Novartis reports promising data for high blood pressure treatments

Phase III data for Novartis" Exforge (amlodipine besylate/valsartan) and new data for Rasilez (aliskiren) have shown the efficacy of both medicines in lowering blood pressure.

Patients with high blood pressure (diastolic blood pressure between 110 mmHg and 120 mmHg) who were treated with Exforge experienced an average drop of 35.8 mmHg in systolic blood pressure compared to 31.8 mmHg with the combination of the ACE-inhibitor lisinopril and the diuretic hydrochlorothiazide (HCTZ). Patients with systolic blood pressures of at least 180 mmHg achieved an average reduction of 43.0 mmHg, compared to 31.2 mmHg with the lisinopril/HCTZ combination. Furthermore, 80% of those treated for six weeks reached the recommended goal of mean sitting diastolic blood pressure of less than 90 mmHg.

The first high blood pressure medication to combine the most commonly prescribed high blood pressure medicines in their respective classes - namely the calcium channel blocker (CCB) amlodipine besylate and the angiotensin receptor blocker (ARB) valsartan - it was shown to be safe and well tolerated in the overall clinical trial program involving 5,000 patients.

Meanwhile, in a randomised, double-blind, multi-centre, placebo-controlled study of 672 people with mild-to-moderate high blood pressure given Rasilez 150 mg, 300 mg, or 600 mg once a day, or placebo, Rasilez showed "durable and persistent" blood pressure lowering over a 24-hour dosing period; a factor that Dr Jerry Mitchell, md of the Texas Center for Drug Development, described as "particularly important" because of blood pressure's natural fluctuations over a 24-hour period and regular "surges in the early morning hours".

The trough-to-peak ratio for lowering diastolic blood pressure over 24 hours was 0.98 with 300 mg, 0.86 with 600mg and 0.64 with 150mg. All results were statistically significant (p<0.0001).

The drug also proved effective in combination with the diuretic HCTZ, inducing reduced mean sitting systolic (p<0.0001) and diastolic blood pressure (p<0.0002) in a randomised double-blind eight-week study of 2,776 high blood pressure patients who received Rasilez at 75 mg, 150 mg or 300 mg in various combinations with HCTZ or placebo. The combination of Rasilez 300 mg and HCTZ 25mg resulted proved most effective in helping patients reach the pre-defined goal of less than 90 mmHg diastolic blood pressure and/or at least a 10 mmHg decrease in blood pressure.

The first orally effective direct renin inhibitor, the drug acts within the renin system, which is central to blood pressure regulation, to decrease plasma renin activity (PRA). It has also shown "significant blood pressure response" when used in combination with ACE inhibitors (particularly ramipril) and calcium channel blockers.

Submissions for US and EU approval for Exforge were completed earlier in 2006, while Rasilez was submitted in the US in April 2006 and remains on track for EU submission by the end of 2006. If approved, the drugs will represent the first new treatments for people with high blood pressure, which is estimated to affect around one billion people globally, in more than a decade.