EDARBI approved by FDA after trials show superior blood pressure control
The Food and Drug Administration approved EDARBI, a blood pressure medicine that is an angiotensin receptor blocker, or ARB. Two classes of drugs are commonly used to treat hypertension - ACE inhibitors and ARB's.
The drug's approval follows findings from phase 3 clinical trials showing EDARBI, manufactured by Takeda Pharmaceuticals lowered 24-hour mean systolic blood pressure (SBP) as measured by Ambulatory Blood Pressure Monitoring and was superior to other ARB's on the market.
Blood pressure changes with EDARBI superior to valsartan, olmesartan medoxomil
In the drug trial, EDARBI - (azilsartan medoxomil) - once a day, was compared to valsartan (Diovan) and omestartan medoxomil (Benicar), either alone or in combination with the antihypertensive drugs chlorthalidone and amlodipine.
The primary end-point was statistically significant blood pressuring lowering compared to the other ARB's and placebo. In the trial, EDARBI 80 mg. lowered blood pressure by 14.3 mm Hg and 13.2 mm Hg in the participants given 40 mg. a day.
Valsartan 320 mg/day, lowered systolic blood pressure 10 points and olmesartan medoxomil 40 mg/day, 11 points that was similar in all 3 studies.
The trials involved more than 5900 patients with high blood pressure.
ARB's work by blocking angiotensin, a naturally occurring hormone that constricts the blood vessels. Blood pressure becomes lower from relaxation and widening of the arteries that results from the blocking action. The most common side effect was diarrhea in 2 percent of the study participants.
Hypertension leads to significant health care spending and is a major contributor to stroke. Blood pressure greater than 140/90 is considered to be too high. For many patients, finding the right combination of drugs to keep blood pressure in check is challenging.
EDARBI was found to lower blood pressure better than two other ARB's on the market, changing 24-hour mean systolic blood pressure (SBP), shown in a clinic setting and with Ambulatory Blood Pressure Monitoring. The FDA announced today it has approved the drug for treatment of high blood pressure.
Updated April 6, 2014