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