OBJECTIVE: The EXforge Clinical evaluation of amlodlpine and valsarTan in hypErtension (EXCITE) study was designed to evaluate the real-world effectiveness and safety of amlodipine/valsartan (Aml/Val) and amlodipine/valsartan/hydrochlorothiazide (Aml/Val/HCT) single-pill combination (SPC) in patients with hypertension.
METHODOLOGY: This 26-week observational, multicenter, prospective, open-label study included patients aged ? 18 years of age with established diagnosis of hypertension. The change in mean sitting systolic BP (msSBP), diastolic BP (msDBP) from baseline to Week 26, proportion of patients achieving BP goal (msSBP/msDBP <130/80 mmHg and <140/90 mmHg for patients with and without diabetes,respectively) at endpoint, and safety were monitored. Here, we report the data of patients from the Philippines.
RESULTS: Of the total 1,054 patients in the full analysis set (Aml/Val, n=928; Aml/Val/HCTZ, n=126), 923 (87.6%) patients completed the study. The baseline BP was 158.5/96.5 and 167.0/99.5 mmHg in the Aml/Val and Aml/Val/HCTZ groups,respectively. Significant reductions in msSBP and msDBP from baseline to week 26 were observed with both Aml/Val (-31.9/-19.2 mmHg). Adverse events were reported by 8.8% of the patients.
CONCLUSION: The Aml/Val and Aml/Val/HCTZ SPCs were effective in controlling BP and were generally well tolerated in patients with hypertension from the Philippines.

Human ; Male ; Female ; Middle Aged ; Adult ; Young Adult ; Amlodipine ; Amlodipine, Valsartan Drug Combination ; Diabetes Mellitus ; Hydrochlorothiazide ; Hypertension ; Philippines ; Tetrazoles ; Valine ; Valsartan

OBJECTIVETo compare the effects of valsartan combined with amlodipine or hydrochlorothiazide regimen on blood pressure variation and plasma nitric oxide (NO) and endothelin (ET) in elderly hypertensive patients.

METHODSA total of 61 elderly patients with grade 2 or 3 hypertension were randomized into valsartan + amlodipine (the amlodipine group, n = 31) or valsartan + hydrochlorothiazide (the hydrochlorothiazide group, n = 30) group. Blood lipids, fasting plasma glucose and uric acid were determined before the treatment. 24-hour dynamic blood pressure, NO and ET were monitored at baseline, 8 and 16 weeks after treatment.

RESULTS24 hours blood pressure and daytime blood pressure were similar between two groups at all 3 time points. At 16 weeks, morning systolic blood pressure surge was significantly lower in amlodipine group than in hydrochlorothiazide group [(22.6 ± 8.8) mm Hg (1 mm Hg = 0.133 kPa) vs. (26.3 ± 13.7) mm Hg, P < 0.05]. 24 hours systolic blood pressure variability (SBPV) decreased progressively in both groups [the amlodipine group: (12.5 ± 2.8) mm Hg vs. (10.2 ± 2.2) mm Hg vs. (8.8 ± 1.6) mm Hg, P < 0.01; the hydrochlorothiazide group: (12.5 ± 2.5) mm Hg vs. (10.7 ± 2.2) mm Hg vs. (9.6 ± 2.0) mm Hg, P < 0.01]. Daytime SBPV also decreased progressively in both groups [the amlodipine group: (12.2 ± 3.0) mm Hg vs. (10.1 ± 2.3) mm Hg vs. (8.4 ± 1.9) mm Hg, P < 0.01; the hydrochlorothiazide group: (11.8 ± 2.7) mm Hg vs. (10.4 ± 1.9) mm Hg vs. (9.6 ± 2.2) mm Hg, P < 0.01]. 24 hours diastolic blood pressure variability (DBPV) was significantly reduced post therapy in the amlodipine group [(15.5 ± 3.4) mm Hg vs. (13.0 ± 3.5) mm Hg vs. (12.3 ± 2.5), P < 0.01] but not in the hydrochlorothiazide group. NO increased progressively [(27.3 ± 13.6) µmol/L vs. (47.2 ± 16.3) µmol/L vs. (69.5 ± 18.9) µmol/L in the amlodipine group, P < 0.01; (33.5 ± 13.9) µmol/L vs. (49.7 ± 21.9) µmol/L vs. (66.7 ± 24.7) µmol/L in the hydrochlorothiazide group, P < 0.01] and ET decreased progressively [(45.3 ± 8.0) ng/L vs. (37.4 ± 3.9) ng/L vs. (34.2 ± 4.4) ng/L in the amlodipine group, P < 0.01; (46.6 ± 10.4) ng/L vs. (37.0 ± 5.4) ng/L vs. (36.1 ± 8.2) ng/L in the hydrochlorothiazide group, P < 0.01] in both groups.

CONCLUSIONValsartan in combination with amlodipine or hydrochlorothiazide can both effectively lower BPV in elderly hypertensive patients and improve the vascular endothelial function and the former regimen is more suitable for elderly hypertensive patients.

Aged ; Amlodipine ; therapeutic use ; Blood Pressure ; drug effects ; Drug Therapy, Combination ; Female ; Humans ; Hydrochlorothiazide ; therapeutic use ; Hypertension ; drug therapy ; physiopathology ; Male ; Middle Aged ; Tetrazoles ; therapeutic use ; Treatment Outcome ; Valine ; analogs & derivatives ; therapeutic use ; Valsartan

OBJECTIVETo evaluate the efficacy and safety of a once daily valsartan/amlodipine 80/5 mg combination tablet in Chinese mild to moderate hypertensive patients without adequate blood pressure control by monotherapy.

METHODSTwo multicenter, randomized, double-blind, double dummy, active-controlled, parallel group trials were conducted. After a washout period (no medication) of 1-4 weeks, patients with Mean Sitting Diastolic Blood Pressure (MSDBP) > or = 95 mm Hg (1 mm Hg = 0.133 kPa) and < 110 mm Hg received a monotherapy of either Amlodipine 5 mg (in study 1) or valsartan 80 mg (in study 2) for 4 weeks. Patients with MSDBP > or = 90 mm Hg and < 110 mm Hg at the end of the monotherapy period were randomized to receive valsartan/amlodipine 80/5 mg treatment, or continue with the monotherapy.

RESULTSIn study 1, compared with amlodipine 5 mg, valsartan/amlodipine 80/5 mg once daily further reduced mean sitting systolic blood pressure (MSSBP)/MSDBP 4.4/3 mm Hg (P < 0.0001). In study 2, compared with valsartan 80 mg, valsartan/amlodipine 80/5 mg once daily further reduced MSSBP/MSDBP 6.4/4.2 mm Hg (P < 0.0001). The blood pressure (BP) control rates (BP < 140/90 mm Hg) of combination treatment group were 71.0% and 71.2% respectively, and significantly higher than the monotherapy groups in both trials. Incidence of adverse events was comparable in monotherapy and combination therapy groups.

CONCLUSIONOur results showed that valsartan/amlodipine 80/5 mg was superior to amlodipine 5 mg or valsartan 80 mg alone in lowering blood pressure and BP control in patients with mild to moderate hypertension not adequately controlled with amlodipine 5 mg or valsartan 80 mg monotherapy. No new or unexpected safety issues were identified with valsartan/amlodipine combination therapy compared with monotherapy.

Adult ; Amlodipine ; administration & dosage ; Antihypertensive Agents ; administration & dosage ; Blood Pressure ; Double-Blind Method ; Drug Therapy, Combination ; Female ; Humans ; Hypertension ; drug therapy ; Male ; Middle Aged ; Tetrazoles ; administration & dosage ; Valine ; administration & dosage ; analogs & derivatives ; Valsartan

No abstract available.
Percutaneous Coronary Intervention ; Tetrazoles ; Valine ; Ventricular Function, Left ; Valsartan

BACKGROUND AND OBJECTIVES: Angiotensin-receptor blockers (ARBs) have beneficial effects on cardiovascular, metabolic, and inflammatory parameters in addition to controlling blood pressure (BP). However, few comparative clinical studies have been conducted with different ARBs. We compared these effects in patients with uncomplicated hypertension who were receiving telmisartan or valsartan. SUBJECTS AND METHODS: The subjects were patients with essential hypertension (48.4+/-9.6 years) who were randomly assigned to take either telmisartan (80 mg/day, n=30) or valsartan (160 mg/day, n=30) for 12 weeks. Their anthropometric, laboratory, vascular, and echocardiographic data were measured at baseline and at the end of the study. RESULTS: Baseline characteristics were not significantly different between the two groups, except for the carotid-femoral pulse wave velocity (cfPWV; telmisartan group vs. valsartan group; 841.2+/-131.0 vs. 761.1+/-104.4 cm/s, p<0.05). After 12 weeks, BP had fallen to a similar extent with mean reductions in the systolic and diastolic BP of 20.7+/-18.1 and 16.3+/-13.0 mm Hg (p<0.001, respectively) for the telmisartan and 22.5+/-17.0 and 16.8+/-9.3 mm Hg (p<0.001, respectively) for the valsartan group. Although the cfPWV and left ventricular mass index (LVMI) fell significantly only with the administration of telmisartan, they were not significantly different when baseline cfPWV was considered. The differences in the cfPWV and LVMI changes from baseline between the two groups were also not significant after adjusting for baseline cfPWV. No significant changes in other vascular, metabolic, or inflammatory parameters were observed with either treatment. CONCLUSION: The effects of a 12-week treatment with the two ARBs, telmisartan and valsartan, on cardiovascular, metabolic, and inflammatory parameters were not different in patients with uncomplicated hypertension.
Benzimidazoles ; Benzoates ; Blood Pressure ; Humans ; Hypertension ; Pulse Wave Analysis ; Tetrazoles ; Valine ; Valsartan

BACKGROUND: Valsartan is an angiotensin II receptor blocker and is used for patient with hypertension. Although response to valsartan varies each individual, there is no study about factors affecting the variability of valsartan response. METHODS: To investigate the effects of valsartan on the baseline characteristics of blood pressure, single group, open label, pre- and post-comparison clinical study was conducted. Total 21 male Korean volunteers were enrolled. Each subject was administered no drugs in first period and valsartan 80 mg (Diovan HCT) in second period. For pharmacodynamic analysis, 24 hours blood pressure changes were monitored by ambulatory blood pressure monitoring. Twenty-four hour blood pressure changes were matched to valsartan concentration and analyzed by correlation analysis. Changes in blood pressure pattern were also analyzed. Subjects were divided into responder, non-responder, and reverse responder according to pre- and post- 24 hours blood monitoring results. For determination of pharmacokinetic parameters, plasma concentration of valsartan was measured by a validated ultra-performance liquid chromatography-tandem mass spectrometry method. Pharmacokinetic parameters including area under the plasma concentration versus time curve from 0 hour to the last measurable concentration (AUCt), area under the plasma concentration versus time curve extrapolated to infinity, maximum plasma concentration (Cmax), and time required to reach maximum plasma concentration (Tmax) were calculated by noncompartmental models in the BA-CALC 2008 program ver. 1.0.0. RESULTS: There were no significant associations between blood pressure changes and pharmacokinetic parameters of valsartan. Blood pressure pattern change analysis showed significant results. For AUCt, total amount of absorbed valsartan was 25,808 +/- 6,863.0 ng.hr/mL, 20,683 +/- 8,782.7 ng.hr/mL, and 12,502 +/- 5,566.6 ng.hr/mL in responder, non-responder, and reverse responder, respectively (p = 0.041). In C max, maximum concentration of valsartan was 4,314 +/- 1,522.6 ng/mL, 2,588 +/- 1,273.9 ng/mL, and 2,056 +/- 1,075.5 ng/mL, respectively. CONCLUSIONS: These results showed that response to valsartan was not associated with blood concentration in healthy volunteers and changes in blood pressure patterns to valsartan might be associated with the amount of drugs which are absorbed to subjects.
Blood Pressure ; Blood Pressure Monitoring, Ambulatory ; Humans ; Hypertension ; Male ; Mass Spectrometry ; Plasma ; Receptors, Angiotensin ; Tetrazoles ; Valine ; Valsartan

BACKGROUND: Activation of renin-angiotensin system (RAS) has been an important mechanism of microvascular and macrovascular complications in diabetic patients. It has been reported that RAS blockades reduce the development and progression of diabetic nephropathy. The aim of this study was to evaluate whether valsartan, an angiotensin II receptor blocker (ARB), reduced blood pressure and urinary albumin excretion rate (UAER) in hypertensive type 2 diabetic patients. METHOD: Three hundred forty-seven hypertensive type 2 diabetic patients who had not taken angiotensin converting enzyme inhibitors or ARB for 6 months prior to this study were enrolled. We measured blood pressure and UAER before and after 24 weeks of valsartan treatment. RESULT: Baseline mean systolic and diastolic blood pressure was 143 +/- 15 and 87 +/- 11 mmHg, respectively and the median albumin excretion rate was 27 ug/mg. Reduction in systolic and diastolic blood pressure was 16 mmHg/10 mmHg and the median UAER was 19.3 ug/mg after 24 weeks (P < 0.01, respectively). When we divided the subjects into three groups according to the UAER (normoalbuminuria, microalbuminuria and macroalbuminuria), significant changes were reported in the microalbuminuria and the macroalbuminuria groups. Thirty-eight (42%) patients with microalbuminuria improved to normoalbuminuria and twelve (41%) patients with macroalbuminuria improved to microalbuminuria. We found an association between the improvement of blood pressure and UAER (R = 0.165, P = 0.015). CONCLUSION: We concluded that valsartan reduces urinary albumin excretion and blood pressure in hypertensive type 2 diabetic patients.
Angiotensin-Converting Enzyme Inhibitors ; Angiotensins ; Blood Pressure ; Diabetes Mellitus ; Diabetic Nephropathies ; Humans ; Receptors, Angiotensin ; Renin-Angiotensin System ; Tetrazoles ; Valine ; Valsartan

BACKGROUND: The aim of this study was to evaluate the mid-term changes in cardiac function by transthoracic echocardiogram (TTE) in patients with ST-segment elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention (PCI) according to valsartan dose. METHODS: Between April 2006 and February 2009, 78 subjects (mean age: 57 +/- 12 years, M : F = 74 : 4) with STEMI who underwent primary PCI were enrolled. Fifty three patients received low dose valsartan (40 or 80 mg) and 25 patients received high dose valsartan (160 or 320 mg). Follow-up TTE was done approximately 2 years later. We evaluated the changes in left ventricular (LV) function between initial and final TTE after primary PCI and compared the changes between low and high dose valsartan group. RESULTS: The mean follow-up TTE duration was 24 +/- 8 months. Deceleration time (188.6 +/- 56.3 msec vs. 221.5 +/- 71.3 msec, p = 0.01), E/e' (12.24 +/- 5.2 vs. 10.1 +/- 4.9, p = 0.002), ejection fraction (52.7 +/- 8% vs. 55.2 +/- 8.4%, p < 0.01), and wall motion score index (1.45 +/- 0.30 vs. 1.33 +/- 0.32, p < 0.01) showed significant changes during the follow-up period. Wall motion improvement in injured myocardial segments was more frequently observed in the high-dose valsartan group compared to the low-dose group [18/25 (72%) vs. 24/53 (43.7%), p = 0.03]. There was no significant difference in the changes in cardiac dimensions and function between the low and high dose valsartan group. CONCLUSION: In patients with STEMI who undergoing primary PCI, high-dose valsartan treatment may be more helpful than low-dose in improving wall motion in the injured myocardium.
Angioplasty, Balloon, Coronary ; Angiotensin II Type 1 Receptor Blockers ; Deceleration ; Echocardiography ; Follow-Up Studies ; Humans ; Myocardial Infarction ; Myocardium ; Percutaneous Coronary Intervention ; Tetrazoles ; Valine ; Valsartan

BACKGROUND AND OBJECTIVES: Angiotensin II receptor blocker (ARB) has emerged as an alternative to angiotensin converting enzyme inhibitor (ACEI) for the treatment of heart failure. This study aimed at comparing the effectiveness and safety of valsartan with ramipril in patients with heart failure, and these patients were hospitalized at Chonnam National University Hospital, Wonkwang University Hospital, Gunsan Medical Center, Presbyterian Medical Center, Seonam University Hospital and Gwangju Christian Hospital. SUBJECTS AND METHODS: Between March 2005 and March 2007, 82 patients (60.5+/-12.4 years, 59 males) who complained of class II to IV dyspnea, according to the New York Heart Association (NYHA) classification, and who had low left ventricular ejection fraction (LVEF) less than 50% were randomly allocated to valsartan or ramipril. After 6 months, the clinical symptoms, vital signs, biochemical tests and echocardiography were compared between the two groups. RESULTS: The NYHA class was improved in both groups (the valsartan group: 2.31+/-0.51 vs. 1.46+/-0.58, p<0.001; the ramipril group: 2.21+/-0.55 vs. 1.61+/-0.50, p<0.001). The incidence of cough, as measured by the cough index, was significantly lower in the valsartan group than in the ramipril group (p=0.045). The LVEF was improved in both groups (the valsartan group: 36.4+/-8.5% vs. 46.9+/-12.9%, p<0.001; the ramipril group: 35.1+/-8.5% vs. 45.3+/-11.2%, p<0.001). The improvements of the left ventricular end-systolic dimension (p=0.754) and end-diastolic dimension (p=0.998) were not different between the two groups. N-terminal Pro-B-type natriuretic peptide level was improved in both groups (the valsartan group: 2619.6+/-4213.5 vs. 995.4+/-2186.0 pg/mL, p=0.012; the ramipril group: 3267.9+/-4320.0 vs. 828.1+/-1232.8 pg/mL, p=0.009), and there was no difference between the groups (p=0.877). CONCLUSION: Both valsartan and ramipril were effective treatments, with relatively low adverse events, in patients with heart failure.
Angiotensins ; Cough ; Dyspnea ; Echocardiography ; Heart ; Heart Failure ; Humans ; Incidence ; New York ; Peptidyl-Dipeptidase A ; Protestantism ; Ramipril ; Receptors, Angiotensin ; Stroke Volume ; Tetrazoles ; Valine ; Ventricular Remodeling ; Vital Signs ; Valsartan

Angiotensin II Type 1 Receptor Blockers ; pharmacology ; Animals ; Cell Proliferation ; drug effects ; Cells, Cultured ; Collagen Type I ; biosynthesis ; Hepatocytes ; cytology ; metabolism ; Tetrazoles ; pharmacology ; Valine ; analogs & derivatives ; pharmacology ; Valsartan