Daiichi Sankyo, Inc. announced that the U.S. Food and Drug Administration (FDA) 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 percent of patients taking current blood pressure-lowering therapies do not reach current recommended blood pressure goal of <140/90 mm Hg or <130/80 mm Hg for patients with diabetes, 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.
A fixed-dose combination treatment, TRIBENZOR, simplifies dosing regimens, reduces pill burden and has the potential to lower co-pays for patients that require three medications to keep blood pressure within recommended levels. Research also shows that the use of fixed-dose antihypertensive combination treatments may improve patient compliance as compared to taking each medication separately.
“Generally speaking, it can be a struggle for some patients who need to take multi-pill regimens to take their medications as prescribed,” said Joseph L. Izzo, MD, Chief of Medicine, Erie County Medical Center, Buffalo, NY. “TRIBENZOR is a three-in-one pill that offers a simple, convenient and consistently effective therapy for patients, and may be just what some patients need to help bring their blood pressure to goal.”
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). Together these three medications allow blood vessels to relax so that blood can flow more easily.
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 mm Hg), the switch to TRIBENZOR 40/10/25 mg from each of the following three 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 eight weeks of treatment in systolic blood pressure/diastolic blood pressure of 8.1/5.4 mm Hg, 7.6/5.4 mm Hg, and 8.4/4.5 mm Hg, respectively (P<0.0001 vs. each dual combination therapy).
“Our comprehensive cardiovascular product portfolio provides a variety of treatment options to patients in a number of disease categories including hypertension, heart disease, diabetes and cholesterol,” said Joseph P. Pieroni, President and CEO of Daiichi Sankyo, Inc. “Although hypertension is a mature category, the differences among patients will continue to support the need for differentiated products to achieve optimal results. The approval of TRIBENZOR shows Daiichi Sankyo is committed to optimizing individual patient care.”
The most common adverse reactions (incidence 2 percent) 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.
Date: July 26, 2010
Source: Daiichi Sankyo, Inc.
Filed Under: Drug Discovery