azilsartan and Essential-Hypertension

The comparison of antihypertensive effects between azilsartan and olmesartan in patients with essential hypertension has been investigated in several studies. The results were not consistent. We performed this meta-analysis determining the antihypertensive effect of azilsartan versus olmesartan in patients with essential hypertension.. Pubmed, Web of Science, and Cochrane Central were searched for all published randomized studies comparing the antihypertensive effects between azilsartan and olmesartan in patients with essential hypertension.. The antihypertensive effects were assessed in 1402 patients included in five trials. The reduction of office systolic blood pressure treated with azilsartan was greater than olmesartan (weighted mean differences (WMD) - 2.15 (95% confidence interval (CI), - 3.78, - 0.53) mm Hg, p < 0.01). There was no significant difference in reduction of office diastolic blood pressure between azilsartan and olmesartan (WMD - 0.99 (95% CI, - 2.06, 0.08) mm Hg, p > 0.05). The reduction of office systolic blood pressure treated with azilsartan was greater than olmesartan at same dose for both drugs (WMD - 2.24 (95% CI, - 4.03, - 0.44) mm Hg, p < 0.05), whereas there was no significant difference in reduction of office diastolic blood pressure between azilsartan and olmesartan (WMD - 0.55 (95% CI, - 1.76, 0.66) mm Hg, p > 0.05).. This meta-analysis provides the evidence that the reduction of office systolic blood pressure treated with azilsartan was greater than olmesartan in patients with essential hypertension. These findings suggest the importance of strict designed randomized controlled trials in determining antihypertensive effects of angiotensin II receptor blockers in clinical practice.

Topics: Antihypertensive Agents; Benzimidazoles; Blood Pressure; Essential Hypertension; Humans; Imidazoles; Oxadiazoles; Tetrazoles

Globally, women and men over the age of 25 years suffer from hypertension, the need for new treatment strategies to treat hypertension is due to the multi-faceted nature of the disease. Lack of optimal blood pressure control can lead to multiple complications. Therefore, this phase 3 study was conducted to assess the efficacy, safety and tolerability of potential product azilsartan hydrochloride for reduction in blood pressure in Indian patients with essential hypertension.. This was a prospective, multicentre, randomized, comparative, parallel study of 303 participants over six weeks of treatment period with either azilsartan 40 mg or azilsartan 80 mg or telmisartan 40 mg in adult patients with essential hypertension. The primary endpoint was the change in mean trough sitting clinic systolic blood pressure (scSBP) from baseline to week 6. The secondary endpoints were the change in mean trough sitting clinic diastolic blood pressure (scDBP) from baseline and change in the 24-hour mean ambulatory systolic blood pressure (SBP)and diastolic blood pressure (DBP) from baseline.. The change in mean trough scSBP from baseline to week 6 was -27.2 ± 9.99, -28.2 ± 10.06 and -26.7 ± 9.72 (Per Patient (PP) Population) and -27.2 ± 9.93, -28.3 ± 10.01 and -26.7 ± 9.67 (Intent to Treat (ITT) Population) in the azilsartan 40mg, 80mg and telmisartan 40mg groups respectively. The lower limit of 95% CI of difference in change in mean systolic blood pressure was -2.35(Azilsartan 40mg) and 1.32 (Azilsartan 80mg) is less than the non-inferiority margin (i.e. 2.67). The change in mean trough scDBP from baseline to week 6 was -13.1 ± 8.46, -12.9 ± 7.20, and -13.0 ± 7.96 (PP) and -13.1 ± 8.42, -12.9 ± 7.16 and -13.0 ± 7.92 (ITT) in Azilsartna 40 mg, Azilsartan 80 mg and Telmisartan 40 mg respectively. 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. The difference in fall in the trough scSBP, scDBP and ambulatory SBP and DBP was similar between the groups from baseline to week 6 (P >0.05). Headache and dizziness were the most frequent treatmentrelated treatment-emergent adverse events.. Azilsartan is an effective blood pressure lowering drug and well tolerated and was non- inferior to telmisartan in its safety and efficacy.

Topics: Adult; Antihypertensive Agents; Benzimidazoles; Blood Pressure; Double-Blind Method; Essential Hypertension; Female; Humans; Hypertension; India; Male; Oxadiazoles; Prospective Studies; Treatment Outcome

Patients with essential hypertension who are receiving treatment with an angiotensin II receptor blocker and a calcium channel blocker often develop inadequate blood pressure (BP) control and require the addition of a diuretic. This study aimed to evaluate the long-term safety and efficacy of a triple combination therapy with 20 mg azilsartan (AZL), 5 mg amlodipine (AML) and 12.5 mg hydrochlorothiazide (HCTZ).. The phase III, open-label, multicenter study (NCT02277691) comprised a 4-week run-in period and 52-week treatment period. Patients with inadequate BP control despite AZL/AML therapy (n = 341) received 4 weeks' treatment with AZL/AML (combination tablet) + HCTZ (tablet) and 4 weeks' treatment with AZL/AML/HCTZ (combination tablet) in a crossover manner, followed by AZL/AML/HCTZ (combination tablet) from Week 8 of the treatment period up to Week 52. The primary and secondary endpoints were long-term safety and BP (office and home), respectively.. Most adverse events (AEs) were mild or moderate in intensity, and no deaths or treatment-related serious AEs were reported. The triple therapy provided consistent BP-lowering effects in both office and home measurements.. The triple combination therapy with AZL/AML/HCTZ was well tolerated and effective for 52 weeks in Japanese patients with essential hypertension.

Topics: Adult; Aged; Amlodipine; Benzimidazoles; Blood Pressure; Drug Administration Schedule; Drug Therapy, Combination; Essential Hypertension; Female; Humans; Hydrochlorothiazide; Male; Middle Aged; Oxadiazoles

The efficacy and safety of triple therapy with azilsartan (AZI), amlodipine besylate (AML), and hydrochlorothiazide (HCTZ) compared with dual therapy with AZI/AML or HCTZ monotherapy were evaluated in Japanese essential hypertensive patients in a double-blinded manner.. A total of 353 patients with office blood pressure (BP) of at least 150/95 mmHg were randomized to a 10-week treatment with AZI/AML/HCTZ 20/5/12.5 mg, AZI/AML/HCTZ 20/5/6.25 mg, AZI/AML 20/5 mg, HCTZ 12.5 mg, or HCTZ 6.25 mg.. The mean change from baseline in office diastolic/systolic BPs at week 10 was -25.9/-41.4, -24.9/-38.6, and -22.4/-34.5 mmHg in the AZI/AML/HCTZ 20/5/12.5 mg, AZI/AML/HCTZ 20/5/6.25 mg, and AZI/AML 20/5 mg groups, respectively. AZI/AML/HCTZ 20/5/12.5 mg led to a significantly greater reduction in diastolic and systolic BP than the dual therapy. In addition, the change in home diastolic BP measured with telemetry devices showed a significant difference between the two triple therapy groups. The incidences of adverse events except dizziness postural were similar among the treatment groups in the triple therapy groups.. Triple therapy with AZI/AML/HCTZ 20/5/12.5 mg shows a greater antihypertensive effect than the dual therapy and has acceptable safety profiles for Japanese essential hypertensive patients. It was also observed that home BP measurement by automated telemetry could detect changes in BP that were not detected in office BP measurement, although further investigation is needed.

Topics: Aged; Amlodipine; Antihypertensive Agents; Benzimidazoles; Blood Pressure; Double-Blind Method; Drug Therapy, Combination; Essential Hypertension; Female; Humans; Hydrochlorothiazide; Japan; Male; Middle Aged; Oxadiazoles; Treatment Outcome

Many patients still have high blood pressure (BP) after treatment with angiotensin II type 1 (AT

Topics: Aged; Angiotensin II Type 1 Receptor Blockers; Benzimidazoles; Blood Pressure; Dose-Response Relationship, Drug; Essential Hypertension; Female; Follow-Up Studies; Humans; Hypertension; Imidazoles; Male; Oxadiazoles; Prospective Studies; Tetrazoles; Time Factors; Treatment Outcome

Angiotensin II receptor blockers (ARBs) have been widely used to treat hypertension and large-scale clinical studies have shown various benefits. In this study, we compared olmesartan with azilsartan, the newest ARB.. The subjects were outpatients who were clinically stable after cardiac surgery. Sixty patients were randomized to receive either azilsartan or olmesartan for 1 year and were switched to the other drug for the following 1 year. The primary endpoints were the levels of plasma renin activity, angiotensin II, and aldosterone.. Home blood pressure exceeded 140/90 mmHg and additional antihypertensive medication was administered to 12 patients (20 episodes) in the azilsartan group versus 4 patients (4 episodes) in the olmesartan group, with the number being significantly higher in the azilsartan group. After 1 year of treatment, both angiotensin II and aldosterone levels were significantly lower in the olmesartan group than the azilsartan group. Left ventricular mass index was also significantly lower in the olmesartan group than the azilsartan group.. This study showed that olmesartan reduces angiotensin II and aldosterone levels more effectively than azilsartan. Accordingly, it may be effective in patients with increased renin-angiotensin-aldosterone system activity after cardiac surgery or patients with severe cardiac hypertrophy.

Topics: Aged; Aldosterone; Angiotensin II; Angiotensin II Type 1 Receptor Blockers; Antihypertensive Agents; Benzimidazoles; Biomarkers; Blood Pressure; Cardiac Surgical Procedures; Drug Substitution; Essential Hypertension; Female; Humans; Hypertension; Hypertrophy, Left Ventricular; Imidazoles; Japan; Male; Middle Aged; Oxadiazoles; Prospective Studies; Renin; Renin-Angiotensin System; Tetrazoles; Time Factors; Treatment Outcome; Ventricular Remodeling

Guidelines for the management of hypertension recommend using drugs with different mechanisms of action in antihypertensive regimens that include simple single-pill fixed-dose combination (FDC) products.. The objective of this study was to compare the efficacy and tolerability of the FDC of azilsartan (AZI) and amlodipine besylate (AML) with those of AZI monotherapy and AML monotherapy in Japanese patients with grade 1 to 2 essential hypertension.. This was a multicenter, randomized, double-blind, parallel-group study. After receiving placebo during a 4-week run-in period in a single-blind manner, patients were randomized to receive 1 of the following 5 treatments for 8 weeks: FDC containing AZI 20 mg and AML 5 mg (AZI/AML 20/5 mg), FDC containing AZI 20 mg and AML 2.5 mg (AZI/AML 20/2.5 mg), AZI 20 mg, AML 5 mg, or AML 2.5 mg once daily in a fasting or fed state. The primary end point was the change from baseline (week 0) in the seated trough diastolic blood pressure at week 8 (last observation carried forward [LOCF]), and the secondary end point was the change from baseline in the seated trough systolic blood pressure at week 8 (LOCF). Tolerability was assessed based on adverse events, vital signs, and physical examination findings.. Of the 800 patients who provided informed consent, 603 were randomized to receive AZI/AML 20/5 mg (150 patients), AZI/AML 20/2.5 mg (151 patients), AZI 20 mg (151 patients), AML 5 mg (75 patients), or AML 2.5 mg (76 patients). The mean baseline systolic/diastolic blood pressure was 160.7/100.3 mm Hg. The mean change from baseline in seated blood pressure at week 8 (LOCF) was -35.3/-22.3 mm Hg in the AZI/AML 20/5 mg group and -31.4/-19.2 mm Hg in the AZI/AML 20/2.5 mg group, indicating a reduction significantly greater than that in corresponding monotherapy groups (-21.5/-13.9 mm Hg in the AZI 20 mg group, -26.4/-15.5 mm Hg in the AML 5 mg group, and -19.3/-11.6 mm Hg in the AML 2.5 mg group; p < 0.0001 for all contrast tests). No remarkable difference was found in the incidences of adverse events, vital signs, and physical examination findings among the treatment groups.. This study found that the FDC of AZI/AML 20/5 mg and 20/2.5 mg exhibited greater antihypertensive effects compared with each monotherapy. The FDC of AZI/AML had a similar safety profile to that of each monotherapy and was tolerable to Japanese patients with grade 1 to 2 essential hypertension.. Japic CTI-111606.

Topics: Aged; Amlodipine; Antihypertensive Agents; Asian People; Benzimidazoles; Dose-Response Relationship, Drug; Double-Blind Method; Drug Therapy, Combination; Essential Hypertension; Humans; Hypertension; Male; Middle Aged; Oxadiazoles

Morning blood pressure (BP) surge is reported as a risk factor for cardiovascular events and end-organ damage independent of the 24-h BP level. Controlling morning BP surge is therefore important to help prevent onset of cardiovascular disease. We compared the efficacy of azilsartan and candesartan in controlling morning systolic BP (SBP) surges by analyzing relevant ambulatory BP monitoring data in patients with/without baseline BP surges. As part of a 16-week randomized, double-blind study of azilsartan (20-40 mg once daily) and candesartan (8-12 mg once daily) in Japanese patients with essential hypertension, an exploratory analysis was carried out using ambulatory BP monitoring at baseline and week 14. The effects of study drugs on morning BP surges, including sleep trough surge (early morning SBP minus the lowest night-time SBP) and prewaking surge (early morning SBP minus SBP before awakening), were evaluated. Patients with sleep trough surge of at least 35 mmHg were defined by the presence of a morning BP surge (the 'surge group'). Sleep trough surge and prewaking surge data were available at both baseline and week 14 in 548 patients, 147 of whom (azilsartan 76; candesartan 71) had a baseline morning BP surge. In surge group patients, azilsartan significantly reduced both the sleep trough surge and the prewaking surge at week 14 compared with candesartan (least squares means of the between-group differences -5.8 mmHg, P=0.0395; and -5.7 mmHg, P=0.0228, respectively). Once-daily azilsartan improved sleep trough surge and prewaking surge to a greater extent than candesartan in Japanese patients with grade I-II essential hypertension.

Topics: Aged; Antihypertensive Agents; Asian People; Benzimidazoles; Biphenyl Compounds; Blood Pressure; Double-Blind Method; Essential Hypertension; Female; Humans; Hypertension; Japan; Male; Middle Aged; Oxadiazoles; Tetrazoles