Aprovel®/Avapro®/Karvea® (irbesartan)

Aprovel® belongs to the fastest-growing class of anti-hypertensive medicines: the angiotensin II receptor antagonists, indicated in the first-line treatment of hypertension. They work by impeding the effects of angiotensin II, the hormone responsible for vasoconstriction, allowing arterial blood pressure to return to normal.

Alongside Aprovel®/ Avapro®/Karvea® in monotherapy, the Group markets CoAprovel®/ Avalide®/Karvezide®, a fixed-dose combination of irbesartan and a diuretic, hydrochlorothiazide (HCTZ), which increases the rate at which water is excreted by the kidneys and thus augments the anti-hypertensive effect. Both products restore normal blood pressure in over 80% of patients and are very well tolerated.

Avapro®/Aprovel® was approved for a new indication, the treatment of nephropathy in hypertensive type 2 diabetic patients, in the United States and Europe in 2002, after the PRIME clinical program demonstrated that it prevents renal impairment in hypertensive diabetic patients in both the early and late stages.

In 2005, the INCLUSIVE study involving hypertensive patients failing to achieve blood pressure goal on monotherapy demonstrated that Avalide®/CoAprovel® enabled 77% patients to achieve blood pressure goal with good tolerability. Given that less than a third of patients treated for hypertension manage to attain blood pressure control to internationally recommended levels, these results hold out great hope for improved management of the condition.

A broad-based international survey, i-SEARCH, was launched to evaluate the prevalence of microalbuminuria, a recognized marker for cardiovascular risk, in hypertensive patients with and without CVD. The survey will recruit 23,000 patients from 33 different countries. Results of this study are expected in 2006.

A new clinical study involving 400 hypertensive patients with metabolic syndrome was launched in 2005, with the aim of studying the metabolic effects of Aprovel® in this patient population. Results of this study are expected in 2007.

Aprovel®/Avapro® was released on the market in 1997 in partnership with Bristol-Myers Squibb, first in Europe and then in the United States, and its sales progressed very strongly in 2000.

Aprovel®/ Avapro®/Karvea® is marketed in over 80 countries, including the United States, through a partnership with Bristol Myers Squibb. Irbesartan is in the process of registration in Japan