The combination of amlodipine/valsartan 5/160 mg produces less peripheral oedema than amlodipine 10 mg in hypertensive patients not adequately controlled with amlodipine 5 mg

J Schrader, A Salvetti, C Calvo, E Akpinar, L Keeling, M Weisskopf, P Brunel, J Schrader, A Salvetti, C Calvo, E Akpinar, L Keeling, M Weisskopf, P Brunel

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 > or = 55 years, MSSBP > or = 130 and < or = 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.

Trial registration: ClinicalTrials.gov NCT00437645.

Figures

Figure 1
Figure 1
Schematic representation of the study design. Aml, amlodipine; Aml/Val, amlodipine/valsartan
Figure 2
Figure 2
Overall patient disposition during the treatment period
Figure 3
Figure 3
Change from baseline in MSSBP and MSDBP. *p

Figure 4

Effect of the treatment regimen…

Figure 4

Effect of the treatment regimen on overall blood pressure (BP) control. *p

Figure 4
Effect of the treatment regimen on overall blood pressure (BP) control. *p

Figure 5

Incidence of peripheral oedema at…

Figure 5

Incidence of peripheral oedema at week 8 and 12

Figure 5
Incidence of peripheral oedema at week 8 and 12
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Figure 4
Figure 4
Effect of the treatment regimen on overall blood pressure (BP) control. *p

Figure 5

Incidence of peripheral oedema at…

Figure 5

Incidence of peripheral oedema at week 8 and 12

Figure 5
Incidence of peripheral oedema at week 8 and 12
Figure 5
Figure 5
Incidence of peripheral oedema at week 8 and 12

References

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