Korean Circ J.  2016 Mar;46(2):222-228. 10.4070/kcj.2016.46.2.222.

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

• Sung J
• Jeong JO
• Kwon SU
• Won KH
• Kim BJ
• Cho BR
• Kim MK
• Lee S
• Kim HJ
• Lim SH
• Park SW
• Park JE

• KMID: 2344474
• DOI: http://doi.org/10.4070/kcj.2016.46.2.222

Abstract

BACKGROUND AND OBJECTIVES
When 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 METHODS
This 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.
RESULTS
Baseline 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).
CONCLUSION
Amlodipine/valsartan 5/160 mg combination was more efficacious than amlodipine 10 mg in hypertensive patients in whom monotherapy of amlodipine 5 mg had failed.

Keyword

Amlodipine-valsartan drug combination; Hypertension; Valsartan; Amlodipine

MeSH Terms

Amlodipine*
Blood Pressure
Blood Pressure Monitoring, Ambulatory
Female
Follow-Up Studies
Humans
Hypertension
Male
Random Allocation
Amlodipine

Figure

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  Fig. 1 Study design. Clinic BP was measured at each visit, and BP at the randomization visit (while on amlodipine 5 mg) was used as the baseline clinic BP. ABPM: ambulatory blood pressure monitoring, BP: blood pressure

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  Fig. 2 Daytime ambulatory blood pressure control rate compared between treatment groups. Adequate BP control was defined as daytime mean SBP<135 mmHg and DBP<85 mmHg (SBP<125 mmHg and DBP<75 mmHg in patients with diabetes mellitus). BP: blood pressure, SBP: systolic blood pressure, DBP: diastolic blood pressure, A: amlodipine, AV: amlodipine/valsartan combination.

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