Key result
Pemafibrate administration in patients with severe renal impairment did not increase systemic exposure compared to those with moderate renal impairment, with a geometric mean AUC ratio of 0.92.
Why the study?
Pemafibrate was contraindicated in patients with severe renal impairment despite its biliary excretion, prompting evaluation of its pharmacokinetics and safety in this population.
Does pemafibrate alter pharmacokinetics or increase adverse events in patients with hypertriglyceridemia and severe renal impairment?
RCT (n=21)
Double-blind
Randomized (3:1 ratio)
Yes
Does pemafibrate alter pharmacokinetics or increase adverse events in patients with hypertriglyceridemia and severe renal impairment?
Effect estimate: Geometric mean ratio 0.92 (95% CI 0.62-1.36)
Absolute Event Rate: 7.333% vs 7.991%
Pemafibrate appears safe and does not show increased exposure in patients with severe renal impairment, challenging its current contraindication in this population.
Pemafibrate exposure appears unaltered in severe renal impairment; hypothesis-generating and requires randomized confirmation before any practice change.
AIMS: Per the package insert, pemafibrate was contraindicated for use in patients with severe renal impairment despite its biliary excretion. To validate this, we evaluated the pharmacokinetics and safety of pemafibrate for 12 weeks in patients with hypertriglyceridemia and renal impairment. METHODS: ) of pemafibrate was measured after 12-week administration. RESULTS: and maximum plasma concentration of pemafibrate with/without statin use. Renal impairment degree did not affect the incidence of adverse events. No safety concerns were observed. CONCLUSION: Pemafibrate repeated administration in patients with severe renal impairment did not increase pemafibrate exposure.
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Ishibashi et al. (2024) conducted an RCT in Dyslipidemia and severe renal impairment (n=21). Pemafibrate vs. Moderate renal impairment (Group C) and Placebo was evaluated on Area under the concentration vs time curve within the dosing interval (AUCτ) of pemafibrate at 12 weeks (Geometric mean ratio 0.92, 95% CI 0.62-1.36). Pemafibrate administration in patients with severe renal impairment did not increase systemic exposure compared to those with moderate renal impairment, with a geometric mean AUC ratio of 0.92.
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