Key result
Single-dose telmisartan 120 mg in subjects with severe renal insufficiency resulted in markedly reduced maximum plasma concentrations and AUC compared with healthy subjects, but was well tolerated.
Why the study?
How does severe renal insufficiency and hemodialysis affect the pharmacokinetics of single-dose oral telmisartan 120 mg compared to healthy volunteers?
Observational
How does severe renal insufficiency and hemodialysis affect the pharmacokinetics of single-dose oral telmisartan 120 mg compared to healthy volunteers?
Severe renal insufficiency reduces the maximum plasma concentration and AUC of telmisartan and increases its unbound fraction, but single doses of 120 mg remain well tolerated without clinically relevant vital sign changes.
Telmisartan 120 mg single doses remain well tolerated despite lower exposure in severe renal impairment; extends PK data but leaves dosing guidance open.
The pharmacokinetics of oral telmisartan 120 mg evaluated in subjects with severe renal insufficiency between dialyses and during hemodialysis were compared with those observed in healthy male subjects. Between dialyses and during dialysis, the plasma concentration-time curves of subjects with renal insufficiency were lower than those of healthy subjects. The mean plasma protein binding of telmisartan was 99.5% in healthy subjects, compared with mean values of 99.1% between dialyses and 98.8% during dialysis. Only very small amounts of telmisartan were removed by dialysis. Single doses of telmisartan 120 mg were well tolerated in subjects with severe renal insufficiency when administered either between dialyses or during dialysis, and no clinically relevant changes in vital signs were detected. In conclusion, the maximum plasma concentrations of telmisartan and areas under the plasma concentration-time curves in subjects with severe renal insufficiency were markedly reduced compared with healthy subjects. The fraction of telmisartan not bound to plasma proteins was increased approximately twofold. Changes in the pharmacokinetic profile in subjects with renal insufficiency did not affect the safety profile of telmisartan, which was well tolerated in these subjects.
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Stangier et al. (2000) conducted an observational in Severe renal insufficiency. Telmisartan vs. Healthy volunteers was evaluated on Pharmacokinetics (plasma concentration-time curves, Cmax, AUC). Single-dose telmisartan 120 mg in subjects with severe renal insufficiency resulted in markedly reduced maximum plasma concentrations and AUC compared with healthy subjects, but was well tolerated.
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