A new combination pill to treat people with high blood pressure has won approval from the U.S. Food and Drug Administration.

 

Prestalia, which combines fixed doses of two high blood pressure drugs perindopril arginine and amlodipine besylate, is intended to be used in patients whose blood pressure is not adequately controlled by one medication. 

It is also approved as a first line therapy for patients who are likely to need multiple drugs to reach their blood pressure goals, the FDA said.

 

Perindopril arginine is an ACE inhibitor and amlodipine is a calcium channel blocker. Each type of drug works in different ways, but both widen blood vessels and improve blood flow, reducing the force of blood through the heart, thereby reducing blood pressure.

 

The FDA approval was based on data from the 837 patients enrolled in the PATH trial (Perindopril Amlodipine for the Treatment of Hypertension). The study demonstrated that the fixed-dose combination of both medications in a single pill controlled blood pressure than either medication alone.

 

“We now have another great combination of two drugs each with an evidence-based outcome history that are combined in a single pill,” said George Bakris, M.D., former president of the American Society of Hypertension and principal investigator for the PATH trial.

 

The drug manufacturer, Symplmed plans to make Prestalia available within the next few months.