Key result
Azilsartan medoxomil/chlortalidone 40/25 mg fixed-dose combination significantly reduced clinic systolic blood pressure by an additional 14.7 mm Hg compared to azilsartan medoxomil monotherapy in patients with uncontrolled hypertension.
Why the study?
Does azilsartan medoxomil/chlortalidone fixed-dose combination reduce clinic SBP in hypertensive patients uncontrolled on azilsartan medoxomil alone?
RCT (n=395)
Double-blind
1:1:1
Yes
Does azilsartan medoxomil/chlortalidone fixed-dose combination reduce clinic SBP in hypertensive patients uncontrolled on azilsartan medoxomil alone?
Azilsartan medoxomil/chlortalidone fixed-dose combination significantly reduces systolic blood pressure compared to azilsartan medoxomil monotherapy in patients with uncontrolled grade 2-3 essential hypertension.
Supports azilsartan/chlortalidone FDC for uncontrolled hypertension; extends RCT evidence for this combination over monotherapy.
Patients with grade 2-3 essential hypertension and postplacebo mean clinic systolic blood pressure (SBP) 160-190 mm Hg and 24-hour SBP 140-175 mm Hg by ambulatory blood pressure monitoring (ABPM) received 40 mg azilsartan medoxomil (AZL-M) monotherapy for 4 weeks. "Nonresponders" were then randomized to 8 weeks of double-blind treatment with AZL-M 40 mg, AZL-M/chlortalidone (CLD) 40/25, or AZL-M/CLD 40/12.5 mg. After 8 weeks, mean clinic SBP change was -21.1 (±1.04) mm Hg for AZL-M/CLD 40/25 mg, -15.8 (±1.08) mm Hg for AZL-M/CLD 40/12.5 mg, and -6.4 (±1.05) mm Hg for AZL-M 40 mg (P < 0.001 for both AZL-M/CLD vs AZL-M, ANCOVA). Drug discontinuation rates were 8.9% (AZL-M/CLD 40/25 mg), 7.5% (AZL-M 40 mg), and 3.9% (AZL-M/CLD 40/12.5 mg). Creatinine increased in 8.1% (AZL-M/CLD 40/25), 3.1% (AZL-M/CLD 40/12.5 mg), and 3.0% (AZL-M 40 mg) of patients. AZL-M/CLD was effective and well tolerated in patients not achieving blood pressure targets with AZL-M.
No takes yet. Share an insight, caveat, or question.
Collier et al. (2018) conducted an RCT in Hypertension (n=395). Azilsartan medoxomil/chlortalidone vs. Azilsartan medoxomil 40 mg was evaluated on Change from double-blind baseline to week 8 in trough, sitting, clinic systolic blood pressure (MD -14.7 mm Hg, 95% CI 17.6-11.8, p=<0.001). Azilsartan medoxomil/chlortalidone 40/25 mg fixed-dose combination significantly reduced clinic systolic blood pressure by an additional 14.7 mm Hg compared to azilsartan medoxomil monotherapy in patients with uncontrolled hypertension.
Synapse has enriched 5 closely related papers on similar clinical questions. Consider them for comparative context: