Key result
Telmisartan 80 mg once daily on top of standard antihypertensive therapy did not significantly reduce systolic office blood pressure compared to placebo in patients with dialysis-associated hypertension.
Why the study?
Does telmisartan 80 mg once daily reduce systolic office blood pressure in patients with dialysis-associated hypertension?
RCT (n=29)
Double-blind
Randomized
No
Does telmisartan 80 mg once daily reduce systolic office blood pressure in patients with dialysis-associated hypertension?
Absolute Event Rate: 132.5% vs 135.7%
Telmisartan 80 mg daily did not significantly lower systolic blood pressure compared to placebo in hemodialysis patients, highlighting the challenges of managing and studying hypertension in this population due to significant confounding factors.
Does not support adding telmisartan for office SBP control in dialysis hypertension; confirms challenges of BP management and trial confounding in this population.
UNLABELLED: Treatment of hypertension in hemodialysis (HD) patients is characterised by lack of evidence for both the blood pressure (BP) target goal and the recommended drug class to use. Telmisartan, an Angiotensin receptor blocker (ARB) that is metabolised in the liver and not excreted via HD extracorporeal circuit might be particularly suitable for HD patients. We designed and conducted a randomised, placebo-controlled, double-blind and cross-over trial for treatment of dialysis-associated hypertension with telmisartan 80 mg once daily or placebo on top of standard antihypertensive treatment excluding other Renin-Angiotensin-System (RAS) blockers. In 29 patients after randomization we analysed BP after a treatment period of 8 weeks, while 13 started with telmisartan and 16 with placebo; after 8 weeks 11 continued with telmisartan and 12 with placebo after cross-over, respectively. Patients exhibited a significant reduction of systolic pre-HD BP from 141.9±21.8 before to 131.3±17.3 mmHg after the first treatment period with telmisartan or placebo. However, no average significant influence of telmisartan was observed compared to placebo. The latter may be due to a large inter-individual variability of BP responses reaching from a 40 mmHg decrease under placebo to 40 mmHg increase under telmisartan. Antihypertensive co-medication was changed for clinical reasons in 7 out of 21 patients with no significant difference between telmisartan and placebo groups. Our starting hypothesis, that telmisartan on top of standard therapy lowers systolic office BP in HD patients could not be confirmed. In conclusion, this small trial indicates that testing antihypertensive drug efficacy in HD patients is challenging due to complicated standardization of concomitant medication and other confounding factors, e.g. volume status, salt load and neurohormonal activation, that influence BP control in HD patients. TRIAL REGISTRATION: Clinicaltrialsregister.eu 2005-005021-60.
No takes yet. Share an insight, caveat, or question.
Huber et al. (2013) conducted an RCT in Dialysis-Associated Hypertension (n=29). Telmisartan vs. Placebo was evaluated on Systolic office blood pressure before hemodialysis sessions. Telmisartan 80 mg once daily on top of standard antihypertensive therapy did not significantly reduce systolic office blood pressure compared to placebo in patients with dialysis-associated hypertension.
Synapse has enriched 5 closely related papers on similar clinical questions. Consider them for comparative context: