Key result
Bezafibrate and fenofibrate do not affect the pharmacokinetics or pharmacodynamics of repaglinide, with the AUC of repaglinide being 99% of the placebo phase for both drugs.
Why the study?
Does bezafibrate or fenofibrate alter the pharmacokinetics and pharmacodynamics of repaglinide in healthy subjects?
RCT (n=12)
randomized, cross-over
Does bezafibrate or fenofibrate alter the pharmacokinetics and pharmacodynamics of repaglinide in healthy subjects?
Bezafibrate and fenofibrate do not significantly alter the pharmacokinetics or pharmacodynamics of repaglinide, indicating they can be safely co-administered unlike gemfibrozil.
Answers are grounded in this paper and cite their sources.
May not require repaglinide adjustment with bezafibrate or fenofibrate; hypothesis-generating for patients with diabetes.
AIMS: Gemfibrozil markedly increases the plasma concentrations and blood glucose-lowering effects of repaglinide, but the effects of other fibrates on repaglinide pharmacokinetics are not known. Our aim was to investigate the effects of bezafibrate and fenofibrate on the pharmacokinetics and pharmacodynamics of repaglinide. METHODS: In a randomized, three-phase cross-over study, 12 healthy subjects received 400 mg bezafibrate, 200 mg fenofibrate or placebo once daily for 5 days. On day 5, a single 0.25 mg dose of repaglinide was ingested 1 h after the last pretreatment dose. The concentrations of plasma repaglinide, bezafibrate and fenofibrate and blood glucose were measured up to 7 h postdose. RESULTS: During the bezafibrate and fenofibrate phases, the total area under the concentration-time curve [AUC(0, infinity )] of repaglinide was 99% (95% confidence interval of the ratio to the control phase 73, 143%) and 99% (85, 127%) of the corresponding value during the placebo (control) phase, respectively. Bezafibrate and fenofibrate had no significant effect on the peak concentration (Cmax) of repaglinide. The mean half-life of repaglinide was 1.3 h in all phases. The blood glucose-lowering effect of repaglinide was not affected by bezafibrate or fenofibrate. The AUC(0,8 h) values for bezafibrate and fenofibrate varied 3.0-fold and 4.4-fold between individual subjects, respectively. Neither bezafibrate nor fenofibrate affected the pharmacokinetic variables of repaglinide. CONCLUSIONS: Bezafibrate and fenofibrate do not affect the pharmacokinetics or pharmacodynamics of repaglinide.
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Kajosaari et al. (2004) conducted an RCT in healthy (n=12). bezafibrate and fenofibrate vs. placebo was evaluated on total area under the concentration-time curve [AUC(0, infinity )] of repaglinide (ratio 99%, 95% CI 73-143% (bezafibrate) and 85-127% (fenofibrate)). Bezafibrate and fenofibrate do not affect the pharmacokinetics or pharmacodynamics of repaglinide, with the AUC of repaglinide being 99% of the placebo phase for both drugs.
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