Efficacy and safety of azilsartan medoxomil/chlortalidone fixed‐dose combination in hypertensive patients uncontrolled on azilsartan medoxomil alone: A randomized trial
Copyright policy )Efficacy and safety of azilsartan medoxomil/chlortalidone fixed‐dose combination in hypertensive patients uncontrolled on azilsartan medoxomil alone: A randomized trial
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.
- William Harvey Research Institute United Kingdom
- Takeda (Japan) Japan
- University of Brescia Italy
- Queen Mary University of London United Kingdom
- GE Healthcare Spain
Male, clinical trials, Oxadiazoles, Hypertensiongeneral, Systole, Sodium Chloride Symporter Inhibitors, Chlorthalidone, Blood Pressure, Blood Pressure Monitoring, Ambulatory, Middle Aged, combination therapy, Outcome Assessment, Health Care, Humans, Benzimidazoles, Drug Therapy, Combination, Female, Essential Hypertension, antihypertensive therapy, Angiotensin II Type 1 Receptor Blockers, clinical management of high blood pressure (HBP), Aged
Male, clinical trials, Oxadiazoles, Hypertensiongeneral, Systole, Sodium Chloride Symporter Inhibitors, Chlorthalidone, Blood Pressure, Blood Pressure Monitoring, Ambulatory, Middle Aged, combination therapy, Outcome Assessment, Health Care, Humans, Benzimidazoles, Drug Therapy, Combination, Female, Essential Hypertension, antihypertensive therapy, Angiotensin II Type 1 Receptor Blockers, clinical management of high blood pressure (HBP), Aged
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