Telmisartan in patients with mild/moderate hypertension and chronic kidney disease.
OBJECTIVE
This study assessed the clinical efficacy and safety of telmisartan, an angiotensin II receptor blocker with a long terminal elimination half-life and almost exclusively excreted in bile, in patients with varying severity of chronic kidney disease (CKD).


METHODS
Adults with diastolic blood pressure (DBP) 90 - 109 mmHg and stable CKD were enrolled: mild/moderate (creatinine clearance (CrCl) 30 - 74 ml/ min/1.73 m2), severe (CrCl < 30 ml/min/1.73 m2) or requiring maintenance hemodialysis. A two- to four-week single-blind, placebo run-in period preceded once-daily telmisartan 40 mg administration for four weeks. Telmisartan 80 mg was given after four- or eight-week treatment ifDBP > or = 85 mmHg. After 12-week treatment, trough DBP/systolic blood pressure (SBP), DBP and SBP control rates, renal function and tolerability were recorded.


RESULTS
Mean changes in DBP/SBP were 10.5/-10.7 mmHg for mild/moderate CKD (n = 27), -11.2/-14.9 mmHg for severe CKD (n = 27) and -15.0/-21.1 mmHg for hemodialysis patients (n = 28). DBP control rates (< 90 mmHg)/SBP responses (< 140 mmHg or > 10 mmHg reduction) occurred in 59.3%/66.7%, 63.0%/70.4% and 71.4%/92.9% of mild/moderate CKD, severe CKD and hemodialysis patients, respectively. Incidences of drug-related adverse events were low, and all were known adverse events of telmisartan and common to other angiotensin II receptor blockers. At the end of treatment, a decrease in 24-h urine creatinine occurred in 5/53 (9.4%) patients. Two patients discontinued treatment prematurely due to the worsening of CKD and one due to aggravated proteinuria.


CONCLUSIONS
Once-daily telmisartan provided effective and well-tolerated treatment of mild/moderate hypertension in CKD patients, with no worsening of renal function.
Sharma
A M
AM
University Clinic Benjamin Franklin, Freie Universität, Berlin. sharma@ccc.mcmaster.ca
Hollander
A
A
Köster
J
J
D000284:Administration, Oral; D000328:Adult; D047228:Angiotensin II Type 1 Receptor Blockers / Q000008:administration & dosage / Q000627:therapeutic use*; D001562:Benzimidazoles / Q000008:administration & dosage / Q000627:therapeutic use*; D001565:Benzoates / Q000008:administration & dosage / Q000627:therapeutic use*; D001794:Blood Pressure / Q000187:drug effects / Q000502:physiology; D003404:Creatinine / Q000097:blood / Q000652:urine; D004334:Drug Administration Schedule; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D006973:Hypertension / Q000150:complications / Q000188:drug therapy* / Q000503:physiopathology; D007676:Kidney Failure, Chronic / Q000150:complications / Q000188:drug therapy* / Q000378:metabolism; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D012720:Severity of Illness Index; D016037:Single-Blind Method; D000077333:Telmisartan; D016896:Treatment Outcome
D047228:Angiotensin II Type 1 Receptor Blockers; D001562:Benzimidazoles; D001565:Benzoates; D003404:Creatinine; D000077333:Telmisartan