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

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

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 AND OBJECTIVES: We compared the efficacy and safety of valsartan and rosuvastatin combination therapy with each treatment alone in hypercholesterolemic hypertensive patients. SUBJECTS AND METHODS: Patients who met inclusion criteria were randomized to receive 1 of the following 2-month drug regimens: valsartan 160 mg plus rosuvastatin 20 mg, valsartan 160 mg plus placebo, or rosuvastatin 20 mg plus placebo. The primary efficacy variables were change in sitting diastolic blood pressure (sitDBP) and sitting systolic blood pressure (sitSBP), and percentage change in low-density lipoprotein-cholesterol (LDL-C) in the combination, valsartan, and rosuvastatin groups. Adverse events (AEs) during the study were analyzed. RESULTS: A total of 354 patients were screened and 123 of them were finally randomized. Changes of sitDBP by least squares mean (LSM) were -11.1, -7.2, and -3.6 mm Hg, respectively, and was greater in the combination, as compared to both valsartan (p=0.02) and rosuvastatin (p<0.001). Changes of sitSBP by LSM were -13.2, -10.8, and -4.9 mm Hg, and was greater in the combination, as compared to rosuvastatin (p=0.006) and not valsartan (p=0.42). Percentage changes of LDL-C by LSM were -52, -4, and -47% in each group, and was greater in the combination, as compared to valsartan (p<0.001), similar to rosuvastatin (p=0.16). Most AEs were mild and resolved by the end of the study. CONCLUSION: Combination treatment with valsartan and rosuvastatin exhibited an additive blood pressure-lowering effect with acceptable tolerability, as compared to valsartan monotherapy. Its lipid lowering effect was similar to rosuvatatin monotherapy.
Blood Pressure ; Drug Therapy, Combination ; Humans ; Least-Squares Analysis ; Rosuvastatin Calcium ; Valsartan

BACKGROUND: Sacubitril/valsartan is currently a standard medication in the treatment of reduced ejection fraction heart failure (HFrEF), and studies have also shown its efficacy for controlling hypertension. However, its efficacy varies between populations, and current recommendations are predominantly based on non Asian data. Hence, this study synthesizes the available evidence to determine its overall efficacy and safety among Asians. METHODS: A systematic search through PubMed, ScienceDirect, Cochrane, HERDIN PLUS, and ClinicalTrials.gov was done to include randomized controlled trials with Asian data comparing sacubitril/valsartan against an active control. The Cochrane Risk of Bias 2.0 was used to assess each article for bias. Forest plots in fixed-effects model for major adverse cardiovascular events (MACEs), hypertension control, and safety were created using RevMan 5.4. RESULTS AND DISCUSSION: Ten articles with an overall low risk of bias were included involving 6120 Asians. Sacubitril/valsartan showed better hypertension control against conventional angiotensin blocker (odds ratio [OR], 1.63; confidence interval [CI], 1.38–1.92; I2 = 7%). However, MACE reduction was not significant in HFrEF (hazard ratio, 0.89; CI, 0.73–1.08; I2 = 0%) or acute myocardial infarction (hazard ratio, 0.90; CI, 0.65–1.24; I2 = 0%). Safety was comparable to conventional angiotensin-converting enzyme inhibitors angiotensin receptor blocker (ARB) with a severe adverse event OR of 0.81 (CI, 0.44–1.50; I2 = 38%) and nonsevere adverse event OR of 1.09 (CI, 0.88–1.35; I2 = 44%). These results implicate the nee for efficacy studies focused on Asians, reassessment of the strength of recommendations in the treatment of heart failure, and consideration of sacubitril/valsartan as a treatment option for hypertension. CONCLUSION Among Asians, better hypertension control is seen with LCZ696 than conventional ARB. However, MACE reduction in HFrEF or acute myocardial infarction is insignificant, although there is a trend toward benefit. Finally, safety is comparable to conventional angiotensin-converting enzyme inhibitors/ARBs.\.
Asian ; Heart Failure ; Hypertension ; LCZ696 ; sacubitril and valsartan sodium hydrate drug combination

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: To compare the parameters of local carotid stiffness with those of global arterial stiffness and to investigate the effects of angiotensin II receptor blocker (ARB) on the parameters of local carotid arterial stiffness as well as global arterial stiffness. METHODS: The correlations of the parameters between local carotid and global arterial stiffness were compared at baseline, and the changes of these parameters were evaluated after 6 months of valsartan therapy in 50 patients with newly diagnosed hypertension. Diameter change, strain, and 2-dimensional circumferential strain (2D CS) of the carotid artery measured by speckle tracking method were used as parameters of local arterial stiffness, and the parameters of pulse wave velocity (PWV) and pulse wave analysis (PWA) were used as standard parameters of global arterial stiffness. RESULTS: Carotid 2D CS, not conventional strain or diameter change, showed significant correlation with age (r = -0.592, p < 0.01), brachial-ankle PWV (r = -0.338, p < 0.05), and augmentation index (r = -0.298, p < 0.05). After 6 months of medical therapy, systolic blood pressure (SBP) and diastolic blood pressure (DBP) were decreased significantly (SBP: 155.9 +/- 14.2 to 137.6 +/- 10.5 mm Hg, p < 0.01; DBP: 90.1 +/- 11.8 to 81.6 +/- 8.0 mm Hg, p < 0.01). The parameters of PWV and PWA were significantly improved, but the parameters of carotid arterial stiffness were not changed significantly. CONCLUSIONS: In hypertensives, carotid 2D CS showed better correlation with ageing and the parameters of global arterial stiffness than conventional strain or diameter change of the carotid artery. Global arterial stiffness was improved by 6 months of medical treatment with ARB, but the local carotid arterial stiffness was not changed.
Angiotensin Receptor Antagonists ; Blood Pressure ; Carotid Arteries ; Humans ; Hypertension* ; Pulse Wave Analysis ; Receptors, Angiotensin ; Vascular Stiffness* ; 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

Adult ; Antihypertensive Agents ; administration & dosage ; therapeutic use ; Cardiomyopathy, Dilated ; diagnosis ; drug therapy ; Echocardiography ; Humans ; Male ; Valsartan ; administration & dosage ; therapeutic use

European Medicines Agency withdrew valsartan from European market in July 2018 because it was contaminated with carcinogen, N-nitrosodimethylamine (NDMA) and N-nitrosodiethylamine (NDEA). Medicines and Healthcare Products Regulatory Agency also found the same contamination and withdrew it from England market. US Food and Drug Administration followed the action after confirming its contamination. Ministry of Food and Drug Safety (MFDS) conducted testing all the valsartans at Korean market and withdrew some of them from market after confirming the contamination with NDMA. MFDS provided the pharmaceutical companies and laboratory institutions with the manual for testing both NDMA and NDEA and educated relevant personnels. MFDS also evaluated the health impact of the contaminated valsartan on the hypertensive patients who took the valsartan, which was shown to be very low risk of additional cancer incidence. MFDS pronounced strengthening of the safety management for the raw materials of the medicines. For guaranteeing the safety of medicines, more comprehensive drug safety management system from developing new drugs to consuming the medicines should be established. For achieving such a goal, active participation of all the stakeholders of the medicines including governmental agencies including MFDS and Ministry of Health and Welfare, the National Assembly, healthcare professionals, pharmaceutical companies, mass media, and general population including patients should be needed.
Antihypertensive Agents ; Delivery of Health Care ; Diethylnitrosamine ; Dimethylnitrosamine ; England ; Humans ; Incidence ; Mass Media ; Safety Management ; United States Food and Drug Administration ; Valsartan