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Published online: 21 March 2013
© Springer International Publishing Switzerland 2013
Abstract Combination therapy is often required in patients with hypertension, and fixed-dose single-pill combinations have been shown to provide an easier regi- men for patients, improving adherence. Irbesartan/amlo- dipine (Aprovasc^) is an angiotensin-receptor blocker/ calcium-channel blocker fixed-dose single-pill combina- tion, whose constituent drugs exert additive effects when coadministered. In two randomized, open-label, multicen- tre, phase III trials, fixed-dose combination therapy with irbesartan/amlodipine was more effective than continuation of irbesartan or amlodipine monotherapy in patients with hypertension not adequately controlled with initial irbe- sartan or amlodipine monotherapy; there was a signifi- cantly greater decrease from baseline in mean seated home systolic blood pressure (primary endpoint) with the fixed- dose combination. The fixed-dose combination was also associated with a greater decrease in mean seated home diastolic blood pressure and mean seated office systolic and diastolic blood pressure than monotherapy. The fixed-dose combination of irbesartan/amlodipine was well tolerated in these patients; most treatment-emergent adverse events were of mild or moderate severity. The most frequent adverse event was peripheral oedema, generally associated with amlodipine treatment.
Keywords: Irbesartan/amlodipine, hypertension, phar- macokinetics, pharmacodynamics, therapeutic use, tol- erability
1 Introduction
Hypertension is a widely recognised major cause of com- mon serious diseases [1]. Approximately half of all coro- nary disease and approximately two thirds of all strokes can be attributed to blood pressure (BP) that is not at an optimal level, thus accounting for &7 million deaths worldwide each year [1].
When classified as an average BP measurement of [140 mmHg systolic or [90 mmHg diastolic (or use of hypertensive medication), hypertension occurs in approxi- mately 26 % of adults worldwide, equating to almost 1 billion people (estimated number in 2000) [2]. This is expected to increase to 1.56 billion people (29 %) by 2025 [2].
The goal of antihypertensive therapy is to remove the increased risk of morbidity and mortality associated with elevated BP, while avoiding tolerability issues and without adversely affecting quality of life [3].
The cause of BP elevation is usually multifactorial, so the chances of normalizing pressure by targeting a single pressor mechanism are very low; moreover, compensatory responses often occur via the other mechanisms, decreasing the response to the drug [3]. As a result,...