Use of Telmisartan and Captopril in Inflammation of Hemodialysis Patients

The aim of this study was to compare the dual use of telmisartan and captopril vs the individual use of such drugs and placebo on the systemic inflammation of patients on hemodialysis (HD).

Once included, patients will be randomly allocated (by a computer-generated randomization list) to one of the following groups: group 1 will receive Captopril, group 2 Telmisartan, group 3 Captopril plus Telmisartan, and group 4 Placebo. Drugs will be provided as tablets during a period of 3 months. All patients will have 3 HD sessions per week, with the same kind of single-use dialysis membrane and dialysate Monthly visits will be scheduled for clinical and biochemical evaluations. A blood sample will be taken at baseline and every month for measurement of complete blood count, urea, creatinine, glucose, albumin, lipids, and electrolytes (measured by usual methods). In serum samples at 0, 1 and 3 months, tumor necrosis factor alpha (TNF-α) and interleukin 6 (IL-6) concentrations will be measured by ELISA using high sensitivity kits. Additionally, in the same serum samples, C-reactive protein (CRP) concentrations will be measured by nephelometry using high sensitivity kits. All laboratory measurements, including inflammation markers, will be performed in the Central Laboratory (Hospital de Especialidades, Centro Médico Nacional de Occidente), by the same personnel blinded to patient's details. Treatment compliance will be recorded by counting tablets left in the container at the end of each monthly visit.

captopril 50 mg/day (1 tablet of 25 mg orally twice a day) plus telmisartan 80 mg/day (1 tablet of 40 mg orally twice a day)

telmisartan 80 mg/day (1 tablet of 40 mg orally twice a day) plus 1 tablet of placebo orally twice a day

patients received captopril 50 mg/day (1 tablet of 25 mg orally twice a day) plus 1 tablet of placebo orally twice a day

This group will receive captopril 50 mg/day (1 tablet of 25 mg orally twice a day) plus 1 tablet of placebo orally twice a day

Patients of this group will receive telmisartan 80 mg/day (1 tablet 40 mg orally twice a day) plus 1 tablet of placebo twice a day

Patients of this group will receive captopril 50 mg/day (1 tablet 25 mg orally twice a day) plus telmisartan 80 mg/day (1 tablet 40 mg orally twice a day)

Inclusion Criteria: Age ≥18 years ≥2 months on hemodialysis Arteriovenous fistula as vascular access Endorsement of informed consent Exclusion Criteria: Inflammatory cause of ESRD Liver disease, cancer, AIDS Any infectious disease 2 months before the study Failed kidney graft Hypersensitivity to angiotensin converting enzyme inhibitors or angiotensin receptor blockers Arterial hypotension Pregnancy Treatment with antibiotics, non-steroidal anti-inflammatory drugs, steroids, immunosuppressives, statins, ACE inhibitors or ARB 3 months previous to the study

Ordaz-Medina SM, Gonzalez-Plascencia J, Martin del Campo F, Rojas-Campos E, Montanez-Fernandez JL, Espinoza-Gomez F, Cueto-Manzano AM. Is systemic inflammation of hemodialysis patients improved with the use of enalapril? Results of a randomized, double-blinded, placebo-controlled clinical trial. ASAIO J. 2010 Jan-Feb;56(1):37-41. doi: 10.1097/MAT.0b013e3181c1d830.