Key result
High-dose telmisartan shows no benefit over low-dose therapy for composite renal events and mortality.
Why the study?
Dose-dependent renoprotective effects of angiotensin II receptor blockers in patients with moderate to severe chronic kidney disease and non-nephrotic proteinuria were not known.
Does high-dose telmisartan (80 mg) compared to low-dose telmisartan (40 mg) reduce the composite of doubling of serum creatinine, transition to stage 5 CKD, end-stage renal disease, or all-cause death in patients with stage 3–4 CKD and non-nephrotic proteinuria?
RCT (n=61)
Open-label
1:1 into pre-allocated block sizes (block size 4) stratified by age, sex, and CKD stage
Yes
Does high-dose telmisartan (80 mg) compared to low-dose telmisartan (40 mg) reduce the composite of doubling of serum creatinine, transition to stage 5 CKD, end-stage renal disease, or all-cause death in patients with stage 3–4 CKD and non-nephrotic proteinuria?
Answers are grounded in this paper and cite their sources.
In patients with stage 3–4 CKD and non-nephrotic proteinuria, high-dose telmisartan (80 mg) reduced urinary protein excretion after 24 weeks compared to 40 mg without increasing severe adverse events, but failed to demonstrate a dose-dependent reduction in hard renal outcomes or mortality.
OBJECTIVES: Although angiotensin II receptor blockers are effective for patients with chronic kidney disease, dose-dependent renoprotective effects of angiotensin II receptor blockers in patients with moderate to severe chronic kidney disease with non-nephrotic proteinuria are not known. Our aim was to elucidate the dose-dependent renoprotective effects of angiotensin II receptor blockers on such patients. METHODS: A multicenter, prospective, randomized trial was conducted from 2009 to 2014. Patients with non-nephrotic stage 3-4 chronic kidney disease were randomized for treatment with either 40 or 80 mg telmisartan and were observed for up to 104 weeks. Overall, 32 and 29 patients were allocated to the 40 and 80 mg telmisartan groups, respectively. The composite primary outcome was renal death, doubling of serum creatinine level, transition to stage 5 chronic kidney disease, and death from any cause. Secondary outcomes included the level of urinary proteins and changes in the estimated glomerular filtration rate. RESULTS: There was no difference in the primary outcome (p = 0.78) and eGFR (p = 0.53) between the two groups; however, after 24 weeks, urinary protein level was significantly lower in the 80 mg group than in the 40 mg group (p < 0.05). No severe adverse events occurred in either group, and the occurrence of adverse events did not significantly differ between them (p = 0.56). CONCLUSION: Our findings do not demonstrate a direct dose-dependent renoprotective effect of telmisartan. The higher telmisartan dose resulted in a decrease in the amount of urinary protein. Even though high-dose angiotensin II receptor blockers may be preferable for patients with stage 3-4 chronic kidney disease, the clinical importance of the study results may be limited. The study was registered in the UMIN-CTR (https://www.umin.ac.jp/ctr) with the registration number UMIN000040875.
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Kitamura et al. (2020) conducted an RCT in Stage 3–4 chronic kidney disease with non-nephrotic proteinuria (n=61). Telmisartan (high-dose) vs. Telmisartan 40 mg/day (low-dose) was evaluated on Composite of doubling of serum creatinine level, transition to CKD stage 5, end-stage renal disease onset (renal death), or death from any cause (p=0.78). High-dose telmisartan (80 mg) did not significantly reduce the composite primary outcome of renal events and all-cause death compared with low-dose telmisartan (40 mg) (p = 0.78).
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