20 Aug Telmisartan in patients with mild/moderate hypertension and chronic kidney disease
A.M. Sharma1, A. Hollander2 and J. Köster3
1University Clinic Benjamin Franklin, Freie Universität, Berlin, 2Bosch Medicentrum,
Den Bosch, The Netherlands, and 3Boehringer Ingelheim Pharma KG, Ingelheim,
Germany, on behalf of the Efficacy and Safety in Patients with Renal Impairment
treated with Telmisartan (ESPRIT) Study Group
Aims: This study as sessed the clinical efficacy and safety of telmisartan, an an gio ten sin II re cep tor blocker with a long terminal elimination half-life and almost exclusively excreted in bile, in pa tients with vary ing se ver ity of chronic kid ney dis ease (CKD). Pa tients and meth ods: Adults with di – a stolic blood pres sure (DBP) 90 – 109 mmHg and sta ble CKD were en rolled: mild/mod er – ate (creatinine clear ance (CrCl) 30 – 74 ml/ min/1.73 m2), se vere (CrCl < 30 ml/min/1.73 m2) or requir ing main te nance hemodialysis.
A two- to four-week sin gle-blind, pla cebo run- in pe riod pre ceded once-daily telmisar – tan 40 mg ad min is tra tion for four weeks. Telmisartan 80 mg was given af ter four- or eight-week treat ment if DBP 85 mmHg. Af – ter 12-week treat ment, trough DBP/sys tolic blood pres sure (SBP), DBP and SBP con trol rates, re nal func tion and tolerability were re – corded. Results: Mean changes in DBP/SBP were -10.5/-10.7 mmHg for mild/mod er ate CKD (n = 27), -11.2/-14.9 mmHg for se vere CKD (n = 27), and -15.0/-21.1 mmHg for hemodialysis pa tients (n = 28). DBP con trol rates (< 90 mmHg)/SBP re sponses (< 140 mmHg or 10 mmHg re duc tion) oc curred in 59.3%/66.7%, 63.0%/70.4% and 71.4%/92.9% of mild/mod er ate CKD, se vere CKD and hemodialysis patients, respectively.
In cidences of drug-re lated ad verse events were low, and all were known ad verse events of telmisartan and com mon to other an gio ten sin II re cep tor blockers. At the end of treat ment, a de crease in 24-h urine creatinine oc curred in 5/53 (9.4%) pa tients. Two pa tients dis con tin – ued treat ment pre ma turely due to the wors en – ing of CKD and one due to ag gra vated pro – teinuria. Con clu sion: Once-daily telmisar tan pro vided ef fective and well-tolerated treat – ment of mild/mod er ate hy per ten sion in CKD pa tients, with no wors en ing of re nal function.