OBJECTIVES

: The aim and objective of current study was to evaluate the safety of losartan 50mg among hypertensive hemodialysis patients

METHODS

: A multicenter, prospective, randomized, single-blind trial was conducted to assess the safety of losartan 50mg every other day (EOD), once a morning (OM) among post-dialysis euvolemic hypertensive patients. Post-dialysis euvolemic assessment was done by a body composition monitor (BCM). Covariate Adaptive Randomization was used for allocation of participants to the standard or intervention arm, and these participants were followed up for twelve months. Pre-, intra- and post-dialysis session blood-pressure (BP) measurements were recorded, and any adverse events were confirmed using Naranjo scale. Adverse events were classified according to K/DOQI Clinical Practice Guidelines on Hypertension and Antihypertensive Agents in Chronic Kidney Disease.

RESULTS

: A final sample of 88 (40.1%) patients were randomized into standard and intervention arms. A total of 21 (47.7%) male and 23 (52.2%) females were randomized to the standard arm, compared to 24 (54.5%) male and 20 (45.4%) females to the intervention arm. Two patients on intervention arm receiving Losartan suffered from mild Hyperkalemia and were categorized as confirmed by Naranjo scale. Similarly 4 cough, 3 dizziness and 1 dyspepsia cases were assessed probable from Naranjo scale assessment. Naranjo scale score for Hyperkalemia was 9 and was assessed as definite. Similarly, Naranjo scale score for cough, dizziness and dyspepsia was 6, 5 and 1 respectively and all were assessed as probable. Hyperkalemia was associated with patient socioeconomic status (p 0.003). Cough was associated patients resident (p 0.006) and diabetic (p0.009) status. Dizziness was associated with patient age group (p <0.001) and patient resident status

CONCLUSIONS

: Losartan is usually well tolerated, though hyperkalemia is frequently encountered among Hemodialysis patients