The purpose of this randomised, double-blind, doubledummy, parallel-group study was to evaluate the efficacy and tolerability of telmisartan 40 mg once daily vs. enalapril 10 mg once daily in 147 Taiwanese patients with mild-to-moderate essential hypertension (diastolic blood pressure [DBP] 90-109 mmHg). After 6 weeks' treatment, telmisartan produced a significantly greater reduction from baseline in the primary endpoint of trough seated DBP compared with enalapril 10 mg (11.7 vs. 8.7 mmHg, respectively; p ¼ 0.02). Numerically greater reductions compared with baseline in seated systolic blood pressure (SBP), standing DBP, and standing SBP were achieved with telmisartan compared with enalapril. Also, numerically greater proportions of patients achieved blood pressure control (DBP ⁄ systolic blood pressure [SBP] <90 ⁄ 140 mmHg) and responded to treatment (reduction from baseline in trough seated DBP ‡10 mmHg and ⁄ or post-treatment DBP <90 mmHg; reduction from baseline in trough seated SBP ‡10 mmHg and ⁄ or post-treatment SBP <140 mmHg) with telmisartan 40 mg compared with enalapril 10 mg. Although both treatments were well tolerated, the incidence of cough was markedly lower with telmisartan 40 mg (8.5%) than with enalapril 10 mg (18.4%) in this population of Taiwanese hypertensive patients.
Fixed-dose combinations (FDCs) are one of the options for improving blood pressure (BP) goal attainment. We enrolled 141 patients and evaluated the efficacy and safety between a fixed dose of olmesartan/amlodipine (OA) and a double dose of amlodipine (DA) for treating mild to moderate hypertension after amlodipine monotherapy failure. After at least 2 weeks of monotherapy failure, the patients were randomized to receive either OA or DA for 8 weeks. We compared the systolic blood pressure (SBP)-lowering efficacy of the OA and DA using both an office BP and an ambulatory blood pressure monitoring (ABPM) device. The intent-to-treat analysis found that the early (2nd week) and final visit (8th week) SBP reductions were significantly greater in those patients receiving OA (n = 70) than DA (n = 71) (17.57 ± 15.49 vs. 10.46 ± 13.36 and 24.89 ± 14.09 vs. 17.03 ± 13.27 mmHg, p = 0.002 and 0.001, respectively). Among those using ABPM, the patients with 8-week OA had a greater SBP-lowering effect in comparison with those on DA (14.08 ± 10.74 vs. 6.32 ± 10.21, p = 0.018). Both treatment strategies were well tolerated. This study showed that an OA FDC is more effective than DA in reducing SBP for mild to moderate hypertension after the failure of amlodipine monotherapy.
Background Poor blood pressure (BP) control is a global problem. Fixdose combination (FDC) is suggested to improve the BP goal attainment. We evaluated the efficacy and safety between olmesartan/ amlodipine FDC (OA) and double-dose amlodipine (DA) for the mild to moderate hypertensives not achieving target BP after amlodipine monotherapy.Methods This study was an open-label, randomized, multi-centers design. After failure of amlodipinemonotherapy, patients were randomized to receive either OA or DA for 8 weeks. This study was intended to compare the systolic BP (SBP)-lowering efficacy of OA and DA by using office BP and ambulatory BP monitoring (ABPM).Results 141 subjects were finally enrolled. The intent-to-treat analysis found early (2th week) and final visit (8th week) SBP reduction were significantly higher in those receiving OA (n ¼ 70) than DA (n ¼ 71) (17.57 AE 15.49 vs. 10.46 AE 13.36 and 24.89 AE 14.09 vs. 17.03 AE 13.27 mmHg, p ¼ 0.002 and 0.001 respectively). Among those with ABPM, patients with 8-week OA (n ¼ 35) also had higher SBP-lowering effect compared with those with DA (n ¼ 25) (14.08 AE 10.74 vs. 6.53 AE 10.64, p ¼ 0.036). Both treatment strategies were tolerated well.Conclusion This study showed that use of olmesartan/amlodipine FDC is more effective than double-dose amlodipine in the SBP reduction for the mild to moderate hypertensives with failure of amlodipine monotherapy.Background To evaluate the short-term effect of amlodipine piustelmisartan or amiloride on reduction of blood pressure and adverse effect in hypertensive patients with moderate or high risk of cardiovascular event.Methods In this randomized, blind-end trial, 106 hypertensive patients met Inclusion criteria are enrolled. Patients were randomly assigned to A group (amlodipine 2.5 mg plus telmisartan 80 mg group) or B group (amlodipine 2.5 mg plus 1 tablet of amiloride group); Amlodipine 2.5 mg could be added if blood pressure beyond control at 4-week. Follow up 24 weeks. Primary efficacy parameter was reduction of blood pressure at 24-week. Physical and laboratory characteristics and side effects were recorded.Results Baseline systolic blood pressure was160.5 AE 16.5 mm Hg and diastolic blood pressure was 98.7 AE 9.7 mm Hg. After 2-week treatment, mean systolic blood pressure in group A and B was (151.5 AE 14.8) mm Hg and (144.4 AE 13.9) mm Hg, respectively (P < 0.05). Mean diastolic blood pressure in group A and B was reduced to (91.7 AE 9.6) mm Hg and (90.1 AE 9.4) mm Hg, respectively (p>0.05). Blood pressure control rate was 47.2% and 58.1% in group A and B (P < 0.05). After 24-week therapy, there were no significant differences on reduction of blood pressures (SBPs 24.3 AE 15.8 vs 26.8 AE 13.4, p > 0.05) (DBPs 15.2 AE 9.2 vs15.7 AE 9.4, p > 0.05) or blood pressure control rates (67.9% of vs 71.7%, p > 0.05) in two groups. Compared with A and B groups, both of them reported equivalent of adverse effects (7.6% of amiloridevs 9.4% of telmisartan, p > 0.05).Conclusion Amlodipine-based antihypertensive combination strategies...
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