Since many hypertensive patients require combination therapy in order to reach optimal blood pressure levels, combining two effective agents into a single drug product may simplify multi-drug treatment regimens.
Toprol-XL is already approved in the US as a treatment for hypertension administered alone and/or in combination with other agents. Additional approved indications include the long-term treatment of angina pectoris, and the treatment of stable, symptomatic heart failure of ischemic, hypertensive, or cardiomyopathic origin.
The NDA submission is based in part on the clinical results from a US study that included 1,571 hypertensive patients that assessed a wide range of doses of Toprol-XL taken in combination with hydrochlorothiazide.