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Positive Phase III Results for Nebivolol/Valsartan Combo in Hypertension

Regulatory filing expected in early 2014 (June 27)

Positive results have been reported from a pivotal phase III trial that evaluated the efficacy and safety of an investigational fixed-dose combination (FDC) of nebivolol and valsartan (Forest Laboratories) for the treatment of hypertension.

The combination demonstrated statistically significant reductions in diastolic blood pressure (DBP) versus both nebivolol alone and valsartan alone (the study’s primary endpoint) at 8 weeks. The FDC also met the key secondary endpoint of a change from baseline in systolic blood pressure (SBP) at 8 weeks.

The pivotal nebivolol/valsartan FDC trial was designed to meet the required regulatory “combination rule,” which compares an FDC with the highest approved dose of each component drug.

A regulatory filing with the FDA is expected in the first quarter of 2014.

In the pivotal 8-week randomized, double-blind, placebo-controlled trial, 4,161 hypertensive patients were randomly assigned to one of eight treatment groups: FDC nebivolol/valsartan 5/80, 5/160, or 10/160 mg; nebivolol 5 or 20 mg; valsartan 80 or 160 mg; or placebo. After 4 weeks, all doses were doubled.

The primary endpoint was the change from baseline in mean sitting trough DBP at 8 weeks for FDC 20/320 mg versus nebivolol 40 mg (the highest approved nebivolol dose) and versus valsartan 320 mg (the highest approved valsartan dose), and FDC doses 10/320 mg and 10/160 mg versus corresponding monotherapies. Across these doses, the incremental reductions in DBP were –1.2 to –2.4 mm Hg (P values: 0.03 to < 0.0001) for the combination versus nebivolol and –3.7 to –4.4 mm Hg (P < 0.0001) for the combination versus valsartan.

The key secondary endpoint was the change from baseline in sitting trough SBP at 8 weeks for the FDC 20/320 mg, 10/320 mg, and 10/160 mg versus the same monotherapy components that were evaluated for DBP. Across these doses, the incremental reductions in SBP were –2.9 to –3.6 mm Hg (P values: 0.0013 to < 0.0001) for the combination versus nebivolol and –3.0 to –3.9 mm Hg (P values: 0.0011 to < 0.0001) for the combination versus valsartan.

Nebivolol (Bystolic, Forest Pharmaceuticals) is indicated for the treatment of hypertension and lowers blood pressure when taken alone or in combination with other antihypertensive agents.

Valsartan is an angiotensin II receptor blocker (ARB) that blocks the binding of angiotensin II to the AT1 receptor in many tissues, such as vascular smooth muscle and the adrenal gland, thereby preventing the receptor’s vasoconstrictor and aldosterone-secreting effects.

Source: Forest Laboratories; June 27, 2013.

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