General Information

Tribenzor is a three-in-one, fixed-dose combination 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) for hypertension.

Tribenzor was specifically approved for the treatment of hypertension.

Mechanism of Action

Tribenzor is a three-in-one, fixed-dose combination 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) for hypertension.

Side Effects

Adverse events associated with the use of Tribenzor may include, but are not limited to, the following:

• dizziness
• peripheral edema
• headache
• fatigue
• nasopharyngitis
• muscle spasms
• nausea
• upper respiratory tract infection
• diarrhea
• urinary tract infection
• joint swelling

Dosing/Administration

Tribenzor is supplied as a tablet for oral administration. The following dose combinations were approved:
20 /5 /12.5 mg
40 /5 /12.5 mg
40 /5 /25 mg
40 /10 /12.5 mg
40 /10 /25 mg
The recommended dose is once daily. Dosage may be increased after two weeks. The maximum recommended dose of Tribenzor is 40/10/25 mg.

Clinical Trial Results

The FDA approval of Tribenzor was based on a double-blind, active-controlled study in 2,492 hypertensive patients. The subjects received triple therapy: olmesartan medoxomil/amlodipine/hydrochlorothiazide 40/10/25 mg, or one of the following dual therapies: olmesartan medoxomil/amlodipine 40/10 mg, olmesartan medoxomil/hydrochlorothiazide 40/25 mg or amlodipine/hydrochlorothiazide 10/25 mg. Each subject was randomized to one of the three dual therapy combinations for two to four weeks. They were then randomized to continue on the dual therapy they were receiving or to receive triple therapy. After eight weeks of treatment, the triple combination therapy produced greater reductions in both systolic and diastolic blood pressures (p< 0.0001) compared to each of the three dual combination therapies. A total of 440 subjects participated in an ambulatory blood pressure monitoring portion of the study. Over the 24-hour period, there was a greater reduction in diastolic and systolic ambulatory blood pressure for the triple therapy compared to each of the dual combination therapies.