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

05:10 EDT 19th May 2013 | BioPortfolio

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

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 once-daily 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.

Affiliation

Hypertension and Related Diseases Centre - AOU, University of Sassari, Viale S. Pietro 8, 07100, Sassari, Italy. glorioso@uniss.it.

Journal Details

This article was published in the following journal.

Name: Current vascular pharmacology
ISSN: 1875-6212
Pages:

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Medical and Biotech [MESH] Definitions

Drug Combinations

Single preparations containing two or more active agents, for the purpose of their concurrent administration as a fixed dose mixture.

Polypharmacy

The use of multiple drugs administered to the same patient, most commonly seen in elderly patients. It includes also the administration of excessive medication. Since in the United States most drugs are dispensed as single-agent formulations, polypharmacy, though using many drugs administered to the same patient, must be differentiated from DRUG COMBINATIONS, single preparations containing two or more drugs as a fixed dose, and from DRUG THERAPY, COMBINATION, two or more drugs administered separately for a combined effect. (From Segen, Dictionary of Modern Medicine, 1992)

Amlodipine

A long-acting dihydropyridine calcium channel blocker. It is effective in the treatment of ANGINA PECTORIS and HYPERTENSION.

Therapeutic Equivalency

The relative equivalency in the efficacy of different modes of treatment of a disease, most often used to compare the efficacy of different pharmaceuticals to treat a given disease.

Capsule Endoscopes

A pill sized videocamera encased in a capsule. It is designed to be swallowed and subsequently traverse the gastrointestinal tract while transmitting diagnostic images along the way.

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