [11]. Telmisartan alleviates collagen type III glomerulopathy: A case report with literature review. The primary endpoint was the change in the homeostasis model assessment ratio of insulin resistance (HOMA-R) from the baseline at the end of the treatment period. https://doi.org/10.1371/journal.pone.0214727.g002. Eligible patients were randomized to the azilsartan or telmisartan groups at a ratio of 1:1 considering baseline HOMA-R (<2.5 or ≥2.5) and concurrent use of biguanides (yes or no) as stratification factors. -, Benson SC, Pershadsingh HA, Ho CI, Chittiboyina A, Desai P, Pravenec M, et al. The present study is aimed to explore the effect of azilsartan compared to telmisartan on insulin sensitivity in hypertensive patients in the clinical setting. On days of scheduled site visits, we administered the study drugs after tests/examinations. NLM The articles addressed in this review have all shown that AZL is superior in lowering BP, compared to both ACE inhibitors and other ARBs 41-43, 49. Data will be freely available upon request to researchers who submit a legitimate academic research proposal for adjudication to an independent review panel (https://www.clinicalstudydatarequest.com/Default.aspx), and sign a data sharing agreement (https://clinicalstudydatarequest.com/Documents/CSDR%20multi-sponsor%20and%20single%20sponsor%20DATA%20SHARING%20AGREEMENT%20template%20%20v%204%2020%20Aug%202018.pdf). Effects of rosuvastatin combined with olmesartan, irbesartan, or telmisartan on indices of glucose metabolism in Greek adults with impaired fasting glucose, hypertension, and mixed hyperlipidemia: a 24-week, randomized, open-label, prospective study. -. -, Lim S, Eckel RH. Project administration, Abstract. here. Conceptualization, Various management guidelines recommend ARBs and ACE inhibitors as the first-line antihypertensive treatments for such patients [1, 17, 18] based on the beneficial reduction in the frequency of cardiovascular events and mortality [19] attributed to the insulin resistance-improving effects of ARBs and ACEs. Roles https://doi.org/10.1371/journal.pone.0214727.t002. It is important to strictly control blood pressure levels to prevent microvascular and macrovascular diseases in patients with hypertension coexisting with type 2 diabetes mellitus [1]. This paper presents data on the efficacy and safety of different AZL‐M doses compared with placebo and an established ARB. No, Is the Subject Area "Drug therapy" applicable to this article? Trial registration: No clinically remarkable differences were observed in the changes in HOMA-R from baseline in the subgroups with HOMA-R values of ≥2.5 and without concurrent use of biguanides. Rizos CV, Milionis HJ, Kostapanos MS, Florentin M, Kostara CE, Elisaf MS, Liberopoulos EN. The reduction in trough scDBP in Azilsartan 40 mg (p=0.9461: PP; p=0.9330: ITT) and Azilsartan 80 mg (p=0.9090: PP; p=0.9158: ITT) was not statistically significant compared to Telmisartan 40 mg. No, Is the Subject Area "Antihypertensives" applicable to this article? We assessed patients for eligibility after obtaining their informed consent. The Japanese Diabetes Society: Evidence-based practice guideline for the treatment for diabetes in Japan 2013. The Guidelines for the Management of Hypertension issued by the Japanese Society of Hypertension state that hypertension and type 2 diabetes mellitus are primary risk factors for major vascular disorders caused by endothelial dysfunction, atherothrombosis, and so on [1]. 2012 Sep 1;32(9):621-39. doi: 10.2165/11209600-000000000-00000. Neither azilsartan nor telmisartan had any clinically remarkable effects on insulin resistance parameters when administered for 12 weeks to patients with grade I or II essential hypertension and coexisting type 2 diabetes mellitus. Thus, we planned to explore the effects of azilsartan compared with telmisartan on insulin resistance by measuring the homeostasis model assessment ratio of insulin resistance (HOMA-R) and other diabetes-related variables in patients with concurrent grade I or II essential hypertension and type 2 diabetes mellitus. NK also reports a grant from Astellas as a principle investigator of a collaborative clinical study. We required participating patients using antihypertensives at the time of obtaining informed consent to undergo a two-week washout period before the start of treatment. Azilsartan is closely related to candesartan with greater potency and prolonged duration of action as compared with other ARBs. A recent phase III trial compared the efficacy of AZL-M with the ACE-inhibitor Ramipril . Epub 2020 Oct 5. Objective: Angiotensive receptor blockers (ARBs) are very potent antihypertensive agents , Telmisartan being the prototype and most widely used.This study was u EFFICACY AND SAFETY OF AZILSARTAN COMPARED WITH TELMISARTAN IN HYPERTENSIVE PATIENTS. NK reports fees for lecturing from Takeda Pharmaceutical, Astellas, MSD, Ono Pharmaceutical, Kissei Pharmaceutical, Kyowa Hakko Kirin, Kowa, Sanofi, Daiichi-Sankyo, Taisho Toyama Pharmaceutical, Sumitomo Dainippon Pharma, Mitsubishi Tanabe Pharma, Terumo, Eli Lilly Japan, Boehringer Ingelheim Japan, Novartis and Novo Nordisk Pharma. Azilsartan (20 mg/day) and telmisartan (40 mg/day) exerted comparable antihypertensive effects. Rev Endocr Metab Disord. No, Is the Subject Area "Insulin" applicable to this article? Exp Ther Med. Yes Identification of telmisartan as a unique Angiotensin II receptor antagonist with selective PPARγ-modulating activity. In rare cases, amlodipine and telmisartan can cause a condition that results in the breakdown of skeletal muscle tissue, leading to kidney failure.Call your doctor right away if you … 2014;37: 253–390. Blood pressure levels at the end of the study are derived from values calculated from blood pressure levels at the last dose in all patients receiving at least one dose of the study drugs. The present study was undertaken to evaluate the effect of azilsartan compared to telmisartan on insulin sensitivity in patients of hypertension coexisted with type 2 diabetes mellitus. This multicenter, randomized, open-label, parallel-group exploratory study was conducted at 27 centers in Japan between June 2014 and April 2016. The authors have read the journal policy and the authors of this manuscript have the following competing interests: MN, RS, and YY declare no competing interests. However, we reduced that number to 20 in each group due to the slow enrollment of patients meeting the stringent eligibility criteria and the limited study period. Azilsartan medoxomil (AZL-M) is a potent ARB for the treatment of stages 1-2 hypertension. Azilsartan is a relatively new drug, and this review aims to enlighten whether the addition to the ARB group in 2011 is worth considering. PLOS ONE promises fair, rigorous peer review, Azilsartan (20 mg/day) and telmisartan (40 mg/day) exerted comparable antihypertensive effects. Of these, 31 (15, azilsartan group; 16, telmisartan group) completed the study, and 2 in the azilsartan group prematurely discontinued the drug due to an AE and voluntary withdrawal (1 each). The changes from the baseline values in blood pressure at the end of the treatment period are summarized in Table 5. More recently, the antihypertensive efficacy of the selective angiotensin II receptor antagonists azilsartan medoxomil, valsartan, and olmesartan medoxomil were compared with placebo in randomized, parallel group, double-blind trial of 1291 patients with stages I and II hypertension. Mean changes in systolic and diastolic blood pressures for the 24-hour interval, the morning, and the daytime periods were significantly greater with telmisartan than with valsartan (p<0.01). Differential pharmacology and benefit/risk of azilsartan compared to other sartans. NIH 2021 Jan;13(1):322-333. doi: 10.21037/jtd-20-3577. NK reports fees for lecturing from Takeda Pharmaceutical, Astellas, MSD, Ono Pharmaceutical, Kissei Pharmaceutical, Kyowa Hakko Kirin, Kowa, Sanofi, Daiichi-Sankyo, Taisho Toyama Pharmaceutical, Sumitomo Dainippon Pharma, Mitsubishi Tanabe Pharma, Terumo, Eli Lilly Japan, Boehringer Ingelheim Japan, Novartis and Novo Nordisk Pharma. The incidence of all adverse events and the most common adverse events were comparable for patients receiving telmisartan and patients receiving valsartan. Clin Drug Investig. Epub 2013 Jan 10. We encountered one case of TEAE reported as a mild decrease in blood pressure in the azilsartan group, and this subject discontinued treatment at an early stage. Micardis (telmisartan) is a good blood pressure-lowering medicine that protects your kidneys and has few side effects. Conceptualization, 2020 Dec;20(6):140. doi: 10.3892/etm.2020.9269. Arao T, Okada Y, Mori H, Nishida K, Tanaka Y. Endocr J. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited. The primary objective of the present study is to explore the effects of azilsartan 20 mg, compared with telmisartan 40 mg, once daily orally for 12 weeks on insulin resistance in participants with essential hypertension complicated by type 2 diabetes mellitus. A literature review. We found no clinically remarkable changes between the groups in diabetes-related variables such as fasting blood glucose, fasting insulin, HbA1c (NGSP), HOMA-β, or 1,5-anhydroglucitol. Both azilsartan and telmisartan resulted in reductions in the clinic diastolic and systolic blood pressure levels, and some patients achieved normal blood pressure levels at the end of the treatment period. All TEAEs were mild to moderate in severity. We analyzed other efficacy endpoints using the FAS population. https://doi.org/10.1371/journal.pone.0214727.g001. No, PLOS is a nonprofit 501(c)(3) corporation, #C2354500, based in San Francisco, California, US, https://doi.org/10.1371/journal.pone.0214727, https://www.clinicalstudydatarequest.com/Default.aspx, https://clinicalstudydatarequest.com/Documents/CSDR%20multi-sponsor%20and%20single%20sponsor%20DATA%20SHARING%20AGREEMENT%20template%20%20v%204%2020%20Aug%202018.pdf, http://www.jds.or.jp/modules/en/index.php?content_id=44. The present study is aimed to explore the effect of azilsartan compared to telmisartan on insulin sensitivity in hypertensive patients in the clinical setting. Since this was an exploratory study, we did not perform statistical significance tests on each variable. For the primary endpoint, we calculated descriptive statistics of HOMA-R for each treatment group on the FAS population as the primary analysis. Azilsartan medoxomil (AZL‐M) is an investigational ARB in development for the treatment of hypertension. Yes Investigation, The clinic systolic and diastolic blood pressure values in the azilsartan and telmisartan groups decreased at comparative levels by week 4 and then remained stable at similar low levels until the end of the treatment (Fig 2). Pharmacological treatment and therapeutic perspectives of metabolic syndrome. The main limitations of this study were the open-label design, small number of enrolled patients, and relatively short treatment period. Of the 78 patients who provided informed consent, we excluded 45 who did not meet the inclusion criteria or who met the exclusion criteria (n = 42) or who withdrew voluntarily (n = 3). We analyzed the efficacy endpoints using the full analysis set (FAS), which comprised patients who were randomized and received at least one dose of the tested drugs during the study period. To compare this ARB with others in the class, we studied the effects of 2 doses of azilsartan medoxomil, with valsartan 320 mg and olmesartan medoxomil (olmesartan) 40 mg, in a randomized, double-blind, placebo-controlled trial using ambulatory blood pressure (BP) … Findings: We allowed the continuous use of other drugs used to treat concurrent diseases. Available from: Destro M, Cagnoni F, Dognini GP, Galimberti V, Taietti C, Cavalleri C., et al. We had originally planned to include 50 patients in each treatment group in consideration of feasibility, not based on a statistical rationale. In our study, we selected strict eligibility criteria to ensure a rigorous approach. 2013;60(5):563-70. doi: 10.1507/endocrj.ej12-0326. Concomitant use of drugs affecting the HOMA-R or blood pressure, including thiazolidines, insulin, GLP-1 receptor agonists, and all antihypertensives, was prohibited during the study. Patient populations were stratified by subgroups based on the baseline HOMA-R values of <2.5 or ≥2.5 and with or without concurrent use of biguanides. However, we did not allow changes in the dosage and administration of oral hypoglycemic agents from those used at the time of obtaining informed consent. Conclusion: Azilsartan is a recently approved ARB and appears to be more efficacious in reducing blood pressure (BP) than the other ARBs with a similar safety and tolerability profile. Please enable it to take advantage of the complete set of features! Moreover, we found no clinically remarkable changes from the baseline values concerning other diabetes-related variables, such as fasting blood glucose, fasting insulin, HbA1c (NGSP), HOMA-β, or 1, 5-AG, in either group. Blood pressure levels at the end of the study are derived from values calculated from blood pressure levels at the last dose in all patients receiving at least one dose of the study drugs. Fig 2. The present study is aimed to explore the effect of azilsartan compared to telmisartan on insulin sensitivity in hypertensive patients in the clinical setting. The mean difference in the changes from the baseline values in HOMA-R between the azilsartan and telmisartan groups was 0.44 (−0.89–1.78). MA is an employee of A2 Healthcare Corporation. broad scope, and wide readership – a perfect fit for your research every time. We randomized adult patients (≥20 years old) with grade I or II essential hypertension and coexisting type 2 diabetes (1:1) to receive either oral azilsartan (20 mg/day;17 patients) or telmisartan (40 mg/day;16 patients) for 12 weeks. Copyright: © 2019 Naruse et al. Yes The authors confirm that they accessed the data in the same manner. The study protocol was reviewed and approved by the Institutional Review Boards of all 27 centers, and the study was conducted in compliance with all Institutional Review Board regulations and in accordance with the principles of the Declaration of Helsinki and the Ethical Guidelines for Clinical Research (Ministry of Health, Labour, and Welfare of Japan). The mean changes in HOMA-R at the end of treatment were 0.22 (95% CI, -1.09-1.52) in the azilsartan group and -0.23 (95% CI, -0.72-0.27) in the telmisartan group. 10.1007/s11154-014-9298-4 The primary endpoint was the change in the homeostasis model assessment ratio of insulin resistance (HOMA-R) from the baseline at the end of the treatment period. Epub 2012 Feb 28. Lowers blood pressure. When compared to our analysis there was no significance observed in serum creatinine of Azilsartan group and Telmisartan group.9 Table 2 It explains the effects of Azilsartan and Telmisartan on Blood pressure, Blood glucose, Lipid profile and Serum creatinine values Such a sample will probably be feasible by easing the inclusion and exclusion criteria of patients with hypertension and coexisting type 2 diabetes, increasing the number of study centers and including patients with a high body mass index (BMI). Writing – original draft,

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