A fixed-dose combination of azilsartan medoxomil and chlorthalidone 40/25 mg (Edarbyclor, Takeda Pharmaceuticals) was statistically superior to a fixed-dose combination of olmesartan medoxomil-hydrochlorothiazide 40/25 mg for the treatment of stage 2 systolic hypertension, according to a study published online in the American Heart Association journal Hypertension.
A fixed-dose combination of azilsartan medoxomil and chlorthalidone 40/25 mg (Edarbyclor, Takeda Pharmaceuticals) was statistically superior to a fixed-dose combination of olmesartan medoxomil-hydrochlorothiazide 40/25 mg for the treatment of stage 2 systolic hypertension, according to a study published online in the American Heart Association journal Hypertension.
Azilsartan medoxomil is a newly approved, long-acting angiotensin II receptor blocker (ARB), and Edarbyclor is the first and only hypertension medication to combine an ARB with chlorthalidone, a diuretic, in a once-daily, single tablet, according to the study and a statement from Takeda Pharmaceuticals.
The multicenter study, lead by William C. Cushman, MD, of the University of Tennessee College of Medicine in Memphis, Tenn., was a large, forced-titration, active-comparator study of the ARB-chlorthalidone combination. Dr Cushman and colleagues compared the antihypertensive efficacy, safety, and tolerability of 2 fixed-dose combinations of azilsartan medoxomil plus chlorthalidone, force titrated from 20/12.5 mg and 40/12.5 mg to 40/25 mg and 80/25 mg, with the ARB fixed-dose combination of olmesartan medoxomil plus hydrochlorothiazide, force titrated from 20/12.5 mg to 40/25 mg, in 1,071 patients with stage 2 systolic hypertension. They used measurements of both clinic and ambulatory blood pressures (BPs) to assess antihypertensive efficacy.
After 12 weeks of treatment, both fixed-dose combinations of azilsartan medoxomil and chlorthalidone had more effectively reduced clinic systolic BP (P<.001) compared with the fixed-dose combination of olmesartan medoxomil-hydrochlorothiazide.
Adverse events that lead to study discontinuation occurred in 7.9% of patients taking azilsartan medoxomil and chlorthalidone 40/25 mg and 7.1% of patients taking olmesartan medoxomil-hydrochlorothiazide 40/25 mg, the most common being increases in serum creatinine and dizziness, which occurred more frequently and in a dose-dependent manner with azilsartan medoxomil/chlorthalidone.
“The implication of these results is that this single-pill combination of 2 antihypertensive drugs may provide BP control to recommended target BP levels for a higher proportion of hypertensive patients than other 2-drug [fixed-dose combinations],” the authors concluded. “Although some hypertensive patients will require more medications to achieve their BP goal, the subsequent regimen will likely require fewer additional drugs.”
FDA Approves Pfizer’s Gene Therapy for Beqvez for Hemophilia
April 26th 2024Beqvez (fidanacogene elaparvovec) is priced at $3.5 million, which is on parity with Hemgenix, the first one-time therapy to treat adults with hemophilia B. Pfizer’s warranty will refund insurers and continue to provide coverage for patients if they change insurers.