Key result
Gemfibrozil markedly increased the mean AUC(0-24) of lovastatin acid to 280% of the placebo value (P<0.001), whereas bezafibrate had no statistically significant effect.
Why the study?
Does concomitant use of gemfibrozil or bezafibrate alter the pharmacokinetics of lovastatin in healthy volunteers?
Population
11 healthy volunteers
Comparison
Gemfibrozil 1200 mg/day or bezafibrate 400… vs Placebo for 3 days, followed by a single 40 mg…
Design
RCT, randomized, 3-phase crossover, double-blind
Follow-up
24 hours
Authors
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Caution against gemfibrozil-lovastatin co-use; confirms fibrate-specific pharmacokinetic interaction absent with bezafibrate.
RCT (n=11)
double-blind
randomized
Does concomitant use of gemfibrozil or bezafibrate alter the pharmacokinetics of lovastatin in healthy volunteers?
Effect estimate: 280% of placebo
p-value: p=< .001
Gemfibrozil, but not bezafibrate, markedly increases plasma concentrations of active lovastatin acid, suggesting a pharmacokinetic mechanism for the increased risk of myopathy with this specific combination.
Kyrklund et al. (2001) conducted an RCT in Healthy volunteers (n=11). Gemfibrozil and bezafibrate vs. Placebo was evaluated on Mean area under the plasma concentration-time curve from 0 to 24 hours [AUC(0-24)] of lovastatin acid (280% of placebo, p=< .001). Gemfibrozil markedly increased the mean AUC(0-24) of lovastatin acid to 280% of the placebo value (P<0.001), whereas bezafibrate had no statistically significant effect.
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