PARSIPPANY, NJ -- July 27, 2010 -- The US Food and Drug Administration (FDA) has approved a new, once-daily treatment for hypertension which combines olmesartan medoxomil, amlodipine, and hydrochlorothiazide in a single tablet. The drug, which will be marketed as Tribenzor in the United States, is approved for patients who are not adequately controlled on any 2 of the following antihypertensive drug classes: angiotensin receptor blockers, calcium channel blockers and diuretics. This new 3-in-1 drug is not approved for initial therapy.
Approximately 56% 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 hypertension will require 2 or more antihypertensive medications in order to achieve goal blood pressure control.
According to The Seventh Report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure, a fixed-dose combination treatment can simplify dosing regimens, reduce pill burden, and has the potential to lower co-pays for patients that require 3 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, New York. "[This agent] is a 3-in-1 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."
The new combination pill combines 3 widely prescribed antihypertensive medications, each working in a different way, to lower blood pressure. It combines the complementary actions of the angiotensin II receptor blocker olmesartan medoxomil, the calcium channel blocker amlodipine, and the diuretic hydrochlorothiazide. Together these 3 medications allow blood vessels to relax so that blood can flow more easily.
After 8 weeks of treatment with this combination pill, patients experienced statistically significantly greater reductions in both systolic and diastolic blood pressures compared to each of the 3 dual combination therapies. According to the Tribenzor pivotal registration trial which included a total of 2,492 patients with hypertension (mean baseline blood pressure 168.5/100.9 mm Hg), the switch to the 3-in-1 pill 40/10/25 mg from each of the following 3 dual combination therapies -- (1) amlodipine/hydrochlorothiazide 10/25 mg, (2) olmesartan/hydrochlorothiazide 40/25 mg, and (3) 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 mm Hg, 7.6/5.4 mm Hg, and 8.4/4.5 mm Hg, respectively (P < .0001 vs each dual combination therapy).
The most common adverse reactions (incidence >=2%) seen in clinical trials for
Tribenzor were dizziness, peripheral oedema, headache, fatigue, nasopharyngitis, muscle spasms, nausea, upper respiratory tract infection, diarrhoea, urinary tract infection, and joint swelling.
SOURCE: Daiichi Sankyo, Inc.
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