Long-term efficacy and tolerability of azilsartan medoxomil/chlorthalidone vs olmesartan medoxomil/hydrochlorothiazide in chronic kidney disease
George L Bakris, Lin Zhao, Stuart Kupfer, Attila Juhasz, Michie Hisada, Eric Lloyd, Suzanne Oparil, George L Bakris, Lin Zhao, Stuart Kupfer, Attila Juhasz, Michie Hisada, Eric Lloyd, Suzanne Oparil
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.
Conflict of interest statement
GLB has received grant or research support from Bayer and is a consultant for AbbVie, Janssen, Bayer, and Merck. LZ, SK, and AJ were employees of Takeda during the time of the study. MH and EL are employees of Takeda Development Center Americas, Inc. GLB was a consultant to Takeda at the time of the study. SO has received research grant support or support/reimbursement for travel to meetings or other from AstraZeneca AB/Duke, Bayer, NIH/NHLBI, NHLBI, NIH/NIAMS, Novartis, Actelion, Rox Medical, Medtronic Ardian, and Merck and has consulted for Actelion, Lundbeck, and Novo Nordisk. SO was an investigator in SPRINT for which Takeda and Arbor Pharmaceuticals donated 5% of medication used.
©2018 Wiley Periodicals, Inc.
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Source: PubMed