Why the study?
Does azilsartan medoxomil/chlorthalidone improve safety and tolerability compared to olmesartan/hydrochlorothiazide in hypertensive participants with stage 3 chronic kidney disease?
Does azilsartan medoxomil/chlorthalidone improve safety and tolerability compared to olmesartan/hydrochlorothiazide in hypertensive participants with stage 3 chronic kidney disease?
Azilsartan medoxomil/chlorthalidone and olmesartan/hydrochlorothiazide demonstrate similar long-term efficacy and tolerability for hypertension management in patients with stage 3 chronic kidney disease.
Similar AE rates in this cohort do not support regimen preference; leaves open randomized safety trials in stage 3 CKD hypertension.
An open-label, long-term study evaluated safety and tolerability of azilsartan medoxomil/chlorthalidone (AZL-M/CLD) vs olmesartan/hydrochlorothiazide (OLM/HCTZ) in hypertensive participants with stage 3 chronic kidney disease. Initial therapy was AZL-M/CLD 20/12.5 mg (n = 77) or OLM/HCTZ 20/12.5 mg (n = 76), but could be up-titrated (AZL-M/CLD to 40/25 mg; OLM/HCTZ to 40/25 mg [US] or 20/25 mg [Europe]) with other agents added during weeks 4-52. Primary endpoint was proportion of participants with ≥ 1 adverse event (AE) through week 52. Baseline demographics were similar. AEs did not differ between groups (88.3%, AZL-M/CLD vs 76.3%, OLM/HCTZ; P = .058). AZL-M/CLD showed greater systolic BP reductions after initial dosing (P = .037) but not during long-term follow-up (P = .588). A greater proportion of participants up-titrated to the highest dose with OLM/HCTZ (48.7%) vs AZL-M/CLD (29.9%) (P = .021) and were taking additional antihypertensive medications (26.3% vs 16.9%). Both AZL-M/CLD and OLM/HCTZ showed similar efficacy and tolerability.
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Bakris et al. (2018) studied this question.
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