Pharmacokinetics of single-dose telmisartan 120 mg given during and between hemodialysis in subjects with severe renal insufficiency: Comparison withhealthy volunteers

The pharmacokinetics of oral telmisartan 120 mg evaluated in subjects wish severe renal insufficiency between dialyses and during hemodialysis were co mpared with those observed in healthy male subjects. Between dialyses and d uring dialysis, the plasma concentration-time curves of subjects with renal insufficiency were lower than those of healthy subjects. The mean plasma p rotein 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 telm isartan 120 mg were well tolerated in subjects with severe renal insufficie ncy when administered either between dialyses or during dialysis, and no cl inically relevant changes in viral signs were detected. In conclusion, the maximum plasma concentrations of telmisartan and areas under the plasma con centration-time curves in subjects with severe renal insufficiency were mar kedly reduced compared with healthy subjects. The fraction of telmisartan n ot bound to plasma proteins was increased approximately twofold. Changes in the pharmacokinetic profile in subjects with renal insufficiency did not a ffect the safety profile of telmisartan, which was well tolerated in these subjects. (C) 2000 the American College of Clinical Pharmacology.