ABSTRACT
BACKGROUND: End stage renal disease (ESRD) patients mainly die of cardiovascular disease, and hypertension is regarded as the major risk factor. Valsartan is an angiotensin receptor blocker (ARB) with a well-established efficacy and safety profile in hypertensive patients, but with relatively few data in patients on hemodialysis (HD). The aim of this 2 A 5-week, open-label, multicenter, randomized cross-over study was to investigate whether valsartan (Val) 80 mg is as effective, safe and well-tolerated as irbesartan (Irb) 150 mg in patients with arterial hypertension on long-term hemodialysis. METHODS: After a wash-out of previous ARBs for 1 week, 67 patients (ITT) on long-term hemodialysis, between 18 and 80 years, with mean supine systolic blood pressure (MSupSBP) >or= 140 mmHg and < 180 mmHg were randomized to either Val 40 or Irb 75 for 1 week with forced titration to Val 80 or Irb 150 for another 4 weeks. After a second wash-out period of 1 week, patients were switched from Val to Irb or vice versa for another 5 weeks (1 week low-dose, 4 weeks target dose). The primary objective was non-inferiority of Val versus Irb on predialytic MSupSBP. Secondary objectives were predialytic MSupDBP, adverse events (AEs), laboratory abnormalities, hypotension during and after dialysis and quality of life. BP values are given as mean A+/- SD. RESULTS: Baseline BP values were 158 A+/- 11 / 78 A+/- 13 mmHg (Val) and 161 A+/- 13 / 83 A+/- 10 mmHg (Irb). The predialytic MSupSBP and MSupDBP after 4 weeks of treatment were similar in both treatment groups (Val 150 A+/- 19 / 79 A+/- 13 mmHg; Irb 151 A+/- 16 / 78 A+/- 14 mmHg). Most of the reported AEs were mild to moderate. The percentage of AEs considered by the investigator to be possibly drug-related was similar between both groups: 15.4% in the valsartan group and 20.4% in the irbesartan group. The most common AEs were nausea, muscle spasms and nasopharyngitis. Eight SAEs occurred, four in each treatment group (all not drug-related), including one death (cardiovascular insufficiency) in the Irb group. Laboratory changes were similar in both groups and not clinically relevant. The number of patients with symptomatic hypotension was similar during (9% each) as well as after dialysis (1.3% each). The quality of life data (SF-36) were comparable for each category. CONCLUSIONS: Valsartan 80 mg is as effective, safe and well tolerated as irbesartan 150 mg in hypertensive patients on chronic hemodialysis.
