For the first time, the U.S. Food and Drug Administration (FDA) has approved a fixed-dose antihypertensive pill combining angiotensin-converting enzyme inhibitor and beta blocker compounds. The drug, brand name Prestalia (Symplmed, Cincinnati, Ohio), contains perindopril arginine, an angiotensin-converting enzyme inhibitor, and amlodipine, a dihydropyridine calcium channel blocker.
Symplmed says Prestalia is intended for patients who fail to lower blood pressure with a single drug. Thus the drug may be used as a first-line therapy in patients likely to need multiple drugs to achieve blood pressure goals.
The FDA approved the drug based on phase III data from the 837-patient PATH trial (Perindopril Amlodipine for the Treatment of Hypertension trial), which demonstrated that the fixed-dose combination in one pill was more effective than either compound taken alone for reducing sitting diastolic and sitting systolic blood pressure after six weeks of treatment.
Both drugs alone can cause hypotension, and perindopril can cause swelling of the head and neck. Warnings include not giving diabetic patients aliskiren (a renin inhibitor for primary hypertension) along with ACE inhibitors, including Prestalia, as well as discontinuing Prestalia immediately when a patient learns she is pregnant.
The company has several other combination drugs for hypertension in the pipeline, all containing perindopril perindopril plus atorvastatin, perindopril plus indapamide, and perindopril plus amlodipine (the two drugs in Prestalia) plus indapamide. Its first product, perindopril erbumine (Aceon), is an antihypertensive drug that can be taken alone or in combination with other classes of hypertension-reducing drugs. Aceon is used to treat patients with high blood pressure and to reduce the risk of heart attack.
