Key result
Olmesartan maintains bioequivalence when coadministered with amlodipine or atenolol versus monotherapy.
Why the study?
The influence of amlodipine or atenolol on olmesartan plasma pharmacokinetics was investigated to assess potential interactions in combination therapy.
Does co-administration with amlodipine or atenolol alter the pharmacokinetics of olmesartan medoxomil in healthy subjects?
Does co-administration with amlodipine or atenolol alter the pharmacokinetics of olmesartan medoxomil in healthy subjects?
There are no significant pharmacokinetic interactions between olmesartan and either amlodipine or atenolol, supporting their use in combination therapy.
Supports combination dosing without adjustment in healthy subjects; leaves open effects in hypertensive patients.
The aim of this study was to investigate any influence on olmesartan plasma pharmacokinetics from amlodipine or atenolol. We analysed pharmacokinetics and safety of olmesartan medoxomil in combination with either amlodipine or atenolol compared to respective monotherapies in two separate studies. In one study, 18 subjects received once daily treatment for 7 days with olmesartan medoxomil 20 mg alone or with amlodipine 5 mg or amlodipine 5 mg alone. In the other study, atenolol 50 mg once daily replaced amlodipine. Concentration vs. time profiles for olmesartan monotherapy were similar to combination therapy. Mean olmesartan AUC(ss,tau) for olmesartan alone and with amlodipine were 2439 and 2388 ng h/mL and for olmesartan alone and with atenolol were 2340 and 2247 ng h/mL. Corresponding olmesartan C(ss,max) values were 465.7 and 439.5 ng/mL for amlodipine, and 447.4 and 423.8 ng/mL for atenolol. Median t(max) values for olmesartan were 1.5 h for each group in each study. Bioequivalence was established for all pharmacokinetic parameters. Lack of significant pharmacokinetic interactions between olmesartan and amlodipine or atenolol provides a basis for combination therapy.
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Bolbrinker et al. (2009) studied Healthy subjects. Olmesartan medoxomil combined with amlodipine or atenolol vs. Respective monotherapies was evaluated on Olmesartan plasma pharmacokinetics (AUC and Cmax). Olmesartan combined with amlodipine or atenolol was bioequivalent to olmesartan monotherapy, showing similar mean AUCs (2388 vs 2439 ng h/mL for amlodipine; 2247 vs 2340 ng h/mL for atenolol).
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