1. Antihypertensive efficacy and tolerability of aliskiren/amlodipine single- pill combinations in patients with an inadequate response to aliskiren monotherapy.
- Author
-
Glorioso N, Thomas M, Troffa C, Argiolas G, Patel S, Baek I, and Zhang J
- Subjects
- Administration, Oral, Adult, Aged, Amides administration & dosage, Amides adverse effects, Amlodipine administration & dosage, Amlodipine adverse effects, Antihypertensive Agents administration & dosage, Antihypertensive Agents adverse effects, Calcium Channel Blockers administration & dosage, Calcium Channel Blockers adverse effects, Double-Blind Method, Drug Administration Schedule, Drug Combinations, Drug Resistance, Europe, Female, Fumarates administration & dosage, Fumarates adverse effects, Humans, Hypertension diagnosis, Hypertension physiopathology, India, Least-Squares Analysis, Logistic Models, Male, Middle Aged, Republic of Korea, Tablets, Time Factors, Treatment Outcome, Vasodilator Agents administration & dosage, Vasodilator Agents adverse effects, Venezuela, Amides therapeutic use, Amlodipine therapeutic use, Antihypertensive Agents therapeutic use, Blood Pressure drug effects, Calcium Channel Blockers therapeutic use, Fumarates therapeutic use, Hypertension drug therapy, Vasodilator Agents therapeutic use
- 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.
- Published
- 2012
- Full Text
- View/download PDF