Long-term efficacy and tolerability of azilsartan medoxomil/chlorthalidone vs olmesartan medoxomil/hydrochlorothiazide in chronic kidney disease

J Clin Hypertens (Greenwich). 2018 Apr;20(4):694-702. doi: 10.1111/jch.13230. Epub 2018 Mar 4.

Abstract

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.

Trial registration: ClinicalTrials.gov NCT01309828.

Keywords: cardiovascular; hypertension; kidney; nephropathy; outcomes; renal.

Publication types

  • Clinical Trial, Phase III
  • Comparative Study
  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Aged
  • Benzimidazoles / administration & dosage*
  • Benzimidazoles / adverse effects
  • Chlorthalidone / administration & dosage*
  • Chlorthalidone / adverse effects
  • Drug Therapy, Combination / adverse effects
  • Female
  • Humans
  • Hydrochlorothiazide / administration & dosage*
  • Hydrochlorothiazide / adverse effects
  • Hypertension / drug therapy*
  • Male
  • Middle Aged
  • Olmesartan Medoxomil / administration & dosage*
  • Olmesartan Medoxomil / adverse effects
  • Oxadiazoles / administration & dosage*
  • Oxadiazoles / adverse effects
  • Renal Insufficiency, Chronic / complications*
  • Treatment Outcome

Substances

  • Benzimidazoles
  • Oxadiazoles
  • Hydrochlorothiazide
  • Olmesartan Medoxomil
  • azilsartan medoxomil
  • Chlorthalidone

Associated data

  • ClinicalTrials.gov/NCT01309828