FDA approves 3-in-1 combination drug for high blood pressure

August 17, 2010

FDA has approved Tribenzor (olmesartan medoxomil, amlodipine, hydrochlorothiazide), a new three-in-one combination product taken once daily for the treatment of hypertension in patients who are not adequately controlled on any 2 of the following antihypertensive drug classes: angiotensin receptor blockers, calcium channel blockers, and diuretics, according to Daiichi Sankyo Inc.

FDA has approved Tribenzor (olmesartan medoxomil, amlodipine, hydrochlorothiazide), a new three-in-one combination product taken once daily for the treatment of hypertension in patients who are not adequately controlled on any 2 of the following antihypertensive drug classes: angiotensin receptor blockers, calcium channel blockers, and diuretics, according to Daiichi Sankyo Inc.

Approximately 56% of patients taking current blood-pressure-lowering therapies do not reach the current recommended blood-pressure goal of

A fixed-dose combination treatment, Tribenzor, simplifies dosing regimens, reduces pill burden, and has the potential to lower co-pays for patients who require 3 medications to keep blood pressure within recommended levels. Research shows that the use of fixed-dose antihypertensive combination treatments may improve patient compliance compared with taking each medication separately.

Tribenzor combines 3 widely prescribed antihypertensive medications, each working in a different way, to lower blood pressure. It combines the complementary actions of olmesartan medoxomil, which blocks angiotensin II receptors; amlodipine, which inhibits the entrance of calcium into the blood vessel walls; and hydrochlorothiazide, a diuretic which reduces water volume in the blood. Together, these medications allow blood vessels to relax so that blood can flow more easily.

After 8 weeks of treatment, Tribenzor produced greater reductions, of high statistical significance, in both systolic and diastolic blood pressures, compared with each of the 3 dual-combination therapies. According to the Tribenzor pivotal registration trial, which included 2,492 patients with hypertension (mean baseline blood pressure, 168.5/100.9 mmHg), the switch to Tribenzor 40/10/25 mg from each of the following 3 dual-combination therapies (amlodipine/hydrochlorothiazide 10/25 mg, olmesartan/hydrochlorothiazide 40/25 mg, and olmesartan/amlodipine 40/10 mg) yielded a further mean reduction after 8 weeks of treatment in systolic blood pressure/diastolic blood pressure of 8.1/5.4 mmHg, 7.6/5.4 mmHg, and 8.4/4.5 mmHg, respectively (P

The most common adverse reactions seen in clinical trials for Tribenzor were dizziness, peripheral edema, headache, fatigue, nasopharyngitis, muscle spasms, nausea, upper respiratory tract infection, diarrhea, urinary tract infection, and joint swelling.Tribenzor is not indicated for initial therapy.