Most patients with hypertension will require treatment with at least two antihypertensive agents to achieve blood
pressure (BP) control. This double-blind study evaluated the efficacy and safety of aliskiren/amlodipine single-pill combination
(SPC) therapy in patients with mild-to-moderate hypertension who are inadequately responsive to amlodipine monotherapy.
Patients with mean sitting diastolic BP (msDBP) ≥ 90 and < 110 mmHg after 4 weeks’ treatment with amlodipine 10 mg were
randomized to once-daily aliskiren/amlodipine 300/10 mg (n = 279) or 150/10 mg (n = 285) or amlodipine 10 mg monotherapy
(n = 283) for 8 weeks. Aliskiren/amlodipine 300/10 and 150/10 mg SPCs provided significantly greater reductions in mean
sitting systolic BP/msDBP (14.4/11.0 and 11.0/9.0 mmHg, respectively) than amlodipine 10 mg (8.2/7.2 mmHg) at week 8
endpoint. This represents additional mean reductions of 6.2/3.8 mmHg (300/10 mg) and 2.8/1.7 mmHg (150/10 mg) over amlodipine
alone (all P < 0.01). Significantly more patients achieved BP control (< 140/90 mmHg) with aliskiren/amlodipine
300/10 mg (58.8%) than amlodipine 10 mg (38.4%; P < 0.0001). Aliskiren/amlodipine SPCs were generally well tolerated.
In conclusion, aliskiren/amlodipine SPCs offers an effective option for management of patients who have an inadequate BP response
to amlodipine alone.
Keywords: Aliskiren, amlodipine, single pill combination, hypertension, non- responder
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