Abstract
Aims:To demonstrate the benefit of the combination amlodipine/valsartan 5/160 mg over amlodipine 10 mg, in producing a lower incidence of peripheral oedema for a comparable mean sitting systolic blood pressure (MSSBP) reduction.Methods:After a 4-week amlodipine 5 mg run-in phase, inadequately controlled hypertension patients (aged ≥ 55 years, MSSBP ≥ 130 and ≤ 160 mmHg) were randomised to receive amlodipine/valsartan 5/160 mg or amlodipine 10 mg for 8 weeks, followed by amlodipine/valsartan 5/160 mg for 4 weeks for all patients. Primary variables were MSSBP change from baseline to week 8 and incidence of peripheral oedema reported as an AE. Resolution of peripheral oedema was assessed 4 weeks after switching patients from amlodipine 10 mg to amlodipine/ valsartan 5/160 mg.Results:At week 8, MSSBP showed greater reduction with amlodipine/valsartan 5/160 mg than amlodipine 10 mg (least square mean: −8.01 vs.−5.95 mmHg, p<0.001 for non-inferiority and p=0.002 for superiority). Systolic control, overall BP control and systolic response rate at week 8 were significantly higher with combination than amlodipine 10 mg (34 vs. 26%; 57 vs. 50%; 36.57 vs. 27.77%, respectively). Incidence of peripheral oedema was significantly lower with the combination than amlodipine 10 mg (6.6 vs. 31.1%, p<0.001). Peripheral oedema resolved in 56% patients who switched from amlodipine 10 mg to the combination, without the loss of effect on BP reduction.Conclusion:In non-responders to amlodipine 5 mg, treatment with amlodipine/valsartan 5/160 mg induced significantly less peripheral oedema than amlodipine 10 mg for similar BP reduction. Peripheral oedema resolved in > 50% patients switching from amlodipine 10 mg to the combination.
Highlights
Hypertension is a well-known major risk factor for target organ damage and cardiovascular (CV) clinical events [1], representing the number one underlying cause of death worldwide [2]
This study shows that adding valsartan to the common starting dose of amlodipine provides similar blood pressure (BP) reduction with a better tolerability profile when compared with the up-titration of amlodipine
We evaluated the non-inferiority of the combination amlodipine ⁄ valsartan 5 ⁄ 160 mg compared with amlodipine 10 mg with respect to antihypertensive efficacy, along with the incidence of peripheral oedema, in patients not adequately controlled with amlodipine 5 mg alone
Summary
Hypertension is a well-known major risk factor for target organ damage and cardiovascular (CV) clinical events [1], representing the number one underlying cause of death worldwide [2]. Available data from controlled clinical studies indicate that blood pressure (BP) reduction to target levels (BP < 140 ⁄ 90 mmHg in all hypertensive patients and < 130 ⁄ 80 mmHg in diabetic patients and high or very high-risk patients) is associated with a significant decrease in CV mortality and morbidity, such target BP values are difficult to achieve [1]. Available data indicate that a major challenge in the treatment of hypertension is inadequate BP control, with only 3–38% of patients worldwide [3] and 31– 63% in developed countries attaining target BP of < 140 ⁄ 90 mmHg [4]. But with uncontrolled BP, the increase in dosage for drugs with dose-dependent efficacy constitutes a further
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