Valsartan 160 mg/Amlodipine 5 mg Combination Therapy versus Amlodipine 10 mg in Hypertensive Patients with Inadequate Response to Amlodipine 5 mg Monotherapy

Abstract

Background and ObjectivesWhen monotherapy is inadequate for blood pressure control, the next step is either to continue monotherapy in increased doses or to add another antihypertensive agent. However, direct comparison of double-dose monotherapy versus combination therapy has rarely been done. The objective of this study is to compare 10 mg of amlodipine with an amlodipine/valsartan 5/160 mg combination in patients whose blood pressure control is inadequate with amlodipine 5 mg.Subjects and MethodsThis study was conducted as a multicenter, open-label, randomized controlled trial. Men and women aged 20-80 who were diagnosed as having hypertension, who had been on amlodipine 5 mg monotherapy for at least 4 weeks, and whose daytime mean systolic blood pressure (SBP) ≥135 mmHg or diastolic blood pressure (DBP) ≥85 mmHg on 24-hour ambulatory blood pressure monitoring (ABPM) were randomized to amlodipine (A) 10 mg or amlodipine/valsartan (AV) 5/160 mg group. Follow-up 24-hour ABPM was done at 8 weeks after randomization.ResultsBaseline clinical characteristics did not differ between the 2 groups. Ambulatory blood pressure reduction was significantly greater in the AV group compared with the A group (daytime mean SBP change: -14±11 vs. -9±9 mmHg, p<0.001, 24-hour mean SBP change: -13±10 vs. -8±8 mmHg, p<0.0001). Drug-related adverse events also did not differ significantly (A:AV, 6.5 vs. 4.5 %, p=0.56).ConclusionAmlodipine/valsartan 5/160 mg combination was more efficacious than amlodipine 10 mg in hypertensive patients in whom monotherapy of amlodipine 5 mg had failed.

Comparison of the Efficacy and Safety of Fixed-dose S-Amlodipine/Telmisartan and Telmisartan in Hypertensive Patients Inadequately Controlled with Telmisartan: A Randomized, Double-blind, Multicenter Study

“…In a clinical trial that compared racemic amlodipine plus TEL combination versus TEL monotherapy, the overall incidence rate of AEs was 22.2% to 34.5% in the TEL monotherapy group compared with 30.1% to 37.5% in the racemic amlodipine plus TEL combination group, but the difference was not significant between the groups. [12][13][14][15] In the present study, the overall incidence rate of AEs in the TEL 80-mg group was similar to those in the previous study, but the rates (approximately 20%) in the S-AM/TEL groups were relatively lower than the incidence rate in the previous study.…”

“…13,14 However, the rate was 1.4% to 5.1% and 3.6% to 7.0% with racemic amlodipine/ TEL 5/40 mg and 10/40 mg, respectively, indicating that increasing the dose of amlodipine did not result in a great increase in the occurrence rate of edema as was with the monotherapy. [11][12][13][14][15] In the present study, edema was observed in 1 person each (approximately 1.7%) in the S-AM/TEL 2.5/40-mg group and S-AM/ TEL 5/40-mg group, supporting that increasing the dose of S-AM (2.5 to 5 mg) does not result in a higher incidence rate of edema. Furthermore, the rate of edema in the S-AM/TEL 5/40-mg group was relatively lower than the rate with racemic amlodipine 10-mg monotherapy (17% to 27.2%) and even lower than the rate with racemic amlodipine/TEL 10/40-mg combination therapy (3.6% to 7.0%).…”

“…A combination of ARB and CCB is particularly effective for decreasing BP and is also recommended because ARB reduces peripheral edema, the main AE of CCB. 12 This was a confirmatory clinical trial to evaluate the efficacy and safety of S-AM/TEL in patients with hypertension inadequately controlled by TEL monotherapy 40-mg/d. In this study, we found that Korean patients with moderate hypertension who did not achieve their BP goals with initial low-dose TEL monotherapy had significant improvement in BP control after switching to a fixed-dose combination of S-AM/TEL compared with high-dose TEL monotherapy without increasing overall AEs.…”

Comparison of Fixed-dose Combinations of Amlodipine/Losartan Potassium/Chlorthalidone and Amlodipine/Losartan Potassium in Patients With Stage 2 Hypertension Inadequately Controlled With Amlodipine/Losartan Potassium: A Randomized, Double-blind, Multicenter, Phase III Study

“…Furthermore, dose-dependent adverse effects of amlodipine, such as ankle edema, can be reduced by combining it with an ARB. 28,29 Chlorthalidone affects the distal convoluted tubule of the nephron, producing diuretic effects. Although head-to-head comparisons of cardiovascular outcomes between chlorthalidone and hydrochlorothiazide have not been conducted, a few studies have suggested that chlorthalidone has superior efficacy compared with that of hydrochlorothiazide.…”

The Impact of Valsartan/Amlodipine Single-Pill Combination on Blood Pressure and Vascular Stiffness in Patients with Grade 1-2 Essential Arterial Hypertension

“…Sung и соавт. [21] проводили сравнительный анализ антигипертензивной эффективности и безопасности ФК В/А в дозе 160/5 мг и монотерапии амлодипином в дозе 10 мг у 221 пациента с АГ (средний возраст 54±11 лет). Период наблюдения после рандомизации составлял 8 нед, по его завершению вновь повторяли СМАД.…”