Nephro Trial Files Throwback Thursday: Spironolactone for Drug-Resistant HTN, HCO-HD for Myeloma Cast Nephropathy, and Avosentan for T2DM
Spironolactone versus placebo, bisoprolol, and doxazosin to determine the optimal treatment for drug-resistant hypertension (PATHWAY-2)
Williams B et al. The Lancet (November 2015)
Bottom Line: This double-blind, placebo-controlled, crossover trial enrolled 335 participants with resistant hypertension and tested the effectiveness of spironolactone (25-50 mg) compared to placebo and two other active treatments. The primary outcome was the average reduction in home systolic blood pressure, which was significantly greater with spironolactone compared to placebo and the other treatments. Spironolactone was well tolerated, with only 6 patients experiencing high serum potassium levels. The study was funded by the British Heart Foundation and National Institute for Health Research. Overall, spironolactone was found to be the most effective add-on drug for the treatment of resistant hypertension, supporting the role of sodium retention in this condition.
High cutoff versus high-flux haemodialysis for myeloma cast nephropathy in patients receiving bortezomib-based chemotherapy (EuLITE)
Hutchison CA et al. The Lancet Haematology (April 2019)
Bottom Line: This open-label, phase 2, multicentre, randomized controlled trial (EuLITE) aimed to assess the effectiveness of high cutoff haemodialysis (HCO-HD) in increasing renal recovery in patients with de novo multiple myeloma, severe acute kidney injury, and myeloma cast nephropathy compared to standard high-flux haemodialysis (HF-HD). A total of 90 patients were recruited and randomly assigned to receive either intensive HCO-HD or standard HF-HD, along with bortezomib, doxorubicin, and dexamethasone chemotherapy. The primary outcome was independence from dialysis at 90 days, with no significant difference between the two groups. Safety outcomes showed a higher number of serious adverse events in the HCO-HD group, with the most common being infections. The study concluded that HCO-HD did not improve clinical outcomes and does not support further research in this patient population.
Avosentan for Overt Diabetic Nephropathy
Mann JFE et al. JASN (March 2010)
Bottom Line: This double-blind, placebo-controlled trial examined the effects of avosentan on the progression of overt diabetic nephropathy in 1392 participants with type 2 diabetes. The primary outcome was the time to doubling of serum creatinine, ESRD, or death. Secondary outcomes included changes in albumin-to-creatinine ratio (ACR) and cardiovascular outcomes. The trial was terminated early due to an excess of cardiovascular events with avosentan. Avosentan significantly reduced ACR, but also led to a higher incidence of fluid overload, congestive heart failure, and death. In conclusion, while avosentan may reduce albuminuria in patients with type 2 diabetes and overt nephropathy, its use is associated with significant risks.
Nephro Trial Files Issue #NPH-2025-11
Want to view past issues? Visit our archive:
