Efficacy and Safety of the Cuban Potassium Citrate Tablet in Urinary Lithiasis

Abstract

Introduction: Urolithiasis is a notorious global health problem, and its treatment with urinary alkalizers is a priority.

Objective: To demonstrate the efficacy and safety of immediate release Cuban potassium citrate-1080 for the treatment of urolithiasis.

Methods: A randomized, monocentric, open, controlled, non-inferiority phase IIIa/IIIb clinical trial (Registration number 00000333) was carried out at the Havana Institute of Nephrology, Cuba, from May 2021 to November 2022. One hundred fifty urolithiasis patients were included in two groups of 75 each. The experimental group was treated with national immediate-release potassium citrate and the control with prolonged-release potassium citrate, both at doses of 30 mEq/day for 15 days. The response variables were changes in citraturia and urinary pH. Adverse events were recorded.

Results: Demographic and anthropometric variables and treatment indications did not differ between the groups. After 15 days, citraturia increased by 85 mg/day and urinary pH by 0.31 with the experimental treatment, with no differences compared to the other group. Adverse events were somewhat more common with the national tablet (26 vs. 18) and nausea was the most common (34.1%).

Conclusions: Cuban potassium citrate tablets at a dose of 30 mEq/day determine an increase in citraturia and urinary pH similar to that produced with the same dose of prolonged release potassium citrate. Gastrointestinal adverse events prevail, which are somewhat more frequent with the Cuban tablet.