V-001 comparison of Efficacy and to Lebility Between Amlodipine/Olmesartan Fix-Dose Combination and Double-Dose Amlodipine in the Mild to Moderate Hypertensives After Failure of Amlodipine Monothrapy

Abstract

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...