Evaluation of the Losartan in Hemodialysis (ELHE) Study.

Angiotensin converting enzyme inhibitors (ACEIs) have been shown to be effective in the treatment of dialysis patients with high blood pressure, however, they also have been associated with anaphylactoid reactions at the start of dialysis, when they have been used concomitantly with AN69 membranes. A multicenter, open six-month study was designed to test the tolerability and efficacy of losartan as antihypertensive in patients under hemodialysis (HD), with particular emphasis on the appearance of anaphylactoid reactions. HD patients with systolic blood pressure (SBP) levels > or = 140 and/or diastolic blood pressure (DBP) > or = 90 mm Hg, previously nontreated, treated but uncontrolled, or treated with a poor tolerability, were included. The study performed three controls: baseline, at month 3, and at study completion. DBP and SBP levels were measured on the six HD sessions previous to the three visits in addition to biochemical and hematology measurements. Four hundred and six patients were included. The mean age was 55 years, 42% were women, and 23.6% of the patients were dialyzed with AN69 membranes. There was a significant reduction in pre- and postdialysis SBP and DBP at three and six months. Fifteen patients discontinued the study due to adverse reactions related to losartan, and in seven of them the adverse reaction was hypotension. Only two patients have reported a possible anaphylactoid reaction on treatment with AN69, in one of them the HD session had to be stopped and losartan was discontinued. On the contrary, nine patients with a history of previous anaphylactoid reaction, with ACEIs and AN69, have not shown this complication with losartan and AN69. We conclude that losartan is a well tolerated antihypertensive by HD patients, with a very low incidence of adverse reactions, and a lower prevalence of anaphylactoid reactions than those detected with ACEIs and AN69.