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Antihypertensive Efficacy and Tolerability of Aliskiren/Amlodipine Single- Pill Combinations in Patients with an Inadequate Response to Aliskiren Monotherapy¥

[ Vol. 10 , Issue. 6 ]

Author(s):

Nicola Glorioso, Mathew Thomas, Chiara Troffa, Giuseppe Argiolas, Samir Patel, Inyoung Baek and Jack Zhang   Pages 748 - 755 ( 8 )

Abstract:


Many patients with hypertension will require multiple antihypertensive drugs to achieve blood pressure (BP) control. This double-blind study evaluated the efficacy and safety of aliskiren/amlodipine single-pill combinations (SPCs) in patients with mild-to-moderate hypertension who were non-responsive to aliskiren monotherapy. After a 4-week run-in with aliskiren 300 mg, patients with mean sitting diastolic BP (msDBP) ≥ 90 and <110 mmHg were randomized to oncedaily aliskiren/ amlodipine 300/10 mg or 300/5 mg, or aliskiren 300 mg for 8 weeks. Aliskiren/amlodipine SPCs provided significantly greater mean reductions in mean sitting systolic BP/msDBP (300/10 mg, 18.0/13.1 mmHg; 300/5 mg, 14.4/10.5 mmHg) than aliskiren 300 mg (6.4/5.8 mmHg) at week 8 endpoint. This represents additional mean reductions of 11.6/7.2 mmHg (300/10 mg) and 8.0/4.7 mmHg (300/5 mg) over aliskiren alone (both p<0.0001). Significantly more patients achieved BP control (<140/90 mmHg) with aliskiren/amlodipine 300/10 mg (65.5%) and 300/5 mg (56.6%) than with aliskiren (31.5%; both p<0.0001). Aliskiren, alone and in combination with amlodipine, was well tolerated, with a slightly higher incidence of adverse events with SPCs (29.0–30.1%) than with monotherapy (22.7%). In conclusion, aliskiren/amlodipine SPCs offer an effective next step for patients who have an inadequate BP response to aliskiren alone.

Keywords:

Aliskiren, amlodipine, hypertension, non-responder, renin–angiotensin–aldosterone system, single-pill combination

Affiliation:

Hypertension and Related Diseases Centre – AOU, University of Sassari, Viale S. Pietro 8, 07100, Sassari, Italy.



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