Amlodipine/valsartan single-pill combination: a review of its use in the management of hypertension.

Single-pill combinations of the dihydropyridine calcium channel blocker (CCB) amlodipine and the angiotensin II receptor blocker valsartan (amlodipine/valsartan) [Exforge] are available in the US for the treatment of patients with hypertension. Prescribing information for amlodipine/valsartan states that it may be used in patients whose BP is not adequately controlled on either component monotherapy, and as initial therapy in patients who are likely to need multiple drugs to achieve their BP goals. The antihypertensive efficacy of combinations of once-daily oral amlodipine and valsartan (administered as separate agents or as amlodipine/valsartan) has been demonstrated in several large, randomized, double-blind clinical trials of 8-16 weeks' duration; BP reductions were maintained for approximately 1 year in open-label extensions of some of these studies. Combination therapy was more effective than amlodipine or valsartan monotherapy in reducing BP in patients with mild to moderate hypertension, and more effective than amlodipine monotherapy in reducing BP in patients with moderate to severe (stage 2) hypertension. In addition, switching to amlodipine plus valsartan was more effective than continuation of monotherapy in reducing BP in patients with hypertension uncontrolled on amlodipine or valsartan monotherapy. The BP-lowering effect of amlodipine plus valsartan was not significantly different from that of other combinations of antihypertensive drugs, including amlodipine plus atenolol, lisinopril plus hydrochlorothiazide (HCTZ), and irbesartan plus HCTZ. Combination therapy with amlodipine and valsartan was generally well tolerated. Based on these results, amlodipine/valsartan offers a rational and convenient treatment option for the management of patients with hypertension, the majority of whom will require at least two drugs to reach target BP levels recommended in US (and international) guidelines.