Azilsartan/Chlorthalidone More Effective Than Azilsartan/HCTZ at Lowering Blood Pressure in Phase III Trial
Results reported in patients with stage-2 hypertension (Sept. 5)
On September 5, Takeda Pharmaceuticals U.S.A., Inc., based in Deerfield, Ill., announced that the clinic systolic blood pressure (SBP) reductions of a fixed-dose combination of azilsartan medoxomil and chlorthalidone were significantly greater at 6 and 10 weeks than those of azilsartan medoxomil coadministered with hydrochlorothiazide (HCTZ) in a 10-week phase III trial.
The data also showed that more patients achieved their target blood pressure levels at the end of 6 and 10 weeks (secondary endpoints) when taking the azilsartan medoxomil and chlorthalidone fixed-dose combination.
The new study was published online in the American Journal of Medicine.
The 10-week, randomized, double-blind, titrate-to-target trial compared blood pressure reductions of the fixed-dose combination of azilsartan medoxomil and chlorthalidone with that of azilsartan medoxomil coadministered with HCTZ in 609 patients with stage-2 hypertension. The average age of the patients was 56.4 years, and the average baseline clinic blood pressure was 164.6/95.4 mm Hg. After 2 weeks of treatment with azilsartan medoxomil (40 mg) alone, patients received 12.5 mg of either diuretic for 4 weeks (up to week 6) and were then titrated to 25 mg for another 4 weeks (up to week 10) if they had not achieved their target blood pressure; otherwise, patients continued their initial dose.
At week 6, the clinic SBP reduction of the fixed-dose combination of azilsartan medoxomil and chlorthalidone was –35.1 mm Hg. This was significantly (P < 0.001) greater than the reduction with azilsartan medoxomil and HCTZ (–29.5 mm Hg), with a mean difference of –5.6 mm Hg. At the end of 10 weeks, greater clinic SBP reductions were maintained in patients taking the fixed-dose combination of azilsartan medoxomil and chlorthalidone (–37.8 mm Hg) versus those taking azilsartan medoxomil and HCTZ (–32.8 mm Hg), with a mean difference of –5.0 mm Hg.
In addition, secondary data showed that a greater proportion of patients taking the fixed-dose combination of azilsartan medoxomil and chlorthalidone achieved their target blood pressure versus those taking azilsartan medoxomil and HCTZ at the end of both 6 weeks (64.1% vs. 45.9%, respectively) and 10 weeks (71.5% vs. 62.3%, respectively).
Azilsartan medoxomil and chlorthalidone (currently marketed as Edarbyclor) is a fixed-dose combination therapy in a single tablet for the treatment of hypertension. Azilsartan medoxomil blocks the action of angiotensin II, a hormone that naturally exists in the body. Chlorthalidone is a diuretic that reduces the amount of salt and water in the body by increasing the flow of urine.
Edarbyclor was approved by the FDA in December 2011 for the treatment of hypertension to lower blood pressure in adults. It is the first hypertension medication to combine an angiotensin II receptor blocker (ARB) with the diuretic chlorthalidone in a once-daily tablet.
The recommended starting dose of Edarbyclor in adults is 40/12.5 mg, taken orally once daily. The maximum recommended dose is 40/25 mg.
For more information, visit the Takeda Pharmaceuticals Web site.