New combination treatment for hypertension

Novartis has launched Exforge (amlodipine besylate + valsartan) for the treatment of hypertension, not adequately controlled by amlodipine or valsartan monotherapy.

PHARMACOLOGY
Exforge combines two antihypertensive compounds with complementary mechanisms of controlling blood pressure – amlodipine, a calcium antagonist and valsartan, an angiotensin II antagonist. The combination has an additive antihypertensive effect, reducing blood pressure to a greater degree than either component alone.

CLINICAL STUDIES
The safety and efficacy of monotherapy with amlodipine or valsartan in hypertension has been established in previous trials, and both drugs have been used for many years in clinical practice. Exforge offers patients a convenient method of administering amlodipine and valsartan as combination therapy.

Several studies have been undertaken to establish the safety and efficacy of this combination versus monotherapy. In two placebo-controlled trials,1 over 1,400 hypertensive patients with mild to moderate uncomplicated essential hypertension (mean sitting diastolic blood pressure >95mmHg and <110mmHg) received Exforge once daily. The results showed that the combination of amlodipine and valsartan produced a dose-related additive reduction in blood pressure across the therapeutic dose range.

Exforge has also been studied in comparison with lisinopril and hydrochlorothiazide (HCT) combination therapy, in a parallel-group trial in 130 patients with hypertension.2 The Exforge regimen of 5mg/160mg titrated to 10mg/160mg reduced sitting blood pressure by 36/29mmHg compared to 32/28mmHg with a regimen of lisinopril/HCT 10mg/12.5mg titrated to 20mg/12.5mg.

1. Exforge Summary of Product Characteristics. Novartis 2007.
2. Poldermans D, Gamboa R, Fomina I et al. A comparison of combination therapy with amlodipine/valsartan and lisinopril/hydrochlorothiazide in patients with hypertension. J Hypertens 2006: 24(4): S20; 1.15.

Further information: Novartis 01276 692255

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