|The following article features coverage from the National Kidney Foundation’s virtual 2020 Spring Clinical Meetings. Click here to read more of Renal and Urology News’ conference coverage.|
Veverimer is effective for treating metabolic acidosis in diabetic patients with chronic kidney disease (CKD), and it results in significant improvements in physical condition regardless of diabetes status, according to data presented at the live virtual 2020 National Kidney Foundation Spring Clinical Meetings.
“The current study examined how well veverimer improved metabolic acidosis and/or how patients felt and functioned in the portion of patients with diabetes,” Donald Wesson, MD, MBA, of the Health and Wellness Center, Baylor Scott & White, Dallas, said in an NKF press statement. “How well or if veverimer works in patients with diabetes is important because diabetes itself can adversely affect how patients feel and function and improvement of their metabolic acidosis alone might not improve how they feel and function.”
An orally administered, non-absorbed polymer, veverimer selectively binds and removes hydrochloric acid from the gastrointestinal tract, which leads to increased serum bicarbonate levels.
The new findings are from a subgroup analysis of 127 patients with a history of diabetes in a 40-week, blinded, placebo-controlled extension study. The study is an extension of a 12-week multicenter, randomized, blinded, placebo-controlled trial of veverimer. Of the 217 patients randomized in that trial, 196 continued in the 40-week extension study. The diabetes subgroup included 70 patients treated with veverimer and 57 placebo recipients. Patients had a mean age of 63.2 years, mean baseline serum bicarbonate of 17.3 mEq/L, and mean baseline estimated glomerular filtration rate of 28.5 mL/min/1.73 m2. Dr Wesson and his colleagues compared the subgroup outcomes with those of the overall population in the extension study (114 veverimer-treated patients and 82 placebo recipients).
The proportion of patients who achieved a 4 mEq/L or greater increase from baseline in serum bicarbonate or serum bicarbonate in the normal range (22-29 mEq/L) at 12 weeks—a secondary study end point—was significantly higher in the veverimer than placebo groups (64% vs 38%), Dr Wesson and his colleagues reported in a poster presentation. By week 52, mean serum bicarbonate levels had increased significantly more in the veverimer than placebo group (4.4 vs 2.9 mEq/L).
Dr Wesson’s team evaluated physical function using the Kidney Disease Quality of Life physical function domain questionnaire (KDQOL-PFD), which asks patients about their ability to perform various tasks, such as climbing a flight of stairs, walking several blocks. Patients can choose “Yes, limited a lot,” “Yes, limited a little,”, or “No, not limited at all.” The questionnaire is scored on scale of 0 (lowest physical function) to 100 (highest physical function).
At week 52, KDQOL-PFD scores improved significantly more from baseline in veverimir group than placebo arm (+12.5 vs +0.3). Veverimer-treated patients also showed significantly greater improvement in objective physical performance on the repeated chair stand test.
All outcomes in the diabetes subgroup were similar to those of the overall study population. The investigators observed no significant effect of the presence or absence of diabetes of veverimer on improvement in either measure of physical function.
Read more of our coverage of the National Kidney Foundation’s virtual 2020 Spring Clinical Meetings by visiting the conference page.
Wesson D, Vandana M, Tangri N, et al. Effects of veverimer on serum bicarbonate and physical function in patients with diabetes and chronic kidney disease: Subgroup analysis from a randomized trial. Data were presented at the live virtual 2020 National Kidney Foundation Spring Clinical Meetings held March 25-29. ePoster 335.