The FDA ( Food and Drug Administration ) 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 two of the following antihypertensive drug classes: angiotensin receptor blockers, calcium channel blockers and diuretics. Tribenzor is not indicated for initial therapy.
Approximately 56% of patients taking current blood pressure-lowering therapies do not reach current recommended blood pressure goal of less than 140/90 mmHg or less than 130/80 mmHg for patients with diabetes mellitus, chronic renal disease, or chronic cardiovascular disease.
More than two-thirds of patients with high blood pressure will require two or more antihypertensive medications in order to achieve goal blood pressure control.
Tribenzor combines three 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 ).
After eight weeks of treatment, Tribenzor produced highly statistically significantly greater reductions in both systolic and diastolic blood pressures compared to each of the three dual combination therapies. According to the Tribenzor pivotal registration trial that included a total of 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 three dual combination therapies: (i) Amlodipine / Hydrochlorothiazide 10/25 mg, (ii) Olmesartan / Hydrochlorothiazide 40/25 mg, and (iii) Olmesartan / Amlodipine 40/10 mg, yielded a further mean reduction after eight 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<0.0001 vs each dual combination therapy ).
The most common adverse reactions ( incidence greater than or equal to 2% ) 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. ( Xagena )
Source: Daiichi Sankyo, 2010