Daiichi Sankyo announced that the FDA has approved Tribenzor (olmesartan medoxomil, amlodipine, hydrochlorothiazide tablets), a fixed-dose combination therapy 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. This approval was based on study data in 2,492 patients that showed that after eight weeks of treatment, Tribenzor produced statistically significantly greater reductions in both systolic and diastolic blood pressures compared to three dual combination therapies. Tribenzor yielded a further mean reduction in systolic blood pressure/diastolic blood pressure of 8.1/5.4mmHg, 7.6/5.4mmHg, and 8.4/4.5mmHg, respectively (p<0.0001 vs. each dual combination therapy), compared to each of the following dual combination therapies: amlodipine/hydrochlorothiazide, olmesartan/hydrochlorothiazide, and olmesartan/amlodipine.
Tribenzor is expected to be available August 2010 in olmesartan medoxomil, amlodipine, hydrochlorothiazide 20/5/12.5mg, 40/5/12.5mg, 40/5/25mg, 40/10/12.5mg, and 40/10/25mg dosage strengths.
For more information call (877) 437-7763 or visit www.tribenzor.com.